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leukemia

Kinase-Activating Alterations Identified in Most Cases of  Philadelphia Chromosome–Like Acute Lymphoblastic Leukemia May Be Targetable With Available Tyrosine Kinase Inhibitors

In a study reported in The New England Journal of Medicine, Kathryn G. Roberts, PhD, of St. Jude Children’s Research Hospital, and colleagues performed detailed genomic analysis of patients with Philadelphia chromosome–like acute lymphoblastic leukemia (ALL) and identified kinase-activating...

gastrointestinal cancer

The RAINBOW Trial: Dawn of a New Era in Upper Gastrointestinal Malignancies

As reviewed in this issue of The ASCO Post (page 155), the RAINBOW trial is an international phase III study demonstrating improved overall survival with ramucirumab (Cyramza) plus paclitaxel as second-line therapy for patients with advanced gastric/gastroesophageal junction adenocarcinoma over...

gastrointestinal cancer

Adding VEGFR2 Inhibitor Ramucirumab to Paclitaxel Increases Overall Survival as Second-Line Treatment for Advanced Gastric Cancer

In the phase III RAINBOW trial reported in The Lancet Oncology, Hansjochen Wilke, MD, Director of Medical Oncology/Hematology at Kliniken Essen-Mitte, Essen, Germany, and colleagues found that adding the vascular endothelial growth factor receptor 2 (VEGFR2) inhibitor ramucirumab (Cyramza) to...

skin cancer

BRAF/MEK Inhibition in BRAF-Mutant Advanced Melanoma

Preliminary evidence of efficacy for BRAF inhibitors as monotherapy in advanced melanoma first emerged in 2009.1 Phase II and III trials rapidly ensued for vemurafenib (Zelboraf) and dabrafenib (Tafinlar), leading to U.S. Food and Drug Administration (FDA) approval in 2011. As a result of melanoma...

skin cancer

Two Phase III Trials Show Benefit With BRAF/MEK Inhibitor Combination vs BRAF Inhibitor Alone in Advanced Melanoma

Two phase III trials have shown that the strategy of adding MEK inhibitor therapy to BRAF inhibitor therapy significantly improves progression-free survival in previously untreated patients with advanced BRAF-mutant melanoma.1,2 Overall survival benefit is also suggested by interim analysis in both ...

issues in oncology

Expert Panels Offer Five Proposals to Address Challenges in Regulating, Implementing Next-Generation Sequencing

At the third annual Blueprint for Drug/Diagnostic Co-Development forum, cohosted by Friends of Cancer Research in Washington, DC, and the Alexandria Center for Life Science in New York, two panels tackled considerations in simultaneous development of drugs and companion diagnostics. Friends of...

breast cancer

Long-Term Overall Survival Benefit Seen With Trastuzumab Added to Adjuvant Chemotherapy in Early-Stage HER2-Positive Breast Cancer

Earlier planned joint analyses of outcomes in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 trial and the North Central Cancer Treatment Group (NCCTG) N9831 trial showed that adding trastuzumab (Herceptin) to adjuvant chemotherapy improved disease-free survival and overall...

multiple myeloma

High-Dose Melphalan, Early Stem Cell Transplant, and Lenalidomide Maintenance in Myeloma: One Size Still Does Not Fit All

In an important recent study by Dr. Antonio Palumbo and colleagues,1 reviewed in this issue of The ASCO Post (page 128), 273 patients aged ≤ 65 years were randomly assigned to early transplant or consolidation therapy using MPR (melphalan, prednisone, and lenalidomide [Revlimid]) after successful...

multiple myeloma

Impact of High-Dose Melphalan/Autologous Stem Cell Transplant and Lenalidomide Maintenance in Myeloma Patients ≤ Age 65

In a phase III trial reported in The New England Journal of Medicine, Antonio Palumbo, MD, Chief of the Myeloma Unit at the University of Turin, Italy, and colleagues found that high-dose melphalan plus autologous stem cell transplantation improved progression-free survival and overall survival...

survivorship
lymphoma

Vigorous Exercise Lowers Risk of Cardiovascular Events in Adult Survivors of Childhood Hodgkin Lymphoma

In a report from the Childhood Cancer Survivor Study published in the Journal of Clinical Oncology,1 Lee W. Jones, PhD, of Memorial Sloan Kettering Cancer Center, and colleagues found that vigorous exercise reduces the risk of major cardiovascular events in adult survivors of childhood Hodgkin...

survivorship

Addressing Patients’ Sexual Dysfunction Throughout Survivorship

Studies show that all cancers and related treatments have the potential to affect sexuality and sexual function. Surgery, chemotherapy, hormonal therapy, bone marrow transplantation, and radiation therapy can physically impact sexual health in myriad ways, including vaginal dryness, dyspareunia,...

