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Postoperative RT Plus Cetuximab Showed Mixed Results in Head and Neck Cancer Trial
TOPLINE:
Adding cetuximab (C) to postoperative radiotherapy (RT) improves disease-free survival (DFS) but not overall survival (OS) in intermediate-risk squamous cell carcinoma of the head and neck. Benefits were specifically observed in human papillomavirus–negative patients, who represented 80.2% of the study participants.
METHODOLOGY:
- Previous research showed that adding high-dose cisplatin to postoperative RT in patients with squamous cell carcinoma of the head and neck (SCCHN) improved outcomes in those with positive margins and nodal extracapsular extension of the tumor.
- The new phase 3 randomized trial, which enrolled patients from November 2009 to March 2018 included 577 individuals with resected SCCHN of the oral cavity, oropharynx, or larynx, specifically.
- Participants were randomly assigned 1:1 to receive either intensity-modulated RT (60-66 Gy) with weekly C (400 mg/m2 loading dose, followed by 250 mg/m2 weekly) or RT alone.
- The primary endpoint was OS in randomly assigned eligible patients, with DFS and toxicity as secondary endpoints.
- Analysis included stratified log-rank test for OS and DFS, while toxicity was compared using Fisher’s exact test.
TAKEAWAY:
- OS was not significantly improved with RT plus C vs RT alone (hazard ratio [HR], 0.81; 95% CI, 0.60-1.08; P = .0747), though 5-year OS rates were 76.5% vs 68.7%.
- DFS showed significant improvement with combined therapy (HR, 0.75; 95% CI, 0.57-0.98; P = .0168), with 5-year rates of 71.7% vs 63.6%.
- Grade 3-4 acute toxicity rates were significantly higher with combination therapy (70.3% vs 39.7%; P < .0001), primarily affecting skin and mucosa, though late toxicity rates were similar (33.2% vs 29.0%; P = .3101).
- The benefit of RT plus C was only observed in those patients who were human papillomavirus–negative, which comprised 80.2% of trial participants.
IN PRACTICE:
RT plus C “significantly improved DFS, but not OS, with no increase in long-term toxicity, compared with RT alone for resected, intermediate-risk SCCHN. RT plus C is an appropriate option for carefully selected patients with HPV-negative disease,” the authors of the study wrote.
SOURCE:
This study was led by Mitchell Machtay, MD, Penn State Health Milton S. Hershey Medical Center in Hershey, Pennsylvania. It was published online in Journal of Clinical Oncology.
LIMITATIONS:
According to the researchers, the OS in the control group was higher than predicted, resulting in the trial being underpowered to detect the initial targeted HR. The authors noted that the better-than-expected survival rates could be attributed to improvements in surgical and radiotherapeutic techniques, including mandatory intensity-modulated RT for all patients. Additionally, the researchers pointed out that patient selection may have influenced outcomes, as only 30% of study participants had more than two risk factors.
DISCLOSURES:
This study was supported by grants from the US National Cancer Institute and Eli Lilly Inc. Machtay received grants from Lilly/ImClone, AstraZeneca, and Merck Sharp & Dohme. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Adding cetuximab (C) to postoperative radiotherapy (RT) improves disease-free survival (DFS) but not overall survival (OS) in intermediate-risk squamous cell carcinoma of the head and neck. Benefits were specifically observed in human papillomavirus–negative patients, who represented 80.2% of the study participants.
METHODOLOGY:
- Previous research showed that adding high-dose cisplatin to postoperative RT in patients with squamous cell carcinoma of the head and neck (SCCHN) improved outcomes in those with positive margins and nodal extracapsular extension of the tumor.
- The new phase 3 randomized trial, which enrolled patients from November 2009 to March 2018 included 577 individuals with resected SCCHN of the oral cavity, oropharynx, or larynx, specifically.
- Participants were randomly assigned 1:1 to receive either intensity-modulated RT (60-66 Gy) with weekly C (400 mg/m2 loading dose, followed by 250 mg/m2 weekly) or RT alone.
- The primary endpoint was OS in randomly assigned eligible patients, with DFS and toxicity as secondary endpoints.
- Analysis included stratified log-rank test for OS and DFS, while toxicity was compared using Fisher’s exact test.
TAKEAWAY:
- OS was not significantly improved with RT plus C vs RT alone (hazard ratio [HR], 0.81; 95% CI, 0.60-1.08; P = .0747), though 5-year OS rates were 76.5% vs 68.7%.
- DFS showed significant improvement with combined therapy (HR, 0.75; 95% CI, 0.57-0.98; P = .0168), with 5-year rates of 71.7% vs 63.6%.
- Grade 3-4 acute toxicity rates were significantly higher with combination therapy (70.3% vs 39.7%; P < .0001), primarily affecting skin and mucosa, though late toxicity rates were similar (33.2% vs 29.0%; P = .3101).
- The benefit of RT plus C was only observed in those patients who were human papillomavirus–negative, which comprised 80.2% of trial participants.
IN PRACTICE:
RT plus C “significantly improved DFS, but not OS, with no increase in long-term toxicity, compared with RT alone for resected, intermediate-risk SCCHN. RT plus C is an appropriate option for carefully selected patients with HPV-negative disease,” the authors of the study wrote.
SOURCE:
This study was led by Mitchell Machtay, MD, Penn State Health Milton S. Hershey Medical Center in Hershey, Pennsylvania. It was published online in Journal of Clinical Oncology.
LIMITATIONS:
According to the researchers, the OS in the control group was higher than predicted, resulting in the trial being underpowered to detect the initial targeted HR. The authors noted that the better-than-expected survival rates could be attributed to improvements in surgical and radiotherapeutic techniques, including mandatory intensity-modulated RT for all patients. Additionally, the researchers pointed out that patient selection may have influenced outcomes, as only 30% of study participants had more than two risk factors.
DISCLOSURES:
This study was supported by grants from the US National Cancer Institute and Eli Lilly Inc. Machtay received grants from Lilly/ImClone, AstraZeneca, and Merck Sharp & Dohme. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Adding cetuximab (C) to postoperative radiotherapy (RT) improves disease-free survival (DFS) but not overall survival (OS) in intermediate-risk squamous cell carcinoma of the head and neck. Benefits were specifically observed in human papillomavirus–negative patients, who represented 80.2% of the study participants.
METHODOLOGY:
- Previous research showed that adding high-dose cisplatin to postoperative RT in patients with squamous cell carcinoma of the head and neck (SCCHN) improved outcomes in those with positive margins and nodal extracapsular extension of the tumor.
- The new phase 3 randomized trial, which enrolled patients from November 2009 to March 2018 included 577 individuals with resected SCCHN of the oral cavity, oropharynx, or larynx, specifically.
- Participants were randomly assigned 1:1 to receive either intensity-modulated RT (60-66 Gy) with weekly C (400 mg/m2 loading dose, followed by 250 mg/m2 weekly) or RT alone.
- The primary endpoint was OS in randomly assigned eligible patients, with DFS and toxicity as secondary endpoints.
- Analysis included stratified log-rank test for OS and DFS, while toxicity was compared using Fisher’s exact test.
TAKEAWAY:
- OS was not significantly improved with RT plus C vs RT alone (hazard ratio [HR], 0.81; 95% CI, 0.60-1.08; P = .0747), though 5-year OS rates were 76.5% vs 68.7%.
- DFS showed significant improvement with combined therapy (HR, 0.75; 95% CI, 0.57-0.98; P = .0168), with 5-year rates of 71.7% vs 63.6%.
- Grade 3-4 acute toxicity rates were significantly higher with combination therapy (70.3% vs 39.7%; P < .0001), primarily affecting skin and mucosa, though late toxicity rates were similar (33.2% vs 29.0%; P = .3101).
- The benefit of RT plus C was only observed in those patients who were human papillomavirus–negative, which comprised 80.2% of trial participants.
IN PRACTICE:
RT plus C “significantly improved DFS, but not OS, with no increase in long-term toxicity, compared with RT alone for resected, intermediate-risk SCCHN. RT plus C is an appropriate option for carefully selected patients with HPV-negative disease,” the authors of the study wrote.
SOURCE:
This study was led by Mitchell Machtay, MD, Penn State Health Milton S. Hershey Medical Center in Hershey, Pennsylvania. It was published online in Journal of Clinical Oncology.
LIMITATIONS:
According to the researchers, the OS in the control group was higher than predicted, resulting in the trial being underpowered to detect the initial targeted HR. The authors noted that the better-than-expected survival rates could be attributed to improvements in surgical and radiotherapeutic techniques, including mandatory intensity-modulated RT for all patients. Additionally, the researchers pointed out that patient selection may have influenced outcomes, as only 30% of study participants had more than two risk factors.
DISCLOSURES:
This study was supported by grants from the US National Cancer Institute and Eli Lilly Inc. Machtay received grants from Lilly/ImClone, AstraZeneca, and Merck Sharp & Dohme. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Physical Activity Before Cancer Diagnosis Linked to Lower Progression and Mortality Risk
TOPLINE:
Physical activity before stage I cancer diagnosis is associated with reduced risk for disease progression and mortality. Members engaging in at least 60 minutes of weekly physical activity showed a 27% lower risk for progression and 47% lower risk for mortality compared with inactive individuals.
METHODOLOGY:
- Physical activity plays a significant role in reducing cancer mortality with high levels having been associated with an 18% reduction in cancer-specific mortality compared with lower levels in patients with pre- and/or post-diagnosed cancer.
- The new analysis included 28,248 members with stage I cancers enrolled in an oncology programme in South Africa, with physical activity recorded through fitness devices, logged gym sessions, and participation in organized events.
