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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
Endoscopic therapy effective for early cancer in Barrett’s esophagus
ORLANDO – Endoscopic therapy is as effective in Barrett’s esophagus patients with early cancer as in those with high-grade dysplasia, according to findings from an international multicenter consortium.
The findings suggest that invasive surgery may be avoidable in many Barrett’s esophagus patients with early cancer, Rajesh Krishnamoorthi, MD, of Virginia Mason Medical Center, Seattle, reported at the World Congress of Gastroenterology at ACG 2017.
Further, after adjustment for age, sex, and Barrett’s esophagus length, there was no statistical difference in the CE-IM rate (hazard ratio, 1.15) or CE-D rate (HR, 1.21) between the two groups.
The rates of recurrent intestinal metaplasia (Re-IM) in the groups were also statistically similar at 43.9% and 34.7%, respectively, said Dr. Krishnamoorthi, whose work received a 2017 Esophagus Category Award at the meeting.
Endoscopic therapy is the treatment of choice for Barrett’s esophagus patients with high-grade dysplasia, and is also used in some cases as a noninvasive alternative to surgery in Barrett’s esophagus patients with intramucosal cancer. However, data comparing outcomes of endoscopic therapy for these two conditions are lacking.
For the current study, all subjects from the EET database of patients from 10 centers in the United States, Europe, and Australia with either intramucosal cancer or high-grade dysplasia who underwent endoscopic therapy since April 2012 were reviewed. The patients were treated with endoscopic mucosal resection if visible lesions were noted, and/or with mucosal ablation for the flat Barrett’s esophagus. Those who underwent at least four esophagogastroduodenoscopies with endoscopic therapy were included.
The median age of the patients was 66 years, 84% were men, and median Barrett’s esophagus segment length was 6 cm. Baseline characteristics did not differ between the groups, Dr. Krishnamoorthi noted.
Although limited by the relatively small number of patients in each study group, by the exclusion of patients who were lost to follow-up, and by the observational nature of the study, the findings could have implications for treatment selection in some patients with Barrett’s esophagus and early cancer.
“In this large well-defined cohort of Barrett’s patients, effectiveness of endoscopic therapy in intramucosal cancer is comparable to that of high-grade dysplasia. Consideration of endoscopic therapy in Barrett’s patients with early cancer could reduce the need for invasive surgery,” he concluded.
During a discussion period, however, it was pointed out that the centers involved in this study are “centers with a lot of expertise in this,” and that the generalizability of the findings to gastroenterology practices is something that should be looked at, especially considering that the diagnosis of intramucosal cancer “may not be uniformly accurate across the spectrum of gastroenterology practices.”
“I completely agree with that,” Dr. Krishnamoorthi said, adding that the diagnosis must be confirmed by a pathologist, and that the procedure should be performed by an endoscopist with extensive experience.
Dr. Krishnamoorthi reported having no disclosures.
ORLANDO – Endoscopic therapy is as effective in Barrett’s esophagus patients with early cancer as in those with high-grade dysplasia, according to findings from an international multicenter consortium.
The findings suggest that invasive surgery may be avoidable in many Barrett’s esophagus patients with early cancer, Rajesh Krishnamoorthi, MD, of Virginia Mason Medical Center, Seattle, reported at the World Congress of Gastroenterology at ACG 2017.
Further, after adjustment for age, sex, and Barrett’s esophagus length, there was no statistical difference in the CE-IM rate (hazard ratio, 1.15) or CE-D rate (HR, 1.21) between the two groups.
The rates of recurrent intestinal metaplasia (Re-IM) in the groups were also statistically similar at 43.9% and 34.7%, respectively, said Dr. Krishnamoorthi, whose work received a 2017 Esophagus Category Award at the meeting.
Endoscopic therapy is the treatment of choice for Barrett’s esophagus patients with high-grade dysplasia, and is also used in some cases as a noninvasive alternative to surgery in Barrett’s esophagus patients with intramucosal cancer. However, data comparing outcomes of endoscopic therapy for these two conditions are lacking.
For the current study, all subjects from the EET database of patients from 10 centers in the United States, Europe, and Australia with either intramucosal cancer or high-grade dysplasia who underwent endoscopic therapy since April 2012 were reviewed. The patients were treated with endoscopic mucosal resection if visible lesions were noted, and/or with mucosal ablation for the flat Barrett’s esophagus. Those who underwent at least four esophagogastroduodenoscopies with endoscopic therapy were included.
The median age of the patients was 66 years, 84% were men, and median Barrett’s esophagus segment length was 6 cm. Baseline characteristics did not differ between the groups, Dr. Krishnamoorthi noted.
Although limited by the relatively small number of patients in each study group, by the exclusion of patients who were lost to follow-up, and by the observational nature of the study, the findings could have implications for treatment selection in some patients with Barrett’s esophagus and early cancer.
“In this large well-defined cohort of Barrett’s patients, effectiveness of endoscopic therapy in intramucosal cancer is comparable to that of high-grade dysplasia. Consideration of endoscopic therapy in Barrett’s patients with early cancer could reduce the need for invasive surgery,” he concluded.
During a discussion period, however, it was pointed out that the centers involved in this study are “centers with a lot of expertise in this,” and that the generalizability of the findings to gastroenterology practices is something that should be looked at, especially considering that the diagnosis of intramucosal cancer “may not be uniformly accurate across the spectrum of gastroenterology practices.”
“I completely agree with that,” Dr. Krishnamoorthi said, adding that the diagnosis must be confirmed by a pathologist, and that the procedure should be performed by an endoscopist with extensive experience.
Dr. Krishnamoorthi reported having no disclosures.
ORLANDO – Endoscopic therapy is as effective in Barrett’s esophagus patients with early cancer as in those with high-grade dysplasia, according to findings from an international multicenter consortium.
The findings suggest that invasive surgery may be avoidable in many Barrett’s esophagus patients with early cancer, Rajesh Krishnamoorthi, MD, of Virginia Mason Medical Center, Seattle, reported at the World Congress of Gastroenterology at ACG 2017.
Further, after adjustment for age, sex, and Barrett’s esophagus length, there was no statistical difference in the CE-IM rate (hazard ratio, 1.15) or CE-D rate (HR, 1.21) between the two groups.
The rates of recurrent intestinal metaplasia (Re-IM) in the groups were also statistically similar at 43.9% and 34.7%, respectively, said Dr. Krishnamoorthi, whose work received a 2017 Esophagus Category Award at the meeting.
Endoscopic therapy is the treatment of choice for Barrett’s esophagus patients with high-grade dysplasia, and is also used in some cases as a noninvasive alternative to surgery in Barrett’s esophagus patients with intramucosal cancer. However, data comparing outcomes of endoscopic therapy for these two conditions are lacking.
For the current study, all subjects from the EET database of patients from 10 centers in the United States, Europe, and Australia with either intramucosal cancer or high-grade dysplasia who underwent endoscopic therapy since April 2012 were reviewed. The patients were treated with endoscopic mucosal resection if visible lesions were noted, and/or with mucosal ablation for the flat Barrett’s esophagus. Those who underwent at least four esophagogastroduodenoscopies with endoscopic therapy were included.
The median age of the patients was 66 years, 84% were men, and median Barrett’s esophagus segment length was 6 cm. Baseline characteristics did not differ between the groups, Dr. Krishnamoorthi noted.
Although limited by the relatively small number of patients in each study group, by the exclusion of patients who were lost to follow-up, and by the observational nature of the study, the findings could have implications for treatment selection in some patients with Barrett’s esophagus and early cancer.
“In this large well-defined cohort of Barrett’s patients, effectiveness of endoscopic therapy in intramucosal cancer is comparable to that of high-grade dysplasia. Consideration of endoscopic therapy in Barrett’s patients with early cancer could reduce the need for invasive surgery,” he concluded.
During a discussion period, however, it was pointed out that the centers involved in this study are “centers with a lot of expertise in this,” and that the generalizability of the findings to gastroenterology practices is something that should be looked at, especially considering that the diagnosis of intramucosal cancer “may not be uniformly accurate across the spectrum of gastroenterology practices.”
“I completely agree with that,” Dr. Krishnamoorthi said, adding that the diagnosis must be confirmed by a pathologist, and that the procedure should be performed by an endoscopist with extensive experience.
Dr. Krishnamoorthi reported having no disclosures.
AT THE 13th WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Outcomes did not differ significantly between Barrett’s esophagus patients with early cancer and those with high-grade dysplasia (hazard ratios for CE-IM and CE-D, respectively: 1.15, and 1.21).
Data source: Study of 276 patients from a prospective database.
Disclosures: Dr. Krishnamoorthi reported having no disclosures.
ADMIRE CD trial: Stem cells promote long-term fistula remission
ORLANDO – A single treatment with a suspension of allogeneic expanded adipose-derived mesenchymal stem cells, or Cx601, promotes long-term combined remission of complex perianal fistulas in patients with Crohn’s disease, according to 52-week results from the phase 3 ADMIRE CD trial.
Combined remission – a stringent endpoint consisting of closure of all treated external openings that were draining at baseline and of an absence of collections more than 2 cm of treated perianal fistulas as confirmed by blinded central MRI – was achieved in 56.3% of 103 treated patients, compared with 38.6% of 101 patients who received placebo (P = .010), Daniel C. Baumgart, MD, reported at the World Congress of Gastroenterology at ACG 2017.
