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issues in oncology
health-care policy

Six Perspectives on the Cancer Moonshot Goal of Making 10 Years of Progress in 5 Years

The Cancer Moonshot initiative is bringing together scientists, oncologists, patient advocates, and representatives of the biopharmaceutical industry with renewed collaborative focus and the ambitious objective of consolidating 10 years of cancer research in 5 years. Achieving this outcome will...

leukemia

Inotuzumab Ozogamicin Improves Outcomes vs Standard Therapy in Relapsed/Refractory Acute Lymphoblastic Leukemia

In a phase III trial reported in The New England Journal of Medicine, Hagop M. Kantarjian, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that treatment with the antibody-drug conjugate inotuzumab ozogamicin resulted in a greater complete remission rate and improved ...

breast cancer

Adding Bevacizumab to Letrozole Improves Progression-Free Survival but Increases Toxicity in Hormone Receptor–Positive Metastatic Breast Cancer

In a phase III trial (CALGB 40503/Alliance) reported in the Journal of Clinical Oncology, Maura N. ­Dickler, MD, of Memorial Sloan Kettering Cancer Center, and colleagues found that the addition of bevacizumab (Avastin) to first-line endocrine therapy with letrozole improved progression-free...

lymphoma

GADOLIN and the Perplexing Role of Obinutuzumab in the Treatment of B-Cell Malignancies

After several dose-finding phase I and II studies in a variety of B-cell malignancies, the potential clinical role of the newer anti-CD20 monoclonal antibody obinutuzumab (Gazyva) remained unclear. These early trials tested low and high doses as well as weekly and every-3-week schedules of...

lymphoma

Phase III Trial Shows Adding Obinutuzumab to Bendamustine Improves Progression-Free Survival in Rituximab-Refractory NHL

In the phase III GADOLIN trial reported in The Lancet Oncology, Laurie H. Sehn, MD, Chair, British Columbia Cancer Agency Lymphoma Tumor Group, and Clinical Associate Professor at the University of British Columbia, Vancouver, and colleagues, found that adding the anti-CD20 antibody obinutuzumab...

lymphoma

Outcomes With Rituximab in DLBCL: Does Gender Matter?

For diffuse large B-cell lymphoma, does the dose of rituximab (Rituxan) matter? Are there patient characteristics that determine outcomes as well as the optimal dose? These questions were explored at the 2016 Pan Pacific Lymphoma Conference by Matthew A. Lunning, DO, Assistant Professor of...

gynecologic cancers

ASCO and SGO Release Clinical Practice Guideline on Neoadjuvant Therapy for Newly Diagnosed Advanced Ovarian Cancer

As reported by Alexi A. Wright, MD, MPH, of Dana-Farber Cancer Institute, and colleagues in the Journal of Clinical Oncology, ASCO and the Society of Gynecologic Oncology (SGO) have released a clinical practice guideline on neoadjuvant therapy for patients with newly diagnosed stage IIIC or IV...

breast cancer

ASCO Guideline Addresses Controversial Areas in Adjuvant Therapy for Breast Cancer

ASCO has published an adaptation of the 2015 Cancer Care Ontario (CCO) clinical practice guideline on adjuvant chemotherapy for early-stage breast cancer.1 There were several areas of controversy that the guideline attempts to address. Should Anthracyclines Be Standard of Care? The guideline...

breast cancer

ASCO Adapts CCO Guideline on Selection of Optimal Adjuvant Therapies for HER2-Negative and HER2-Positive Breast Cancers

As reported in the Journal of Clinical Oncology by Neelima Denduluri, MD, and colleagues, ASCO has adapted a Cancer Care Ontario (CCO) clinical practice guideline on selection of optimal adjuvant chemotherapy for HER2-negative and adjuvant targeted therapy for HER2-positive breast cancer.1 The...

leukemia

Inotuzumab Ozogamicin Shows Clear Benefit in Acute Lymphoblastic Leukemia

In patients with relapsed/refractory acute lymphoblastic leukemia (ALL), the antibody-drug conjugate inotuzumab ozogamicin produced significantly more complete remissions and was a better bridge to transplant than treatment by physician’s choice, according to the final results of a phase III trial...

skin cancer

Study Confirms Benefit of Cobimetinib Plus Vemurafenib in Advanced BRAF V600–Mutant Melanoma

As reported by Ascierto et al in The Lancet Oncology, longer-term follow-up in the pivotal phase III coBRIM trial confirmed the benefit of adding cobimetinib to vemurafenib (Zelboraf) in first-line treatment of BRAF V600–mutant unresectable stage IIIC or IV melanoma. Study Details In the...