NIH Awards Aim to Improve Understanding of Cell Pathways, Development of New Therapies

Building on a successful 3-year pilot project, the National Institutes of Health (NIH) has awarded more than $64 million to six individuals at five research institutions to create a database of human cellular responses—the Library of Integrated Network-based Cellular Signatures (LINCS)....

skin cancer

Ipilimumab/Sargramostim Improves Overall Survival vs Ipilimumab Alone in Patients With Advanced Metastatic Melanoma

A randomized clinical trial of patients with advanced metastatic melanoma treated with ipilimumab (Yervoy), an immune checkpoint inhibitor, in combination with sargramostim (Leukine), an immune stimulant, vs ipilimumab alone, has found a 1-year survival rate of 68.9% vs 52.9% in the ipilimumab-only ...

supportive care

Fixed-Combination Netupitant/Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On October 10, 2014, oral fixed-combination netupitant and...

gastroesophageal cancer

FDA Approves Ramucirumab in Combination With Paclitaxel for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma. Ramucirumab was approved in April 2014 as a single agent for the treatment of...

hematologic malignancies
solid tumors
issues in oncology

Top 10 Myths About FDA’s Office of Hematology and Oncology Products

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...

lymphoma

Bortezomib in Previously Untreated Mantle Cell Lymphoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On October 9, 2014, bortezomib (Velcade) was granted approval for ...

gynecologic cancers

Maintenance Therapy in Ovarian Cancer: What’s at Stake?

Maintenance therapy in ovarian cancer refers to a cohort of women achieving response to initial adjuvant chemotherapy who then go on to additional therapy in the hopes of extending time to recurrence or inducing a lasting remission. The concept is not new and retains its scientific and clinical...

gynecologic cancers

Pazopanib Maintenance Improves Progression-Free Survival in Ovarian Cancer

In a phase III trial reported in the Journal of Clinical Oncology, ­Andreas du Bois, MD, PhD, Professor of Gynecologic Oncology at Kliniken Essen-Mitte in Essen, Germany, and colleagues found that maintenance therapy with the vascular endothelial growth factor receptor (VEGFR) and platelet-derived...

breast cancer

Complexity of the Contralateral Prophylactic Mastectomy Decision

The powerful and important study by Kurian et al,1 reviewed in this issue of The ASCO Post, adds vital information to the discussion regarding use of contralateral prophylactic mastectomy among patients with unilateral breast cancer in the United States.2,3 Based upon data from the California...

breast cancer

Study Finds Significant Increase in Bilateral Mastectomy for Unilateral Breast Cancer Despite Lack of Survival Benefit

In an observational cohort study reported in JAMA, Allison W. Kurian, MD, MSc, Assistant Professor of Medicine and of Health Research and Policy at Stanford University School of Medicine, and colleagues assessed use of and mortality after bilateral mastectomy, breast-conserving surgery plus...

multiple myeloma

Treatment of Newly Diagnosed Multiple Myeloma With Lenalidomide Plus Low-Dose Dexamethasone

The FIRST trial—reported by Benboubker and colleagues in The New England Journal of Medicine and summarized in this issue of The ASCO Post (page 93)—is a landmark study.1 It is one of the largest randomized trials in multiple myeloma ever conducted. More importantly, it is a well-designed trial...

multiple myeloma

Continuous Lenalidomide/Dexamethasone Improves Progression-Free  Survival in Transplant-Ineligible Patients With Myeloma

In the phase III FIRST trial reported in The New England Journal of Medicine, Lotfi Benboubker, MD, Service d’Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France, and colleagues found that continuous lenalidomide (Revlimid) plus...

colorectal cancer

Incidence of Colorectal Cancer in Young Adults Expected to Rise

While the incidence of colorectal cancer in people 50 years or older has declined, the incidence among people 20 to 49 years has increased, according to a report published online recently by JAMA Surgery.1 From 1998 through 2006, the incidence of colorectal cancer declined 3% per year in men and...

ASTRO Initiatives Aimed at Practice Improvement

At the opening press conference of the 56th Annual Meeting of the American Society for Radiation Oncology (ASTRO), 2014 President Bruce G. Haffty, MD, FASTRO, Professor and Chairman of the Department of Radiation Oncology at Rutgers–Robert Wood Johnson Medical School and Associate Director at the...

