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Split-dose R-CHOP: a new approach to administer cytotoxic chemo-immunotherapy to elderly patients with DLBCL

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Split-dose R-CHOP: a new approach to administer cytotoxic chemo-immunotherapy to elderly patients with DLBCL

Background Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. It is challenging to deliver standard rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy in the very elderly or elderly with comorbidities because of age-related changes in metabolism and performance.

Objectives To describe outcomes of a unique approach to the delivery of standard R-CHOP chemotherapy in split-doses for the treatment of elderly DLBCL patients.

Methods We performed a single center, retrospective analysis of all patients with DLBCL treated with split-dose R-CHOP during January 2007-April 2015. The patients received R-CHOP at a 50% dose reduction on days 1 and 15 of each 28-day cycle (split dose), with full dose rituximab on day 1 for up to 6 cycles. The total amount of chemotherapy delivered during each 28-day cycle of split-dose R-CHOP was equivalent to the cumulative dose in each 21-day cycle of standard R-CHOP.

Results We identified 22 patients who had been treated with split-dose R-CHOP (median age, 81 years). 10 patients had a Charlson Comorbidity Index score of 2 or more, and 13 were aged 80 or older. 12 patients completed their prescribed treatments, and 10 required further de-escalation or early termination owing to toxicity. All of the patients who completed therapy were in a complete remission at the end of treatment. The median overall survival for the entire cohort was 47 months, and median progression-free survival was 43 months.

Limitations Retrospective, single institution study, small cohort Conclusions Split-dose R-CHOP allowed administration of curative-intent therapy in an elderly population with encouraging outcomes.

Conclusions Split-dose R-CHOP allowed administration of curative-intent therapy in an elderly population with encouraging outcomes.

Funding/sponsorship Cancer Center Research Training Program, NCI 5-T32 CA09615-25 (fellowship funding for Dr Shah).
 

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The Journal of Community and Supportive Oncology - 14(11)
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450-456
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Background Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. It is challenging to deliver standard rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy in the very elderly or elderly with comorbidities because of age-related changes in metabolism and performance.

Objectives To describe outcomes of a unique approach to the delivery of standard R-CHOP chemotherapy in split-doses for the treatment of elderly DLBCL patients.

Methods We performed a single center, retrospective analysis of all patients with DLBCL treated with split-dose R-CHOP during January 2007-April 2015. The patients received R-CHOP at a 50% dose reduction on days 1 and 15 of each 28-day cycle (split dose), with full dose rituximab on day 1 for up to 6 cycles. The total amount of chemotherapy delivered during each 28-day cycle of split-dose R-CHOP was equivalent to the cumulative dose in each 21-day cycle of standard R-CHOP.

Results We identified 22 patients who had been treated with split-dose R-CHOP (median age, 81 years). 10 patients had a Charlson Comorbidity Index score of 2 or more, and 13 were aged 80 or older. 12 patients completed their prescribed treatments, and 10 required further de-escalation or early termination owing to toxicity. All of the patients who completed therapy were in a complete remission at the end of treatment. The median overall survival for the entire cohort was 47 months, and median progression-free survival was 43 months.

Limitations Retrospective, single institution study, small cohort Conclusions Split-dose R-CHOP allowed administration of curative-intent therapy in an elderly population with encouraging outcomes.

Conclusions Split-dose R-CHOP allowed administration of curative-intent therapy in an elderly population with encouraging outcomes.

Funding/sponsorship Cancer Center Research Training Program, NCI 5-T32 CA09615-25 (fellowship funding for Dr Shah).
 

Click on the PDF icon at the top of this introduction to read the full article.
 

Background Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. It is challenging to deliver standard rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy in the very elderly or elderly with comorbidities because of age-related changes in metabolism and performance.

Objectives To describe outcomes of a unique approach to the delivery of standard R-CHOP chemotherapy in split-doses for the treatment of elderly DLBCL patients.