prostate cancer

Similar Functional Outcomes Reported With Robot-Assisted Laparoscopic and Open Radical Retropubic Prostatectomy

Robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy yielded similar domain-specific quality-of-life or pathologic outcomes at 12 weeks in men with newly diagnosed, clinically localized prostate cancer, according to the results of a randomized phase III trial reported ...

supportive care
symptom management

FDA Approves Extended-Release Granisetron Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Heron Therapeutics, Inc, announced on August 10, 2016, that the U.S. Food and Drug Administration (FDA) has approved granisetron (Sustol) extended-release injection. Granisetron is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention ...

prostate cancer

Hypofractionated Radiotherapy Not Inferior to Conventional Radiotherapy in Low-Risk Prostate Cancer

In a phase III noninferiority trial (NRG Oncology RTOG 0415) reported by Lee et al in the Journal of Clinical Oncology, W. Robert Lee, MD, MS, Med, of Duke University Medical Center, and colleagues found that hypofractionated radiotherapy was not inferior to conventional hypofractionated...

lung cancer

Nivolumab Did Not Meet Primary Endpoint of Progression-Free Survival in NSCLC in CheckMate-026 Trial

Bristol-Myers Squibb Company announced last week that CheckMate-026, a phase III trial investigating the use of nivolumab (Opdivo) as monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non–small cell lung cancer (NSCLC)...

gynecologic cancers

Adding Pertuzumab to Chemotherapy in Platinum-Resistant Ovarian Cancer

According to the European phase III PENELOPE trial reported in the Journal of Clinical Oncology, Christian Kurzeder, MD, of Kliniken Essen-Mitte, Essen, Germany, et al found that adding pertuzumab (Perjeta) to investigator’s choice chemotherapy did not improve progression-free survival in women...

kidney cancer

Quality of Life With Nivolumab vs Everolimus in Advanced Renal Cell Carcinoma

Patients with previously treated advanced renal cell carcinoma receiving nivolumab (Opdivo) in the phase III CheckMate 025 trial had improved health-related quality of life compared with those receiving everolimus (Afinitor), as reported by David Cella, PhD, of Northwestern University, Chicago, et...

kidney cancer

Final Results of METEOR Trial: Cabozantinib vs Everolimus in Advanced Renal Cell Carcinoma

As reported by Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, et al in The Lancet Oncology, the final results of the phase III METEOR trial indicate significantly improved overall survival with cabozantinib (Cabometyx) vs everolimus (Afinitor) in patients with advanced renal cell carcinoma...

FDA Approves Sofosbuvir/Velpatasvir for Treatment of Chronic Hepatitis C Virus Infection

The U.S. Food and Drug Administration (FDA) approved Epclusa (sofosbuvir at 400 mg/velpatasvir at 100 mg) on June 28, 2016, to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis (decompensated cirrhosis),...

lung cancer

Phase III Trial Finds No Survival Benefit of Adding Ipilimumab to Etoposide/Platinum in Extensive-Stage SCLC

The addition of the anti–CTLA-4 (cytotoxic T-lymphocyte–associated protein 4) checkpoint inhibitor ipilimumab (Yervoy) to etoposide/platinum did not improve overall survival in the first-line treatment of patients with extensive-stage small cell lung cancer (SCLC), according to a phase...

issues in oncology

Actively Recruiting Clinical Trials Focused on the Role of Obesity in Cancer

Study Title: A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors Study Type: Pilot/interventional/single-group assignment Study Sponsor and Collaborators: Case Comprehensive Cancer Center, National Cancer Institute  Purpose: To study whether the...

breast cancer

Ribociclib Receives FDA Breakthrough Therapy Designation for Treatment of Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ribociclib in combination with letrozole for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib...

lymphoma

Is Post-Transplantation Cyclophosphamide Disruptive Technology?

There was a time when transplantation across human leukocyte antigen (HLA) barriers was fraught with so much difficulty that many thought it was impossible and we should stop trying. However, most patients do not have an HLA-matched sibling donor, and death was therefore certain if they had a...

lymphoma

Reduced-Intensity Related-Donor Haploidentical vs HLA-Matched Sibling-Donor Hematopoietic Cell Transplantation in Lymphoma

In an analysis of the observational database of the Center for International Blood and Marrow Transplant Research reported in the Journal of Clinical Oncology, Nilanjan Ghosh, MD, PhD, of Levine Cancer Institute, Carolinas Healthcare System, Charlotte, North Carolina, and colleagues found that...

geriatric oncology
survivorship

The Complexities of Care for Older Cancer Survivors

Integrated care, a focus on prevention and screening, and acknowledgment of comorbidities on the impact of treatment all play a critical role in the cancer survivorship of older patients, according to Martine Extermann, MD, PhD, a medical oncologist at Moffitt Cancer Center in Tampa, Florida....

