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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....

prostate cancer

Hypofractionation May Be Poised to Become New Standard of Care for Prostate Cancer

There has been an ongoing debate about which type of radiation therapy is preferable in the treatment of localized prostate cancer: hypofractionation (larger fractions given over 4–5 weeks) or conventional radiotherapy (given over 8–9 weeks). A new study presented at the 2016 ASCO Annual Meeting...

issues in oncology
health-care policy

Moonshots and ‘Onco-nauts’

Where were you on July 20, 1969? I certainly remember where I was—sitting in a mess hall at summer camp watching a grainy black-and-white TV as Neil Armstrong took “one small step for man, one giant leap for mankind.” I recall the sense of jubilation and accomplishment that all American citizens...

issues in oncology

ASCO and Friends of Cancer Research Launch Initiative to Modernize Eligibility Criteria for Clinical Trials

The dismal accrual rates in cancer clinical trials are well known: Just 3% to 5% of adults with cancer enroll in clinical trials.1 The reasons patients are reluctant to participate in clinical trials are equally well known: fear of reduced quality of life, concern about receiving a placebo, and...

skin cancer

Potential Link Between Pembrolizumab Use and Demyelinating Polyradiculoneuropathy Reported in Two Cases of Advanced Melanoma

In a letter to the editor in The New England Journal of Medicine, de Maleissye et al described two cases of severe demyelinating polyradiculoneuropathy that occurred after pembrolizumab (Keytruda) treatment for advanced melanoma. Case 1 A 45-year-old woman receiving pembrolizumab at 2 mg/kg every ...

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...

leukemia

Study Evaluates Chronic Graft-vs-Host Disease Burden and Complications in Patients Receiving Bone Marrow Transplants

A University of Colorado Cancer Center study compared outcomes of leukemia patients receiving bone marrow transplants from 2009 to 2014, finding that 3 years post transplant, the incidence of severe chronic graft-vs-host disease was significantly higher in patients who had received transplants from ...

skin cancer

Pathway Defects in Acquired Resistance to PD-1 Inhibition in Melanoma Identified

In a study reported in The New England Journal of Medicine, Zaretsky et al found that defects in interferon receptor signaling and antigen-presenting pathways were associated with acquired resistance to PD-1 (programmed cell death protein 1) inhibition in melanoma. Resistance Mutations Identified ...

solid tumors
lung cancer

Ceritinib Shows Overall and Intracranial Activity in Advanced NSCLC Previously Treated With Crizotinib and Chemotherapy

Crinò et al found that ceritinib (Zykadia) was active overall and in central nervous system (CNS) metastases in patients with ALK-rearranged advanced non–small cell lung cancer (NSCLC) previously treated with crizotinib (Xalkori) and chemotherapy, according to the ASCEND-2 phase II...

issues in oncology

Delirium Frequent and Underdiagnosed Among Advanced Cancer Patients Presenting to an Emergency Department

A new study indicates that delirium is relatively frequent and underdiagnosed by physicians in patients with advanced cancer visiting the emergency department. Delirium was similarly common among older and younger patients, which suggests that in the setting of advanced cancer, all patients should...

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),...

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 ...

prostate cancer

Patients With Low-Risk Prostate Cancer on Active Surveillance Experience Good Quality of Life

Active surveillance has become an increasingly important alternative to surgery, chemotherapy, or radiation treatment for men diagnosed with low-risk prostate cancer. However, what is the impact of active surveillance on health-related quality of life in patients selected or opting for this...

survivorship
leukemia
lymphoma

My Commitment to Helping Other Survivors of Childhood Cancers

When I was diagnosed with acute lymphocytic leukemia (ALL) at the age of 2 in 1974, not much was known about the cancer or the side effects of its treatment. Too young to understand what was happening to me, the burden fell to my parents and older sibling to protect and care for me. For more than...

breast cancer

In Vitro Fertilization Not Associated With Increased Risk of Breast Cancer in Dutch Study

Among women undergoing fertility treatment in the Netherlands between 1980 and 1995, the use of in vitro fertilization (IVF) compared with non-IVF treatment was not associated with increased risk of breast cancer after a median follow-up of 21 years, according to a study published by van den...

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,...

lymphoma

No Apparent Benefit of GnRH in Preserving Ovarian Function and Fertility in Young Women With Lymphoma

In a long-term follow-up of a European trial reported by Isabelle Demeestere, MD, PhD, of the Université Libre de Bruxelles in Belgium, and colleagues in the Journal of Clinical Oncology, gonadotropin-releasing hormone (GnRH) agonist treatment during chemotherapy in young women with lymphoma was...

An Epic Medical Story by an Old-Style Doctor on the Front Lines of Care

The U.S. health-care system is a $3 trillion behemoth of dizzying complexity. Government oversight, ever-changing regulations, mountains of paperwork, electronic health records, initiative after initiative, and so forth, all of which has reshaped the delivery of care, for the good and bad. But...