Interviews With Candidates for 2015-2016 ASCO President-Elect

The ASCO Nominating Committee has selected Daniel F. Hayes, MD, FASCO, and Patrick J. Loehrer, Sr, MD, FASCO, as candidates for the position of 2015-2016 President-Elect (2016-2017 President). In the abridged interviews below, the candidates discuss their vision for the Society and their leadership ...

breast cancer

Patient-Reported Data Indicate that Radiation Therapy Does Not Increase Risk of Lymphedema in Patients With Node-Negative Breast Cancer

A secondary analysis of the National Surgical Adjuvant Breast and Bowel Project B-32 trial1 indicates that radiation therapy does not increase the incidence of lymphedema in patients with node-negative breast cancer, according to research presented at the American Society for Radiation Oncology’s...

Expert Point of View: Hope S. Rugo, MD

Hope S. Rugo, MD, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, discussed the results of the RESILIENCE trial presented at the European Society for Medical Oncology ...

breast cancer

Adding Sorafenib to Capecitabine Fails to Improve Progression-Free Survival in Advanced Breast Cancer

In patients with locally advanced or metastatic breast cancer, the addition of sorafenib (Nexavar), a broad-spectrum tyrosine kinase inhibitor, to capecitabine did not improve progression-free or overall survival in the phase III RESILIENCE trial. The findings were presented at the European Society ...

lung cancer

Moving Forward With Biomarkers in Non–Small Cell Lung Cancer

The effort to identify new biomarkers for response and outcomes in lung cancer is advancing, according to studies presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid. Immunohistochemical expression of folate receptor for vintafolide and thymidylate synthase for...

lung cancer

Emerging Drugs Effectively Tackle Non–Small Cell Lung Cancer Mutations

For advanced nonsquamous non–small cell lung cancer (NSCLC), targeting of the epidermal growth factor receptor (EGFR) mutation and the ALK abnormality has become an established strategy. Later-generation drugs in these categories are now showing efficacy in trials, including for the treatment of...

multiple myeloma

Single-Agent Carfilzomib, Compared to Corticosteroids Plus Cyclophosphamide, Fails to Improve Survival in Myeloma

Carfilzomib (Kyprolis), as a single agent, failed to improve survival in relapsed and refractory myeloma patients, as compared with a corticosteroid and optional cyclophosphamide, in the phase III FOCUS trial, presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid.1...

Expert Point of View: Alexandria Phan, MD

Formal discussant of the RADIANT-3 trial at the European Society for Medical Oncology (ESMO) Congress, Alexandria Phan, MD, of Houston Methodist Cancer Center, agreed that the crossover to open-label everolimus (Afinitor) by placebo patients probably muddied the waters in the survival estimate....

neuroendocrine tumors

Clinically Relevant Survival Benefit Seen for Everolimus in Pancreatic Neuroendocrine Tumors

Final results from the RADIANT-3 trial showed a 6-month difference in overall survival favoring everolimus (Afinitor) plus best supportive care over placebo plus best supportive care in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumors.1 Although the...

colorectal cancer

QUASAR2 Final Analysis: Bevacizumab Still of No Value in Adjuvant Treatment of Colorectal Cancer

The final analysis of the international phase III QUASAR2 trial confirmed the lack of benefit for bevacizumab (Avastin) as part of the adjuvant treatment of colorectal cancer. “There is no role for bevacizumab in combination with capecitabine as adjuvant treatment for colorectal cancer,” said...

supportive care

Oral Rivaroxaban Has Efficacy Similar to Enoxaparin Plus Vitamin K Antagonist in Preventing Recurrent Venous Thromboembolism

In a subgroup analysis of the pooled results of the EINSTEIN-DVT and EINSTEIN-PE trials reported at the 2014 European Society for Medical Oncology (ESMO) 2014 Congress and published recently in The Lancet Haematology, Martin H. Prins, MD, of Maastricht University Medical Centre, Maastricht,...

colorectal cancer

Phase III Study Confirms Regorafenib’s Survival Benefit in Metastatic Colorectal Cancer

The phase III CONCUR trial1 of regorafenib (Stivarga) monotherapy in Asian patients with previously treated metastatic colorectal cancer confirmed the overall survival benefit seen in the previous ­CORRECT trial,2 and in a planned subgroup analysis, suggesting the benefit is substantial in patients ...

colorectal cancer

European Studies Explore Maintenance Strategies for Metastatic Colorectal Cancer

Studies presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid added insight regarding maintenance therapy in metastatic colorectal cancer, an area lacking a clear recommended strategy following first-line regimens. Two phase III trials found benefit for bevacizumab...

