INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, Robert Dean, MBA, Director, and Michael Sauers, Deputy Director, of Division II in the FDA’s Office of Prescription Drug Promotion discuss the FDA’s Bad Ad program. The...
In 2011, the Multiple Myeloma Research Foundation (MMRF) announced the launch of CoMMpass (Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile), a clinical study at the heart of its Personalized Medicine Initiative. CoMMpass will follow 1,000 newly diagnosed...
Specialist bias, in which specialists recommend the therapy that they are capable of delivering, is thought to influence the treatment of patients with localized prostate cancer and to contribute to overtreatment of men with limited life expectancy,” Ayal A. Aizer, MD, MPH, and colleagues, from the ...
For decades, dedicated members of the oncology community have fought to increase the nation’s focus on lung cancer prevention and treatment. Although smoking cessation initiatives have reduced cigarette consumption, lung cancer 5-year survival has remained stagnant at 15%, lagging far below most...
The goal of effective adjuvant therapy is to increase overall survival. It has been suggested cynically that all we need to accomplish, actually, is to delay recurrence until after the time the patients die from another cause. However, patients want to hear from us that “it’s never coming back,”...
Pathologic complete response to neoadjuvant therapy has been proposed as a surrogate endpoint for long-term clinical benefit in breast cancer. The U.S. Food and Drug Administration (FDA) established the international Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) working group to...
The USTAR Center for Genetic Discovery is partnering with California-based Omicia, Inc, to make analyzing a patient’s genome as routine as performing a blood test. The center, codirected by Mark Yandell, PhD, and Gabor Marth, DSc, was launched this month with $6 million from the University of Utah...
Although cancer survival rates among pediatric and older adult patients continue to rise, survival rates for adolescents and young adults (AYAs), defined by the National Cancer Institute as those between the ages of 15 and 39, have remained stagnant for decades. In breast cancer especially, AYAs...
On February 24, the Institute of Medicine National Cancer Policy Forum convened a workshop, “Contemporary Issues in Human Subjects Protection in Cancer Research,” in Washington, DC. In his introduction to the workshop, Steven Piantadosi, MD, PhD, Director, Samuel Oschin Cancer Institute,...
Ten projects that will enable nongovernment researchers to conduct clinical research at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, were announced recently. Through these 3-year, renewable awards of up to $500,000 per year, scientists from institutions across the...
On the Cancer.Net Blog, your patients can read about the various health professionals involved in their diagnosis, treatment, and survivorship and listen to podcasts with these professionals discussing their roles in caring for people with cancer. This month, the Cancer.Net Blog highlighted...
ASCO has joined 26 of the nation’s leading public health and medical organizations in signing a joint letter calling on drug stores and other retailers to end the sale of cigarettes and other tobacco products. The open letter came just weeks after CVS Caremark announced it would stop selling...
ASCO has signed a joint letter to U.S. Department of Health and Human Services Secretary Kathleen Sebelius asking for clear and comprehensive guidance on the tobacco cessation benefit in the Affordable Care Act regulations. In the letter, the organizations applaud the Department of Health and Human ...
Join oncology professionals from around the world for the 2014 ASCO Annual Meeting, which will be held May 30 through June 3 in Chicago. This year’s meeting will offer opportunities to learn about, debate, and discuss practice-changing advances in the field, and also highlight promising clinical...
By simply designating Conquer Cancer Foundation as a beneficiary of your estate, you will be leaving a legacy that builds the future of cancer research and cancer care. Typical bequest language is: “I give [the sum of $__] OR [__% of my estate] OR [all or __% of the rest, residue, and remainder of ...
Have you given any thought to the legacy you would like to leave? For many of you, your professional legacy will include the patients you have cared for, the research you have conducted, the students you have mentored, and the lives you have touched in the world of cancer care. You also have your...
The Society’s 2013 Policy for Relationships with Companies is scheduled to go into effect on April 22, with one large change to its original requirements. The policy will still require the full disclosure of all financial relationships by all authors; however, since announcing the new policy in...