FDA Advances Precision Medicine Initiative by Issuing Draft Guidances on Next-Generation Sequencing–Based Tests

In support of the President’s Precision Medicine Initiative, on July 6, the U.S. Food and Drug Administration (FDA) issued two draft guidances. When finalized, they will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s...

Fred Hutchinson Cancer Research Center Appoints 2016–2017 Board Members, Including Microsoft CEO and Former Governor of Washington

Fred Hutchinson Cancer Research Center announced the appointment of Microsoft CEO Satya Nadella to its Board of Trustees. He is among five new board members at Fred Hutch, a Seattle-based pioneer in advancing groundbreaking research to prevent, diagnose, and treat cancer and related diseases. “I’m ...

integrative oncology

Acupuncture: Does It Alleviate Symptoms Associated With Cancer Care?

A therapeutic modality of traditional Chinese medicine, acupuncture has been extensively investigated in Western medical settings. Its clinical use is increasingly common for the management of pain and other conditions. In the oncology setting, research demonstrates that acupuncture can...

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...

issues in oncology

As Low-Dose CT Screening Moves Into the Clinic, Implementation Issues Move Up on the Agenda

Low-dose computed tomography (CT) screening for lung cancer in high-risk groups is moving into the clinic in the wake of its approval by the U.S. Centers for Medicaid & Medicare Services. That does not mean, however, the discussion is over. As low-dose CT moves from research to everyday...

lung cancer

Lung Cancer Screening: Beneficial for Certain Populations but Not Without Controversy

The National Cancer Policy Forum of the National Academies of Sciences took up the issue of lung cancer screening at its mid-June workshop. Greta Massetti, PhD, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention (CDC), and chair of ...

lymphoma

Andrew D. Zelenetz, MD, on Diffuse Large B-Cell Lymphoma: CHOP-R and EPOCH-R?

Andrew D. Zelenetz, MD, of Memorial Sloan Kettering Cancer Center, discusses the pros and cons of these two regimens, with or without another agent, in diffuse large B-cell lymphoma.

breast cancer

ASCO Guideline on Endocrine Therapy for Hormone Receptor–Positive Metastatic Breast Cancer

As reported by Hope S. Rugo, MD, of the University of California San Francisco Comprehensive Cancer Center, and colleagues in the Journal of Clinical Oncology, ASCO has released a clinical practice guideline on endocrine therapy for hormone receptor–positive metastatic breast cancer.1 The...

issues in oncology

Discovery of Fragment Length of Circulating Tumor DNA Might Increase Liquid Biopsy Sensitivity

The liquid biopsy may be a welcome reprieve from typical biopsies. The minimally invasive test could reduce the need for the sometimes painful and risky procedures involved in sampling tumors, particularly those that reside deep within the body. However, thus far, the utility of the test has been...

lymphoma

Five-Year Survival Data: Brentuximab Vedotin May Be Curative in Some Patients With Hodgkin Lymphoma

Five-year survival data published by Chen et al in Blood suggest that the targeted therapy brentuximab vedotin (Adcetris) may be curative in some patients with Hodgkin lymphoma whose disease has persisted despite receiving previous therapies. This multinational phase II study examined brentuximab...

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...

ASCO and MECC Sponsor International Palliative Care Workshop in Kazakhstan

ASCO recently collaborated with the Middle East Cancer Consortium (MECC) to provide a 3-day International Palliative Care Workshop in Kazakhstan for health-care professionals, advocates, and volunteers in the former capital of Almaty. Dilyara Kaidarova, MD, PhD, Director of the Almaty Oncology...

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...

HHS Announces Physician Groups Selected for Initiative Promoting Better Cancer Care

The U.S. Department of Health and Human Services (HHS) has announced that it has selected nearly 200 physician group practices and 17 health insurance companies to participate in a care delivery model that supports and encourages higher quality and more coordinated cancer care. The Medicare arm of...

Brachytherapy Pioneer Haakon Ragde, MD, Chosen as ASTRO 2016 Honorary Member

The American Society for Radiation Oncology (ASTRO) has selected Haakon Ragde, MD, as its 2016 Honorary Member, the highest honor ASTRO confers on distinguished cancer researchers, scientists, and leaders in disciplines other than radiation oncology, radiobiology, or radiation physics. Dr. Ragde...