This parallel-group, double-blind, multicenter study included patients who had draining, treatment-refractory, complex perianal fistulas and inactive or mildly active luminal Crohn’s disease (Crohn’s Disease Activity Index scores of 220 or less) at baseline. Those randomized to the Cx601 group received a single intralesional injection of 120 million expanded adipose-derived stem cells and standard of care. Those in the control arm received a placebo injection plus standard of care, said Dr. Baumgart of Charité Medical School, which is affiliated with both Humboldt University in Berlin and the Free University of Berlin.
Prior to receiving treatment or placebo, the patients underwent fistula curettage and, if indicated, seton placement and subsequent removal, he noted, adding that baseline concomitant medications, including immunosuppressants and anti–tumor necrosis factors, were continued without dose or regimen modification and that antibiotics were allowed for up to 4 weeks.
The 52-week findings were evaluated in the modified intention-to-treat population of patients who were randomized, were treated, and had at least one postbaseline efficacy assessment (61.8% of the study population). These findings showed that Cx601 is associated with even better outcomes at 1 year than those reported at 24 weeks; those prior results, published in The Lancet in July 2016, showed combined remission rates in the modified intention-to-treat population of 51% vs. 36% for placebo.
Furthermore, 75% of treated patients who achieved combined remission at 24 weeks maintained that remission at 52 weeks, compared with 55.9% of those in the placebo group (P = .052), Dr. Baumgart said.
Sensitivity analyses in this long-term assessment supported the long-term effectiveness of Cx601 over that of the control treatment, which provided evidence on the robustness of its advantage, he said, noting that safety results were also encouraging.
“The safety profile was similar to week 24; there were no new safety signals there at all,” he said.
The findings are of note because existing therapies for complex perianal fistulas in Crohn’s disease are often ineffective, he said, adding that fistulas occur in up to 50% of Crohn’s disease patients and that 70%-80% are complex and difficult to treat. Most are refractory to conventional anti–tumor necrosis factor therapies, and 60%-70% of patients relapse, he explained.
“If we’re honest, very few medications have been properly studied,” he said, adding that fistula patients often are excluded from industry trials.
“So [the ADMIRE CD trial] is new, design-wise, and has addressed a true medical need,” he said.
He attributed the good placebo response in this trial to the ongoing standard of care treatment in both groups, as well as to the team approach to care used in the trial. He also noted that a number of questions regarding the use of Cx601 remain to be answered, including the when the ideal retreatment time point should be, whether the treatment can be used for rectovaginal fistulas, and which patients should not receive treatment.
“So there is a lot to learn still, but I think it’s a revolutionary step forward, compared to what we have today, due to the trial design, which I think is robust, and also the encouraging outcomes,” he said.
The ADMIRE CD trial was sponsored by TiGenix SAU. Dr. Baumgart has received consulting fees and nonfinancial support from AbbVie, Biogen, and BMS.
ORLANDO – A single treatment with a suspension of allogeneic expanded adipose-derived mesenchymal stem cells, or Cx601, promotes long-term combined remission of complex perianal fistulas in patients with Crohn’s disease, according to 52-week results from the phase 3 ADMIRE CD trial.
Combined remission – a stringent endpoint consisting of closure of all treated external openings that were draining at baseline and of an absence of collections more than 2 cm of treated perianal fistulas as confirmed by blinded central MRI – was achieved in 56.3% of 103 treated patients, compared with 38.6% of 101 patients who received placebo (P = .010), Daniel C. Baumgart, MD, reported at the World Congress of Gastroenterology at ACG 2017.
This parallel-group, double-blind, multicenter study included patients who had draining, treatment-refractory, complex perianal fistulas and inactive or mildly active luminal Crohn’s disease (Crohn’s Disease Activity Index scores of 220 or less) at baseline. Those randomized to the Cx601 group received a single intralesional injection of 120 million expanded adipose-derived stem cells and standard of care. Those in the control arm received a placebo injection plus standard of care, said Dr. Baumgart of Charité Medical School, which is affiliated with both Humboldt University in Berlin and the Free University of Berlin.
Prior to receiving treatment or placebo, the patients underwent fistula curettage and, if indicated, seton placement and subsequent removal, he noted, adding that baseline concomitant medications, including immunosuppressants and anti–tumor necrosis factors, were continued without dose or regimen modification and that antibiotics were allowed for up to 4 weeks.
The 52-week findings were evaluated in the modified intention-to-treat population of patients who were randomized, were treated, and had at least one postbaseline efficacy assessment (61.8% of the study population). These findings showed that Cx601 is associated with even better outcomes at 1 year than those reported at 24 weeks; those prior results, published in The Lancet in July 2016, showed combined remission rates in the modified intention-to-treat population of 51% vs. 36% for placebo.
Furthermore, 75% of treated patients who achieved combined remission at 24 weeks maintained that remission at 52 weeks, compared with 55.9% of those in the placebo group (P = .052), Dr. Baumgart said.
Sensitivity analyses in this long-term assessment supported the long-term effectiveness of Cx601 over that of the control treatment, which provided evidence on the robustness of its advantage, he said, noting that safety results were also encouraging.
“The safety profile was similar to week 24; there were no new safety signals there at all,” he said.
The findings are of note because existing therapies for complex perianal fistulas in Crohn’s disease are often ineffective, he said, adding that fistulas occur in up to 50% of Crohn’s disease patients and that 70%-80% are complex and difficult to treat. Most are refractory to conventional anti–tumor necrosis factor therapies, and 60%-70% of patients relapse, he explained.
“If we’re honest, very few medications have been properly studied,” he said, adding that fistula patients often are excluded from industry trials.
“So [the ADMIRE CD trial] is new, design-wise, and has addressed a true medical need,” he said.
He attributed the good placebo response in this trial to the ongoing standard of care treatment in both groups, as well as to the team approach to care used in the trial. He also noted that a number of questions regarding the use of Cx601 remain to be answered, including the when the ideal retreatment time point should be, whether the treatment can be used for rectovaginal fistulas, and which patients should not receive treatment.
“So there is a lot to learn still, but I think it’s a revolutionary step forward, compared to what we have today, due to the trial design, which I think is robust, and also the encouraging outcomes,” he said.
The ADMIRE CD trial was sponsored by TiGenix SAU. Dr. Baumgart has received consulting fees and nonfinancial support from AbbVie, Biogen, and BMS.
ORLANDO – A single treatment with a suspension of allogeneic expanded adipose-derived mesenchymal stem cells, or Cx601, promotes long-term combined remission of complex perianal fistulas in patients with Crohn’s disease, according to 52-week results from the phase 3 ADMIRE CD trial.
Combined remission – a stringent endpoint consisting of closure of all treated external openings that were draining at baseline and of an absence of collections more than 2 cm of treated perianal fistulas as confirmed by blinded central MRI – was achieved in 56.3% of 103 treated patients, compared with 38.6% of 101 patients who received placebo (P = .010), Daniel C. Baumgart, MD, reported at the World Congress of Gastroenterology at ACG 2017.
This parallel-group, double-blind, multicenter study included patients who had draining, treatment-refractory, complex perianal fistulas and inactive or mildly active luminal Crohn’s disease (Crohn’s Disease Activity Index scores of 220 or less) at baseline. Those randomized to the Cx601 group received a single intralesional injection of 120 million expanded adipose-derived stem cells and standard of care. Those in the control arm received a placebo injection plus standard of care, said Dr. Baumgart of Charité Medical School, which is affiliated with both Humboldt University in Berlin and the Free University of Berlin.
Prior to receiving treatment or placebo, the patients underwent fistula curettage and, if indicated, seton placement and subsequent removal, he noted, adding that baseline concomitant medications, including immunosuppressants and anti–tumor necrosis factors, were continued without dose or regimen modification and that antibiotics were allowed for up to 4 weeks.
The 52-week findings were evaluated in the modified intention-to-treat population of patients who were randomized, were treated, and had at least one postbaseline efficacy assessment (61.8% of the study population). These findings showed that Cx601 is associated with even better outcomes at 1 year than those reported at 24 weeks; those prior results, published in The Lancet in July 2016, showed combined remission rates in the modified intention-to-treat population of 51% vs. 36% for placebo.
Furthermore, 75% of treated patients who achieved combined remission at 24 weeks maintained that remission at 52 weeks, compared with 55.9% of those in the placebo group (P = .052), Dr. Baumgart said.
Sensitivity analyses in this long-term assessment supported the long-term effectiveness of Cx601 over that of the control treatment, which provided evidence on the robustness of its advantage, he said, noting that safety results were also encouraging.
“The safety profile was similar to week 24; there were no new safety signals there at all,” he said.
The findings are of note because existing therapies for complex perianal fistulas in Crohn’s disease are often ineffective, he said, adding that fistulas occur in up to 50% of Crohn’s disease patients and that 70%-80% are complex and difficult to treat. Most are refractory to conventional anti–tumor necrosis factor therapies, and 60%-70% of patients relapse, he explained.
“If we’re honest, very few medications have been properly studied,” he said, adding that fistula patients often are excluded from industry trials.
“So [the ADMIRE CD trial] is new, design-wise, and has addressed a true medical need,” he said.