- Participants were categorized into three groups: No physical activity (0 min/wk), low physical activity (< 60 min/wk), and moderate to high physical activity (≥ 60 min/wk) based on activity levels 12 months before diagnosis.
- Researchers measured outcomes including time to progression, time to death, and all-cause mortality, with a follow-up period ranging from 1-154 months.
- Analysis adjusted for covariates including age, sex, socioeconomic status, and patient complexity measured by Johns Hopkins Adjusted Clinical Groups Systems software.
TAKEAWAY:
- Members with low physical activity showed a hazard ratio (HR) of 0.84 (95% CI, 0.79-0.89) for progression or death compared with those with no activity, whereas those with moderate to high activity showed an HR of 0.73 (95% CI, 0.70-0.77).
- For all-cause mortality, low physical activity members demonstrated an HR of 0.67 (95% CI, 0.61-0.74), whereas moderate to high activity members showed an HR of 0.53 (95% CI, 0.50-0.58) compared with inactive members.
- At 24 months post-diagnosis, individuals with moderate to high physical activity showed 80% probability of nonprogression compared with 74% for inactive individuals.
- Survival probability at 24 months was 95% for moderate to high activity members vs 91% for those with no physical activity.
IN PRACTICE:
“Physical activity may be considered to confer substantial benefits in terms of progression and overall mortality to those diagnosed with cancer. In a world where cancer continues to be a significant public health burden, the promotion of physical activity can yield important benefits regarding the progression of cancer as well as its prevention and management,” the authors of the study wrote.
SOURCE:
This study was led by Ntokozo Mabena of Discovery Vitality in Sandton, South Africa. It was published online in British Journal of Sports Medicine.
LIMITATIONS:
According to the authors, potential biases exist from not adjusting for confounding factors such as smoking status and alcohol consumption, along with incomplete body mass index data. The study assumed members without recorded physical activity points were inactive, which may not be accurate for all individuals. The findings may not be generalizable to the broader South African population as the study cohort had access to private medical insurance.
DISCLOSURES:
Authors Mabena, Sandra Lehmann, Deepak Patel, and Mosima Mabunda are employed by Discovery. Other authors Mike Greyling and Jon S. Patricios serve as a consultant for Discovery and an editor of British Journal of Sports Medicine, respectively.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Physical activity before stage I cancer diagnosis is associated with reduced risk for disease progression and mortality. Members engaging in at least 60 minutes of weekly physical activity showed a 27% lower risk for progression and 47% lower risk for mortality compared with inactive individuals.
METHODOLOGY:
- Physical activity plays a significant role in reducing cancer mortality with high levels having been associated with an 18% reduction in cancer-specific mortality compared with lower levels in patients with pre- and/or post-diagnosed cancer.
- The new analysis included 28,248 members with stage I cancers enrolled in an oncology programme in South Africa, with physical activity recorded through fitness devices, logged gym sessions, and participation in organized events.
- Participants were categorized into three groups: No physical activity (0 min/wk), low physical activity (< 60 min/wk), and moderate to high physical activity (≥ 60 min/wk) based on activity levels 12 months before diagnosis.
- Researchers measured outcomes including time to progression, time to death, and all-cause mortality, with a follow-up period ranging from 1-154 months.
- Analysis adjusted for covariates including age, sex, socioeconomic status, and patient complexity measured by Johns Hopkins Adjusted Clinical Groups Systems software.
TAKEAWAY:
- Members with low physical activity showed a hazard ratio (HR) of 0.84 (95% CI, 0.79-0.89) for progression or death compared with those with no activity, whereas those with moderate to high activity showed an HR of 0.73 (95% CI, 0.70-0.77).
- For all-cause mortality, low physical activity members demonstrated an HR of 0.67 (95% CI, 0.61-0.74), whereas moderate to high activity members showed an HR of 0.53 (95% CI, 0.50-0.58) compared with inactive members.
- At 24 months post-diagnosis, individuals with moderate to high physical activity showed 80% probability of nonprogression compared with 74% for inactive individuals.
- Survival probability at 24 months was 95% for moderate to high activity members vs 91% for those with no physical activity.
IN PRACTICE:
“Physical activity may be considered to confer substantial benefits in terms of progression and overall mortality to those diagnosed with cancer. In a world where cancer continues to be a significant public health burden, the promotion of physical activity can yield important benefits regarding the progression of cancer as well as its prevention and management,” the authors of the study wrote.
SOURCE:
This study was led by Ntokozo Mabena of Discovery Vitality in Sandton, South Africa. It was published online in British Journal of Sports Medicine.
LIMITATIONS:
According to the authors, potential biases exist from not adjusting for confounding factors such as smoking status and alcohol consumption, along with incomplete body mass index data. The study assumed members without recorded physical activity points were inactive, which may not be accurate for all individuals. The findings may not be generalizable to the broader South African population as the study cohort had access to private medical insurance.
DISCLOSURES:
Authors Mabena, Sandra Lehmann, Deepak Patel, and Mosima Mabunda are employed by Discovery. Other authors Mike Greyling and Jon S. Patricios serve as a consultant for Discovery and an editor of British Journal of Sports Medicine, respectively.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Physical activity before stage I cancer diagnosis is associated with reduced risk for disease progression and mortality. Members engaging in at least 60 minutes of weekly physical activity showed a 27% lower risk for progression and 47% lower risk for mortality compared with inactive individuals.
METHODOLOGY:
- Physical activity plays a significant role in reducing cancer mortality with high levels having been associated with an 18% reduction in cancer-specific mortality compared with lower levels in patients with pre- and/or post-diagnosed cancer.
- The new analysis included 28,248 members with stage I cancers enrolled in an oncology programme in South Africa, with physical activity recorded through fitness devices, logged gym sessions, and participation in organized events.
- Participants were categorized into three groups: No physical activity (0 min/wk), low physical activity (< 60 min/wk), and moderate to high physical activity (≥ 60 min/wk) based on activity levels 12 months before diagnosis.
- Researchers measured outcomes including time to progression, time to death, and all-cause mortality, with a follow-up period ranging from 1-154 months.
- Analysis adjusted for covariates including age, sex, socioeconomic status, and patient complexity measured by Johns Hopkins Adjusted Clinical Groups Systems software.
TAKEAWAY:
- Members with low physical activity showed a hazard ratio (HR) of 0.84 (95% CI, 0.79-0.89) for progression or death compared with those with no activity, whereas those with moderate to high activity showed an HR of 0.73 (95% CI, 0.70-0.77).
- For all-cause mortality, low physical activity members demonstrated an HR of 0.67 (95% CI, 0.61-0.74), whereas moderate to high activity members showed an HR of 0.53 (95% CI, 0.50-0.58) compared with inactive members.
- At 24 months post-diagnosis, individuals with moderate to high physical activity showed 80% probability of nonprogression compared with 74% for inactive individuals.
- Survival probability at 24 months was 95% for moderate to high activity members vs 91% for those with no physical activity.
IN PRACTICE:
“Physical activity may be considered to confer substantial benefits in terms of progression and overall mortality to those diagnosed with cancer. In a world where cancer continues to be a significant public health burden, the promotion of physical activity can yield important benefits regarding the progression of cancer as well as its prevention and management,” the authors of the study wrote.
SOURCE:
This study was led by Ntokozo Mabena of Discovery Vitality in Sandton, South Africa. It was published online in British Journal of Sports Medicine.
LIMITATIONS:
According to the authors, potential biases exist from not adjusting for confounding factors such as smoking status and alcohol consumption, along with incomplete body mass index data. The study assumed members without recorded physical activity points were inactive, which may not be accurate for all individuals. The findings may not be generalizable to the broader South African population as the study cohort had access to private medical insurance.
DISCLOSURES:
Authors Mabena, Sandra Lehmann, Deepak Patel, and Mosima Mabunda are employed by Discovery. Other authors Mike Greyling and Jon S. Patricios serve as a consultant for Discovery and an editor of British Journal of Sports Medicine, respectively.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
KRAS Mutations Linked to Varied Treatment Outcomes in Metastatic Pancreatic Cancer
TOPLINE:
METHODOLOGY:
- Researchers conducted a retrospective cohort study analyzing deidentified clinical data from 2,433 patients with metastatic pancreatic ductal adenocarcinoma (PDAC), diagnosed between February 2010 and September 2022.
- They assessed the association of KRAS mutations in metastatic PDAC with the clinical outcomes and responses to first-line chemotherapy regimens.
- Data originated from approximately 280 US cancer clinics, encompassing about 800 sites of care, with comprehensive genomic profiling performed on all patients.
- Analysis focused on median overall survival (OS) and time to next treatment (TTNT) across different KRAS mutation groups, using multivariate Cox proportional hazards models.
TAKEAWAY:
- Patients with KRAS G12D and G12V mutations showed significantly higher risk for disease progression (hazard ratio [HR], 1.15; 95% CI, 1.04-1.29; P = .009) and (HR, 1.16; 95% CI, 1.04-1.30; P = .01), respectively, compared with KRAS wild type.
- KRAS G12R mutations were associated with the longest median OS at 13.2 months (95% CI, 10.6-15.2) and longest median TTNT at 6.0 months (95% CI, 5.2-6.6).
- FOLFIRINOX treatment demonstrated better outcomes than gemcitabine-based therapies across all patients, with lower risk for treatment progression (HR, 1.19; 95% CI, 1.09-1.29; P < .001) and death (HR, 1.18; 95% CI, 1.07-1.29; P < .001).
- Specifically, when FOLFIRINOX was used as first-line treatment in patients with KRAS G12D and G12V mutations, the therapy was associated with improved TTNT and OS vs gemcitabine with or without nab-paclitaxel.