Expert Point of View: Andrés Cervantes, MD, PhD

During a special session at the European Society for Medical Oncology (ESMO) 2014 Congress, additional analyses from the FIRE-3 and Cancer and Leukemia Group B ­(CALGB)/SWOG 80405 trial were presented, and an expert panel was charged with putting the findings into context. Role of Subsequent...

colorectal cancer

All-RAS Testing in Metastatic Colorectal Cancer: Just the First Step

Now that clinicians know to “think beyond KRAS” in metastatic colorectal cancer—and test for all RAS mutations, not just those in exon 2—it seems this is still not sufficient for selecting the best drugs. At the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, a proffered paper ...

breast cancer

Noteworthy Abstracts From the Breast Cancer Symposium Include Studies of Novel Therapies and of the Impact of Disease Subtypes on Outcomes

More than 150 oral and poster presentations were featured at the 2014 Breast Cancer Symposium, held September 4–6 in San Francisco. The multidisciplinary meeting is sponsored by ASCO, the American Society of Breast Disease, American Society of Breast Surgeons, American Society for Radiation...

lymphoma

Targeted Therapies in Indolent Lymphoma: Challenging the Current Paradigm

The use of targeted therapies in indolent non-Hodgkin lymphoma (NHL) is a burgeoning area. New targeted therapies directed at the cell surface, intracellular pathways, and the microenvironment are being studied for relapsed indolent NHL. These treatments, if validated in large randomized trials,...

prostate cancer

ASCO Endorses AUA/ASTRO Guideline on Adjuvant and Salvage Radiotherapy After Prostatectomy

ASCO has issued an endorsement of the American Urological Association (AUA)/American Society for Radiation Oncology (ASTRO) guideline on the use of adjuvant and salvage radiotherapy after prostatectomy, which was based on a systematic review of medical literature. The ASCO endorsement was published ...

colorectal cancer

For Selected Patients With Metastatic Colorectal Cancer, Taking a Break From Combination Chemotherapy Might Be Appropriate and Appreciated

Two phase III studies presented at the Best of ASCO meeting in Chicago shed more light on the role of maintenance therapy in patients with metastatic colorectal cancer undergoing first-line treatment with oxaliplatin-based chemotherapy. The two studies compared maintenance therapy with bevacizumab...

sarcoma

Advances in Sarcoma Owe Much to Children’s Oncology Group

Improvements over the past 3 decades in 5-year survival rates for patients with osteosarcoma and Ewing’s sarcoma owe a lot to chemotherapy clinical trials conducted by the Children’s Oncology Group (COG), Mark Agulnik, MD, acknowledged at the Best of ASCO meeting in Chicago. Dr. Agulnik is...

sarcoma

Targeted Agents Making Inroads Against Sarcoma

Targeted agents have started to make inroads in sarcoma therapies, and gastrointestinal stromal tumor (GIST) is the poster child for this success,” Mark Agulnik, MD, stated in summarizing progress in GIST and other sarcomas at the Best of ASCO meeting in Chicago. Dr. Agulnik is Associate Professor, ...

cost of care

Financial Toxicity Potentially Harmful Treatment‑Related Effect

It turns out that in addition to treatment-related toxicity, cancer patients commonly experience “financial toxicity,” a phrase that is increasingly coming into parlance in the cancer community. Patients should be assessed for financial toxicity as early as possible following diagnosis so that they ...

geriatric oncology

The ‘Silver Oncologic Tsunami’: Rise in Elderly Cancer Patients Brings New Challenges to Oncology Workforce

The “graying of America” poses increasing challenges for the cancer community in terms of rising numbers of cases of cancer and costs associated with geriatric care. The scope of this problem and potential solutions were explored by Andrew E. Chapman, DO, FACP, at the ASCO Quality Care Symposium in ...

issues in oncology

Choosing Wildly: A Patient’s Perspective on Overtreatment and Quality Care

Over the past decade, there has been growing concern in the oncology community about overdiagnosis and overtreatment of cancers that prove to be indolent and nonlethal, resulting in unnecessary and sometimes harmful procedures.  At this year’s ASCO Quality Care Symposium in Boston, this important...

cost of care

Overutilization a Key Target in Efforts to Control Health-Care Costs

Overutilization of health-care interventions has become a prime target of efforts to rein in health-care costs. Overtreatment of cancer patients is associated with a number of common harms to the patient—not just financial harm to the health-care system. At the recent ASCO Quality Care Symposium in ...

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