He attributed the good placebo response in this trial to the ongoing standard of care treatment in both groups, as well as to the team approach to care used in the trial. He also noted that a number of questions regarding the use of Cx601 remain to be answered, including the when the ideal retreatment time point should be, whether the treatment can be used for rectovaginal fistulas, and which patients should not receive treatment.
“So there is a lot to learn still, but I think it’s a revolutionary step forward, compared to what we have today, due to the trial design, which I think is robust, and also the encouraging outcomes,” he said.
The ADMIRE CD trial was sponsored by TiGenix SAU. Dr. Baumgart has received consulting fees and nonfinancial support from AbbVie, Biogen, and BMS.
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Combined remission was achieved in 56.3% of treated patients, compared with 38.6% of controls.
Data source: The phase 3 ADMIRE CD trial of 204 patients.
Disclosures: The ADMIRE CD trial was sponsored by TiGenix SAU. Dr. Baumgart has received consulting fees and nonfinancial support from AbbVie, Biogen, and Bristol-Myers Squibb.
Barrett’s esophagus length predicts disease progression
ORLANDO – Barrett’s esophagus length is a readily accessible endoscopic marker for disease progression, and it could aid in risk stratification and decision making about patient management, according to a review of records at a tertiary care center.
Of 301 patients who were diagnosed with Barrett’s esophagus and who underwent radiofrequency ablation (RFA) between March 2006 and 2016, 106 met a standardized definition of Barrett’s esophagus and were included in the study on the basis of the remaining criteria, including having nondysplastic Barrett’s esophagus and at least 1 year of follow-up from the time of initial diagnosis.
Of those 106 patients, 53 progressed to high-grade dysplasia/esophageal adenocarcinoma (HGD/EAC). The overall annual risk of EAC and combined HGD/EAC for the entire cohort was 1.23%/year and 5.94%/year, respectively. Those who progressed had significantly longer Barrett’s esophagus length, compared with 53 nonprogressors (6.37 cm vs. 4.3 cm).
In fact, of all characteristics assessed, including Barrett’s esophagus length, age, sex, race, mean body mass index, family history of esophageal cancer, proton pump inhibitor use, and total duration of follow-up, only the first was a significant predictor of progression.
“For every 1-cm increase in length of BE [Barrett’s esophagus], the risk of progression to EAC increases by 16%,” Dr. Spataro said.
Although this work, which was awarded a “Presidential Poster” ribbon, is limited by the retrospective design, lack of standardization of surveillance intervals and biopsy protocols, and by the possibility of elevated progression rates due to the nature of the center (a referral center with ablative therapy options), the study included a “decent sample and follow-up,” and has important implications for patient care, he noted, explaining that the incidence of EAC has increased faster than any other malignancy in the Western world.
Despite therapeutic advances, the prognosis for patients with EAC remains poor; the annual risk of progression from Barrett’s esophagus to HGD is 0.38%, he added.
Currently, the most commonly used risk-stratification tool for determining surveillance intervals and management of patients with Barrett’s esophagus is the degree of dysplasia. Prior studies have evaluated Barrett’s esophagus length as a predictor of progression to HGD/EAC, but findings have been conflicting, he said.
The current findings suggest that until molecular biomarkers are identified and validated as adjunctive tools for risk stratification, Barrett’s esophagus length could be used to identify patients with nondysplastic Barrett’s esophagus at risk for disease progression.
This could facilitate more rational tailoring of endoscopic surveillance, explained lead author Christina Tofani, MD.
Currently, Barrett’s esophagus patients at the center who have dysplasia generally undergo ablation, while those without dysplasia generally undergo surveillance. Barrett’s esophagus length could be used to adjust surveillance intervals, or to lower the bar for ablation in some cases, she said.
The authors reported having no disclosures.
ORLANDO – Barrett’s esophagus length is a readily accessible endoscopic marker for disease progression, and it could aid in risk stratification and decision making about patient management, according to a review of records at a tertiary care center.
Of 301 patients who were diagnosed with Barrett’s esophagus and who underwent radiofrequency ablation (RFA) between March 2006 and 2016, 106 met a standardized definition of Barrett’s esophagus and were included in the study on the basis of the remaining criteria, including having nondysplastic Barrett’s esophagus and at least 1 year of follow-up from the time of initial diagnosis.
Of those 106 patients, 53 progressed to high-grade dysplasia/esophageal adenocarcinoma (HGD/EAC). The overall annual risk of EAC and combined HGD/EAC for the entire cohort was 1.23%/year and 5.94%/year, respectively. Those who progressed had significantly longer Barrett’s esophagus length, compared with 53 nonprogressors (6.37 cm vs. 4.3 cm).
In fact, of all characteristics assessed, including Barrett’s esophagus length, age, sex, race, mean body mass index, family history of esophageal cancer, proton pump inhibitor use, and total duration of follow-up, only the first was a significant predictor of progression.
“For every 1-cm increase in length of BE [Barrett’s esophagus], the risk of progression to EAC increases by 16%,” Dr. Spataro said.
Although this work, which was awarded a “Presidential Poster” ribbon, is limited by the retrospective design, lack of standardization of surveillance intervals and biopsy protocols, and by the possibility of elevated progression rates due to the nature of the center (a referral center with ablative therapy options), the study included a “decent sample and follow-up,” and has important implications for patient care, he noted, explaining that the incidence of EAC has increased faster than any other malignancy in the Western world.
Despite therapeutic advances, the prognosis for patients with EAC remains poor; the annual risk of progression from Barrett’s esophagus to HGD is 0.38%, he added.
Currently, the most commonly used risk-stratification tool for determining surveillance intervals and management of patients with Barrett’s esophagus is the degree of dysplasia. Prior studies have evaluated Barrett’s esophagus length as a predictor of progression to HGD/EAC, but findings have been conflicting, he said.
The current findings suggest that until molecular biomarkers are identified and validated as adjunctive tools for risk stratification, Barrett’s esophagus length could be used to identify patients with nondysplastic Barrett’s esophagus at risk for disease progression.
This could facilitate more rational tailoring of endoscopic surveillance, explained lead author Christina Tofani, MD.
Currently, Barrett’s esophagus patients at the center who have dysplasia generally undergo ablation, while those without dysplasia generally undergo surveillance. Barrett’s esophagus length could be used to adjust surveillance intervals, or to lower the bar for ablation in some cases, she said.
The authors reported having no disclosures.
ORLANDO – Barrett’s esophagus length is a readily accessible endoscopic marker for disease progression, and it could aid in risk stratification and decision making about patient management, according to a review of records at a tertiary care center.
Of 301 patients who were diagnosed with Barrett’s esophagus and who underwent radiofrequency ablation (RFA) between March 2006 and 2016, 106 met a standardized definition of Barrett’s esophagus and were included in the study on the basis of the remaining criteria, including having nondysplastic Barrett’s esophagus and at least 1 year of follow-up from the time of initial diagnosis.
Of those 106 patients, 53 progressed to high-grade dysplasia/esophageal adenocarcinoma (HGD/EAC). The overall annual risk of EAC and combined HGD/EAC for the entire cohort was 1.23%/year and 5.94%/year, respectively. Those who progressed had significantly longer Barrett’s esophagus length, compared with 53 nonprogressors (6.37 cm vs. 4.3 cm).
In fact, of all characteristics assessed, including Barrett’s esophagus length, age, sex, race, mean body mass index, family history of esophageal cancer, proton pump inhibitor use, and total duration of follow-up, only the first was a significant predictor of progression.
“For every 1-cm increase in length of BE [Barrett’s esophagus], the risk of progression to EAC increases by 16%,” Dr. Spataro said.
Although this work, which was awarded a “Presidential Poster” ribbon, is limited by the retrospective design, lack of standardization of surveillance intervals and biopsy protocols, and by the possibility of elevated progression rates due to the nature of the center (a referral center with ablative therapy options), the study included a “decent sample and follow-up,” and has important implications for patient care, he noted, explaining that the incidence of EAC has increased faster than any other malignancy in the Western world.
Despite therapeutic advances, the prognosis for patients with EAC remains poor; the annual risk of progression from Barrett’s esophagus to HGD is 0.38%, he added.
Currently, the most commonly used risk-stratification tool for determining surveillance intervals and management of patients with Barrett’s esophagus is the degree of dysplasia. Prior studies have evaluated Barrett’s esophagus length as a predictor of progression to HGD/EAC, but findings have been conflicting, he said.
The current findings suggest that until molecular biomarkers are identified and validated as adjunctive tools for risk stratification, Barrett’s esophagus length could be used to identify patients with nondysplastic Barrett’s esophagus at risk for disease progression.
This could facilitate more rational tailoring of endoscopic surveillance, explained lead author Christina Tofani, MD.
Currently, Barrett’s esophagus patients at the center who have dysplasia generally undergo ablation, while those without dysplasia generally undergo surveillance. Barrett’s esophagus length could be used to adjust surveillance intervals, or to lower the bar for ablation in some cases, she said.
The authors reported having no disclosures.
AT THE 13TH WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Barrett’s esophagus length was found to be a significant independent predictor of progression to adenocarcinoma (odds ratio, 1.16).
Data source: A retrospective review of 106 cases.
Disclosures: The authors reported having no disclosures.