IN PRACTICE:
“In its totality, these data set a benchmark for future studies on KRAS inhibitors for specific KRAS variants and highlights the groups for which treatment combinations may ultimately be necessary,” the authors concluded.
SOURCE:
The study was led by Carter Norton, Huntsman Cancer Institute in Salt Lake City, Utah. It was published online on January 7 in JAMA Network Open.
LIMITATIONS:
According to the authors, the study’s limitations include the heterogeneity of clinical data collected retrospectively, which is subject to residual confounding. The sample size was limited for certain mutational groups, particularly KRAS G12C, leading to limited statistical power. Additionally, the detection rate of genomic alterations by commercially available assays may be affected by the high stromal content and low cellularity characteristic of PDAC.
DISCLOSURES:
The study was supported by Cancer Center Support grant P30CA042014 from the National Institutes of Health. Heloisa P. Soares, MD, PhD, one of the study authors, disclosed receiving consulting fees from Ipsen, Exelixis Inc, BMS, Novartis AG, AstraZeneca, and TerSera Therapeutics LLC and symposium speaker fees from ITM Radiopharma outside the submitted work. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a retrospective cohort study analyzing deidentified clinical data from 2,433 patients with metastatic pancreatic ductal adenocarcinoma (PDAC), diagnosed between February 2010 and September 2022.
- They assessed the association of KRAS mutations in metastatic PDAC with the clinical outcomes and responses to first-line chemotherapy regimens.
- Data originated from approximately 280 US cancer clinics, encompassing about 800 sites of care, with comprehensive genomic profiling performed on all patients.
- Analysis focused on median overall survival (OS) and time to next treatment (TTNT) across different KRAS mutation groups, using multivariate Cox proportional hazards models.
TAKEAWAY:
- Patients with KRAS G12D and G12V mutations showed significantly higher risk for disease progression (hazard ratio [HR], 1.15; 95% CI, 1.04-1.29; P = .009) and (HR, 1.16; 95% CI, 1.04-1.30; P = .01), respectively, compared with KRAS wild type.
- KRAS G12R mutations were associated with the longest median OS at 13.2 months (95% CI, 10.6-15.2) and longest median TTNT at 6.0 months (95% CI, 5.2-6.6).
- FOLFIRINOX treatment demonstrated better outcomes than gemcitabine-based therapies across all patients, with lower risk for treatment progression (HR, 1.19; 95% CI, 1.09-1.29; P < .001) and death (HR, 1.18; 95% CI, 1.07-1.29; P < .001).
- Specifically, when FOLFIRINOX was used as first-line treatment in patients with KRAS G12D and G12V mutations, the therapy was associated with improved TTNT and OS vs gemcitabine with or without nab-paclitaxel.
IN PRACTICE:
“In its totality, these data set a benchmark for future studies on KRAS inhibitors for specific KRAS variants and highlights the groups for which treatment combinations may ultimately be necessary,” the authors concluded.
SOURCE:
The study was led by Carter Norton, Huntsman Cancer Institute in Salt Lake City, Utah. It was published online on January 7 in JAMA Network Open.
LIMITATIONS:
According to the authors, the study’s limitations include the heterogeneity of clinical data collected retrospectively, which is subject to residual confounding. The sample size was limited for certain mutational groups, particularly KRAS G12C, leading to limited statistical power. Additionally, the detection rate of genomic alterations by commercially available assays may be affected by the high stromal content and low cellularity characteristic of PDAC.
DISCLOSURES:
The study was supported by Cancer Center Support grant P30CA042014 from the National Institutes of Health. Heloisa P. Soares, MD, PhD, one of the study authors, disclosed receiving consulting fees from Ipsen, Exelixis Inc, BMS, Novartis AG, AstraZeneca, and TerSera Therapeutics LLC and symposium speaker fees from ITM Radiopharma outside the submitted work. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers conducted a retrospective cohort study analyzing deidentified clinical data from 2,433 patients with metastatic pancreatic ductal adenocarcinoma (PDAC), diagnosed between February 2010 and September 2022.
- They assessed the association of KRAS mutations in metastatic PDAC with the clinical outcomes and responses to first-line chemotherapy regimens.
- Data originated from approximately 280 US cancer clinics, encompassing about 800 sites of care, with comprehensive genomic profiling performed on all patients.
- Analysis focused on median overall survival (OS) and time to next treatment (TTNT) across different KRAS mutation groups, using multivariate Cox proportional hazards models.
TAKEAWAY:
- Patients with KRAS G12D and G12V mutations showed significantly higher risk for disease progression (hazard ratio [HR], 1.15; 95% CI, 1.04-1.29; P = .009) and (HR, 1.16; 95% CI, 1.04-1.30; P = .01), respectively, compared with KRAS wild type.
- KRAS G12R mutations were associated with the longest median OS at 13.2 months (95% CI, 10.6-15.2) and longest median TTNT at 6.0 months (95% CI, 5.2-6.6).
- FOLFIRINOX treatment demonstrated better outcomes than gemcitabine-based therapies across all patients, with lower risk for treatment progression (HR, 1.19; 95% CI, 1.09-1.29; P < .001) and death (HR, 1.18; 95% CI, 1.07-1.29; P < .001).
- Specifically, when FOLFIRINOX was used as first-line treatment in patients with KRAS G12D and G12V mutations, the therapy was associated with improved TTNT and OS vs gemcitabine with or without nab-paclitaxel.
IN PRACTICE:
“In its totality, these data set a benchmark for future studies on KRAS inhibitors for specific KRAS variants and highlights the groups for which treatment combinations may ultimately be necessary,” the authors concluded.
SOURCE:
The study was led by Carter Norton, Huntsman Cancer Institute in Salt Lake City, Utah. It was published online on January 7 in JAMA Network Open.
LIMITATIONS:
According to the authors, the study’s limitations include the heterogeneity of clinical data collected retrospectively, which is subject to residual confounding. The sample size was limited for certain mutational groups, particularly KRAS G12C, leading to limited statistical power. Additionally, the detection rate of genomic alterations by commercially available assays may be affected by the high stromal content and low cellularity characteristic of PDAC.
DISCLOSURES:
The study was supported by Cancer Center Support grant P30CA042014 from the National Institutes of Health. Heloisa P. Soares, MD, PhD, one of the study authors, disclosed receiving consulting fees from Ipsen, Exelixis Inc, BMS, Novartis AG, AstraZeneca, and TerSera Therapeutics LLC and symposium speaker fees from ITM Radiopharma outside the submitted work. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Does Watch and Wait Increase Distant Metastasis Risk in Rectal Cancer?
TOPLINE:
The new study highlights the importance of timely surgical intervention to improve distant metastases–free survival rates.
METHODOLOGY:
- Organ preservation has become an attractive alternative to surgery for patients with rectal cancer who achieve a clinical complete response after neoadjuvant therapy, with the risk for local regrowth after initial clinical complete response being around 25%-30%.
- The new study aimed to compare the risk for distant metastases between patients with local regrowth after watch and wait and patients with near-complete pathologic response managed by total mesorectal excision.
- A total of 508 patients with local regrowth were included from the International Watch & Wait Database, and 893 patients with near-complete pathologic response were included from the Spanish Rectal Cancer Project.
- The primary endpoint was distant metastases–free survival at 3 years from the decision to watch and wait or total mesorectal excision, and the secondary endpoints included possible risk factors associated with distant metastases.
TAKEAWAY:
- Patients with local regrowth had a significantly higher rate of distant metastases (rate, 22.8% vs 10.2%; P ≤.001) than those with near-complete pathologic response managed by total mesorectal excision.
- Distant metastases–free survival at 3 years was significantly worse for patients with local regrowth (rate, 75% vs 87%; P < .001).
- Independent risk factors for distant metastases included local regrowth (vs total mesorectal excision at reassessment; P = .001), ypT3-4 status (P = .016), and ypN+ status (P = .001) at the time of surgery.
- Patients with local regrowth had worse distant metastases–free survival across all pathologic stages than those managed by total mesorectal excision.
IN PRACTICE:
“Patients with local regrowth appear to have a higher risk for subsequent distant metastases development than patients with near-complete pathologic response managed by total mesorectal excision at restaging irrespective of final pathology,” the authors wrote.
SOURCE:
This study was led by Laura M. Fernandez, MD, of the Champalimaud Foundation in Lisbon, Portugal. It was published online in Journal of Clinical Oncology.
LIMITATIONS:
This study’s limitations included the heterogeneity in defining clinical complete response and the decision to watch and wait across different institutions. The majority of patients did not receive total neoadjuvant therapy regimens, which may have affected the generalizability of the findings. The study had a considerable amount of follow-up losses, which could have introduced bias.
DISCLOSURES:
This study was supported by the European Society of Surgical Oncology, the Champalimaud Foundation, the Bas Mulder Award, the Alpe d’HuZes Foundation, the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. Fernandez disclosed receiving grants from Johnson & Johnson. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
The new study highlights the importance of timely surgical intervention to improve distant metastases–free survival rates.
METHODOLOGY:
- Organ preservation has become an attractive alternative to surgery for patients with rectal cancer who achieve a clinical complete response after neoadjuvant therapy, with the risk for local regrowth after initial clinical complete response being around 25%-30%.
- The new study aimed to compare the risk for distant metastases between patients with local regrowth after watch and wait and patients with near-complete pathologic response managed by total mesorectal excision.
- A total of 508 patients with local regrowth were included from the International Watch & Wait Database, and 893 patients with near-complete pathologic response were included from the Spanish Rectal Cancer Project.
- The primary endpoint was distant metastases–free survival at 3 years from the decision to watch and wait or total mesorectal excision, and the secondary endpoints included possible risk factors associated with distant metastases.