Methods We performed a single center, retrospective analysis of all patients with DLBCL treated with split-dose R-CHOP during January 2007-April 2015. The patients received R-CHOP at a 50% dose reduction on days 1 and 15 of each 28-day cycle (split dose), with full dose rituximab on day 1 for up to 6 cycles. The total amount of chemotherapy delivered during each 28-day cycle of split-dose R-CHOP was equivalent to the cumulative dose in each 21-day cycle of standard R-CHOP.

Results We identified 22 patients who had been treated with split-dose R-CHOP (median age, 81 years). 10 patients had a Charlson Comorbidity Index score of 2 or more, and 13 were aged 80 or older. 12 patients completed their prescribed treatments, and 10 required further de-escalation or early termination owing to toxicity. All of the patients who completed therapy were in a complete remission at the end of treatment. The median overall survival for the entire cohort was 47 months, and median progression-free survival was 43 months.

Limitations Retrospective, single institution study, small cohort Conclusions Split-dose R-CHOP allowed administration of curative-intent therapy in an elderly population with encouraging outcomes.

Conclusions Split-dose R-CHOP allowed administration of curative-intent therapy in an elderly population with encouraging outcomes.

Funding/sponsorship Cancer Center Research Training Program, NCI 5-T32 CA09615-25 (fellowship funding for Dr Shah).
 

Click on the PDF icon at the top of this introduction to read the full article.
 

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The Journal of Community and Supportive Oncology - 14(11)
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The Journal of Community and Supportive Oncology - 14(11)
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450-456
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450-456
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Split-dose R-CHOP: a new approach to administer cytotoxic chemo-immunotherapy to elderly patients with DLBCL
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Lessons learned from using CDK 4/6 inhibitors to treat metastatic breast cancer

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Lessons learned from using CDK 4/6 inhibitors to treat metastatic breast cancer

It is amazing to see how many new drugs are being developed and approved for patients with cancer. In 2015 alone, the US Food and Drug Administration approved 45 new cancer drugs – a significant jump from the average 26 approvals annually from 2006 to 2014. This major shift in the number of approvals is due to many factors, including the intensified efforts by scientists and clinicians to develop new drugs, especially novel immunotherapies, and changes in the FDA’s drug approval process under the leadership of Dr Richard Pazdur.

 

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The Journal of Community and Supportive Oncology - 14(10)
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407-408
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It is amazing to see how many new drugs are being developed and approved for patients with cancer. In 2015 alone, the US Food and Drug Administration approved 45 new cancer drugs – a significant jump from the average 26 approvals annually from 2006 to 2014. This major shift in the number of approvals is due to many factors, including the intensified efforts by scientists and clinicians to develop new drugs, especially novel immunotherapies, and changes in the FDA’s drug approval process under the leadership of Dr Richard Pazdur.

 

Click on the PDF icon at the top of this introduction to read the full article. 

 

It is amazing to see how many new drugs are being developed and approved for patients with cancer. In 2015 alone, the US Food and Drug Administration approved 45 new cancer drugs – a significant jump from the average 26 approvals annually from 2006 to 2014. This major shift in the number of approvals is due to many factors, including the intensified efforts by scientists and clinicians to develop new drugs, especially novel immunotherapies, and changes in the FDA’s drug approval process under the leadership of Dr Richard Pazdur.

 

Click on the PDF icon at the top of this introduction to read the full article. 

 

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The Journal of Community and Supportive Oncology - 14(10)
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The Journal of Community and Supportive Oncology - 14(10)
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407-408
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407-408
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Lessons learned from using CDK 4/6 inhibitors to treat metastatic breast cancer
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Slow and steady progress in managing gynecologic cancer

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Slow and steady progress in managing gynecologic cancer

Slow but steady progress has been made in the management of the major types of gynecologic malignancy, with particularly significant advancements in the treatment of the biggest killer, ovarian cancer. Here we describe how that progress has shaped the current treatment landscape and is forging a path forward.

A therapeutic challenge
More than 90,000 new cases of gynecologic malignancy are diagnosed in the United States each year, and about a third of patients will ultimately succumb to their disease.1 Five major tumor types make up this large and varied group of cancers: cervical, ovarian, endometrial, vaginal, and vulvar, each with unique biology, etiology, and pathology.2

Most cervical cancers are squamous cell carcinomas and are caused by infection with human papillomaviruses (HPVs), a group of more than 200 related viruses. Development of effective screening methods and prophylactic vaccination have driven a substantial reduction in the incidence of cervical cancer in developed countries, though it remains a major cause of mortality in developing countries.

