INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this first installment, FDA Clinical Reviewers Laleh Amiri-Kordestani, MD, and Suparna Wedam, MD, discuss FDA’s recent approval of pertuzumab (Perjeta) for the neoadjuvant treatment of...
Hepatocellular carcinoma is a devastating disease worldwide. Although advances in liver transplantation, surgery, and locoregional therapies have made tumor control or even cure possible for a minority of patients, the majority of patients diagnosed with hepatocellular carcinoma will develop...
The investigational drug brivanib is a dual inhibitor of vascular endothelial growth factor and fibroblast growth factor signaling, both implicated in hepatocellular carcinoma. The agent was recently evaluated in two phase III trials, one comparing first-line brivanib with sorafenib (Nexavar) in...
The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the tyrosine kinase inhibitor ponatinib (Iclusig) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Ariad Pharmaceuticals has agreed to...
In the October 15, 2013 issue of The ASCO Post, production instructions were inadvertently placed on an advertisement for Tafinlar® (page 4) and printed in the final version of the advertisement. Harborside Press, publisher of The ASCO Post, regrets this error and accepts full responsibility for...
The Institute of Medicine (IOM) recently announced the names of 70 new members and 10 foreign associates during its 43rd Annual Meeting. “It is an honor to welcome our highly distinguished colleagues to the Institute of Medicine,” said IOM President Harvey V. Fineberg. “These individuals have...
The optimal use of bevacizumab (Avastin) in ovarian cancer appears to be in high-risk subgroups and in patients with platinum-resistant ovarian cancer, according to results of two phase III trials presented at the 2013 European Cancer Congress (ECC) in Amsterdam. AURELIA investigated the safety and ...
Press conference moderator Cora N. Sternberg, MD, Chief of Medical Oncology at San Camillo and Forlanini Hospitals, Rome, called the 2- to 3-month improvement in overall survival “worthwhile, and clinically meaningful.” She said this should be viewed in the context of manageable toxicity....
Since its introduction, the positron-emission tomography (PET) scan has shown great potential to improve our ability to care for patients with lymphoma. By demonstrating which masses seen on a computed tomography (CT) scan represent viable tumor, and by identifying viable tumor in places that were...
In September, the Institute of Medicine (IOM) of the National Academies issued its report, Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis,1 published more than a decade after its first study on the quality of cancer care in the United States. The authors of the...
In the treatment of metastatic or locally advanced unresectable melanoma, the anti–CTLA-4 monoclonal antibody ipilimumab (Yervoy) conveys long-term survival benefits, with some patients alive out to 10 years, according to the largest survival analysis of the immunomodulating agent, presented at the ...
Recent years have witnessed much heated debate about the benefits of breast cancer screening and optimal screening strategies. Unlike with mammography, no randomized data are available to determine whether screening with magnetic resonance imaging (MRI) reduces mortality from breast cancer....
Five recent articles in JAMA Otolaryngology–Head & Neck Surgery1-5 span a spectrum of issues related to head and neck cancers. These include risk factors, concentration of care to teaching hospitals, avoiding venous thromboembolism, and encouraging patients to eat and do swallowing exercises to ...
Quality measurement—how we assess cost and effectiveness of cancer care—cannot be separated from policy decisions that have a profound influence on the overall health-care system. At the recent ASCO Quality Care Symposium, Jennifer L. Malin, MD, PhD, Medical Director for Oncology at WellPoint, Inc, ...
Max S. Wicha, MD, has announced he will step down as Director of the University of Michigan Comprehensive Cancer Center where he has served for the past 27 years. Dr. Wicha founded University of Michigan’s Cancer Center in 1986 and shepherded it to its first National Cancer Institute Cancer Center ...
According to data from the Surveillance, Epidemiology, and End Results Program (SEER) and the U.S. Census Bureau registries,1 there are currently about 13.7 million cancer survivors in the United States, and that number is projected to grow to 18 million by 2022. In addition, 64% of this population ...
NewYork-Presbyterian/Columbia University Medical Center has opened its new Irving Radiation Oncology Center, part of the medical center’s Herbert Irving Comprehensive Cancer Center. The 12,500-square-foot facility provides precision radiation therapies and advanced diagnostic imaging for children...
