September 15, 2011 (View All Issues)
FDA Approves Brentuximab Vedotin in Two Lymphoma Indications
The antibody-drug conjugate brentuximab vedotin (Adcetris) was granted accelerated approval on August 19 for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Brentuximab vedotin is the first new drug to be approved in Hodgkin lymphoma in more...
Important Benefit for Small Population Is a Major Milestone in Lymphoma
The approval of brentuximab vedotin (Adcetris) is a major milestone for the treatment of patients with relapsed Hodgkin lymphoma and anaplastic large cell lymphoma. It represents an excellent example of personalized cancer therapy. Patients are preselected based on a predictive biomarker that is...
Palliative Care, Quality of Life, and Cost
More than half of our nation’s patients with cancer are Medicare beneficiaries, making the entitlement program ground zero in the heated debate on health-care spending. Total Medicare expenditures attributable to beneficiaries in their last year of life runs upward of 30%; this statistic serves as...
We Can Conduct Clinical Trials of Protons
A great deal has been written about proton therapy, with a good deal of heat and only a modest amount of light. I would like to comment on an aspect of the proton vs photon controversy that I believe has not been adequately addressed: Should we run clinical trials that would allow us to prove that...
Novel BRAF Inhibitor Receives FDA Approval in Metastatic Melanoma
Vemurafenib (Zelboraf) received FDA approval on August 17, 2011, for treatment of metastatic or unresectable melanoma, based on the results of the phase III BRIM3 trial.1 BRIM3 compared vemurafenib to dacarbazine in 675 untreated patients with the BRAF V600E mutation. Vemurafenib targets the...
Using the New Melanoma Drugs in the Clinic
With two effective new treatments for advanced melanoma, the question has become how to best use them and how to manage their toxicities.
Vemurafenib (Zelboraf) and ipilimumab (Yervoy)1 have different pharmacokinetics, which lend themselves to different patient types. Omid Hamid, MD, of The...
A Conversation with Monica Morrow, MD, FACS
Over the past 15 years, practice guidelines have become an accepted tool to help physicians optimize patient care by offering informed assessment of the benefits and potential harms associated with various care options. However, a plethora of new guidelines have entered the market, many of which...
Oncology Drug Shortage: An Unintended Consequence of the Medicare Modernization Act and Free-market Forces?
Oncology has a drug shortage problem, and the FDA says that it is getting worse. Drug shortages are not a new phenomenon, but over the past few years we have seen a rapidly growing number of shortfalls that are limiting providers’ ability to care for their patients. In 2004, the FDA reported 58...
Developing Targeted-agent Combinations: Business and Regulatory Issues, and Legal Obstacles
The Institute of Medicine’s National Cancer Policy Forum recently convened a public workshop, “Facilitating Collaborations to Develop Combination Investigational Cancer Therapies,” to address the promises and challenges involved in the development of combination oncologic drug therapies. In the...
ASCO’s Immediate Past President Helps Build Future of Cancer Research and Care by Supporting Conquer Cancer Foundation
George W. Sledge, Jr, MD, has been treating patients with breast cancer, and pursuing research in the field, for more than 30 years—the last few electrified by a rapid proliferation of knowledge.
“We have so much to offer our patients today,” says Dr. Sledge, who serves as Ballve-Lantero Professor ...
ASCO’s International Clinical Trials Workshop Educates Nascent Researchers on the Inner Workings of Clinical Trials
Pharmaceutical companies are increasingly conducting drug development research outside of the United States, Western Europe, and Japan. Attracted to the perceived lower costs, easier patient recruitment, and market potential, drug developers are now conducting more phase III clinical trials in...
New ASCO in Action Website
For the past 2 years, ASCO members and others who have looked to ASCO for insight on policy issues have turned to the ASCO in Action section of the Society’s website for up-to-date information. Now, ASCO has launched a whole new website devoted entirely to policy issues and ASCO’s specific efforts...
What the Latest Breast Cancer News Means for Patients
Direct your patients to www.cancer.net/breastsymposium to learn about the research highlighted at the 2011 Breast Cancer Symposium in the special online newsletter, Cancer Advances: News for Patients from the 2011 Breast Cancer Symposium. Also, your patients can listen to a podcast of the...
FDA Grants Orphan Drug Status to MM-398, a Nanotherapeutic Encapsulation of Irinotecan, to Treat Pancreatic Cancer
Merrimack Pharmaceuticals, Inc, announced that the FDA has granted MM-398 orphan drug status for the treatment of pancreatic cancer. MM-398 is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. MM-398 is partnered with PharmaEngine, Inc, for development and...
Action Date Set for Denosumab Supplemental Application
Amgen announced that the FDA will target a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012, for the supplemental Biologics License Application to expand the indication for denosumab (Xgeva) to treat men with castrate-resistant prostate cancer to reduce the risk of developing...