 

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The Journal of Community and Supportive Oncology - 14(8)
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367-372
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gynecologic cancer, ovarian cancer, endometrial cancer, cervical cancer, HPV, bevacizumab, cediranib, PARP inhibitors, olaparib, immunotherapy
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Slow but steady progress has been made in the management of the major types of gynecologic malignancy, with particularly significant advancements in the treatment of the biggest killer, ovarian cancer. Here we describe how that progress has shaped the current treatment landscape and is forging a path forward.

A therapeutic challenge
More than 90,000 new cases of gynecologic malignancy are diagnosed in the United States each year, and about a third of patients will ultimately succumb to their disease.1 Five major tumor types make up this large and varied group of cancers: cervical, ovarian, endometrial, vaginal, and vulvar, each with unique biology, etiology, and pathology.2

Most cervical cancers are squamous cell carcinomas and are caused by infection with human papillomaviruses (HPVs), a group of more than 200 related viruses. Development of effective screening methods and prophylactic vaccination have driven a substantial reduction in the incidence of cervical cancer in developed countries, though it remains a major cause of mortality in developing countries.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Slow but steady progress has been made in the management of the major types of gynecologic malignancy, with particularly significant advancements in the treatment of the biggest killer, ovarian cancer. Here we describe how that progress has shaped the current treatment landscape and is forging a path forward.

A therapeutic challenge
More than 90,000 new cases of gynecologic malignancy are diagnosed in the United States each year, and about a third of patients will ultimately succumb to their disease.1 Five major tumor types make up this large and varied group of cancers: cervical, ovarian, endometrial, vaginal, and vulvar, each with unique biology, etiology, and pathology.2

Most cervical cancers are squamous cell carcinomas and are caused by infection with human papillomaviruses (HPVs), a group of more than 200 related viruses. Development of effective screening methods and prophylactic vaccination have driven a substantial reduction in the incidence of cervical cancer in developed countries, though it remains a major cause of mortality in developing countries.

 

Click on the PDF icon at the top of this introduction to read the full article.

 
Issue
The Journal of Community and Supportive Oncology - 14(8)
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The Journal of Community and Supportive Oncology - 14(8)
Page Number
367-372
Page Number
367-372
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Slow and steady progress in managing gynecologic cancer
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Slow and steady progress in managing gynecologic cancer
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gynecologic cancer, ovarian cancer, endometrial cancer, cervical cancer, HPV, bevacizumab, cediranib, PARP inhibitors, olaparib, immunotherapy
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gynecologic cancer, ovarian cancer, endometrial cancer, cervical cancer, HPV, bevacizumab, cediranib, PARP inhibitors, olaparib, immunotherapy
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Evolving therapeutic strategies maintain clinical momentum in melanoma

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Evolving therapeutic strategies maintain clinical momentum in melanoma

The past 5 years have witnessed a watershed moment in the management of metastatic melanoma. The successes of molecularly targeted and immune-based therapies have transformed it from an aggressively lethal malignancy into one that is readily treatable. Here, we discuss continued efforts to find new therapies and broaden the clinical impact of existing options to maintain the unprecedented momentum of improving patient outcomes.

 

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The Journal of Community and Supportive Oncology - 14(6)
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Page Number
280-286
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melanoma, BRAF, MAPK signaling, immunotherapy, vemurafenib, dabrafenib, ipilimumab
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The past 5 years have witnessed a watershed moment in the management of metastatic melanoma. The successes of molecularly targeted and immune-based therapies have transformed it from an aggressively lethal malignancy into one that is readily treatable. Here, we discuss continued efforts to find new therapies and broaden the clinical impact of existing options to maintain the unprecedented momentum of improving patient outcomes.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

The past 5 years have witnessed a watershed moment in the management of metastatic melanoma. The successes of molecularly targeted and immune-based therapies have transformed it from an aggressively lethal malignancy into one that is readily treatable. Here, we discuss continued efforts to find new therapies and broaden the clinical impact of existing options to maintain the unprecedented momentum of improving patient outcomes.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