The American Association for Cancer Research (AACR) and the Ocular Melanoma Foundation (OMF) are pleased to announce a new partnership to provide a grant opportunity for researchers focused on ocular melanoma, which is diagnosed in approximately 2,000 adults in the United States each year....
The adjuvant use of bisphosphonates in breast cancer continues to yield seemingly contradictory data despite a sound biologic basis and smaller pilot studies suggesting that dampening bone turnover with bisphosphonates can lessen the bone reservoir of micrometastases.1,2 Early adjuvant trials with...
ASCO has announced that Amy P. Abernethy, MD, PhD, FACP, has agreed to chair a new CancerLinQ™ Advisory Committee within the Institute for Quality, an ASCO affiliate dedicated to innovative quality improvement programs, that will guide this multiphase effort. The advisory committee consists of...
Ernst Lengyel, MD, PhD, was recently named Chair of the Department of Obstetrics and Gynecology at the University of Chicago. He succeeds Arthur Haney, MD, who served as Chair of the Department of Obstetrics and Gynecology since April 2003. Under the leadership of Dr. Haney, the Department...
Oncologists are getting a handle on BRCA1/2 in breast cancer, becoming more adept at treating and counseling patients with these mutations. But the BRCA mutation is only one example of a host of genetic variations that can increase breast cancer risk, according to James M. Ford, MD, Associate...
ASCO and its affiliate, the Quality Oncology Practice Initiative (QOPI®) Certification Program (QCP™), have announced that more than 200 practices have received certification. Since its start in 2010, the QOPI Certification Program has evaluated individual outpatient oncology practice performance...
On August 1 of this year, requirements of the Physician Payments Sunshine Act, or Open Payments, went into effect. The legislation, passed as part of the Patient Protection and Affordable Care Act, was designed to create greater transparency around financial relationships between physicians,...
Lynne Blasi, Director, Patient Education and Advocacy, ASCO Why do you choose to support the Conquer Cancer Foundation? I support the Conquer Cancer Foundation because of the tremendous impact it has across so many vital areas. From funding grants for young researchers with innovative ideas,...
Lawrence C. Brody, PhD, has been selected to be the first Director of the newly established Division of Genomics and Society at the National Human Genome Research Institute (NHGRI). Dr. Brody, a genetics and genomics researcher, is currently Chief of the Genome Technology Branch within NHGRI’s...
The U.S. Food and Drug Administration has authorized the marketing of the UroLift system, a permanent implant to relieve low or blocked urine flow in men age 50 and older with benign prostatic hyperplasia. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia....
For a number of years following the approval of gemcitabine for advanced pancreatic cancer, one phase III clinical trial after the next failed to demonstrate a survival benefit of combination chemotherapy compared to gemcitabine alone. Even the one positive study from the mid-2000s—the PA.3 trial...
Eric Van Cutsem, MD, PhD, Professor of Internal Medicine at the University of Leuven in Belgium, the formal discussant of the late-breaking abstract, noted there is strong rationale for studying TP53 status in relation to rectal cancer outcomes, but he felt the findings of EXPERT-C could not yet be ...
In a retrospective analysis of the randomized phase II EXPERT-C trial, TP53 emerged as a strong, independent predictive biomarker for the benefit of cetuximab (Eribitux) in MRI-defined high-risk, locally advanced rectal cancer, according to Francesco Sclafani, MD, of The Royal Marsden NHS...
Excitement continues to build in the metastatic melanoma arena, as novel agents keep upping the ante for efficacy. The following news from the 2013 European Cancer Congress has added to the buzz. New MEK Inhibitor In the phase IB BRIM7 study, cobimetinib, a novel MEK inhibitor, when combined with...
Relapsed and refractory transplant-eligible Hodgkin lymphoma patients who achieve complete responses after treatment with brentuximab vedotin (Adcetris) can often avoid more toxic salvage chemotherapy, according to investigators from Memorial Sloan-Kettering Cancer Center, New York....
For the front-line treatment of advanced Hodgkin lymphoma, ABVD is a standard treatment, but not all patients have good outcomes with this regimen. The addition of brentuximab vedotin (Adcetris), or its substitution for bleomycin, produces high complete response rates but with a moderate increase...