Pilot study: Novel spray powder stops GI bleeding
ORLANDO – TC-325 (Hemospray), a proprietary mineral powder blend developed for endoscopic hemostasis, promoted immediate hemostasis and prevented rebleeding in patients with malignant gastrointestinal bleeding in a randomized pilot trial.
Nine of 10 patients randomized to receive treatment with TC-325 experienced immediate hemostasis, compared with 4 of 10 patients randomized to receive standard of care (usually argon plasma coagulation, sometimes with radiation therapy), Alan Barkun, MD, of McGill University, Montreal reported at the World Congress of Gastroenterology at ACG 2017.
Five of six patients in the standard of care group who did not achieve immediate hemostasis crossed over to TC-325. Hemostasis was then achieved at index endoscopy in 80% of these crossovers, said Dr. Barkun, whose work received the 2017 GI Bleeding Category Award at the congress.
“So a total of 15 patients were treated with Hemospray among both groups, and 100% of them achieved immediate hemostasis,” he said. “We also assessed feasibility of recruitment and randomization, and it was indeed demonstrated in the context of this feasibility trial.”
Secondary measures, including the use of additional hemostatic approaches, blood transfusions, length of stay, and mortality, among others, did not differ between the two groups.
“This pilot trial is the first to assess TC-325 in patients with malignant bleeding, allowing us to plan for adequate powering and demonstrating feasibility for a larger multicenter, randomized, controlled trial,” he said. “Although this trial was not powered to seek statistically significant differences, the observed results suggest that TC-325 may indeed be a promising hemostatic modality in managing patients with malignant bleeding in achieving both immediate hemostasis and in our minds, surprisingly, perhaps delayed rebleeding.”
Hemospray, which is approved in Canada for upper/lower gastrointestinal bleeding of any etiology, as well as in Mexico and in some countries in Europe, Asia, and South America, works by forming a mechanical barrier over the bleeding site. The powder absorbs water, then acts both cohesively and adhesively to form that barrier, according to information from Cook Medical, which developed the product. It is not currently approved for this indication in the United States.
“An adequately powered randomized, controlled trial is now needed to better determine any beneficial downstream effect on subsequent rebleeding and health care resource use when compared to existing standard of care,” he concluded.
Dr. Barkun is an advisory committee/board member and consultant for Cook Medical and has received grant/research support from the company.
ORLANDO – TC-325 (Hemospray), a proprietary mineral powder blend developed for endoscopic hemostasis, promoted immediate hemostasis and prevented rebleeding in patients with malignant gastrointestinal bleeding in a randomized pilot trial.
Nine of 10 patients randomized to receive treatment with TC-325 experienced immediate hemostasis, compared with 4 of 10 patients randomized to receive standard of care (usually argon plasma coagulation, sometimes with radiation therapy), Alan Barkun, MD, of McGill University, Montreal reported at the World Congress of Gastroenterology at ACG 2017.
Five of six patients in the standard of care group who did not achieve immediate hemostasis crossed over to TC-325. Hemostasis was then achieved at index endoscopy in 80% of these crossovers, said Dr. Barkun, whose work received the 2017 GI Bleeding Category Award at the congress.
“So a total of 15 patients were treated with Hemospray among both groups, and 100% of them achieved immediate hemostasis,” he said. “We also assessed feasibility of recruitment and randomization, and it was indeed demonstrated in the context of this feasibility trial.”
Secondary measures, including the use of additional hemostatic approaches, blood transfusions, length of stay, and mortality, among others, did not differ between the two groups.
“This pilot trial is the first to assess TC-325 in patients with malignant bleeding, allowing us to plan for adequate powering and demonstrating feasibility for a larger multicenter, randomized, controlled trial,” he said. “Although this trial was not powered to seek statistically significant differences, the observed results suggest that TC-325 may indeed be a promising hemostatic modality in managing patients with malignant bleeding in achieving both immediate hemostasis and in our minds, surprisingly, perhaps delayed rebleeding.”
Hemospray, which is approved in Canada for upper/lower gastrointestinal bleeding of any etiology, as well as in Mexico and in some countries in Europe, Asia, and South America, works by forming a mechanical barrier over the bleeding site. The powder absorbs water, then acts both cohesively and adhesively to form that barrier, according to information from Cook Medical, which developed the product. It is not currently approved for this indication in the United States.
“An adequately powered randomized, controlled trial is now needed to better determine any beneficial downstream effect on subsequent rebleeding and health care resource use when compared to existing standard of care,” he concluded.
Dr. Barkun is an advisory committee/board member and consultant for Cook Medical and has received grant/research support from the company.
ORLANDO – TC-325 (Hemospray), a proprietary mineral powder blend developed for endoscopic hemostasis, promoted immediate hemostasis and prevented rebleeding in patients with malignant gastrointestinal bleeding in a randomized pilot trial.
Nine of 10 patients randomized to receive treatment with TC-325 experienced immediate hemostasis, compared with 4 of 10 patients randomized to receive standard of care (usually argon plasma coagulation, sometimes with radiation therapy), Alan Barkun, MD, of McGill University, Montreal reported at the World Congress of Gastroenterology at ACG 2017.
Five of six patients in the standard of care group who did not achieve immediate hemostasis crossed over to TC-325. Hemostasis was then achieved at index endoscopy in 80% of these crossovers, said Dr. Barkun, whose work received the 2017 GI Bleeding Category Award at the congress.
“So a total of 15 patients were treated with Hemospray among both groups, and 100% of them achieved immediate hemostasis,” he said. “We also assessed feasibility of recruitment and randomization, and it was indeed demonstrated in the context of this feasibility trial.”
Secondary measures, including the use of additional hemostatic approaches, blood transfusions, length of stay, and mortality, among others, did not differ between the two groups.
“This pilot trial is the first to assess TC-325 in patients with malignant bleeding, allowing us to plan for adequate powering and demonstrating feasibility for a larger multicenter, randomized, controlled trial,” he said. “Although this trial was not powered to seek statistically significant differences, the observed results suggest that TC-325 may indeed be a promising hemostatic modality in managing patients with malignant bleeding in achieving both immediate hemostasis and in our minds, surprisingly, perhaps delayed rebleeding.”
Hemospray, which is approved in Canada for upper/lower gastrointestinal bleeding of any etiology, as well as in Mexico and in some countries in Europe, Asia, and South America, works by forming a mechanical barrier over the bleeding site. The powder absorbs water, then acts both cohesively and adhesively to form that barrier, according to information from Cook Medical, which developed the product. It is not currently approved for this indication in the United States.
“An adequately powered randomized, controlled trial is now needed to better determine any beneficial downstream effect on subsequent rebleeding and health care resource use when compared to existing standard of care,” he concluded.
Dr. Barkun is an advisory committee/board member and consultant for Cook Medical and has received grant/research support from the company.
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: All 15 patients treated with Hemospray achieved immediate hemostasis.
Data source: A randomized pilot study of 20 patients.
Disclosures: Dr. Barkun is an advisory committee/board member and consultant for Cook Medical and has received grant/research support from the company.
Vedolizumab improves social satisfaction among IBD patients
ORLANDO – Vedolizumab therapy was associated with significant improvements in social satisfaction scores and steroid-free remission rates in biologic-naive patients with inflammatory bowel diseases (IBD) in a large prospective cohort.
The Internet-based cohort – Crohn’s & Colitis Foundation of America (CCFA) Partners – includes more than 15,000 IBD patients. For the current study, researchers evaluated 348 participants with Crohn’s disease or ulcerative colitis who initiated vedolizumab therapy between 2014 and 2017 and who had at least 6 months’ follow-up.
The difference in social satisfaction T scores was also improved among biologic-exposed patients (45.8 vs. 47.2, respectively), but the difference did not reach statistical significance, said Dr. Long of the University of North Carolina, Chapel Hill.
Improvements were also seen for numerous other measures, including anxiety, depression, fatigue, pain interference, and sleep disturbance – for both biologic-naive and -exposed patients – but the differences were not significant.
“But these [patient-reported outcomes] are clearly improving,” she said, explaining that trends toward minimally clinically important differences were seen for multiple measures.
As for steroid-free remission, the rate improved from 20% to 45% from baseline to 6-12 months among biologic-naive patients, and from 24% to 30% among biologic-exposed patients, Dr. Long said.
Vedolizumab in this real-world cohort was predominantly used in patients with refractory disease and prior biologic exposure.
The CCFA cohort provides an important glimpse into the effects of vedolizumab on patient-reported outcomes in real-world settings, Dr. Long said, noting that while vedolizumab has demonstrated important quality of life improvements in IBD clinical trials, little has been known about the effects of vedolizumab on quality of life in real-world settings.
The finding with respect to social satisfaction is particularly important, she said.
“These are sick patients. [These scores show that] they’re able to leave the house, they’re able to do the things they want to do,” she said. “It has made a big impact to be able to address this.”
This study was funded by Takeda Pharmaceuticals USA. CCFA Partners is supported by the Crohn’s & Colitis Foundation and the Patient Centered Outcomes Research Institute.
ORLANDO – Vedolizumab therapy was associated with significant improvements in social satisfaction scores and steroid-free remission rates in biologic-naive patients with inflammatory bowel diseases (IBD) in a large prospective cohort.