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The Journal of Community and Supportive Oncology - 14(6)
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The Journal of Community and Supportive Oncology - 14(6)
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280-286
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280-286
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Evolving therapeutic strategies maintain clinical momentum in melanoma
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Evolving therapeutic strategies maintain clinical momentum in melanoma
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melanoma, BRAF, MAPK signaling, immunotherapy, vemurafenib, dabrafenib, ipilimumab
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melanoma, BRAF, MAPK signaling, immunotherapy, vemurafenib, dabrafenib, ipilimumab
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More success for immunotherapy with nivolumab approval for metastatic RCC

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More success for immunotherapy with nivolumab approval for metastatic RCC
Following its recent success in non–small-cell lung cancer (NSCLC), the immunotherapeutic agent nivolumab received approval from the US Food and Drug Administration last fall for the treatment of advanced clear-cell renal-cell carcinoma (RCC) after prior antiangiogenic therapy. Nivolumab, an immune checkpoint inhibitor, is a fully human immunoglobulin G4 monoclonal antibody that binds to the programmed cell death 1 (PD-1) receptor on the surface of T cells, prevents their inactivation by tumor cells overexpressing PD-1 ligands, and helps to reinstate the anti-tumor immune response.
 
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The Journal of Community and Supportive Oncology - 14(4)
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138-140
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renal cell carcinoma, RCC, immunotherapy, nivolumab, CheckMate-025, programmed death cell

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Following its recent success in non–small-cell lung cancer (NSCLC), the immunotherapeutic agent nivolumab received approval from the US Food and Drug Administration last fall for the treatment of advanced clear-cell renal-cell carcinoma (RCC) after prior antiangiogenic therapy. Nivolumab, an immune checkpoint inhibitor, is a fully human immunoglobulin G4 monoclonal antibody that binds to the programmed cell death 1 (PD-1) receptor on the surface of T cells, prevents their inactivation by tumor cells overexpressing PD-1 ligands, and helps to reinstate the anti-tumor immune response.
 
Click on the PDF icon at the top of this introduction to read the full article.  
 
Following its recent success in non–small-cell lung cancer (NSCLC), the immunotherapeutic agent nivolumab received approval from the US Food and Drug Administration last fall for the treatment of advanced clear-cell renal-cell carcinoma (RCC) after prior antiangiogenic therapy. Nivolumab, an immune checkpoint inhibitor, is a fully human immunoglobulin G4 monoclonal antibody that binds to the programmed cell death 1 (PD-1) receptor on the surface of T cells, prevents their inactivation by tumor cells overexpressing PD-1 ligands, and helps to reinstate the anti-tumor immune response.
 
Click on the PDF icon at the top of this introduction to read the full article.  
 
Issue
The Journal of Community and Supportive Oncology - 14(4)
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The Journal of Community and Supportive Oncology - 14(4)
Page Number
138-140
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138-140
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More success for immunotherapy with nivolumab approval for metastatic RCC
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More success for immunotherapy with nivolumab approval for metastatic RCC
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renal cell carcinoma, RCC, immunotherapy, nivolumab, CheckMate-025, programmed death cell

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renal cell carcinoma, RCC, immunotherapy, nivolumab, CheckMate-025, programmed death cell

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Encouraging data on immunotherapy, cardiotoxicity, and DFS

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Encouraging data on immunotherapy, cardiotoxicity, and DFS
The immunologic checkpoint inhibitors avelumab and pemrolizomab show promise in patients with metastatic breast cancer; a trastuzumab-based, nonanthracycline regimen yields cardiac safety benefits in early HER2-positive disease; and the oral tyrosine kinase inhibitor neratinib delivers consistent disease-free survival at 3 years: Bruce Jancin and Susan London report from the 2015 annual meeting of the San Antonio Breast Cancer Symposium.

