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...
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,”...
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,...
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...
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...
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 ...
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...
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...
First-Line Therapy Please describe current medical oncology approaches to first-line therapy for metastatic renal cell carcinoma. The current first-line therapy for most patients with good- to intermediate-risk metastatic renal cell carcinoma is a vascular endothelial growth factor (VEGF) receptor...
In the March 1, 2014, issue of The ASCO Post we talked with Francis S. Collins, MD, PhD, Director of the National Institutes of Health (NIH), about the future of biomedical research at the NIH during this time of constrained federal funding. We continue that conversation here with our interview of...
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...
The Society of Surgical Oncology (SSO) and American Society for Radiation Oncology (ASTRO) formed a multidisciplinary expert panel in 2013 to examine the relationship between surgical margin width and ipsilateral breast tumor recurrence and develop guidelines on margins for breast-conserving...
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 February, the American Psychosocial Oncology Society (APOS) held its 11th Annual Conference in Tampa, Florida, and it marked a number of firsts. With over 500 registrants and more than 300 abstracts presented over the 3-day program, this was the largest APOS event to date. The theme of this...
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...
Prophylactic surgery to remove the ovaries and fallopian tubes is advised for women who carry BRCA mutations to reduce the risk of breast and ovarian cancer. This procedure, referred to as risk-reducing salpingo-oophorectomy, typically does not require a hysterectomy. However, a new study presented ...
Women with gynecologic cancers who are treated at hospitals that frequently manage these conditions appear to live significantly longer than those who receive their care at lower-volume centers, according to a large study presented at the Society of Gynecologic Oncology (SGO) Annual Meeting on...
The term “novel agents” has been used for the past decade to describe proteasome inhibitors and immunomodulatory drugs that are now conventionally used for multiple myeloma. However, even newer agents in development will be considered truly novel when they hit the market, as they represent new...
In 2012, three randomized placebo-controlled trials reported a significant prolongation of progression-free survival with lenalidomide (Revlimid) as maintenance therapy for multiple myeloma.1-3 Two of these trials tested lenalidomide maintenance after stem cell transplantation, and one investigated ...
The challenge of deciding when to administer uridine triacetate was explored by the panel. Dr. Schwartzberg: I assume uridine triacetate would work more effectively if given very early; otherwise we would see the same kind of downstream toxicity we see with methotrexate. Dr. Campen: Exactly, but...
Q. What is uridine triacetate? A. It is an investigational, orally active prodrug of uridine currently under development as an antidote to overexposure of fluorouracil (5-FU). Although not yet approved by the U.S. Food and Drug Administration, it has been shown to be effective in treating patients...
Indications and Dosing of Methotrexate and 5-FU Dr. Campen: The interesting thing about methotrexate is that it has been used for such a long time. You would think there would be a specific dose that would be considered “high dose,” but high dose is actually quite variable. [Dosage] depends on the...
ASCO recently issued two clinical practice guidelines on treating women with advanced, HER2-positive breast cancer. The first guideline lists the appropriate systemic therapies for women newly diagnosed with advanced disease and those whose early-stage disease progressed to advanced cancer. The...
In an op-ed article in The New York Times (February 27, 2014) about the challenges of designing training courses to help physicians communicate more effectively with patients about important topics such as end-of-life care, Timothy D. Gilligan, MD, and Mikkael A. Sekeres, MD, of the Cleveland...
Although most patients want to know about the potential outcome of their disease and whether treatment is likely to have a significant impact on it, the information needs of patients and how best to fulfill those needs are very variable, Walter F. Baile, MD, told The ASCO Post. Dr. Baile is...
When the prognosis is poor, breaking the bad news badly can exacerbate the distress experienced by cancer patients and their families. A lack of sensitivity to patient and family emotions and not being attuned to how individual patients would prefer to be informed about their prognoses can result...
When Jane Cooke Wright, MD, met with six other oncologists at the Edgewater Beach Hotel in Chicago on April 9, 1964, to discuss the creation of American Society of Clinical Oncology, the first medical society dedicated to bringing patient-oriented issues to clinical oncology, the Civil Rights Act...
On April 9, 1964, seven physicians—Jane Cooke Wright, MD, FASCO; Arnoldus Goudsmit, MD, PhD; Fred J. Ansfield, MD, FASCO; Harry F. Bisel, MD, FASCO; Herman H. Freckman, MD, FASCO; Robert W. Talley, MD, FASCO; and William Wilson, MD, FASCO—met for lunch at the Edgewater Beach Hotel in Chicago. They...
Ten years ago, at ASCO’s Annual Meeting, we were celebrating 40 Years of Quality Cancer Care. We have certainly seen many improvements in cancer care quality since then, especially in more effective agents and patient-centeredness care. When I joined ASCO in 1984, I never imagined that I would be...
Serving as ASCO’s President was one of the most exciting years of my professional career. Although that year presented a number of challenges, it also marked a number of accomplishments, including a record number of new ASCO members, which then reached more than 30,000 in 122 countries (today,...
One of the pleasures during my year as President was the ability to bring personal and professional passions and a sense of what really matters into focus for the work of our membership. My Presidential theme, Building Bridges to Conquer Cancer, reflected my particular interest in outreach to...
MAY ASPHO’s 27th Annual MeetingMay 14-17 • Chicago, Illinois For more information: www.aspho.org Oral Oncology: Oncologic Dentistry and Maxillofacial Prosthetics SymposiumMay 15-17 • Houston, TexasFor more information: www.mdanderson.org/conferences 2014 State of the Art Radiation Therapy:...
The Leukemia & Lymphoma Society (LLS) has announced that it has passed the $1 billion mark in research investment, a significant milestone in the cancer research landscape as the Society continues its 65-year pursuit of advancing breakthrough therapies, finding cures, and ensuring access to...
Is pursuing a Master of Business Administration (MBA) degree a good idea for ambitious surgical oncologists who want to advance their careers? The ASCO Post recently spoke with Martin J. Heslin, MD, MSHA, Chief, Section of Surgical Oncology, University of Alabama at Birmingham (UAB) Medical Center, ...
Clinical research is vital for the development and improvement of methods designed to prevent and treat cancer. The majority of clinical trials take place in the developed world through sponsored pharmaceutical research companies.1 The corresponding lack of research in developing countries results...
ASCO’s State Affiliate Council is composed of the State Society Presidents and/or designated physician Council Representatives as well as the Executive Directors of each state and/or regional oncology society. The Council convened in late February to address the most relevant issues affecting...
The number of cancer survivors has been steadily increasing in recent years. According to the Ministry of Health National Cancer Registry, in 2010 there were 254,000 cancer survivors in Israel (3.3% of the population) compared with 15,700 (0.4% of the population, P < .005) in 1975.1 Forty years...
When Barrie R. Cassileth, MS, PhD, began researching complementary medicine and its potential for use in oncology care over 30 years ago, not much was known about the importance of complementary therapies for the well-being of patients with cancer. She chose to conduct her doctoral dissertation...
In January, Eric S. Lander, PhD, Director of the Broad Institute of MIT and Harvard in Cambridge, Massachusetts, and his colleagues published the results from their landmark study,1 which explored the feasibility of creating a comprehensive catalog of cancer genes. The researchers collected and...