Nationally regarded health-care expert Lee N. Newcomer, MD, MHA, began his presentation at this year’s ASCO Quality Care Symposium with a rhetorical question. “Why are we talking about money when we’re gathered in San Diego for 2 days to discuss some wonderful ways to impact the quality of cancer...
Disease-free survival is an acceptable surrogate for overall survival in trials of cytotoxic agents for gastric cancer in the adjuvant setting, the GASTRIC group concluded after conducting a meta-analysis of data from 3,288 individual patients enrolled in 14 randomized clinical trials. The trials...
City of Hope has selected Steven T. Rosen, MD, the Director of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University Feinberg School of Medicine, as its first Provost and Chief Scientific Officer. Dr. Rosen will set the scientific direction of City of Hope as it embarks on a...
In the late 1980s, Brian J. Druker, MD, was investigating the BCR-ABL tyrosine kinase as a target for therapeutic intervention for chronic myeloid leukemia (CML) in a laboratory at Dana-Farber Cancer Institute in Boston. By 1993, Dr. Druker had moved to Oregon Health & Science University in...
The use of dietary supplements by patients with cancer has increased significantly over the past 2 decades despite insufficient evidence of safety and effectiveness. Finding reliable sources of information about dietary supplements can be daunting. Patients typically rely on family, friends, and...
Heather Greenlee, ND, PhD, was named President of the Society for Integrative Oncology (SIO) at the organization’s 10th International Conference in October. Dr. Greenlee is Assistant Professor in the Department of Epidemiology at the Mailman School of Public Health at Columbia University in New...
Targeted anticancer therapies like epidermal growth factor receptor (EGFR) inhibitors, multitargeted tyrosine kinase inhibitors (mTKIs), and mammalian target of rapamycin (mTOR) inhibitors frequently result in dermatologic adverse events and mucosal adverse events, or, taken together, mucocutaneous ...
Welcome to the meeting we hold every 3 years to choose our next projects,” said John Mendelsohn, MD, Chair of the National Cancer Policy Forum and Director of the Khalifa Institute for Personalized Cancer Therapy at The University of Texas M.D. Anderson Cancer Center, Houston. “We have here a...
The U.S. Food and Drug Administration recently expanded the approved uses of sorafenib (Nexavar) to treat late-stage differentiated thyroid cancer. The new indication is for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to...
The American Association for the Advancement of Science (AAAS) has identified 388 individuals who have been named AAAS Fellows. These individuals have been recognized by their peers for their efforts to advance science or its applications. The new AAAS Fellows, whose names were published in the...
Several presentations at the 2013 Quality Care Symposium demonstrated the current and potential impact of ASCO’s initiatives to achieve higher-quality cancer care with better outcomes for patients. Key presentations at the conference centered on the development of ASCO’s ground-breaking “big data”...
The recently released Clinical Cancer Advances 2013: ASCO’s Annual Report on Progress Against Cancer, highlights the most impactful advances in clinical cancer research of the year, and this year’s report identifies two studies that were funded by the Conquer Cancer Foundation. Advances in Targeted ...
The Society has recently published Clinical Cancer Advances 2013: ASCO’s Annual Report on Progress Against Cancer, a comprehensive review of progress in clinical cancer research that has come to fruition in 2013. The report highlights advances across the entire continuum of cancer care, from...
High-throughput “omics” technologies that generate molecular profiles on tumor specimens are increasingly being incorporated into clinical trials, but some of these assays have not been well validated, leading many in the research community to question their fitness for use in patient-care...
As reported in Journal of Clinical Oncology by Glenwood D. Goss, MD, of the Ottawa Hospital Cancer Center, and colleagues, the prematurely closed NCIC CTG BR19 study showed no apparent survival benefit of adjuvant gefitinib (Iressa, withdrawn from U.S. market) vs placebo in patients with completely ...
The therapeutic landscape for the treatment of castration-resistant prostate cancer has changed dramatically in the past 4 years, as five new agents affecting different aspects of the malignant process were proven to prolong life. The results are a great benefit to patients, but at the same time...
The duration of adjuvant systemic chemotherapy for breast cancer has been a subject of investigation, scrutiny, and meta-analysis.1,2 With the appreciation that prolonged regimens of cytotoxic chemotherapy of, for example, 1 to 2 years in duration were not superior in reducing breast cancer...