The Internet-based cohort – Crohn’s & Colitis Foundation of America (CCFA) Partners – includes more than 15,000 IBD patients. For the current study, researchers evaluated 348 participants with Crohn’s disease or ulcerative colitis who initiated vedolizumab therapy between 2014 and 2017 and who had at least 6 months’ follow-up.
The difference in social satisfaction T scores was also improved among biologic-exposed patients (45.8 vs. 47.2, respectively), but the difference did not reach statistical significance, said Dr. Long of the University of North Carolina, Chapel Hill.
Improvements were also seen for numerous other measures, including anxiety, depression, fatigue, pain interference, and sleep disturbance – for both biologic-naive and -exposed patients – but the differences were not significant.
“But these [patient-reported outcomes] are clearly improving,” she said, explaining that trends toward minimally clinically important differences were seen for multiple measures.
As for steroid-free remission, the rate improved from 20% to 45% from baseline to 6-12 months among biologic-naive patients, and from 24% to 30% among biologic-exposed patients, Dr. Long said.
Vedolizumab in this real-world cohort was predominantly used in patients with refractory disease and prior biologic exposure.
The CCFA cohort provides an important glimpse into the effects of vedolizumab on patient-reported outcomes in real-world settings, Dr. Long said, noting that while vedolizumab has demonstrated important quality of life improvements in IBD clinical trials, little has been known about the effects of vedolizumab on quality of life in real-world settings.
The finding with respect to social satisfaction is particularly important, she said.
“These are sick patients. [These scores show that] they’re able to leave the house, they’re able to do the things they want to do,” she said. “It has made a big impact to be able to address this.”
This study was funded by Takeda Pharmaceuticals USA. CCFA Partners is supported by the Crohn’s & Colitis Foundation and the Patient Centered Outcomes Research Institute.
ORLANDO – Vedolizumab therapy was associated with significant improvements in social satisfaction scores and steroid-free remission rates in biologic-naive patients with inflammatory bowel diseases (IBD) in a large prospective cohort.
The Internet-based cohort – Crohn’s & Colitis Foundation of America (CCFA) Partners – includes more than 15,000 IBD patients. For the current study, researchers evaluated 348 participants with Crohn’s disease or ulcerative colitis who initiated vedolizumab therapy between 2014 and 2017 and who had at least 6 months’ follow-up.
The difference in social satisfaction T scores was also improved among biologic-exposed patients (45.8 vs. 47.2, respectively), but the difference did not reach statistical significance, said Dr. Long of the University of North Carolina, Chapel Hill.
Improvements were also seen for numerous other measures, including anxiety, depression, fatigue, pain interference, and sleep disturbance – for both biologic-naive and -exposed patients – but the differences were not significant.
“But these [patient-reported outcomes] are clearly improving,” she said, explaining that trends toward minimally clinically important differences were seen for multiple measures.
As for steroid-free remission, the rate improved from 20% to 45% from baseline to 6-12 months among biologic-naive patients, and from 24% to 30% among biologic-exposed patients, Dr. Long said.
Vedolizumab in this real-world cohort was predominantly used in patients with refractory disease and prior biologic exposure.
The CCFA cohort provides an important glimpse into the effects of vedolizumab on patient-reported outcomes in real-world settings, Dr. Long said, noting that while vedolizumab has demonstrated important quality of life improvements in IBD clinical trials, little has been known about the effects of vedolizumab on quality of life in real-world settings.
The finding with respect to social satisfaction is particularly important, she said.
“These are sick patients. [These scores show that] they’re able to leave the house, they’re able to do the things they want to do,” she said. “It has made a big impact to be able to address this.”
This study was funded by Takeda Pharmaceuticals USA. CCFA Partners is supported by the Crohn’s & Colitis Foundation and the Patient Centered Outcomes Research Institute.
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: T scores in biologic-naive patients improved significantly (46.1 before treatment vs. 51.0 after 6 months).
Data source: A prospective cohort study of 348 patients.
Disclosures: This study was funded by Takeda Pharmaceuticals USA. CCFA Partners is supported by the Crohn’s and Colitis Foundation and the Patient Centered Outcomes Research Institute.
VIDEO: IBD epidemiology provides clues into disease underpinnings
ORLANDO – The incidence of Crohn’s disease and ulcerative colitis has stabilized in the Western world, but is rising rapidly in newly industrialized countries, according to a systematic review of population-based studies.
The findings could provide important new insights into the environmental, genetic, and microbiome-related factors and interactions that form the underpinnings of IBD, Gilaad Kaplan, MD, of the University of Calgary (Alta.) said at the World Congress of Gastroenterology at ACG 2017.
In turn, that information could lead to approaches to reduce IBD incidence, he said in a video interview.
It has been known that Crohn’s disease and ulcerative colitis are “modern diseases of modern times,” but few studies have addressed the epidemiology of IBD in newly industrialized countries in Asia, Africa, and South America, he said.
“We see a pattern that as newly industrialized countries transition toward a westernized society, IBD emerges and its incidence rises, and there are many different explanations for that,” he said, noting that in part, the increase is due to improved health care infrastructure and advances in adoption of medical technology that lead to better identification of new cases.
“But probably one of the most important factors is that there are environmental exposures linked to the westernization of society that are creating this pressure that’s driving incidence of IBD up in many of the countries of the world,” he said. “I think if we do a lot more research focused on how environment influences microbiome, we might start to see things we could do that could potentially stem the tide of IBD.”
Dr. Kaplan reported having no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – The incidence of Crohn’s disease and ulcerative colitis has stabilized in the Western world, but is rising rapidly in newly industrialized countries, according to a systematic review of population-based studies.
The findings could provide important new insights into the environmental, genetic, and microbiome-related factors and interactions that form the underpinnings of IBD, Gilaad Kaplan, MD, of the University of Calgary (Alta.) said at the World Congress of Gastroenterology at ACG 2017.
In turn, that information could lead to approaches to reduce IBD incidence, he said in a video interview.
It has been known that Crohn’s disease and ulcerative colitis are “modern diseases of modern times,” but few studies have addressed the epidemiology of IBD in newly industrialized countries in Asia, Africa, and South America, he said.
“We see a pattern that as newly industrialized countries transition toward a westernized society, IBD emerges and its incidence rises, and there are many different explanations for that,” he said, noting that in part, the increase is due to improved health care infrastructure and advances in adoption of medical technology that lead to better identification of new cases.
“But probably one of the most important factors is that there are environmental exposures linked to the westernization of society that are creating this pressure that’s driving incidence of IBD up in many of the countries of the world,” he said. “I think if we do a lot more research focused on how environment influences microbiome, we might start to see things we could do that could potentially stem the tide of IBD.”
Dr. Kaplan reported having no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – The incidence of Crohn’s disease and ulcerative colitis has stabilized in the Western world, but is rising rapidly in newly industrialized countries, according to a systematic review of population-based studies.
The findings could provide important new insights into the environmental, genetic, and microbiome-related factors and interactions that form the underpinnings of IBD, Gilaad Kaplan, MD, of the University of Calgary (Alta.) said at the World Congress of Gastroenterology at ACG 2017.
In turn, that information could lead to approaches to reduce IBD incidence, he said in a video interview.
It has been known that Crohn’s disease and ulcerative colitis are “modern diseases of modern times,” but few studies have addressed the epidemiology of IBD in newly industrialized countries in Asia, Africa, and South America, he said.
“We see a pattern that as newly industrialized countries transition toward a westernized society, IBD emerges and its incidence rises, and there are many different explanations for that,” he said, noting that in part, the increase is due to improved health care infrastructure and advances in adoption of medical technology that lead to better identification of new cases.
“But probably one of the most important factors is that there are environmental exposures linked to the westernization of society that are creating this pressure that’s driving incidence of IBD up in many of the countries of the world,” he said. “I think if we do a lot more research focused on how environment influences microbiome, we might start to see things we could do that could potentially stem the tide of IBD.”
Dr. Kaplan reported having no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE 13TH WORLD CONGRESS OF GASTROENTEROLOGY
VIDEO: Mechanical colonoscope enhancements improve adenoma detection
ORLANDO – Mechanical enhancements to existing colonoscopes may be better than optical enhancements for improving adenoma detection, according to findings from a meta-analysis of data from 240 studies.
“Even though colonoscopy is felt to be our best test compared to others … we also recognize that we do not see every square inch of the colon,” Seth Gross, MD, of New York University Langone Medical Center said in a video interview at the World Congress of Gastroenterology at ACG 2017.
There has been a “tremendous drive” to improve the ability to inspect blind spots in the colon, and also to better recognize subtle precancerous lesions in visible areas of the colon, but it has been unclear whether optical or mechanical enhancements will better achieve that goal, Dr. Gross said.
Based on the findings of his meta-analysis, it appears that mechanical enhancements, including integrated balloons and single-use caps with finger-like projections or discs that clip on to the colonoscope to engage the colon wall and flatten areas to allow access to areas behind folds, are most effective.
The preliminary data should lead to more clinical questions about what can be done to improve exams, he said.
In fact, one four-arm study looking at standard colonoscopy vs. colonoscopy with various mechanical enhancements was just completed, and others looking at “deep learning” and computer assistance are underway.
The latter technology is intriguing, as “not every polyp that we’re missing is behind a fold,” Dr. Gross noted.