supportive care
symptom management

More Focus Needed on Chemotherapy-Induced Nausea as a Cluster of Symptoms

Management of chemotherapy-induced vomiting has improved with the use of antiemetics, but chemotherapy-induced nausea remains a major clinical problem, according to Alex Molassiotis, RN, PhD, Professor and Head of the School of Nursing at The Hong Kong Polytechnic University. And, he added, the...

colorectal cancer

Anti–Interleukin-1 Alpha Antibody MABp1 Improves Outcomes Significantly Over Placebo in Advanced Colorectal Cancer

A novel anti–interleukin-1 alpha (IL-1α) antibody has shown a significant impact on symptoms and a high level of safety and tolerability in patients with advanced colorectal cancer, according to phase III data presented by Hickish et al at the European Society for Medical Oncology’s 18th World...

gastrointestinal cancer

Chemoradiotherapy After Surgery for Gastric Cancer Shows Similar Outcomes to Postoperative Chemotherapy

Postoperative treatment intensification with chemoradiotherapy does not achieve better outcomes when compared with postoperative chemotherapy in patients with gastric cancer who have already undergone preoperative chemotherapy, according to phase III data presented by Marcel Verheij, MD, PhD, et...

hepatobiliary cancer

Phase III RESORCE Study Data Show Regorafenib Improves Overall Survival in Previously Treated Patients With Unresectable Liver Cancer

Results from the phase III RESORCE trial show that regorafenib (Stivarga) tablets achieved a median overall survival improvement in patients with unresectable hepatocellular carcinoma that progressed after treatment with sorafenib (Nexavar) tablets. The study, presented by Jordi Bruix, MD, et al...

colorectal cancer

Anti–PD-L1 Immunotherapy Shows Response in Microsatellite-Stable Metastatic Colorectal Cancer in Combination With MEK Inhibition

Anti–PD-L1 (programmed death ligand 1) immunotherapy may achieve a response in patients with microsatellite-stable metastatic colorectal cancer if combined with a MEK inhibitor, according to phase I data presented at the European Society for Medical Oncology (ESMO) 18th World Congress on...

breast cancer
solid tumors

Neoadjuvant Veliparib/Carboplatin and Neratinib ‘Graduate’ From Adaptive Randomization I-SPY 2 Trial in Early Breast Cancer

As reported by Rugo et al and Park et al in The New England Journal of Medicine, the adaptive randomization phase II I-SPY 2 trial has shown that the addition of veliparib/carboplatin and the addition of neratinib to standard neoadjuvant therapy have met criteria predictive of success in a phase...

Expert Point of View: W. Robert Lee, MD

Formal discussant W. Robert Lee, MD, of Duke University School of Medicine, Durham, North Carolina, placed himself firmly in the camp supporting hypofractionation as a new standard of care. “We now have three large noninferiority trials with different eligibility criteria and different regimens....

cost of care

ASCO Plenary Studies: Assessing the ‘Value’ of New Treatments

At the 2016 ASCO Annual Meeting, studies presented at the Plenary Session gave attendees new treatment strategies to employ back home. But in the emerging push to contain the cost of new cancer treatments, do the four interventions fit within the new “value framework” for oncology? Deborah Schrag, ...

colorectal cancer

No Improvement in Outcome Reported With Longer Wait Between Radiochemotherapy and Surgery in Rectal Cancer

Pathologic complete response rate was not improved by increasing the interval between neoadjuvant chemoradiotherapy and surgery from 7 to 11 weeks in patients with rectal cancer, according to the French phase III GRECCAR-6 trial reported by Lefevre et al in the Journal of Clinical Oncology. In...

lymphoma

Is Nivolumab Active in Classical Hodgkin Lymphoma After Failure of Autologous SCT and Brentuximab Vedotin?

Treatment with the anti–PD-1 (programmed cell death protein 1) immune checkpoint inhibitor nivolumab (Opdivo) produced response in two-thirds of patients with classical Hodgkin lymphoma after failure of both autologous stem cell transplantation (SCT) and brentuximab vedotin (Adcetris),...

kidney cancer

Poorer Outcome in Favorable-Histology Wilms Tumor Associated With Chromosome 1q Gain Reported in U.S. Study

The Children’s Oncology Group found that chromosome 1q gain is associated with poorer event-free and overall survival in patients with favorable-histology Wilms tumor. Gratias et al reported these findings in the Journal of Clinical Oncology. Study Details The study involved analysis of...

multiple myeloma

FDA Grants Breakthrough Therapy Designation for Daratumumab in Combination With Standard of Care for Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the immunotherapy daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have ...