 

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The Journal of Community and Supportive Oncology - 14(2)
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Page Number
85-88
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avelumab, metastatic breast cancer, programmed death-ligand 1, PD-L1, immune checkpoint inhibitor, triple-negative breast cancer, TNBC, pembrolizumab, estrogen receptor-positive, human epidermal growth factor receptor 2, HER2, trastuzumab, cardiac toxicity, neratinib, disease-free survival, DFS
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The immunologic checkpoint inhibitors avelumab and pemrolizomab show promise in patients with metastatic breast cancer; a trastuzumab-based, nonanthracycline regimen yields cardiac safety benefits in early HER2-positive disease; and the oral tyrosine kinase inhibitor neratinib delivers consistent disease-free survival at 3 years: Bruce Jancin and Susan London report from the 2015 annual meeting of the San Antonio Breast Cancer Symposium.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

The immunologic checkpoint inhibitors avelumab and pemrolizomab show promise in patients with metastatic breast cancer; a trastuzumab-based, nonanthracycline regimen yields cardiac safety benefits in early HER2-positive disease; and the oral tyrosine kinase inhibitor neratinib delivers consistent disease-free survival at 3 years: Bruce Jancin and Susan London report from the 2015 annual meeting of the San Antonio Breast Cancer Symposium.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 14(2)
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The Journal of Community and Supportive Oncology - 14(2)
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85-88
Page Number
85-88
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Encouraging data on immunotherapy, cardiotoxicity, and DFS
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Encouraging data on immunotherapy, cardiotoxicity, and DFS
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avelumab, metastatic breast cancer, programmed death-ligand 1, PD-L1, immune checkpoint inhibitor, triple-negative breast cancer, TNBC, pembrolizumab, estrogen receptor-positive, human epidermal growth factor receptor 2, HER2, trastuzumab, cardiac toxicity, neratinib, disease-free survival, DFS
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avelumab, metastatic breast cancer, programmed death-ligand 1, PD-L1, immune checkpoint inhibitor, triple-negative breast cancer, TNBC, pembrolizumab, estrogen receptor-positive, human epidermal growth factor receptor 2, HER2, trastuzumab, cardiac toxicity, neratinib, disease-free survival, DFS
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Making immunotherapy part of routine breast cancer treatment

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Making immunotherapy part of routine breast cancer treatment

Cancer treatment is evolving rapidly, and 2015 was no exception. It was the year of immunotherapy. Following the approval by the US Food and Drug Administration in 2014 of pembrolizumab for melanoma, 2015 saw approvals of nivolumab for melanoma, lung cancer, and kidney cancer; pembrolizumab for lung cancer; and the combination of ipilimumab and nivolimab for melanoma. That’s an impressive list of immunotherapy approvals for a single year.
 

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The Journal of Community and Supportive Oncology - 14(2)
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49-50
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breast cancer, immunotherapy, avelumab, pembrolizumab, HER2-negative, HER2-positive, docetaxel, carboplatin, trastuzumab, TCH, doxorubicin, cyclophosphamide, paclitaxel, AC-TH, mammogram
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Cancer treatment is evolving rapidly, and 2015 was no exception. It was the year of immunotherapy. Following the approval by the US Food and Drug Administration in 2014 of pembrolizumab for melanoma, 2015 saw approvals of nivolumab for melanoma, lung cancer, and kidney cancer; pembrolizumab for lung cancer; and the combination of ipilimumab and nivolimab for melanoma. That’s an impressive list of immunotherapy approvals for a single year.
 

Click on the PDF icon at the top of this introduction to read the full article.

 

Cancer treatment is evolving rapidly, and 2015 was no exception. It was the year of immunotherapy. Following the approval by the US Food and Drug Administration in 2014 of pembrolizumab for melanoma, 2015 saw approvals of nivolumab for melanoma, lung cancer, and kidney cancer; pembrolizumab for lung cancer; and the combination of ipilimumab and nivolimab for melanoma. That’s an impressive list of immunotherapy approvals for a single year.
 

Click on the PDF icon at the top of this introduction to read the full article.