Preliminary findings from a study out of China demonstrated the feasibility of such computer assistance, and the researchers are now working on a prospective study of real-time cases to see if that type of integrated learning with computer assistance can improve polyp detection.
“Sometimes it’s just these subtle mucosal changes that we have to train our eye to identify,” he said. “So imagine having another set of eyes … where there’s a computer sort of highlighting an area that we should focus on.”
Dr. Gross reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – Mechanical enhancements to existing colonoscopes may be better than optical enhancements for improving adenoma detection, according to findings from a meta-analysis of data from 240 studies.
“Even though colonoscopy is felt to be our best test compared to others … we also recognize that we do not see every square inch of the colon,” Seth Gross, MD, of New York University Langone Medical Center said in a video interview at the World Congress of Gastroenterology at ACG 2017.
There has been a “tremendous drive” to improve the ability to inspect blind spots in the colon, and also to better recognize subtle precancerous lesions in visible areas of the colon, but it has been unclear whether optical or mechanical enhancements will better achieve that goal, Dr. Gross said.
Based on the findings of his meta-analysis, it appears that mechanical enhancements, including integrated balloons and single-use caps with finger-like projections or discs that clip on to the colonoscope to engage the colon wall and flatten areas to allow access to areas behind folds, are most effective.
The preliminary data should lead to more clinical questions about what can be done to improve exams, he said.
In fact, one four-arm study looking at standard colonoscopy vs. colonoscopy with various mechanical enhancements was just completed, and others looking at “deep learning” and computer assistance are underway.
The latter technology is intriguing, as “not every polyp that we’re missing is behind a fold,” Dr. Gross noted.
Preliminary findings from a study out of China demonstrated the feasibility of such computer assistance, and the researchers are now working on a prospective study of real-time cases to see if that type of integrated learning with computer assistance can improve polyp detection.
“Sometimes it’s just these subtle mucosal changes that we have to train our eye to identify,” he said. “So imagine having another set of eyes … where there’s a computer sort of highlighting an area that we should focus on.”
Dr. Gross reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – Mechanical enhancements to existing colonoscopes may be better than optical enhancements for improving adenoma detection, according to findings from a meta-analysis of data from 240 studies.
“Even though colonoscopy is felt to be our best test compared to others … we also recognize that we do not see every square inch of the colon,” Seth Gross, MD, of New York University Langone Medical Center said in a video interview at the World Congress of Gastroenterology at ACG 2017.
There has been a “tremendous drive” to improve the ability to inspect blind spots in the colon, and also to better recognize subtle precancerous lesions in visible areas of the colon, but it has been unclear whether optical or mechanical enhancements will better achieve that goal, Dr. Gross said.
Based on the findings of his meta-analysis, it appears that mechanical enhancements, including integrated balloons and single-use caps with finger-like projections or discs that clip on to the colonoscope to engage the colon wall and flatten areas to allow access to areas behind folds, are most effective.
The preliminary data should lead to more clinical questions about what can be done to improve exams, he said.
In fact, one four-arm study looking at standard colonoscopy vs. colonoscopy with various mechanical enhancements was just completed, and others looking at “deep learning” and computer assistance are underway.
The latter technology is intriguing, as “not every polyp that we’re missing is behind a fold,” Dr. Gross noted.
Preliminary findings from a study out of China demonstrated the feasibility of such computer assistance, and the researchers are now working on a prospective study of real-time cases to see if that type of integrated learning with computer assistance can improve polyp detection.
“Sometimes it’s just these subtle mucosal changes that we have to train our eye to identify,” he said. “So imagine having another set of eyes … where there’s a computer sort of highlighting an area that we should focus on.”
Dr. Gross reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
More IBD remissions with higher induction vedolizumab levels
ORLANDO – Higher vedolizumab levels during induction were associated with better responses to therapy at 22 weeks in patients with inflammatory bowel diseases in a prospective cohort study.
The findings suggest that therapeutic drug monitoring and early optimization could play an important role in improving outcomes in patients with Crohn’s disease or ulcerative colitis who are receiving treatment with the monoclonal antibody, Andres J. Yarur, MD, reported in a poster at the World Congress of Gastroenterology at ACG 2017.
Patients with a VTL of 24 mcg/mL or greater at week 2, and 10.6 mcg/mL or greater at week 6, were more likely to be in remission at week 22 (odds ratios, 5 and 13.5, respectively).
Of note, VTLs were numerically higher in patients receiving combination therapy, compared with those receiving vedolizumab monotherapy, but the difference was statistically significant only at week 2 (24.7 vs. 21.8 mcg/mL, respectively), he said.
Similar correlations between trough levels and response rates have been seen with other biologics, but data on such correlations has been lacking for vedolizumab. Since some patients develop primary or secondary nonresponse, Dr. Yarur and his colleagues assessed the relationship between serum VTLs during induction and disease remission after 22 weeks, he explained in an interview.
They also investigated the presence of antibodies to vedolizumab .
The primary outcome of deep remission at 22 weeks was defined as normal C-reactive protein levels and Simple Endoscopic Score for Crohn’s Disease of 2 or less in patients with Crohn’s disease, and Mayo Endoscopic score of 1 or less in patients with ulcerative colitis, plus clinical remission (Harvey-Bradshaw Index score of less than 5 in patients with Crohn’s disease and Mayo Clinical Score of less than 3 in ulcerative colitis).
Three patients developed antibodies to vedolizumab during induction, but the antibodies were undetectable by week 14 in all three, he said.
“The findings open the question of whether higher doses during induction will improve the rate of remission,” he said, noting that such early optimization is currently being evaluated in ongoing studies.
Dr. Yarur reported having no relevant disclosures.
ORLANDO – Higher vedolizumab levels during induction were associated with better responses to therapy at 22 weeks in patients with inflammatory bowel diseases in a prospective cohort study.
The findings suggest that therapeutic drug monitoring and early optimization could play an important role in improving outcomes in patients with Crohn’s disease or ulcerative colitis who are receiving treatment with the monoclonal antibody, Andres J. Yarur, MD, reported in a poster at the World Congress of Gastroenterology at ACG 2017.
Patients with a VTL of 24 mcg/mL or greater at week 2, and 10.6 mcg/mL or greater at week 6, were more likely to be in remission at week 22 (odds ratios, 5 and 13.5, respectively).
Of note, VTLs were numerically higher in patients receiving combination therapy, compared with those receiving vedolizumab monotherapy, but the difference was statistically significant only at week 2 (24.7 vs. 21.8 mcg/mL, respectively), he said.
Similar correlations between trough levels and response rates have been seen with other biologics, but data on such correlations has been lacking for vedolizumab. Since some patients develop primary or secondary nonresponse, Dr. Yarur and his colleagues assessed the relationship between serum VTLs during induction and disease remission after 22 weeks, he explained in an interview.
They also investigated the presence of antibodies to vedolizumab .
The primary outcome of deep remission at 22 weeks was defined as normal C-reactive protein levels and Simple Endoscopic Score for Crohn’s Disease of 2 or less in patients with Crohn’s disease, and Mayo Endoscopic score of 1 or less in patients with ulcerative colitis, plus clinical remission (Harvey-Bradshaw Index score of less than 5 in patients with Crohn’s disease and Mayo Clinical Score of less than 3 in ulcerative colitis).
Three patients developed antibodies to vedolizumab during induction, but the antibodies were undetectable by week 14 in all three, he said.
“The findings open the question of whether higher doses during induction will improve the rate of remission,” he said, noting that such early optimization is currently being evaluated in ongoing studies.
Dr. Yarur reported having no relevant disclosures.
ORLANDO – Higher vedolizumab levels during induction were associated with better responses to therapy at 22 weeks in patients with inflammatory bowel diseases in a prospective cohort study.
The findings suggest that therapeutic drug monitoring and early optimization could play an important role in improving outcomes in patients with Crohn’s disease or ulcerative colitis who are receiving treatment with the monoclonal antibody, Andres J. Yarur, MD, reported in a poster at the World Congress of Gastroenterology at ACG 2017.
Patients with a VTL of 24 mcg/mL or greater at week 2, and 10.6 mcg/mL or greater at week 6, were more likely to be in remission at week 22 (odds ratios, 5 and 13.5, respectively).
Of note, VTLs were numerically higher in patients receiving combination therapy, compared with those receiving vedolizumab monotherapy, but the difference was statistically significant only at week 2 (24.7 vs. 21.8 mcg/mL, respectively), he said.
Similar correlations between trough levels and response rates have been seen with other biologics, but data on such correlations has been lacking for vedolizumab. Since some patients develop primary or secondary nonresponse, Dr. Yarur and his colleagues assessed the relationship between serum VTLs during induction and disease remission after 22 weeks, he explained in an interview.
They also investigated the presence of antibodies to vedolizumab .
The primary outcome of deep remission at 22 weeks was defined as normal C-reactive protein levels and Simple Endoscopic Score for Crohn’s Disease of 2 or less in patients with Crohn’s disease, and Mayo Endoscopic score of 1 or less in patients with ulcerative colitis, plus clinical remission (Harvey-Bradshaw Index score of less than 5 in patients with Crohn’s disease and Mayo Clinical Score of less than 3 in ulcerative colitis).
Three patients developed antibodies to vedolizumab during induction, but the antibodies were undetectable by week 14 in all three, he said.