TAKEAWAY:
- Patients with local regrowth had a significantly higher rate of distant metastases (rate, 22.8% vs 10.2%; P ≤.001) than those with near-complete pathologic response managed by total mesorectal excision.
- Distant metastases–free survival at 3 years was significantly worse for patients with local regrowth (rate, 75% vs 87%; P < .001).
- Independent risk factors for distant metastases included local regrowth (vs total mesorectal excision at reassessment; P = .001), ypT3-4 status (P = .016), and ypN+ status (P = .001) at the time of surgery.
- Patients with local regrowth had worse distant metastases–free survival across all pathologic stages than those managed by total mesorectal excision.
IN PRACTICE:
“Patients with local regrowth appear to have a higher risk for subsequent distant metastases development than patients with near-complete pathologic response managed by total mesorectal excision at restaging irrespective of final pathology,” the authors wrote.
SOURCE:
This study was led by Laura M. Fernandez, MD, of the Champalimaud Foundation in Lisbon, Portugal. It was published online in Journal of Clinical Oncology.
LIMITATIONS:
This study’s limitations included the heterogeneity in defining clinical complete response and the decision to watch and wait across different institutions. The majority of patients did not receive total neoadjuvant therapy regimens, which may have affected the generalizability of the findings. The study had a considerable amount of follow-up losses, which could have introduced bias.
DISCLOSURES:
This study was supported by the European Society of Surgical Oncology, the Champalimaud Foundation, the Bas Mulder Award, the Alpe d’HuZes Foundation, the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. Fernandez disclosed receiving grants from Johnson & Johnson. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
The new study highlights the importance of timely surgical intervention to improve distant metastases–free survival rates.
METHODOLOGY:
- Organ preservation has become an attractive alternative to surgery for patients with rectal cancer who achieve a clinical complete response after neoadjuvant therapy, with the risk for local regrowth after initial clinical complete response being around 25%-30%.
- The new study aimed to compare the risk for distant metastases between patients with local regrowth after watch and wait and patients with near-complete pathologic response managed by total mesorectal excision.
- A total of 508 patients with local regrowth were included from the International Watch & Wait Database, and 893 patients with near-complete pathologic response were included from the Spanish Rectal Cancer Project.
- The primary endpoint was distant metastases–free survival at 3 years from the decision to watch and wait or total mesorectal excision, and the secondary endpoints included possible risk factors associated with distant metastases.
TAKEAWAY:
- Patients with local regrowth had a significantly higher rate of distant metastases (rate, 22.8% vs 10.2%; P ≤.001) than those with near-complete pathologic response managed by total mesorectal excision.
- Distant metastases–free survival at 3 years was significantly worse for patients with local regrowth (rate, 75% vs 87%; P < .001).
- Independent risk factors for distant metastases included local regrowth (vs total mesorectal excision at reassessment; P = .001), ypT3-4 status (P = .016), and ypN+ status (P = .001) at the time of surgery.
- Patients with local regrowth had worse distant metastases–free survival across all pathologic stages than those managed by total mesorectal excision.
IN PRACTICE:
“Patients with local regrowth appear to have a higher risk for subsequent distant metastases development than patients with near-complete pathologic response managed by total mesorectal excision at restaging irrespective of final pathology,” the authors wrote.
SOURCE:
This study was led by Laura M. Fernandez, MD, of the Champalimaud Foundation in Lisbon, Portugal. It was published online in Journal of Clinical Oncology.
LIMITATIONS:
This study’s limitations included the heterogeneity in defining clinical complete response and the decision to watch and wait across different institutions. The majority of patients did not receive total neoadjuvant therapy regimens, which may have affected the generalizability of the findings. The study had a considerable amount of follow-up losses, which could have introduced bias.
DISCLOSURES:
This study was supported by the European Society of Surgical Oncology, the Champalimaud Foundation, the Bas Mulder Award, the Alpe d’HuZes Foundation, the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. Fernandez disclosed receiving grants from Johnson & Johnson. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
PSMA-PET Detects Metastatic Disease in Prostate Cancer Patients With Negative Conventional Imaging
TOPLINE:
Results were positive in 84% of patients, with polymetastatic disease found in 24% of cases.
METHODOLOGY:
- Recurrent nonmetastatic hormone-sensitive prostate cancer is characterized by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy, without evidence of metastasis on conventional imaging.
- A post hoc, retrospective, cross-sectional analysis included 182 patients from four prospective studies conducted from September 2016 to September 2021, with participants having recurrent prostate cancer after radical prostatectomy, definitive radiotherapy, or salvage radiotherapy.
- Inclusion criteria encompassed PSA levels > 1.0 ng/mL after radical prostatectomy and salvage radiotherapy or > 2.0 ng/mL above nadir after definitive radiotherapy, PSA doubling time ≤ 9 months, and serum testosterone ≥ 150 ng/dL.
- Researchers at the University of California, Los Angeles, performed Gallium-68-PSMA-11 PET/CT imaging with a median injection of 5.0 mCi and uptake time of 61 minutes, with 98% of patients receiving CT contrast.
TAKEAWAY:
- PSMA-PET findings were positive in 80% of patients after radical prostatectomy, 92% after definitive radiotherapy, 85% after radical prostatectomy and salvage radiotherapy, and 84% overall (153 of 182 patients).
- Distant metastatic disease was detected in 34% of patients after radical prostatectomy, 56% after definitive radiotherapy, 60% after radical prostatectomy and salvage radiotherapy, and 46% overall.
- Polymetastatic disease (≥ 5 lesions) was identified in 19% of patients after radical prostatectomy, 36% after definitive radiotherapy, 23% after radical prostatectomy and salvage radiotherapy, and 24% overall.
- According to the authors, these findings suggest that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging.
IN PRACTICE:
“In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease in 24% of patients. ... The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer,” the authors of the new paper wrote. “Further studies are needed to assess its independent prognostic value and use for treatment guidance.”
SOURCE:
This study was led by Adrien Holzgreve, MD, and Wesley R. Armstrong, BS, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles. It was published online on January 3 in JAMA Network Open.
LIMITATIONS:
The analysis included significantly fewer patients treated with combined radical prostatectomy and salvage radiotherapy than the original EMBARK trial (29% vs 49%). Patients in this study had a lower median PSA doubling time and serum PSA level at enrollment than those in the EMBARK study. The retrospective nature of this study precluded systematic baseline imaging that would be standard for clinical trial enrollment. Additionally, while PSMA-PET offers the best diagnostic accuracy for prostate cancer staging, it can produce false-positive findings, particularly in bone metastases, with a positive predictive value of 0.84% in biochemical recurrence.
DISCLOSURES:
Holzgreve reported receiving personal fees from ABX advanced biochemical compounds outside the submitted work. This study was supported by grants from the Deutsche Forschungsgemeinschaft, the Prostate Cancer Foundation, and the Society of Nuclear Medicine and Molecular Imaging. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Results were positive in 84% of patients, with polymetastatic disease found in 24% of cases.
METHODOLOGY:
- Recurrent nonmetastatic hormone-sensitive prostate cancer is characterized by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy, without evidence of metastasis on conventional imaging.
- A post hoc, retrospective, cross-sectional analysis included 182 patients from four prospective studies conducted from September 2016 to September 2021, with participants having recurrent prostate cancer after radical prostatectomy, definitive radiotherapy, or salvage radiotherapy.
- Inclusion criteria encompassed PSA levels > 1.0 ng/mL after radical prostatectomy and salvage radiotherapy or > 2.0 ng/mL above nadir after definitive radiotherapy, PSA doubling time ≤ 9 months, and serum testosterone ≥ 150 ng/dL.
- Researchers at the University of California, Los Angeles, performed Gallium-68-PSMA-11 PET/CT imaging with a median injection of 5.0 mCi and uptake time of 61 minutes, with 98% of patients receiving CT contrast.
TAKEAWAY:
- PSMA-PET findings were positive in 80% of patients after radical prostatectomy, 92% after definitive radiotherapy, 85% after radical prostatectomy and salvage radiotherapy, and 84% overall (153 of 182 patients).
- Distant metastatic disease was detected in 34% of patients after radical prostatectomy, 56% after definitive radiotherapy, 60% after radical prostatectomy and salvage radiotherapy, and 46% overall.
- Polymetastatic disease (≥ 5 lesions) was identified in 19% of patients after radical prostatectomy, 36% after definitive radiotherapy, 23% after radical prostatectomy and salvage radiotherapy, and 24% overall.
- According to the authors, these findings suggest that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging.
IN PRACTICE:
“In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease in 24% of patients. ... The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer,” the authors of the new paper wrote. “Further studies are needed to assess its independent prognostic value and use for treatment guidance.”
SOURCE:
This study was led by Adrien Holzgreve, MD, and Wesley R. Armstrong, BS, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles. It was published online on January 3 in JAMA Network Open.
LIMITATIONS:
The analysis included significantly fewer patients treated with combined radical prostatectomy and salvage radiotherapy than the original EMBARK trial (29% vs 49%). Patients in this study had a lower median PSA doubling time and serum PSA level at enrollment than those in the EMBARK study. The retrospective nature of this study precluded systematic baseline imaging that would be standard for clinical trial enrollment. Additionally, while PSMA-PET offers the best diagnostic accuracy for prostate cancer staging, it can produce false-positive findings, particularly in bone metastases, with a positive predictive value of 0.84% in biochemical recurrence.