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...

skin cancer

Studies Suggest Bright Future for Combination Immunotherapy in Advanced Melanoma, but Questions Remain

Two studies presented at the 2016 ASCO Annual Meeting focused on the use of combination immunotherapy in the treatment of patients with advanced melanoma. Updated results from the phase III CheckMate 067 trial centered on the combination of nivolumab (Opdivo) plus ipilimu­mab (Yervoy) compared...

health-care policy
cost of care
issues in oncology

Charting a New Course at the FDA

In February, after serving for a year as the U.S. Food and Drug Administration’s (FDA’s) Deputy Commissioner for Medical Products and Tobacco, Robert M. Califf, MD, MACC, was named the agency’s Commissioner of Food and Drugs. Prior to his appointment at the FDA, Dr. Califf was the Donald F....

breast cancer

Results of Two Practice-Changing Breast Cancer Trials Upheld

Results of two pivotal breast cancer trials reported at the 2016 ASCO Annual Meeting confirmed the practice-changing findings that resulted from earlier findings. PALOMA-2 The phase III PALOMA-2 trial confirmed results from the smaller, open-label phase II PALOMA-1 trial that led to the U.S. Food...

issues in oncology

Patient-Oncologist Difference of Opinion About Advanced Cancer Prognosis Is Common, Study Shows

Misunderstandings about prognosis between patients with advanced cancer and their doctors was common, according to a study by Gramling et al in JAMA Oncology—and the vast majority of patients didn't know that their doctors held different opinions about how long they might live. “We've...

prostate cancer

Early Evidence of Anti–PD-1 Activity in Enzalutamide-Resistant Prostate Cancer

Restoring tumor-specific immunity is a treatment strategy that works well in melanoma and lung cancer patients. Now a new study out of the Oregon Health & Science University (OSHU) Knight Cancer Institute is reviving hope that the approach also may help men with life-threatening prostate...

hematologic malignancies
lymphoma

Early Results Find Pembrolizumab Active in Classical Hodgkin Lymphoma After Brentuximab Vedotin Failure

Findings in a classical Hodgkin lymphoma cohort in the phase Ib KEYNOTE-013 trial, reported by Armand et al in the Journal of Clinical Oncology, indicate that pembrolizumab (Keytruda) is active in patients with disease progressing on or after brentuximab vedotin (Adcetris) treatment. Study Details ...

leukemia

Juno Therapeutics to Resume JCAR015 Phase II ROCKET Trial After FDA Clinical Hold

Juno Therapeutics, Inc, announced on July 12, 2016, that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the phase II clinical trial of JCAR015 (known as the ROCKET trial) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Under the ...

Internationally Renowned Geneticist, Alfred George Knudson, MD, PhD, Dies

Considered a visionary in cancer research, Alfred George Knudson, MD, PhD, was internationally recognized for his “two-hit theory” of cancer causation, which explained the relationship between hereditary and nonhereditary cancer types, predicting the existence of tumor-suppressor genes. ...

gynecologic cancers

FDA Approves First HPV Test for Use With SurePath Preservative Fluid

On July 7, the U.S. Food and Drug Administration (FDA) approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Papanicolau (Pap) test and collected in SurePath Preservative Fluid. The FDA approves HPV tests to be used...

health-care policy

FDA Advances Precision Medicine Initiative by Issuing Draft Guidances on Next-Generation Sequencing–Based Tests

In support of the President’s Precision Medicine Initiative, on July 6, the U.S. Food and Drug Administration (FDA) issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a...

lung cancer

First-Line Nivolumab Active in Combination With Platinum-Based Doublets in Advanced NSCLC

Nivolumab (Opdivo) was found to be active combined with platinum-based doublets as first-line treatment of advanced non–small cell lung cancer (NSCLC), as part of the phase I CheckMate 012 study reported by Rizvi et al in the Journal of Clinical Oncology. The study is also evaluating...

gastrointestinal cancer

World GI 2016: Chemoradiotherapy After Surgery for Gastric Cancer Shows Similar Outcomes to Postoperative Chemotherapy

Postoperative treatment intensification with chemoradiotherapy does not achieve better outcomes compared to postoperative chemotherapy in patients with gastric cancer who have already undergone preoperative chemotherapy, according to phase III data presented by Verheij et al at the ESMO 18th World...

colorectal cancer

World GI 2016: Anti–PD-L1 Immunotherapy Combined With MEK Inhibition Shows Response in Microsatellite-Stable Metastatic Colorectal Cancer

Anti–PD-L1 (programmed cell 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 ...

prostate cancer

Study Finds Incidence of Mutations in DNA-Repair Genes Significantly Higher in Men With Metastatic Prostate Cancer

The incidence of mutations in DNA-repair genes was significantly higher among men with metastatic prostate cancer than among men with localized disease (11.8% vs 4.6%), according to a study by Pritchard et al reported in The New England Journal of Medicine. In addition, the frequency ...

prostate cancer

Mixed Results With Hypofractionated vs Conventional Radiotherapy for Localized Prostate Cancer

Investigators of two European phase III trials have reached different conclusions on whether hypofractionated radiotherapy should replace conventional radiotherapy as a new standard of treatment in localized prostate cancer. The CHHiP trial findings favoring hypofractionation were reported by David ...

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