INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 9, 2014, bortezomib (Velcade) was granted approval for ...
The costs associated with skin cancer increased five times as fast as treatments for other cancers between 2002 and 2011, according to a Centers for Disease Control and Prevention (CDC) study published online in the American Journal of Preventive Medicine.1 The average annual cost for skin cancer...
Maintenance therapy in ovarian cancer refers to a cohort of women achieving response to initial adjuvant chemotherapy who then go on to additional therapy in the hopes of extending time to recurrence or inducing a lasting remission. The concept is not new and retains its scientific and clinical...
In a phase III trial reported in the Journal of Clinical Oncology, Andreas du Bois, MD, PhD, Professor of Gynecologic Oncology at Kliniken Essen-Mitte in Essen, Germany, and colleagues found that maintenance therapy with the vascular endothelial growth factor receptor (VEGFR) and platelet-derived...
The powerful and important study by Kurian et al,1 reviewed in this issue of The ASCO Post, adds vital information to the discussion regarding use of contralateral prophylactic mastectomy among patients with unilateral breast cancer in the United States.2,3 Based upon data from the California...
In an observational cohort study reported in JAMA, Allison W. Kurian, MD, MSc, Assistant Professor of Medicine and of Health Research and Policy at Stanford University School of Medicine, and colleagues assessed use of and mortality after bilateral mastectomy, breast-conserving surgery plus...
The FIRST trial—reported by Benboubker and colleagues in The New England Journal of Medicine and summarized in this issue of The ASCO Post (page 93)—is a landmark study.1 It is one of the largest randomized trials in multiple myeloma ever conducted. More importantly, it is a well-designed trial...
In the phase III FIRST trial reported in The New England Journal of Medicine, Lotfi Benboubker, MD, Service d’Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France, and colleagues found that continuous lenalidomide (Revlimid) plus...
While the incidence of colorectal cancer in people 50 years or older has declined, the incidence among people 20 to 49 years has increased, according to a report published online recently by JAMA Surgery.1 From 1998 through 2006, the incidence of colorectal cancer declined 3% per year in men and...
David G. Nathan, MD, President Emeritus of Dana-Farber Cancer Institute and Physician-in-Chief Emeritus of Boston Children’s Hospital, was recently honored as the inaugural recipient of the Boston Children’s Hospital Lifetime Impact Award at the Hospital’s second Annual Global Pediatric Innovation...
As part of ASCO’s 50th anniversary, the Society has published a weekly series on special moments in its history. In this edition of The ASCO Post, we revisit a unique time when ASCO’s history intersected with major world events. To read the entire series, visit the “News and Views” page on...
ASCO’s latest video series, Navigating Challenges: Perspectives from Survivors and Doctors, available at www.cancer.net/navigatingchallenges, offers information for people newly diagnosed with cancer who are facing real-world barriers to high-quality cancer care. In the four featured videos, health ...
Since 2003, the Conquer Cancer Foundation of ASCO has recognized more than 100 high-quality, community-based clinical research sites through the Clinical Trial Participation Award (CTPA). The program has been generously supported by the Coalition of Cancer Cooperative Groups for the past decade....
The ASCO Nominating Committee has selected Daniel F. Hayes, MD, FASCO, and Patrick J. Loehrer, Sr, MD, FASCO, as candidates for the position of 2015-2016 President-Elect (2016-2017 President). In the abridged interviews below, the candidates discuss their vision for the Society and their leadership ...
A secondary analysis of the National Surgical Adjuvant Breast and Bowel Project B-32 trial1 indicates that radiation therapy does not increase the incidence of lymphedema in patients with node-negative breast cancer, according to research presented at the American Society for Radiation Oncology’s...
Hope S. Rugo, MD, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, discussed the results of the RESILIENCE trial presented at the European Society for Medical Oncology ...
In patients with locally advanced or metastatic breast cancer, the addition of sorafenib (Nexavar), a broad-spectrum tyrosine kinase inhibitor, to capecitabine did not improve progression-free or overall survival in the phase III RESILIENCE trial. The findings were presented at the European Society ...