DISCLOSURES:
Holzgreve reported receiving personal fees from ABX advanced biochemical compounds outside the submitted work. This study was supported by grants from the Deutsche Forschungsgemeinschaft, the Prostate Cancer Foundation, and the Society of Nuclear Medicine and Molecular Imaging. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Results were positive in 84% of patients, with polymetastatic disease found in 24% of cases.
METHODOLOGY:
- Recurrent nonmetastatic hormone-sensitive prostate cancer is characterized by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy, without evidence of metastasis on conventional imaging.
- A post hoc, retrospective, cross-sectional analysis included 182 patients from four prospective studies conducted from September 2016 to September 2021, with participants having recurrent prostate cancer after radical prostatectomy, definitive radiotherapy, or salvage radiotherapy.
- Inclusion criteria encompassed PSA levels > 1.0 ng/mL after radical prostatectomy and salvage radiotherapy or > 2.0 ng/mL above nadir after definitive radiotherapy, PSA doubling time ≤ 9 months, and serum testosterone ≥ 150 ng/dL.
- Researchers at the University of California, Los Angeles, performed Gallium-68-PSMA-11 PET/CT imaging with a median injection of 5.0 mCi and uptake time of 61 minutes, with 98% of patients receiving CT contrast.
TAKEAWAY:
- PSMA-PET findings were positive in 80% of patients after radical prostatectomy, 92% after definitive radiotherapy, 85% after radical prostatectomy and salvage radiotherapy, and 84% overall (153 of 182 patients).
- Distant metastatic disease was detected in 34% of patients after radical prostatectomy, 56% after definitive radiotherapy, 60% after radical prostatectomy and salvage radiotherapy, and 46% overall.
- Polymetastatic disease (≥ 5 lesions) was identified in 19% of patients after radical prostatectomy, 36% after definitive radiotherapy, 23% after radical prostatectomy and salvage radiotherapy, and 24% overall.
- According to the authors, these findings suggest that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging.
IN PRACTICE:
“In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease in 24% of patients. ... The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer,” the authors of the new paper wrote. “Further studies are needed to assess its independent prognostic value and use for treatment guidance.”
SOURCE:
This study was led by Adrien Holzgreve, MD, and Wesley R. Armstrong, BS, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles. It was published online on January 3 in JAMA Network Open.
LIMITATIONS:
The analysis included significantly fewer patients treated with combined radical prostatectomy and salvage radiotherapy than the original EMBARK trial (29% vs 49%). Patients in this study had a lower median PSA doubling time and serum PSA level at enrollment than those in the EMBARK study. The retrospective nature of this study precluded systematic baseline imaging that would be standard for clinical trial enrollment. Additionally, while PSMA-PET offers the best diagnostic accuracy for prostate cancer staging, it can produce false-positive findings, particularly in bone metastases, with a positive predictive value of 0.84% in biochemical recurrence.
DISCLOSURES:
Holzgreve reported receiving personal fees from ABX advanced biochemical compounds outside the submitted work. This study was supported by grants from the Deutsche Forschungsgemeinschaft, the Prostate Cancer Foundation, and the Society of Nuclear Medicine and Molecular Imaging. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Camrelizumab Plus Chemotherapy Boosts Response in Triple-Negative Breast Cancer
TOPLINE:
The combination shows consistent benefits across patient subgroups with a manageable safety profile.
METHODOLOGY:
- A randomized, double-blind, phase 3 trial enrolled 441 females (median age, 48 years) with early or locally advanced triple-negative breast cancer from 40 hospitals in China between November 2020 and May 2023.
- Participants were randomized 1:1 to receive either camrelizumab 200 mg (n = 222) or placebo (n = 219) combined with chemotherapy every 2 weeks, with median follow-up period of 14.4 months.
- Treatment included nab-paclitaxel (100 mg/m²) plus carboplatin (area under curve, 1.5) on days 1, 8, and 15 in 28-day cycles for 16 weeks, followed by epirubicin (90 mg/m²) and cyclophosphamide (500 mg/m²) every 2 weeks for 8 weeks.
- The primary endpoint was pathological complete response, defined as no invasive tumor in breast and lymph nodes.
TAKEAWAY:
- Pathological complete response was achieved in 56.8% (95% CI, 50.0%-63.4%) of patients in the camrelizumab-chemotherapy group vs 44.7% (95% CI, 38.0%-51.6%) in the placebo-chemotherapy group (rate difference, 12.2%; 95% CI, 3.3%-21.2%; P = .004).
- Grade 3 or higher adverse events occurred in 89.2% of camrelizumab-chemotherapy group vs 83.1% in placebo-chemotherapy group, with serious adverse events in 34.7% vs 22.8%, respectively.
- Event-free survival rate at 18 months was 86.6% (95% CI, 79.9%-91.1%) with camrelizumab-chemotherapy vs 83.6% (95% CI, 76.2%-88.9%) with placebo-chemotherapy (hazard ratio [HR], 0.80; 95% CI, 0.46-1.42).
- Disease-free survival rate at 12 months reached 91.9% (95% CI, 85.5%-95.5%) with camrelizumab-chemotherapy compared with 87.8% (95% CI, 80.3%-92.6%) with placebo-chemotherapy (HR, 0.58; 95% CI, 0.27-1.24).
IN PRACTICE:
“The addition of camrelizumab to neoadjuvant chemotherapy significantly improved pathological complete response... The benefits of camrelizumab-chemotherapy with respect to pCR were generally consistent across subgroups,” wrote the authors of the study.
SOURCE:
The study was led by Zhi-Ming Shao, MD, Fudan University Shanghai Cancer Center in Shanghai, China. It was published online on December 13 in JAMA.
LIMITATIONS:
According to the authors, the study’s limitations include short follow-up duration preventing assessment of mature survival data and long-term safety profile, uncertainty about optimal duration of adjuvant camrelizumab treatment, small sample sizes in some subgroups warranting cautious interpretation, and potential limited generalizability as the study was conducted only in Chinese patients with triple-negative breast cancer.
DISCLOSURES:
The study was supported by Jiangsu Hengrui Pharmaceuticals. The authors and funder were involved in data collection, analysis, and interpretation and guaranteed the accuracy, completeness of the data, writing of the report, and the decision to submit the manuscript for publication.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
The combination shows consistent benefits across patient subgroups with a manageable safety profile.
METHODOLOGY:
- A randomized, double-blind, phase 3 trial enrolled 441 females (median age, 48 years) with early or locally advanced triple-negative breast cancer from 40 hospitals in China between November 2020 and May 2023.
- Participants were randomized 1:1 to receive either camrelizumab 200 mg (n = 222) or placebo (n = 219) combined with chemotherapy every 2 weeks, with median follow-up period of 14.4 months.
- Treatment included nab-paclitaxel (100 mg/m²) plus carboplatin (area under curve, 1.5) on days 1, 8, and 15 in 28-day cycles for 16 weeks, followed by epirubicin (90 mg/m²) and cyclophosphamide (500 mg/m²) every 2 weeks for 8 weeks.
- The primary endpoint was pathological complete response, defined as no invasive tumor in breast and lymph nodes.
TAKEAWAY:
- Pathological complete response was achieved in 56.8% (95% CI, 50.0%-63.4%) of patients in the camrelizumab-chemotherapy group vs 44.7% (95% CI, 38.0%-51.6%) in the placebo-chemotherapy group (rate difference, 12.2%; 95% CI, 3.3%-21.2%; P = .004).
- Grade 3 or higher adverse events occurred in 89.2% of camrelizumab-chemotherapy group vs 83.1% in placebo-chemotherapy group, with serious adverse events in 34.7% vs 22.8%, respectively.
- Event-free survival rate at 18 months was 86.6% (95% CI, 79.9%-91.1%) with camrelizumab-chemotherapy vs 83.6% (95% CI, 76.2%-88.9%) with placebo-chemotherapy (hazard ratio [HR], 0.80; 95% CI, 0.46-1.42).
- Disease-free survival rate at 12 months reached 91.9% (95% CI, 85.5%-95.5%) with camrelizumab-chemotherapy compared with 87.8% (95% CI, 80.3%-92.6%) with placebo-chemotherapy (HR, 0.58; 95% CI, 0.27-1.24).
IN PRACTICE:
“The addition of camrelizumab to neoadjuvant chemotherapy significantly improved pathological complete response... The benefits of camrelizumab-chemotherapy with respect to pCR were generally consistent across subgroups,” wrote the authors of the study.
SOURCE:
The study was led by Zhi-Ming Shao, MD, Fudan University Shanghai Cancer Center in Shanghai, China. It was published online on December 13 in JAMA.
LIMITATIONS:
According to the authors, the study’s limitations include short follow-up duration preventing assessment of mature survival data and long-term safety profile, uncertainty about optimal duration of adjuvant camrelizumab treatment, small sample sizes in some subgroups warranting cautious interpretation, and potential limited generalizability as the study was conducted only in Chinese patients with triple-negative breast cancer.
DISCLOSURES:
The study was supported by Jiangsu Hengrui Pharmaceuticals. The authors and funder were involved in data collection, analysis, and interpretation and guaranteed the accuracy, completeness of the data, writing of the report, and the decision to submit the manuscript for publication.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
The combination shows consistent benefits across patient subgroups with a manageable safety profile.
METHODOLOGY:
- A randomized, double-blind, phase 3 trial enrolled 441 females (median age, 48 years) with early or locally advanced triple-negative breast cancer from 40 hospitals in China between November 2020 and May 2023.
- Participants were randomized 1:1 to receive either camrelizumab 200 mg (n = 222) or placebo (n = 219) combined with chemotherapy every 2 weeks, with median follow-up period of 14.4 months.