 

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The Journal of Community and Supportive Oncology - 14(2)
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The Journal of Community and Supportive Oncology - 14(2)
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49-50
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49-50
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Making immunotherapy part of routine breast cancer treatment
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Making immunotherapy part of routine breast cancer treatment
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breast cancer, immunotherapy, avelumab, pembrolizumab, HER2-negative, HER2-positive, docetaxel, carboplatin, trastuzumab, TCH, doxorubicin, cyclophosphamide, paclitaxel, AC-TH, mammogram
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breast cancer, immunotherapy, avelumab, pembrolizumab, HER2-negative, HER2-positive, docetaxel, carboplatin, trastuzumab, TCH, doxorubicin, cyclophosphamide, paclitaxel, AC-TH, mammogram
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Entering an era of intelligent combination therapy in cancer

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Entering an era of intelligent combination therapy in cancer

The past few decades have witnessed unprecedented advances in our understanding of the molecular underpinnings of cancer. Although indiscriminately cytotoxic therapies like chemo- and radiation therapy remain standard of care for many cancer types, more precise targeted therapies and immune-boosting immunotherapies have added to our arsenal and afforded considerable survival gains. Despite those advances, we are still no closer to a cure, particularly for the most aggressive and insidious cancers that progress rapidly or go undiagnosed until advanced stages of disease. The substantial genetic diversity of tumors and universal nature of drug resistance present the most formidable and enduring challenges to effective cancer treatment. 

 

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The Journal of Community and Supportive Oncology - 13(12)
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446-450
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Jane de Lartigue, PhD
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The past few decades have witnessed unprecedented advances in our understanding of the molecular underpinnings of cancer. Although indiscriminately cytotoxic therapies like chemo- and radiation therapy remain standard of care for many cancer types, more precise targeted therapies and immune-boosting immunotherapies have added to our arsenal and afforded considerable survival gains. Despite those advances, we are still no closer to a cure, particularly for the most aggressive and insidious cancers that progress rapidly or go undiagnosed until advanced stages of disease. The substantial genetic diversity of tumors and universal nature of drug resistance present the most formidable and enduring challenges to effective cancer treatment. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 

The past few decades have witnessed unprecedented advances in our understanding of the molecular underpinnings of cancer. Although indiscriminately cytotoxic therapies like chemo- and radiation therapy remain standard of care for many cancer types, more precise targeted therapies and immune-boosting immunotherapies have added to our arsenal and afforded considerable survival gains. Despite those advances, we are still no closer to a cure, particularly for the most aggressive and insidious cancers that progress rapidly or go undiagnosed until advanced stages of disease. The substantial genetic diversity of tumors and universal nature of drug resistance present the most formidable and enduring challenges to effective cancer treatment. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 
Issue
The Journal of Community and Supportive Oncology - 13(12)
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The Journal of Community and Supportive Oncology - 13(12)
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446-450
Page Number
446-450
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Entering an era of intelligent combination therapy in cancer
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Entering an era of intelligent combination therapy in cancer
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Jane de Lartigue, PhD
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Jane de Lartigue, PhD
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Dinutuximab combination therapy becomes first approval for high-risk neuroblastoma

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Dinutuximab combination therapy becomes first approval for high-risk neuroblastoma
The approval of dinutuximab by the US Food and Drug Administration marks the third approval for a pediatric cancer and the first for patients with high-risk neuroblastoma.1 Dinutuximab is an immunotherapeutic agent; a monoclonal antibody (mAb) targeting a glycolipid that is highly expressed on the surface of neuroblastoma cells.

The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2

Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible. 

 

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The Journal of Community and Supportive Oncology - 13(10)
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344-346
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dinutuximab, neuroblastoma, immunotherapeutic agent, monoclonal antibody, mAb, cytokine, granulocyte macrophage colony-stimulating factor, GM-CSF, interleukin-2, IL-2, retinoid isotretinoin, RA, glycolipid disialoganglioside, GD2
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The approval of dinutuximab by the US Food and Drug Administration marks the third approval for a pediatric cancer and the first for patients with high-risk neuroblastoma.1 Dinutuximab is an immunotherapeutic agent; a monoclonal antibody (mAb) targeting a glycolipid that is highly expressed on the surface of neuroblastoma cells.

The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2

Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible. 