Hope S. Rugo, MD, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education for the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, discussed the two studies on maintenance bevacizumab (Avastin) for metastatic breast cancer...
Although bevacizumab (Avastin) may no longer be an active player in metastatic breast cancer, phase III studies presented at this year’s European Society for Medical Oncology (ESMO) Congress reignited interest in the drug as part of maintenance therapy. The TANIA trial met its primary endpoint,...
Formal discussant Giorgio V. Scagliotti, MD, PhD, Professor and Chair of Medical Oncology at the University of Turin and San Luigi Hospital, Orbassano, Italy, tackled each of the studies presented at the European Society for Medical Oncology (ESMO) session on metastatic non–small cell lung cancer...
The effort to identify new biomarkers for response and outcomes in lung cancer is advancing, according to studies presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid. Immunohistochemical expression of folate receptor for vintafolide and thymidylate synthase for...
Patients who received postoperative radiation therapy lived an average of 4 months longer when compared to the patients who had the same disease site, tumor histology, and treatment criteria and who did not receive postoperative radiotherapy, according to research presented at the 2014 Chicago...
For advanced nonsquamous non–small cell lung cancer (NSCLC), targeting of the epidermal growth factor receptor (EGFR) mutation and the ALK abnormality has become an established strategy. Later-generation drugs in these categories are now showing efficacy in trials, including for the treatment of...
Carfilzomib (Kyprolis), as a single agent, failed to improve survival in relapsed and refractory myeloma patients, as compared with a corticosteroid and optional cyclophosphamide, in the phase III FOCUS trial, presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid.1...
Formal discussant of the PAZOGIST trial at the European Society for Medical Oncology (ESMO) 2014 Congress, Stefan Sleijfer, MD, PhD, of Erasmus MC Cancer Institute, Rotterdam, the Netherlands, said “The title of my talk is ‘Small Molecules: Greater Success,’ and we are not yet there.” He agreed...
Patients with gastrointestinal stromal tumor (GIST) can achieve remission on tyrosine kinase inhibitors, but almost all of them eventually develop resistance to these agents. The PAZOGIST trial results suggest that pazopanib (Votrient)—a broad-spectrum tyrosine kinase inhibitor—may be an effective ...
Formal discussant of the poster presented by Cullen et al at the ESMO Congress, Mark A. Rubin, MD, of Weill Cornell Medical College, New York, said the Oncotype DX Genomic Prostate Score could be used to measure disease aggressiveness in paraffin-embedded prostatectomy and biopsy samples and should ...
A prospectively designed study establishes the17-gene Oncotype DX prostate cancer test as a robust and independent predictor of the aggressiveness of prostate cancer based on a patient’s diagnostic specimen. Tumor aggressiveness, as measured by the test’s Genomic Prostate Score, was similar in...
Final results from the RADIANT-3 trial showed a 6-month difference in overall survival favoring everolimus (Afinitor) plus best supportive care over placebo plus best supportive care in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumors.1 Although the...
The final analysis of the international phase III QUASAR2 trial confirmed the lack of benefit for bevacizumab (Avastin) as part of the adjuvant treatment of colorectal cancer. “There is no role for bevacizumab in combination with capecitabine as adjuvant treatment for colorectal cancer,” said...
In a subgroup analysis of the pooled results of the EINSTEIN-DVT and EINSTEIN-PE trials reported at the 2014 European Society for Medical Oncology (ESMO) 2014 Congress and published recently in The Lancet Haematology, Martin H. Prins, MD, of Maastricht University Medical Centre, Maastricht,...
The phase III CONCUR trial1 of regorafenib (Stivarga) monotherapy in Asian patients with previously treated metastatic colorectal cancer confirmed the overall survival benefit seen in the previous CORRECT trial,2 and in a planned subgroup analysis, suggesting the benefit is substantial in patients ...
Putting the maintenance trials into context was Axel Grothey, MD, Professor of Oncology at the Mayo Clinic, Rochester, Minnesota, who commented, “These studies inform our clinical practice and have a meaningful impact on how we treat our patients.” DREAM Trial In the DREAM Trial, Dr. Grothey...