- Treatment included nab-paclitaxel (100 mg/m²) plus carboplatin (area under curve, 1.5) on days 1, 8, and 15 in 28-day cycles for 16 weeks, followed by epirubicin (90 mg/m²) and cyclophosphamide (500 mg/m²) every 2 weeks for 8 weeks.
- The primary endpoint was pathological complete response, defined as no invasive tumor in breast and lymph nodes.
TAKEAWAY:
- Pathological complete response was achieved in 56.8% (95% CI, 50.0%-63.4%) of patients in the camrelizumab-chemotherapy group vs 44.7% (95% CI, 38.0%-51.6%) in the placebo-chemotherapy group (rate difference, 12.2%; 95% CI, 3.3%-21.2%; P = .004).
- Grade 3 or higher adverse events occurred in 89.2% of camrelizumab-chemotherapy group vs 83.1% in placebo-chemotherapy group, with serious adverse events in 34.7% vs 22.8%, respectively.
- Event-free survival rate at 18 months was 86.6% (95% CI, 79.9%-91.1%) with camrelizumab-chemotherapy vs 83.6% (95% CI, 76.2%-88.9%) with placebo-chemotherapy (hazard ratio [HR], 0.80; 95% CI, 0.46-1.42).
- Disease-free survival rate at 12 months reached 91.9% (95% CI, 85.5%-95.5%) with camrelizumab-chemotherapy compared with 87.8% (95% CI, 80.3%-92.6%) with placebo-chemotherapy (HR, 0.58; 95% CI, 0.27-1.24).
IN PRACTICE:
“The addition of camrelizumab to neoadjuvant chemotherapy significantly improved pathological complete response... The benefits of camrelizumab-chemotherapy with respect to pCR were generally consistent across subgroups,” wrote the authors of the study.
SOURCE:
The study was led by Zhi-Ming Shao, MD, Fudan University Shanghai Cancer Center in Shanghai, China. It was published online on December 13 in JAMA.
LIMITATIONS:
According to the authors, the study’s limitations include short follow-up duration preventing assessment of mature survival data and long-term safety profile, uncertainty about optimal duration of adjuvant camrelizumab treatment, small sample sizes in some subgroups warranting cautious interpretation, and potential limited generalizability as the study was conducted only in Chinese patients with triple-negative breast cancer.
DISCLOSURES:
The study was supported by Jiangsu Hengrui Pharmaceuticals. The authors and funder were involved in data collection, analysis, and interpretation and guaranteed the accuracy, completeness of the data, writing of the report, and the decision to submit the manuscript for publication.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Higher Early-Onset CRC Mortality Seen in Racial, Ethnic Minorities
TOPLINE:
The largest racial and ethnic disparities in survival were linked to neighborhood socioeconomic status.
METHODOLOGY:
- US rates of EOCRC are increasing, with differences across racial and ethnic groups, but few studies have provided detailed risk estimates in the categories of Asian American and of Native Hawaiian or Other Pacific Islander, as well as the contribution of sociodemographic factors to these differences.
- A population-based cohort study analyzed California Cancer Registry data for 22,834 individuals aged 18-49 years diagnosed with EOCRC between January 2000 and December 2019.
- Researchers examined the association between mortality risk and racial and ethnic groups, including Asian American (15.5%, separated into seven subcategories), Hispanic (30.2%), Native Hawaiian or Other Pacific Islander (0.6%), non-Hispanic American Indian or Alaska Native (0.5%), non-Hispanic Black (7.3%), and non-Hispanic White (45.9%) individuals, with a median follow-up of 4.2 years.
- Statistical models measured baseline associations adjusting for clinical features and then tested for the contribution of socioeconomic factors together and separately, with adjustments for insurance status, neighborhood socioeconomic status, and more.
TAKEAWAY:
- Native Hawaiian or Other Pacific Islander individuals demonstrated the highest EOCRC mortality risk compared with non-Hispanic White individuals (socioeconomic status–adjusted HR [SES aHR], 1.34; 95% CI, 1.01-1.76).
- Non-Hispanic Black individuals showed a higher EOCRC mortality risk than non-Hispanic White individuals (SES aHR, 1.18; 95% CI, 1.07-1.29).
- Hispanic individuals’ higher EOCRC mortality (base aHR, 1.15; 95% CI, 1.08-1.22) disappeared after adjusting for neighborhood socioeconomic status (SES aHR, 0.98; 95% CI, 0.92-1.04).
- Southeast Asian individuals’ increased mortality risk (base aHR, 1.17; 95% CI, 1.03-1.34) was no longer significant after adjusting for insurance status (SES aHR, 1.10; 95% CI, 0.96-1.26).
IN PRACTICE:
“As clinicians and researchers, we should ask ourselves how to act on these findings,” wrote the authors of an invited commentary. “The effort cannot stop with data analysis alone, it must extend to actionable steps,” such as tailored efforts to deliver culturally competent care and patient navigation services to those with greatest need and at highest risk, they added.
SOURCE:
The study was led by Joshua Demb, PhD, University of California, San Diego. The study was published online on November 22 in JAMA Network Open (2024. doi: 10.1001/jamanetworkopen.2024.46820) with the invited commentary led by Clare E. Jacobson, MD, University of Michigan, Ann Arbor.
LIMITATIONS:
The study was limited by a relatively short follow-up time and small sample sizes in some racial and ethnic groups, potentially leading to imprecise aHR estimates. The generalizability of findings beyond California requires further investigation, and the ability to examine potential associations between neighborhood socioeconomic status and other factors was also constrained by small sample sizes.
DISCLOSURES:
The study received support from the National Cancer Institute at the National Institutes of Health. One study author reported receiving consulting fees from Guardant Health, InterVenn Biosciences, Geneoscopy, and Universal DX; research support from Freenome; and stock options from CellMax outside the submitted work. No other disclosures were reported by other authors of the study or the commentary.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
The largest racial and ethnic disparities in survival were linked to neighborhood socioeconomic status.
METHODOLOGY:
- US rates of EOCRC are increasing, with differences across racial and ethnic groups, but few studies have provided detailed risk estimates in the categories of Asian American and of Native Hawaiian or Other Pacific Islander, as well as the contribution of sociodemographic factors to these differences.
- A population-based cohort study analyzed California Cancer Registry data for 22,834 individuals aged 18-49 years diagnosed with EOCRC between January 2000 and December 2019.
- Researchers examined the association between mortality risk and racial and ethnic groups, including Asian American (15.5%, separated into seven subcategories), Hispanic (30.2%), Native Hawaiian or Other Pacific Islander (0.6%), non-Hispanic American Indian or Alaska Native (0.5%), non-Hispanic Black (7.3%), and non-Hispanic White (45.9%) individuals, with a median follow-up of 4.2 years.
- Statistical models measured baseline associations adjusting for clinical features and then tested for the contribution of socioeconomic factors together and separately, with adjustments for insurance status, neighborhood socioeconomic status, and more.
TAKEAWAY:
- Native Hawaiian or Other Pacific Islander individuals demonstrated the highest EOCRC mortality risk compared with non-Hispanic White individuals (socioeconomic status–adjusted HR [SES aHR], 1.34; 95% CI, 1.01-1.76).
- Non-Hispanic Black individuals showed a higher EOCRC mortality risk than non-Hispanic White individuals (SES aHR, 1.18; 95% CI, 1.07-1.29).
- Hispanic individuals’ higher EOCRC mortality (base aHR, 1.15; 95% CI, 1.08-1.22) disappeared after adjusting for neighborhood socioeconomic status (SES aHR, 0.98; 95% CI, 0.92-1.04).
- Southeast Asian individuals’ increased mortality risk (base aHR, 1.17; 95% CI, 1.03-1.34) was no longer significant after adjusting for insurance status (SES aHR, 1.10; 95% CI, 0.96-1.26).
IN PRACTICE:
“As clinicians and researchers, we should ask ourselves how to act on these findings,” wrote the authors of an invited commentary. “The effort cannot stop with data analysis alone, it must extend to actionable steps,” such as tailored efforts to deliver culturally competent care and patient navigation services to those with greatest need and at highest risk, they added.
SOURCE:
The study was led by Joshua Demb, PhD, University of California, San Diego. The study was published online on November 22 in JAMA Network Open (2024. doi: 10.1001/jamanetworkopen.2024.46820) with the invited commentary led by Clare E. Jacobson, MD, University of Michigan, Ann Arbor.
LIMITATIONS:
The study was limited by a relatively short follow-up time and small sample sizes in some racial and ethnic groups, potentially leading to imprecise aHR estimates. The generalizability of findings beyond California requires further investigation, and the ability to examine potential associations between neighborhood socioeconomic status and other factors was also constrained by small sample sizes.
DISCLOSURES:
The study received support from the National Cancer Institute at the National Institutes of Health. One study author reported receiving consulting fees from Guardant Health, InterVenn Biosciences, Geneoscopy, and Universal DX; research support from Freenome; and stock options from CellMax outside the submitted work. No other disclosures were reported by other authors of the study or the commentary.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
The largest racial and ethnic disparities in survival were linked to neighborhood socioeconomic status.
METHODOLOGY:
- US rates of EOCRC are increasing, with differences across racial and ethnic groups, but few studies have provided detailed risk estimates in the categories of Asian American and of Native Hawaiian or Other Pacific Islander, as well as the contribution of sociodemographic factors to these differences.
- A population-based cohort study analyzed California Cancer Registry data for 22,834 individuals aged 18-49 years diagnosed with EOCRC between January 2000 and December 2019.
- Researchers examined the association between mortality risk and racial and ethnic groups, including Asian American (15.5%, separated into seven subcategories), Hispanic (30.2%), Native Hawaiian or Other Pacific Islander (0.6%), non-Hispanic American Indian or Alaska Native (0.5%), non-Hispanic Black (7.3%), and non-Hispanic White (45.9%) individuals, with a median follow-up of 4.2 years.