colorectal cancer

Gene-Expression Signature Assay Identifies High-Risk Stage II Colon Cancer

In an analysis reported in the Journal of Clinical Oncology, Niedzwiecki et al found that the ColDx gene-expression signature assay identified high-risk stage II colon cancer among patients in the phase III Alliance C9581 trial. This assay has been shown to be independently prognostic for...

supportive care
symptom management

Olanzapine Combination Reduces Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy

In a phase III trial reported by Navari et al in The New England Journal of Medicine, the addition of the antipsychotic agent olanzapine vs placebo to dexamethasone, aprepitant, or fosaprepitant, and a 5-hydroxytryptamine type 3–receptor antagonist reduced nausea and improved antiemetic...

leukemia

Clinical Trials Actively Recruiting Patients With Acute Myeloid Leukemia

Phase I/II Study Title: A Phase I-II Randomized Trial of a Combination of ­Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First-Relapse AML Study Type: Phase I/II/interventional/parallel assignment Study Sponsor and Collaborators: Yale University,...

breast cancer

Mindfulness-Based Stress-Reduction Program May Reduce Psychological and Physical Symptoms in Breast Cancer Survivors

A mindfulness-based stress-reduction program for breast cancer survivors was associated with psychological and physical symptom benefits during and at 6 weeks after intervention, according to a randomized trial reported in the Journal of Clinical Oncology by Cecile A. Lengacher, RN, PhD, of the...

colorectal cancer

New ASTRO Clinical Practice Statement Updates Treatment Standard for Rectal Cancer

The American Society for Radiation Oncology (ASTRO) recently issued a new clinical practice statement, “Appropriate Customization of Radiation Therapy for Stage II and III Rectal Cancer: An ASTRO Clinical Practice Statement Using the RAND/UCLA Appropriateness Method.” An executive...

pancreatic cancer

ASCO 2016 Guidelines for the Treatment of Pancreatic Cancer: Why Another Guideline?

The 5-year survival rate of those diagnosed with pancreatic cancer remains stubbornly fixed around 5%. Even in the 20% of cases in which surgical resection is undertaken for curative intent, the 5-year survival rate after surgery is 20% to 30%. As we make progress in other cancers with decreasing...

breast cancer
survivorship
symptom management

Can Self-Administered Acupressure Reduce Fatigue in Breast Cancer Survivors?

Self-administered relaxing acupressure and stimulating acupressure were both associated with reduced persistent fatigue vs usual care in breast cancer survivors, according to a randomized clinical trial reported by Zick et al in JAMA Oncology. However, only relaxing acupressure had significant...

issues in oncology
health-care policy

Road to Successful Use of Real-World Evidence for Drug Development Is Long and Rocky

Friends of Cancer Research (Friends) has been a leader in the push for better and faster cancer drug development. Now it is tackling the use of real-world evidence in clinical trials. This is the report of a meeting on the subject that took place on June 16 in Washington, DC.1 Real-world evidence...

breast cancer

Quick Takes on Promising New Approaches to Treating Breast Cancer

At the 2016 ASCO Annual Meeting, researchers reported encouraging results for several new drugs and treatment strategies for breast cancer. The ASCO Post brings you brief summaries of a select few. Abemaciclib Trial The cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib produced responses...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

Selected Hematology Abstracts From the 2016 ASCO Annual Meeting

Here are several abstracts selected from the proceedings of the 2016 ASCO Annual Meeting, focusing on clinical trials on therapeutics in different types of leukemia, multiple myeloma, follicular lymphoma, and central nervous system (CNS) lymphoma. For full details of these study abstracts, visit...

lung cancer

App Triggers Earlier Detection of Relapse, May Help Improve Survival of Patients With Lung Cancer

Web-based applications have invaded mainstream culture and grabbed the attention of multitudes of people around the world. According to a study presented at the 2016 ASCO Annual Meeting, an app may also contribute to extending the lives of people with cancer and, at the same time, reduce...

Expert Point of View: Sunil Verma, MD

Sunil Verma, MD, Professor and Head of the Department of Oncology and Medical Director of the Tom Baker Cancer Centre of the University of Calgary in Canada, was the study’s formal discussant. He cited several limitations of the study: It was an open-label study, was initially a phase II study but ...

breast cancer

PHEREXA: Benefit for Second-Line Pertuzumab Questionable

In the second-line metastatic breast cancer setting, the addition of pertuzumab (Perjeta) to trastuzumab (Herceptin)/capecitabine did not significantly improve progression-free survival, results of the phase III ­PHEREXA trial showed.1 This is the first randomized trial to evaluate the efficacy of ...

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