Studies presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid added insight regarding maintenance therapy in metastatic colorectal cancer, an area lacking a clear recommended strategy following first-line regimens. Two phase III trials found benefit for bevacizumab...
During a special session at the European Society for Medical Oncology (ESMO) 2014 Congress, additional analyses from the FIRE-3 and Cancer and Leukemia Group B (CALGB)/SWOG 80405 trial were presented, and an expert panel was charged with putting the findings into context. Role of Subsequent...
Now that clinicians know to “think beyond KRAS” in metastatic colorectal cancer—and test for all RAS mutations, not just those in exon 2—it seems this is still not sufficient for selecting the best drugs. At the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, a proffered paper ...
The Ohio State University Comprehensive Cancer Center and Moffitt Cancer Center have joined forces to create the Oncology Research Information Exchange Network (ORIEN), the largest collaboration of its kind designed to accelerate discoveries in cancer research. Members of this alliance of cancer...
Suleika Jaouad, a journalist, was 22 and had just gotten her first chance to cover a major news story—the revolution underway in Tunisia—when she was diagnosed with myelodysplastic syndrome that had evolved into acute myeloid leukemia (AML). Months into her treatment, she began to write again, but...
More than 150 oral and poster presentations were featured at the 2014 Breast Cancer Symposium, held September 4–6 in San Francisco. The multidisciplinary meeting is sponsored by ASCO, the American Society of Breast Disease, American Society of Breast Surgeons, American Society for Radiation...
The use of targeted therapies in indolent non-Hodgkin lymphoma (NHL) is a burgeoning area. New targeted therapies directed at the cell surface, intracellular pathways, and the microenvironment are being studied for relapsed indolent NHL. These treatments, if validated in large randomized trials,...
ASCO has issued an endorsement of the American Urological Association (AUA)/American Society for Radiation Oncology (ASTRO) guideline on the use of adjuvant and salvage radiotherapy after prostatectomy, which was based on a systematic review of medical literature. The ASCO endorsement was published ...
Over the past 50 years, there have been incredible changes in the field of colorectal cancer,” Emily K. Bergsland, MD, noted in opening the colorectal cancer session at the Best of ASCO meeting in Chicago. Dr. Bergsland is a gastrointestinal oncologist at the Helen Diller Family Comprehensive...
Two phase III studies presented at the Best of ASCO meeting in Chicago shed more light on the role of maintenance therapy in patients with metastatic colorectal cancer undergoing first-line treatment with oxaliplatin-based chemotherapy. The two studies compared maintenance therapy with bevacizumab...
Targeted agents have started to make inroads in sarcoma therapies, and gastrointestinal stromal tumor (GIST) is the poster child for this success,” Mark Agulnik, MD, stated in summarizing progress in GIST and other sarcomas at the Best of ASCO meeting in Chicago. Dr. Agulnik is Associate Professor, ...
New studies reported at ASCO’s 2014 Quality Care Symposium provided insight on the role social factors play in cancer treatment disparities, as well as effective approaches to improving the quality of care. “The research presented [here] highlights how the conditions facing people living with...
It turns out that in addition to treatment-related toxicity, cancer patients commonly experience “financial toxicity,” a phrase that is increasingly coming into parlance in the cancer community. Patients should be assessed for financial toxicity as early as possible following diagnosis so that they ...
Over the past decade, there has been growing concern in the oncology community about overdiagnosis and overtreatment of cancers that prove to be indolent and nonlethal, resulting in unnecessary and sometimes harmful procedures. At this year’s ASCO Quality Care Symposium in Boston, this important...
Overutilization of health-care interventions has become a prime target of efforts to rein in health-care costs. Overtreatment of cancer patients is associated with a number of common harms to the patient—not just financial harm to the health-care system. At the recent ASCO Quality Care Symposium in ...
The image of aging that Ezekiel Emanuel, MD, PhD, expresses in his essay, “Why I Hope to Die at 75,” in the October issue of The Atlantic,1 is bleak indeed and one that has contributed mightily to the negative views of aging imbedded in our society. But I refute his description of growing older as...