- Statistical models measured baseline associations adjusting for clinical features and then tested for the contribution of socioeconomic factors together and separately, with adjustments for insurance status, neighborhood socioeconomic status, and more.
TAKEAWAY:
- Native Hawaiian or Other Pacific Islander individuals demonstrated the highest EOCRC mortality risk compared with non-Hispanic White individuals (socioeconomic status–adjusted HR [SES aHR], 1.34; 95% CI, 1.01-1.76).
- Non-Hispanic Black individuals showed a higher EOCRC mortality risk than non-Hispanic White individuals (SES aHR, 1.18; 95% CI, 1.07-1.29).
- Hispanic individuals’ higher EOCRC mortality (base aHR, 1.15; 95% CI, 1.08-1.22) disappeared after adjusting for neighborhood socioeconomic status (SES aHR, 0.98; 95% CI, 0.92-1.04).
- Southeast Asian individuals’ increased mortality risk (base aHR, 1.17; 95% CI, 1.03-1.34) was no longer significant after adjusting for insurance status (SES aHR, 1.10; 95% CI, 0.96-1.26).
IN PRACTICE:
“As clinicians and researchers, we should ask ourselves how to act on these findings,” wrote the authors of an invited commentary. “The effort cannot stop with data analysis alone, it must extend to actionable steps,” such as tailored efforts to deliver culturally competent care and patient navigation services to those with greatest need and at highest risk, they added.
SOURCE:
The study was led by Joshua Demb, PhD, University of California, San Diego. The study was published online on November 22 in JAMA Network Open (2024. doi: 10.1001/jamanetworkopen.2024.46820) with the invited commentary led by Clare E. Jacobson, MD, University of Michigan, Ann Arbor.
LIMITATIONS:
The study was limited by a relatively short follow-up time and small sample sizes in some racial and ethnic groups, potentially leading to imprecise aHR estimates. The generalizability of findings beyond California requires further investigation, and the ability to examine potential associations between neighborhood socioeconomic status and other factors was also constrained by small sample sizes.
DISCLOSURES:
The study received support from the National Cancer Institute at the National Institutes of Health. One study author reported receiving consulting fees from Guardant Health, InterVenn Biosciences, Geneoscopy, and Universal DX; research support from Freenome; and stock options from CellMax outside the submitted work. No other disclosures were reported by other authors of the study or the commentary.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
New ILD diagnostic test is available
IPF can be difficult to distinguish from other ILDs, S. Samuel Weigt, MD, of the University of California, Los Angeles, and director of UCLA Health’s Interstitial Lung Disease Center, said in a statement from Veracyte, the company marketing the test.
In fact, more than half of patients with ILDs were misdiagnosed at least once, according to a study published by the Pulmonary Fibrosis Foundation.
The new test, known as the Envisia Genomic Classifier, combines RNA sequencing and machine learning to help physicians differentiate IPF from ILDs in samples obtained through transbronchial biopsy. Its specificity and sensitivity for detecting the genomic pattern of usual interstitial pneumonia, are 88% and 70%, respectively, according to the Veracyte statement.
“Multiple studies have demonstrated that the Envisia Genomic Classifier supports more confident IPF diagnosis and optimal patient management,” Bonnie Anderson, chairman and CEO of Veracyte, said in the statement.
A benefit of the new test is that its use does not require patients to undergo risky, expensive surgery, which may not even be possible for some patients, noted Dr. Weigt. “We are pleased to be one of the few medical facilities in the country to have access to this breakthrough technology.”
To obtain more information about the Envisia Genomic Classifier and how to use the early-access program, contact Veracyte at 844-464-5864 or support@veracyte.com.
IPF can be difficult to distinguish from other ILDs, S. Samuel Weigt, MD, of the University of California, Los Angeles, and director of UCLA Health’s Interstitial Lung Disease Center, said in a statement from Veracyte, the company marketing the test.
In fact, more than half of patients with ILDs were misdiagnosed at least once, according to a study published by the Pulmonary Fibrosis Foundation.
The new test, known as the Envisia Genomic Classifier, combines RNA sequencing and machine learning to help physicians differentiate IPF from ILDs in samples obtained through transbronchial biopsy. Its specificity and sensitivity for detecting the genomic pattern of usual interstitial pneumonia, are 88% and 70%, respectively, according to the Veracyte statement.
“Multiple studies have demonstrated that the Envisia Genomic Classifier supports more confident IPF diagnosis and optimal patient management,” Bonnie Anderson, chairman and CEO of Veracyte, said in the statement.
A benefit of the new test is that its use does not require patients to undergo risky, expensive surgery, which may not even be possible for some patients, noted Dr. Weigt. “We are pleased to be one of the few medical facilities in the country to have access to this breakthrough technology.”
To obtain more information about the Envisia Genomic Classifier and how to use the early-access program, contact Veracyte at 844-464-5864 or support@veracyte.com.
IPF can be difficult to distinguish from other ILDs, S. Samuel Weigt, MD, of the University of California, Los Angeles, and director of UCLA Health’s Interstitial Lung Disease Center, said in a statement from Veracyte, the company marketing the test.
In fact, more than half of patients with ILDs were misdiagnosed at least once, according to a study published by the Pulmonary Fibrosis Foundation.
The new test, known as the Envisia Genomic Classifier, combines RNA sequencing and machine learning to help physicians differentiate IPF from ILDs in samples obtained through transbronchial biopsy. Its specificity and sensitivity for detecting the genomic pattern of usual interstitial pneumonia, are 88% and 70%, respectively, according to the Veracyte statement.
“Multiple studies have demonstrated that the Envisia Genomic Classifier supports more confident IPF diagnosis and optimal patient management,” Bonnie Anderson, chairman and CEO of Veracyte, said in the statement.
A benefit of the new test is that its use does not require patients to undergo risky, expensive surgery, which may not even be possible for some patients, noted Dr. Weigt. “We are pleased to be one of the few medical facilities in the country to have access to this breakthrough technology.”
To obtain more information about the Envisia Genomic Classifier and how to use the early-access program, contact Veracyte at 844-464-5864 or support@veracyte.com.
EPA proposal on research data to be discussed at ATS meeting
A press conference on the Environmental Protection Agency’s proposed policy on research data will be held at the American Thoracic Society International Conference on Sunday, May 20.
The conference, entitled “Silencing Science: EPA’s Proposed Policy on Research Data,” will occur at 11:15 a.m. Pacific Standard Time in the San Diego Convention Center, Meeting Room 23A (Upper Level).
For information about this press conference, contact Dacia Morris, director of communications and marketing of the ATS, at 212-315-8620.
A press conference on the Environmental Protection Agency’s proposed policy on research data will be held at the American Thoracic Society International Conference on Sunday, May 20.
The conference, entitled “Silencing Science: EPA’s Proposed Policy on Research Data,” will occur at 11:15 a.m. Pacific Standard Time in the San Diego Convention Center, Meeting Room 23A (Upper Level).
For information about this press conference, contact Dacia Morris, director of communications and marketing of the ATS, at 212-315-8620.
A press conference on the Environmental Protection Agency’s proposed policy on research data will be held at the American Thoracic Society International Conference on Sunday, May 20.
The conference, entitled “Silencing Science: EPA’s Proposed Policy on Research Data,” will occur at 11:15 a.m. Pacific Standard Time in the San Diego Convention Center, Meeting Room 23A (Upper Level).
For information about this press conference, contact Dacia Morris, director of communications and marketing of the ATS, at 212-315-8620.
FROM ATS 2018
CHEST® Physician’s preview of ATS 2018
Here is a glimpse of some of the important research that will be presented at this meeting.
The findings of several chronic obstructive pulmonary disease (COPD) drug trials will be discussed during a session entitled “ICS [Inhaled corticosteroids] in COPD: The Pendulum Keeps Swinging,” which is scheduled to occur at 9:15 a.m. in Room 14 A-B (Mezzanine Level). Among the research to be presented are the latest findings of the phase 3 IMPACT study of 10,355 symptomatic COPD patients with a history of moderate to severe exacerbations. This study compared the use of an inhaled therapy that comprised a corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-agonist (LABA) with the use of two other therapy combinations – a corticosteroid and a LABA, or a LABA and a LAMA. (Lipson DA et al. N Engl J Med. 2018 Apr 18;378:1671-80). Patients were randomized to receive either a once-daily combination of 100 mcg fluticasone furoate (a corticosteroid); 62.5 mcg of the LAMA, umeclidinium; and 25 mcg of the LABA, vilanterol; or dual inhaled therapy involving either 100 mcg fluticasone furoate plus 25 mcg of vilanterol, or 62.5 mcg of umeclidinium plus 25 mcg of vilanterol for 52 weeks.
One of the updates on this trial is that using the triple therapy significantly reduced on-treatment all-cause mortality over using the LAMA (62.5 mcg of umeclidinium) plus LABA (25 mcg of the vilanterol) dual therapy. Fifty of the patients who received triple therapy died (1.20%), versus 49 patients in the corticosteroid plus LABA group (1.19%) and 30 patients (1.88%) in the LAMA plus LABA group. A 42.1% reduction in risk of all-cause mortality occurred for patients who took the triple therapy, when compared with patients who took the LAMA/LABA combo (95% confidence interval, 11.9%-61.9%; P = .011), according to an abstract on the ATS International Conference’s website.