It is a challenge faced time and time again by oncologists: how to achieve the best possible outcomes for patients while simultaneously controlling costs, providing care that is both high quality and high value. Raj Mantena, RPh, the first individual to donate $1 million dollars to the Conquer...
Margaret Foti, PhD, MD (hc), CEO of the American Association for Cancer Research (AACR), welcomed about 150 congressional staffers to a March briefing in Washington, DC, with a plea for increased federal funding. “Extraordinary progress is being made in cancer research today, as evidenced by the...
Learning about the particulars of each cancer patient’s pain and treating each case uniquely is the key to keeping pain manageable. That is the goal of the Duffey Pain and Palliative Care Program at The Sidney Kimmel Comprehensive Cancer Center in Baltimore. The team consists of physicians, nurse...
According to data from the Surveillance, Epidemiology, and End Results (SEER) program, rates for new cases of thyroid cancer in the United States have been rising on average 6.4% each year over the past 10 years, and death rates have been rising on average 0.9% each year over the same period. The...
In 2010, Jennifer S. Temel, MD, published her landmark study in The New England Journal of Medicine showing that the introduction of palliative care early after a diagnosis of metastatic non–small cell lung cancer, along with cancer therapy, not only provided patients with a better quality of life...
Preclinical models have suggested that cancer stem cells play a role in tumor recurrence and metastasis following adjuvant therapy, and Max S. Wicha, MD, and his research team are deciphering the mechanisms by which this might happen. A true understanding of cancer stem cells will have important...
Last fall, Kirsten K. Ness, PhD, published her study1 on the prevalence of frailty as a sign of accelerated aging in adult survivors of childhood cancer, and the results are startling. Among the 1,922 participants in the study, the prevalence of prefrailty was 31.5% among women and 12.9% among men; ...
The recent study by Nam et al in The Lancet Oncology—reviewed in this issue of The ASCO Post—provides a fresh perspective on complications other than incontinence or erectile dysfunction that commonly arise after primary treatment of localized prostate cancer.1 The authors conducted a...
Men with newly diagnosed localized prostate cancer face a decision between prostatectomy and radiotherapy, treatments deemed similarly effective but with well-established trade-offs in terms of treatment-related morbidity. Numerous clinical trials and other prospective studies, from both academic...
Studies of complications of surgery or radiotherapy for prostate cancer generally focus on incontinence and erectile dysfunction. In a population-based cohort study reported in The Lancet Oncology, Robert Nam, MD, MSc, FRCS(C), Professor of Surgery, Sunnybrook Health Sciences Centre, University of...
Colorectal cancer is a common malignancy that will impact 1.4 million individuals globally each year.1 Approximately 70% to 75% of patients will present with locally advanced disease. For patients with stage III colon cancer, adjuvant chemotherapy is commonly offered, whereas chemotherapy for those ...
In the FACS trial, reported in JAMA, John N. Primrose, MD, FRCS, of University of Southampton, England, and colleagues compared outcomes with intensive follow-up with carcinoembryonic antigen (CEA) measurement, computed tomography (CT), both, or minimum follow-up after curative surgery for primary...
Currently, one of the most challenging problems in oncology is to accurately predict whether neoplastic lesions detected by screening tests will progress. The focus on developing ever-more sensitive cancer screening tests has produced the clinical dilemma of overdiagnosis. Overdiagnosis occurs when ...
If a randomized, controlled trial of therapy for breast cancer was submitted for publication in which 1. The drug being tested was old and ineffective, and 2. prior to randomization, the women underwent a clinical breast examination and the study coordinators knew who had the largest cancers, and...
The recent report from the Canadian National Breast Screening Study (CNBSS)—published in BMJ and reviewed in this issue of The ASCO Post—concluded that annual mammography in women aged 40 to 59 does not result in a reduction in mortality from breast cancer beyond that of physical examination alone...
As reported in BMJ by Anthony B. Miller, MD, Professor Emeritus at the Dalla Lana School of Public Health, University of Toronto, and colleagues, the 25-year follow-up of the Canadian National Breast Screening Study has shown no mortality benefit of annual mammography screening for breast cancer...