 

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The approval of dinutuximab by the US Food and Drug Administration marks the third approval for a pediatric cancer and the first for patients with high-risk neuroblastoma.1 Dinutuximab is an immunotherapeutic agent; a monoclonal antibody (mAb) targeting a glycolipid that is highly expressed on the surface of neuroblastoma cells.

The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2

Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible. 

 

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Issue
The Journal of Community and Supportive Oncology - 13(10)
Issue
The Journal of Community and Supportive Oncology - 13(10)
Page Number
344-346
Page Number
344-346
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Dinutuximab combination therapy becomes first approval for high-risk neuroblastoma
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Dinutuximab combination therapy becomes first approval for high-risk neuroblastoma
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dinutuximab, neuroblastoma, immunotherapeutic agent, monoclonal antibody, mAb, cytokine, granulocyte macrophage colony-stimulating factor, GM-CSF, interleukin-2, IL-2, retinoid isotretinoin, RA, glycolipid disialoganglioside, GD2
Legacy Keywords
dinutuximab, neuroblastoma, immunotherapeutic agent, monoclonal antibody, mAb, cytokine, granulocyte macrophage colony-stimulating factor, GM-CSF, interleukin-2, IL-2, retinoid isotretinoin, RA, glycolipid disialoganglioside, GD2
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JCSO 2015;13:344-346
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Nivolumab: first immunotherapy approved for lung cancer

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Nivolumab: first immunotherapy approved for lung cancer
The approval of nivolumab in early 2015 by the US Food and Drug Administration (FDA) for the treatment of squamous cell non-small-cell lung cancer (NSCLC) marks a second approval for this drug, following a 2014 approval for metastatic melanoma. Approved 3 months ahead of schedule, nivolumab is the first immunotherapy to be approved for the treatment of lung cancer. The drug can help to reinstate the antitumor immune response by targeting the programmed cell death-1 (PD-1) receptor, an “immune checkpoint” protein found on the surface of activated T cells that is involved in inhibiting T-cell activity.

 

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Issue
The Journal of Community and Supportive Oncology - 13(9)
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312-315
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nivolumab, non-small-cell-lung cancer, NSCLC, immunotherapy, PD-1, PD-L1, CTLA-4, checkpoint inhibitor, CheckMate
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Article PDF
The approval of nivolumab in early 2015 by the US Food and Drug Administration (FDA) for the treatment of squamous cell non-small-cell lung cancer (NSCLC) marks a second approval for this drug, following a 2014 approval for metastatic melanoma. Approved 3 months ahead of schedule, nivolumab is the first immunotherapy to be approved for the treatment of lung cancer. The drug can help to reinstate the antitumor immune response by targeting the programmed cell death-1 (PD-1) receptor, an “immune checkpoint” protein found on the surface of activated T cells that is involved in inhibiting T-cell activity.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

The approval of nivolumab in early 2015 by the US Food and Drug Administration (FDA) for the treatment of squamous cell non-small-cell lung cancer (NSCLC) marks a second approval for this drug, following a 2014 approval for metastatic melanoma. Approved 3 months ahead of schedule, nivolumab is the first immunotherapy to be approved for the treatment of lung cancer. The drug can help to reinstate the antitumor immune response by targeting the programmed cell death-1 (PD-1) receptor, an “immune checkpoint” protein found on the surface of activated T cells that is involved in inhibiting T-cell activity.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 13(9)
Issue
The Journal of Community and Supportive Oncology - 13(9)
Page Number
312-315
Page Number
312-315
Publications
Publications
Topics
Article Type
Display Headline
Nivolumab: first immunotherapy approved for lung cancer
Display Headline
Nivolumab: first immunotherapy approved for lung cancer
Legacy Keywords
nivolumab, non-small-cell-lung cancer, NSCLC, immunotherapy, PD-1, PD-L1, CTLA-4, checkpoint inhibitor, CheckMate
Legacy Keywords
nivolumab, non-small-cell-lung cancer, NSCLC, immunotherapy, PD-1, PD-L1, CTLA-4, checkpoint inhibitor, CheckMate
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Citation Override
JCSO 2015;13:312-315
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Alternative CME
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