At the same time on Sunday, researchers will be presenting their research in a session entitled “Sleep Disordered Breathing, Cardiovascular Disease, and Mortality,” in Room 3 (Upper Level) of the convention center. One of the abstracts that will be discussed compared the long-term effectiveness of noninvasive ventilation (NIV) with continuous positive airway pressure (CPAP) in patients with obesity hypoventilation syndrome with severe obstructive sleep apnea. In this multicenter open-label, randomized, controlled trial, Sanchez Quiroga M et al. analyzed the results for 202 patients who used one of the two treatments for at least 3 years. Among this study’s findings were that the mortality rates and the number of cardiovascular events that occurred were similar in the two treatment groups. The mortality rate for patients who used CPAP was 14.7%, compared with 11.3% for the patients who received NIV (adjusted hazard ratio, 0.73; P = .439), and the cardiovascular events per 100 person-years were 5.1 for CPAP and 7.46 for NIV (P = .315). The researchers concluded that both treatments are equally effective for the long term, but that CPAP should be “the preferred treatment modality,” because it’s cheaper and easier to implement.
On Monday morning, researchers will present their findings of the short-term cardiovascular effects of 30 pulmonary arterial hypertension patients’ use of the beta blocker carvedilol, in 3.125 mg doses taken twice a day. Right ventricular systolic pressure (RVSP) decreased by an average of 11 mmHg (P = .003) in this double-blinded, randomized, controlled open-label trial with a 1-week run-in period. Cardiac output decreased by an average of –1.8 L/min (P less than .0001), but RVSP was inversely associated with cardiac output. “Short-term carvedilol could potentially identify a subgroup for long-term therapy based on initial drop in RVSP and heart rate response,” noted Farha SY et al. in their abstract. None of the patients experienced any side effects from taking the drug. More details on this research and other studies on pulmonary hypertension will be presented at 9:15 am in Area B (Hall A-B2, Ground level) of the convention center, in the session entitled “Surf’s Up: Riding the Wave of Clinical Research in Pulmonary Hypertension.”
Look for all of our on-site coverage of the conference at mdedge.com/chestphysician next week.
Here is a glimpse of some of the important research that will be presented at this meeting.
The findings of several chronic obstructive pulmonary disease (COPD) drug trials will be discussed during a session entitled “ICS [Inhaled corticosteroids] in COPD: The Pendulum Keeps Swinging,” which is scheduled to occur at 9:15 a.m. in Room 14 A-B (Mezzanine Level). Among the research to be presented are the latest findings of the phase 3 IMPACT study of 10,355 symptomatic COPD patients with a history of moderate to severe exacerbations. This study compared the use of an inhaled therapy that comprised a corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-agonist (LABA) with the use of two other therapy combinations – a corticosteroid and a LABA, or a LABA and a LAMA. (Lipson DA et al. N Engl J Med. 2018 Apr 18;378:1671-80). Patients were randomized to receive either a once-daily combination of 100 mcg fluticasone furoate (a corticosteroid); 62.5 mcg of the LAMA, umeclidinium; and 25 mcg of the LABA, vilanterol; or dual inhaled therapy involving either 100 mcg fluticasone furoate plus 25 mcg of vilanterol, or 62.5 mcg of umeclidinium plus 25 mcg of vilanterol for 52 weeks.
One of the updates on this trial is that using the triple therapy significantly reduced on-treatment all-cause mortality over using the LAMA (62.5 mcg of umeclidinium) plus LABA (25 mcg of the vilanterol) dual therapy. Fifty of the patients who received triple therapy died (1.20%), versus 49 patients in the corticosteroid plus LABA group (1.19%) and 30 patients (1.88%) in the LAMA plus LABA group. A 42.1% reduction in risk of all-cause mortality occurred for patients who took the triple therapy, when compared with patients who took the LAMA/LABA combo (95% confidence interval, 11.9%-61.9%; P = .011), according to an abstract on the ATS International Conference’s website.
At the same time on Sunday, researchers will be presenting their research in a session entitled “Sleep Disordered Breathing, Cardiovascular Disease, and Mortality,” in Room 3 (Upper Level) of the convention center. One of the abstracts that will be discussed compared the long-term effectiveness of noninvasive ventilation (NIV) with continuous positive airway pressure (CPAP) in patients with obesity hypoventilation syndrome with severe obstructive sleep apnea. In this multicenter open-label, randomized, controlled trial, Sanchez Quiroga M et al. analyzed the results for 202 patients who used one of the two treatments for at least 3 years. Among this study’s findings were that the mortality rates and the number of cardiovascular events that occurred were similar in the two treatment groups. The mortality rate for patients who used CPAP was 14.7%, compared with 11.3% for the patients who received NIV (adjusted hazard ratio, 0.73; P = .439), and the cardiovascular events per 100 person-years were 5.1 for CPAP and 7.46 for NIV (P = .315). The researchers concluded that both treatments are equally effective for the long term, but that CPAP should be “the preferred treatment modality,” because it’s cheaper and easier to implement.
On Monday morning, researchers will present their findings of the short-term cardiovascular effects of 30 pulmonary arterial hypertension patients’ use of the beta blocker carvedilol, in 3.125 mg doses taken twice a day. Right ventricular systolic pressure (RVSP) decreased by an average of 11 mmHg (P = .003) in this double-blinded, randomized, controlled open-label trial with a 1-week run-in period. Cardiac output decreased by an average of –1.8 L/min (P less than .0001), but RVSP was inversely associated with cardiac output. “Short-term carvedilol could potentially identify a subgroup for long-term therapy based on initial drop in RVSP and heart rate response,” noted Farha SY et al. in their abstract. None of the patients experienced any side effects from taking the drug. More details on this research and other studies on pulmonary hypertension will be presented at 9:15 am in Area B (Hall A-B2, Ground level) of the convention center, in the session entitled “Surf’s Up: Riding the Wave of Clinical Research in Pulmonary Hypertension.”
Look for all of our on-site coverage of the conference at mdedge.com/chestphysician next week.
Here is a glimpse of some of the important research that will be presented at this meeting.
The findings of several chronic obstructive pulmonary disease (COPD) drug trials will be discussed during a session entitled “ICS [Inhaled corticosteroids] in COPD: The Pendulum Keeps Swinging,” which is scheduled to occur at 9:15 a.m. in Room 14 A-B (Mezzanine Level). Among the research to be presented are the latest findings of the phase 3 IMPACT study of 10,355 symptomatic COPD patients with a history of moderate to severe exacerbations. This study compared the use of an inhaled therapy that comprised a corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-agonist (LABA) with the use of two other therapy combinations – a corticosteroid and a LABA, or a LABA and a LAMA. (Lipson DA et al. N Engl J Med. 2018 Apr 18;378:1671-80). Patients were randomized to receive either a once-daily combination of 100 mcg fluticasone furoate (a corticosteroid); 62.5 mcg of the LAMA, umeclidinium; and 25 mcg of the LABA, vilanterol; or dual inhaled therapy involving either 100 mcg fluticasone furoate plus 25 mcg of vilanterol, or 62.5 mcg of umeclidinium plus 25 mcg of vilanterol for 52 weeks.
One of the updates on this trial is that using the triple therapy significantly reduced on-treatment all-cause mortality over using the LAMA (62.5 mcg of umeclidinium) plus LABA (25 mcg of the vilanterol) dual therapy. Fifty of the patients who received triple therapy died (1.20%), versus 49 patients in the corticosteroid plus LABA group (1.19%) and 30 patients (1.88%) in the LAMA plus LABA group. A 42.1% reduction in risk of all-cause mortality occurred for patients who took the triple therapy, when compared with patients who took the LAMA/LABA combo (95% confidence interval, 11.9%-61.9%; P = .011), according to an abstract on the ATS International Conference’s website.
At the same time on Sunday, researchers will be presenting their research in a session entitled “Sleep Disordered Breathing, Cardiovascular Disease, and Mortality,” in Room 3 (Upper Level) of the convention center. One of the abstracts that will be discussed compared the long-term effectiveness of noninvasive ventilation (NIV) with continuous positive airway pressure (CPAP) in patients with obesity hypoventilation syndrome with severe obstructive sleep apnea. In this multicenter open-label, randomized, controlled trial, Sanchez Quiroga M et al. analyzed the results for 202 patients who used one of the two treatments for at least 3 years. Among this study’s findings were that the mortality rates and the number of cardiovascular events that occurred were similar in the two treatment groups. The mortality rate for patients who used CPAP was 14.7%, compared with 11.3% for the patients who received NIV (adjusted hazard ratio, 0.73; P = .439), and the cardiovascular events per 100 person-years were 5.1 for CPAP and 7.46 for NIV (P = .315). The researchers concluded that both treatments are equally effective for the long term, but that CPAP should be “the preferred treatment modality,” because it’s cheaper and easier to implement.
On Monday morning, researchers will present their findings of the short-term cardiovascular effects of 30 pulmonary arterial hypertension patients’ use of the beta blocker carvedilol, in 3.125 mg doses taken twice a day. Right ventricular systolic pressure (RVSP) decreased by an average of 11 mmHg (P = .003) in this double-blinded, randomized, controlled open-label trial with a 1-week run-in period. Cardiac output decreased by an average of –1.8 L/min (P less than .0001), but RVSP was inversely associated with cardiac output. “Short-term carvedilol could potentially identify a subgroup for long-term therapy based on initial drop in RVSP and heart rate response,” noted Farha SY et al. in their abstract. None of the patients experienced any side effects from taking the drug. More details on this research and other studies on pulmonary hypertension will be presented at 9:15 am in Area B (Hall A-B2, Ground level) of the convention center, in the session entitled “Surf’s Up: Riding the Wave of Clinical Research in Pulmonary Hypertension.”
Look for all of our on-site coverage of the conference at mdedge.com/chestphysician next week.
FROM ATS 2018