“The findings open the question of whether higher doses during induction will improve the rate of remission,” he said, noting that such early optimization is currently being evaluated in ongoing studies.
Dr. Yarur reported having no relevant disclosures.
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Vedolizumab trough levels at weeks 2 and 6 were higher among those who achieved remission at week 22, compared with those who did not (25 vs. 21.8 mcg/mL and 26.1 vs. 12.7 mcg/mL, respectively).
Data source: A prospective cohort study of 45 patients.
Disclosures: Dr. Yarur reported having no relevant disclosures.
Dabrafenib/trametinib bests docetaxel for advanced NSCLC in indirect comparison
CHICAGO – Compared with docetaxel in matched external controls, combination therapy with dabrafenib and trametinib was associated with significantly prolonged progression-free and overall survival in previously treated patients with metastatic non–small cell lung cancer in a phase 2 trial.
Median progression-free survival (PFS) was 9.7 months in 57 patients in an open-label, multicenter phase 2 trial that investigated dabrafenib/trametinib treatment for metastatic BRAF V600E–mutated NSCLC, compared with 4.2 months in 290 patients treated with docetaxel in the randomized phase 3 CheckMate057 trial, which compared nivolumab and docetaxel in similar patients (hazard ratio, 0.32). Overall survival in the groups was 19.2 vs. 9.3 months, respectively (HR, 0.41), Junlong Li, MD, of Analysis Group, Boston, reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
Patients treated with the combination of dabrafenib and trametinib also had a significantly higher overall response rate (61% vs. 12%) and disease control rate (77% vs. 55%), Dr. Li said.
Patient-level data for the combination therapy patients and summary data for the docetaxel-treated patients were used for the current analysis. Patients and controls were matched based on age, sex, race, smoking history, performance score, tumor histology, prior regimens, prior radiotherapy, and prior maintenance therapy. The two trials used for the analysis (NCT01336634 and CheckMate 057) were comparable in design and inclusion/exclusion criteria, and both used RECIST v1.1 to evaluate response to therapy.
“In the absence of head-to-head trials ... this study contributes some comparative efficacy evidence in this area,” Dr. Li concluded.
Invited discussant, Thomas Eldridge Stinchcombe, MD, of Duke University, Durham, N.C., said that the findings are unsurprising but important in that they are confirmatory.
Dr. Li is a consultant for Novartis, which sponsored the analysis.
CHICAGO – Compared with docetaxel in matched external controls, combination therapy with dabrafenib and trametinib was associated with significantly prolonged progression-free and overall survival in previously treated patients with metastatic non–small cell lung cancer in a phase 2 trial.
Median progression-free survival (PFS) was 9.7 months in 57 patients in an open-label, multicenter phase 2 trial that investigated dabrafenib/trametinib treatment for metastatic BRAF V600E–mutated NSCLC, compared with 4.2 months in 290 patients treated with docetaxel in the randomized phase 3 CheckMate057 trial, which compared nivolumab and docetaxel in similar patients (hazard ratio, 0.32). Overall survival in the groups was 19.2 vs. 9.3 months, respectively (HR, 0.41), Junlong Li, MD, of Analysis Group, Boston, reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
Patients treated with the combination of dabrafenib and trametinib also had a significantly higher overall response rate (61% vs. 12%) and disease control rate (77% vs. 55%), Dr. Li said.
Patient-level data for the combination therapy patients and summary data for the docetaxel-treated patients were used for the current analysis. Patients and controls were matched based on age, sex, race, smoking history, performance score, tumor histology, prior regimens, prior radiotherapy, and prior maintenance therapy. The two trials used for the analysis (NCT01336634 and CheckMate 057) were comparable in design and inclusion/exclusion criteria, and both used RECIST v1.1 to evaluate response to therapy.
“In the absence of head-to-head trials ... this study contributes some comparative efficacy evidence in this area,” Dr. Li concluded.
Invited discussant, Thomas Eldridge Stinchcombe, MD, of Duke University, Durham, N.C., said that the findings are unsurprising but important in that they are confirmatory.
Dr. Li is a consultant for Novartis, which sponsored the analysis.
CHICAGO – Compared with docetaxel in matched external controls, combination therapy with dabrafenib and trametinib was associated with significantly prolonged progression-free and overall survival in previously treated patients with metastatic non–small cell lung cancer in a phase 2 trial.
Median progression-free survival (PFS) was 9.7 months in 57 patients in an open-label, multicenter phase 2 trial that investigated dabrafenib/trametinib treatment for metastatic BRAF V600E–mutated NSCLC, compared with 4.2 months in 290 patients treated with docetaxel in the randomized phase 3 CheckMate057 trial, which compared nivolumab and docetaxel in similar patients (hazard ratio, 0.32). Overall survival in the groups was 19.2 vs. 9.3 months, respectively (HR, 0.41), Junlong Li, MD, of Analysis Group, Boston, reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.
Patients treated with the combination of dabrafenib and trametinib also had a significantly higher overall response rate (61% vs. 12%) and disease control rate (77% vs. 55%), Dr. Li said.
Patient-level data for the combination therapy patients and summary data for the docetaxel-treated patients were used for the current analysis. Patients and controls were matched based on age, sex, race, smoking history, performance score, tumor histology, prior regimens, prior radiotherapy, and prior maintenance therapy. The two trials used for the analysis (NCT01336634 and CheckMate 057) were comparable in design and inclusion/exclusion criteria, and both used RECIST v1.1 to evaluate response to therapy.
“In the absence of head-to-head trials ... this study contributes some comparative efficacy evidence in this area,” Dr. Li concluded.
Invited discussant, Thomas Eldridge Stinchcombe, MD, of Duke University, Durham, N.C., said that the findings are unsurprising but important in that they are confirmatory.
Dr. Li is a consultant for Novartis, which sponsored the analysis.
AT A SYMPOSIUM IN THORACIC ONCOLOGY
Key clinical point:
Major finding: Median PFS with dabrafenib and trametinib vs. docetaxel: 9.7 vs. 4.2 months (HR, 0.32); overall survival: 19.2 vs. 9.3 months (HR, 0.41).
Data source: An adjusted indirect comparison of data from 347 patients from two separate studies.
Disclosures: Dr. Li is a consultant for Novartis, which sponsored the analysis.
Novel models predict Parkinson’s disease motor progression
An ensemble of prediction models developed using genetic data and both baseline molecular and clinical variables from patients with Parkinson’s disease, as well as healthy controls, confirmed established predictors of the disease and identified new ones in a longitudinal cohort study.
Furthermore, the models were shown via simulated, randomized, placebo-controlled trials to have utility for clinical trial design and evaluation, as well as for clinical disease monitoring and treatment, Jeanne C. Latourelle, DSc, of GNS Healthcare, Cambridge, Mass., and her colleagues reported in Lancet Neurology.
“Understanding the causal and physiological factors that contribute to this variability in the evolution of symptoms of Parkinson’s disease is, therefore, a high priority area of Parkinson’s disease research,” they wrote (Lancet Neurol. 2017 Sep 25. doi: 10.1016/S1474-4422[17]30328-9).
The investigators developed the models by applying a Bayesian, machine-learning, multivariate predictive inference platform – known as Reverse Engineering and Forward Simulation – to data from the Parkinson’s Progression Markers Initiative (PPMI) study; they used these models to predict the annual rate of change in combined scores from the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III. The investigators tested the overall explanatory power of the models using the coefficient of determination (R2); their models also replicated novel findings from an independent clinical cohort from the Longitudinal and Biomarker Study in Parkinson’s disease (LABS-PD).
In 117 healthy age- and sex-matched controls and 312 patients with early-stage Parkinson’s disease from the PPMI study, the model ensemble showed strong performance (fivefold cross-validated Pearson R2, 41%), the investigators said.
In the 317-patient LABS-PD validation cohort, the performance of the models was reduced, but still statistically significant (R2, 9%).
Individual predictive features – including significant replication of higher baseline motor score on MDS-UPDRS, male sex, increased age, and novel Parkinson’s disease–specific epistatic interaction, which all were indicative of faster motor progression in the disease – were confirmed in the LABS-PD cohort, they said. The most useful predictive marker of motor progression was genetic variation (R2, 2.9%), the investigators said, and the cerebrospinal fluid biomarkers at baseline also significantly affected prediction of motor progression, although more modestly (R2, 0.3%).
In 5,000 trial simulations, the incorporation of predicted rates of motor progression into the final models of treatment effect reduced the variability in study outcome, which allowed for the detection of significant differences in sample sizes up to 20% smaller than in trials of drug-naive patients.
The investigators noted that the Bayesian model inference using Reverse Engineering and Forward Simulation was particularly good at predicting Parkinson’s motor progression in early disease stages, which has “immediate relevance toward enabling more effective trial recruitment and clinical disease management.”
This study was supported by grants from the Michael J. Fox Foundation for Parkinson’s Research and the National Institute of Neurological Disorders and Stroke. PPMI is funded by the Michael J. Fox Foundation for Parkinson’s Research, and it also has many industry funding partners. Dr. Latourelle and several of her coauthors are or were employees of GNS Healthcare.
The study by Latourelle and her colleagues adds substantial value to Parkinson’s disease research not only because of the findings but also because it introduces the topic of using multimodal data in disease prediction, an approach that is sure to grow in popularity, and one that is complex in its application and interpretation.