FDA Clears Genetic FISH Panel for Leukemia Patient Prognosis
Abbott announced it has received 510k clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL). Abbott’s Vysis CLL FISH Probe Kit is the first FDA-cleared CLL test to aid in prognosis. The test detects genetic...
Radium-223 Chloride Gets Fast Track Designation
Bayer HealthCare Pharmaceuticals, Inc, announced that its investigational compound radium-223 chloride, which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the FDA for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with...
Lifestyle Changes Can Benefit Patients with Cancer
Oncologists may successfully manage their patients with cancer by following treatment guidelines, but they come up short when it comes to prescribing simple measures to enhance their patients’ health, according to Ann Partridge, MD, MPH, of Dana-Farber Cancer Institute, Boston, who spoke on the...
Integrative Oncology Modalities Supported by Varying Levels of Evidence, but More Research Needed Overall
Over the past couple of decades, unregulated nonstandard oncology approaches have gained growing popularity among cancer patients. The relatively new field of integrative oncology was established to promote a more holistic and multidisciplinary approach to cancer care and to encourage scientific...
Treating Cancer in Japan: A Conversation with Kensei Tobinai, MD
In this installment of Oncology Worldwide, internationally regarded lymphoma expert and cancer survivor, Kensei Tobinai, MD, Chief, National Cancer Center Hospital, Tokyo, sheds light on the Japanese oncology experience.
Medical Education
What was the medical school experience in Japan like?
...
Tissue of Origin Test Evaluated in Patients with Cancer of Unknown Primary
According to results of a study published in the Journal of Molecular Biomarkers and Diagnosis,1 the recently developed Tissue of Origin Test (Pathwork Diagnostics, Inc) aids in the diagnosis of challenging cancer cases such as those that are metastatic or that have a complex clinical history,...
Crizotinib plus Companion Diagnostic Test Approved in NSCLC
On August 26, 2011, the FDA granted accelerated approval to Pfizer’s crizotinib (Xalkori) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA approved the...
Many Women Treated for High-risk Breast Cancer Do Not Receive Recommended Postmastectomy Radiation Therapy
Despite major studies showing that postmastectomy radiation therapy improves survival for women with high-risk breast cancer and evidence-based guidelines supporting the use of postmastectomy radiotherapy, 45% of these patients do not receive such treatment, according to an analysis of data from...
Long-term Data Show Benefit of Degarelix Beyond 3 Years in Advanced Hormone-dependent Prostate Cancer
Degarelix (Firmagon) is effective and well tolerated beyond 3 years in patients with advanced prostate cancer, according to a recent study published in The Journal of Urology.1 The new study (CS21A) extends the conclusions of the pivotal phase III study (CS21) in which the risk of prostate-specific ...
Wide Variation in Use of Radioactive Iodine for Thyroid Cancer
The proportion of patients with well-differentiated thyroid cancer who received radioactive iodine following total thyroidectomy increased significantly since 1990, and there is wide variation in the use of adjuvant radioactive iodine, according to a study in the Journal of the American Medical...
Androgen Deprivation plus Radiotherapy Increases Survival in Men with Localized Prostate Cancer
Adding short-term androgen-deprivation therapy to radiotherapy “conferred a modest but significant increase in the 10-year rate of overall survival, from 57% to 62%,” in men with localized prostate cancer enrolled in Radiation Therapy Oncology Group (RTOG) trial 94-08. “This increase was...
Comorbidities Can Be as Important as Stage in Predicting Breast Cancer Survival in Older Patients
Comorbidities can be as important as stage in predicting survival among older women with breast cancer, according to a study in the Journal of the National Cancer Institute. While previous studies have combined comorbidities into a summary measure or comorbidity index, the current study assessed...
Patients with HER2-positive Breast Cancer Benefit from Trastuzumab plus Chemotherapy
Adding trastuzumab (Herceptin) to standard anthracycline/taxane–based chemotherapy continued to produce disease-free and overall survival benefits in patients with HER2-positive breast cancer enrolled in the North Central Cancer Treatment Group (NCCTG) N9831 and the National Surgical Adjuvant...
Unexpected Results May Push Breast Cancer Research toward More Productive Approaches
Two recent articles on breast cancer prognostic factors in the Journal of Clinical Oncology “do not jibe with accepted—and profoundly influential—notions of malignant progression,” according to an editorial accompanying the articles in the Journal of Clinical Oncology. One of the articles found...
Pathways Reconsidered: Let’s Not Stop ‘Thinking Outside the Box’
I read “Are Clinical Pathways Inevitable in Oncology’s Future?” (The ASCO Post, July 15, 2011) including Lesli Lord’s interview with great interest and agree with most everything said in the article. However, I do want to make one comment: There is no specialty for which the 80/20 rule applies more ...
Keeping a Positive Attitude
I’ve been in alcohol and drug recovery for 20 years, and my wife of nearly 50 years, Arlene, and I have been through a lot together during that time. So 2 years ago, when my doctor told us that I had stage III prostate cancer and a Gleason score of 8, we both looked at him and asked if we could...