Webster K. Cavenee, PhD, was honored with the eighth annual American Association for Cancer Research (AACR) Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research at the AACR Annual Meeting held recently in San Diego. Dr. Cavenee is Director of the Ludwig Institute for ...
Emerging effective treatment options for salvage therapy in Hodgkin lymphoma were described by Anas Younes, MD, Chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center, New York, at the 2014 Highlights of ASH in North America meeting in Miami. “This is an exciting time in Hodgkin...
More data have emerged that discount the potential for benefit with epidermal growth factor receptor (EGFR) inhibitors in esophageal cancer. The latest comes from the RTOG 0436 randomized phase III trial in patients with nonoperable esophageal cancer, the results of which were presented at the 2014 ...
Cancer Immunotherapy What is the role of immunotherapy in the treatment of metastatic renal cell carcinoma? The harnessing of the immune system as an effective treatment for cancer was recently selected by the journal Science as the top scientific Breakthrough of the Year for 2013.1 With this...
On March 11, ASCO released its first-ever comprehensive assessment of the daunting challenges facing America’s ability to continue to deliver high-quality care to all patients with cancer. ASCO President Clifford A. Hudis, MD, FACP, introduced the assessment at a Congressional news briefing in...
Although breast-conserving therapy has been a standard practice for more than 20 years, controversy still exists over what constitutes the appropriate margin of normal breast tissue around a tumor that minimizes local recurrence while maintaining a good cosmetic outcome. Surveys of surgeons1 and...
In a phase II study, the 34 evaluable patients with peripheral T-cell lymphomas who received brentuximab vedotin (Adcetris) had an overall response rate of 41%, including an overall response rate of 54% among the 13 patients with angioimmunoblastic T-cell lymphoma. The median progression-free...
The information in this Clinical Trials Resource Guide includes details of actively recruiting clinical studies of patients with Hodgkin lymphomas, including patients with human immunodeficiency virus–associated and Epstein-Barr virus–positive Hodgkin lymphoma. Two of the studies are also...
For much of her career in oncology, Teresa A. Gilewski, MD, has sought to bridge the science of medicine with the humanistic aspect of care. She has created the Art of Medicine lecture series at Memorial Sloan Kettering Cancer Center in New York, where she is a medical oncologist on the Breast...
In an editorial accompanying publication of the AURELIA study results, Joyce F. Liu, MD, MPH, of Dana-Farber Cancer Institute, and Stephen A. Cannistra, MD, of Beth Israel Deaconess Medical Center, Boston, considered the implications of the benefits observed in the trial and limitations in...
Single-agent chemotherapy is standard in platinum-resistant ovarian cancer. In the open-label phase III AURELIA trial reported in the Journal of Clinical Oncology, Eric Pujade-Lauraine, MD, PhD, of Université Paris Descartes, and colleagues found that the addition of bevacizumab (Avastin) to...
Big changes came to the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program requirements in 2014. As of January 1, all diplomates, including “grandfathers” (or those certified before 1990 who are “board-certified for life”), must actively participate in MOC...
ASCO’s Community Research Forum has released the ASCO Research Program Quality Assessment Tool, designed to help community-based practices to assess their research programs. Quality Components The new tool provides an overview of important components of an internal quality assessment program as...
ASCO and 20 other organizations representing people impacted by serious or life-threatening diseases, specialty providers, and research professionals are urging the Centers for Medicare & Medicaid Services (CMS) to correct a long-standing inequity in Medicare coverage by requiring that Medicare ...
Based on ASCO’s recent recommendations, Cancer.Net has provided your patients with an article and an infographic on the importance of collecting family cancer history, what information to collect, what it can mean, and when and with whom to share this information. Direct your patients to...
At the end of the month, more than 25,000 oncology professionals from around the world will meet in Chicago for the 2014 ASCO Annual Meeting. Will you be joining this global community? As you’re beginning to consider what to pack for your trip, keep in mind that you have a host of electronic...
Throughout the year, we are celebrating not only ASCO’s 50th anniversary, but also the tremendous progress achieved against cancer in the last 50 years. Thanks to the dedication and contributions of patients and researchers, and our nation’s long-standing commitment to funding clinical research,...