Although the discovery and replication efforts are of somewhat limited power – indicating a need for expansion of such efforts in terms of sample size and length of follow-up – the study marks a movement in the development of methods to predict disease progression and, therefore, assist clinicians, patients with Parkinson’s disease, and their family members with treatment and individualized disease management.
The methodology is promising, but fine-tuning and extension of current efforts are important because, while these endeavors are costly, they are vital for the development of disease-modifying therapies and the treatment of Parkinson’s disease.
Cornelis Blauwendraat, MD, and his colleagues are with the Laboratory of Neurogenetics at the National Institute on Aging. They declared having no competing interests. Their comments are taken from an editorial accompanying Dr. Latourelle and her colleagues’ report (Lancet Neurol. 2017 Sep 25. doi: 10.106/S1474-4422[17]30331-9).
The study by Latourelle and her colleagues adds substantial value to Parkinson’s disease research not only because of the findings but also because it introduces the topic of using multimodal data in disease prediction, an approach that is sure to grow in popularity, and one that is complex in its application and interpretation.
Although the discovery and replication efforts are of somewhat limited power – indicating a need for expansion of such efforts in terms of sample size and length of follow-up – the study marks a movement in the development of methods to predict disease progression and, therefore, assist clinicians, patients with Parkinson’s disease, and their family members with treatment and individualized disease management.
The methodology is promising, but fine-tuning and extension of current efforts are important because, while these endeavors are costly, they are vital for the development of disease-modifying therapies and the treatment of Parkinson’s disease.
Cornelis Blauwendraat, MD, and his colleagues are with the Laboratory of Neurogenetics at the National Institute on Aging. They declared having no competing interests. Their comments are taken from an editorial accompanying Dr. Latourelle and her colleagues’ report (Lancet Neurol. 2017 Sep 25. doi: 10.106/S1474-4422[17]30331-9).
The study by Latourelle and her colleagues adds substantial value to Parkinson’s disease research not only because of the findings but also because it introduces the topic of using multimodal data in disease prediction, an approach that is sure to grow in popularity, and one that is complex in its application and interpretation.
Although the discovery and replication efforts are of somewhat limited power – indicating a need for expansion of such efforts in terms of sample size and length of follow-up – the study marks a movement in the development of methods to predict disease progression and, therefore, assist clinicians, patients with Parkinson’s disease, and their family members with treatment and individualized disease management.
The methodology is promising, but fine-tuning and extension of current efforts are important because, while these endeavors are costly, they are vital for the development of disease-modifying therapies and the treatment of Parkinson’s disease.
Cornelis Blauwendraat, MD, and his colleagues are with the Laboratory of Neurogenetics at the National Institute on Aging. They declared having no competing interests. Their comments are taken from an editorial accompanying Dr. Latourelle and her colleagues’ report (Lancet Neurol. 2017 Sep 25. doi: 10.106/S1474-4422[17]30331-9).
An ensemble of prediction models developed using genetic data and both baseline molecular and clinical variables from patients with Parkinson’s disease, as well as healthy controls, confirmed established predictors of the disease and identified new ones in a longitudinal cohort study.
Furthermore, the models were shown via simulated, randomized, placebo-controlled trials to have utility for clinical trial design and evaluation, as well as for clinical disease monitoring and treatment, Jeanne C. Latourelle, DSc, of GNS Healthcare, Cambridge, Mass., and her colleagues reported in Lancet Neurology.
“Understanding the causal and physiological factors that contribute to this variability in the evolution of symptoms of Parkinson’s disease is, therefore, a high priority area of Parkinson’s disease research,” they wrote (Lancet Neurol. 2017 Sep 25. doi: 10.1016/S1474-4422[17]30328-9).
The investigators developed the models by applying a Bayesian, machine-learning, multivariate predictive inference platform – known as Reverse Engineering and Forward Simulation – to data from the Parkinson’s Progression Markers Initiative (PPMI) study; they used these models to predict the annual rate of change in combined scores from the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III. The investigators tested the overall explanatory power of the models using the coefficient of determination (R2); their models also replicated novel findings from an independent clinical cohort from the Longitudinal and Biomarker Study in Parkinson’s disease (LABS-PD).
In 117 healthy age- and sex-matched controls and 312 patients with early-stage Parkinson’s disease from the PPMI study, the model ensemble showed strong performance (fivefold cross-validated Pearson R2, 41%), the investigators said.
In the 317-patient LABS-PD validation cohort, the performance of the models was reduced, but still statistically significant (R2, 9%).
Individual predictive features – including significant replication of higher baseline motor score on MDS-UPDRS, male sex, increased age, and novel Parkinson’s disease–specific epistatic interaction, which all were indicative of faster motor progression in the disease – were confirmed in the LABS-PD cohort, they said. The most useful predictive marker of motor progression was genetic variation (R2, 2.9%), the investigators said, and the cerebrospinal fluid biomarkers at baseline also significantly affected prediction of motor progression, although more modestly (R2, 0.3%).
In 5,000 trial simulations, the incorporation of predicted rates of motor progression into the final models of treatment effect reduced the variability in study outcome, which allowed for the detection of significant differences in sample sizes up to 20% smaller than in trials of drug-naive patients.
The investigators noted that the Bayesian model inference using Reverse Engineering and Forward Simulation was particularly good at predicting Parkinson’s motor progression in early disease stages, which has “immediate relevance toward enabling more effective trial recruitment and clinical disease management.”
This study was supported by grants from the Michael J. Fox Foundation for Parkinson’s Research and the National Institute of Neurological Disorders and Stroke. PPMI is funded by the Michael J. Fox Foundation for Parkinson’s Research, and it also has many industry funding partners. Dr. Latourelle and several of her coauthors are or were employees of GNS Healthcare.
An ensemble of prediction models developed using genetic data and both baseline molecular and clinical variables from patients with Parkinson’s disease, as well as healthy controls, confirmed established predictors of the disease and identified new ones in a longitudinal cohort study.
Furthermore, the models were shown via simulated, randomized, placebo-controlled trials to have utility for clinical trial design and evaluation, as well as for clinical disease monitoring and treatment, Jeanne C. Latourelle, DSc, of GNS Healthcare, Cambridge, Mass., and her colleagues reported in Lancet Neurology.
“Understanding the causal and physiological factors that contribute to this variability in the evolution of symptoms of Parkinson’s disease is, therefore, a high priority area of Parkinson’s disease research,” they wrote (Lancet Neurol. 2017 Sep 25. doi: 10.1016/S1474-4422[17]30328-9).
The investigators developed the models by applying a Bayesian, machine-learning, multivariate predictive inference platform – known as Reverse Engineering and Forward Simulation – to data from the Parkinson’s Progression Markers Initiative (PPMI) study; they used these models to predict the annual rate of change in combined scores from the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III. The investigators tested the overall explanatory power of the models using the coefficient of determination (R2); their models also replicated novel findings from an independent clinical cohort from the Longitudinal and Biomarker Study in Parkinson’s disease (LABS-PD).
In 117 healthy age- and sex-matched controls and 312 patients with early-stage Parkinson’s disease from the PPMI study, the model ensemble showed strong performance (fivefold cross-validated Pearson R2, 41%), the investigators said.
In the 317-patient LABS-PD validation cohort, the performance of the models was reduced, but still statistically significant (R2, 9%).
Individual predictive features – including significant replication of higher baseline motor score on MDS-UPDRS, male sex, increased age, and novel Parkinson’s disease–specific epistatic interaction, which all were indicative of faster motor progression in the disease – were confirmed in the LABS-PD cohort, they said. The most useful predictive marker of motor progression was genetic variation (R2, 2.9%), the investigators said, and the cerebrospinal fluid biomarkers at baseline also significantly affected prediction of motor progression, although more modestly (R2, 0.3%).
In 5,000 trial simulations, the incorporation of predicted rates of motor progression into the final models of treatment effect reduced the variability in study outcome, which allowed for the detection of significant differences in sample sizes up to 20% smaller than in trials of drug-naive patients.
The investigators noted that the Bayesian model inference using Reverse Engineering and Forward Simulation was particularly good at predicting Parkinson’s motor progression in early disease stages, which has “immediate relevance toward enabling more effective trial recruitment and clinical disease management.”
This study was supported by grants from the Michael J. Fox Foundation for Parkinson’s Research and the National Institute of Neurological Disorders and Stroke. PPMI is funded by the Michael J. Fox Foundation for Parkinson’s Research, and it also has many industry funding partners. Dr. Latourelle and several of her coauthors are or were employees of GNS Healthcare.
FROM LANCET NEUROLOGY
Key clinical point:
Major finding: The model ensemble showed strong performance (fivefold cross-validated Pearson R2, 41%) and remained significant in a validation cohort (R2, 9%).
Data source: A longitudinal cohort study of 429 patients and controls, as well as a validation cohort of 317 patients.
Disclosures: This study was supported by grants from the Michael J. Fox Foundation for Parkinson’s Research and the National Institute of Neurological Disorders and Stroke. The Parkinson’s Progression Markers Initiative is funded by the Michael J. Fox Foundation for Parkinson’s Research, and it also has many industry funding partners. Dr. Latourelle and several of her coauthors are or were employees of GNS Healthcare.