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Showing 8701 - 8750FDA Approves Nab-Paclitaxel for Late-Stage Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has expanded the approved uses of paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) to treat patients with late-stage pancreatic cancer. “Patients with pancreatic cancer are often diagnosed after the...
Pathologic Complete Response as a Test Bed for Novel Therapies: Proceed—With Caution!
Pathologic complete response as assessed surgically after neoadjuvant treatment is being touted by some researchers as a stand-alone endpoint justifying early drug approval for breast cancer. They argue that it provides a more efficient means of testing the value of agents that might be useful in...
Expert Point of View on ductal carcinoma in situ
In an e-mail interview, E. Shelley Hwang, MD, an expert who has coauthored several papers on ductal carcinoma in situ (DCIS), weighed in on the two abstracts about management of DCIS featured in this issue of The ASCO Post—one presented by Melissa L. Pilewskie, MD (perioperative MRI in DCIS, page...
Expert Point of View: Steven J. O’Day, MD
This is an important large retrospective single-institution study …[conducted in the context of a] tremendous increase in use of MRI for invasive and noninvasive breast cancer,” said Steven J. O’Day, MD, who moderated a presscast held just prior to the 2013 Breast Cancer Symposium. “The study...
Single-Institution Study Evaluates Routine Use of Perioperative MRI in Patients With Ductal Carcinoma In Situ
Perioperative MRI for patients with ductal carcinoma in situ (DCIS) was not associated with a reduction in locoregional recurrence or contralateral breast cancer development in a large single-center study reported at the 2013 ASCO Breast Cancer Symposium. The study also was presented at a...
What Is on the Horizon in the Management of Breast Cancer?
In Keynote Lectures during the 2013 ASCO Breast Cancer Symposium, experts George Sledge, MD, and Monica Morrow, MD, offered their opinions and outlook on how the medical and surgical management of breast cancer may continue to evolve over the next 5 to 10 years.1 Dr. Sledge is Chief of Oncology at...
Trying to Improve Value in Cancer Care: An Experiment
One of the more significant problems in modern oncology practice is to provide increased value at a time when costs are spiraling upward, and new parameters of “success” are being introduced into the equation—most visibly, inside the Beltway in Washington, DC. Thus, oncologists will need to address ...
Breast Cancer Care in the Era of Accountable Care Organizations
Prepare for big changes ahead, Lawrence N. Shulman, MD, Senior Vice President for Medical Affairs at the Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School in Boston, told oncologists at the 2013 Breast Cancer Symposium.1 One change is the emergence of...
Inequality in Delivery of Palliative Radiotherapy Among Black Patients With Cancer and Elderly With Comorbidities
An analysis of data from more than 51,000 patients with stage IV cancer shows “significant inequality” in the delivery of palliative radiotherapy among the elderly, patients with comorbidity, and black patients with prostate and colorectal cancer, reported James D. Murphy, MD, MS, and colleagues...
Front-Line Treatment Strategies to Achieve Long-Term Control of CLL Combined With Optimal Quality of Life
“The management of chronic lymphocytic leukemia (CLL) is undergoing profound changes. Several new drugs have been approved for CLL treatment (fludarabine, bendamustine [Treanda], and the monoclonal antibodies alemtuzumab [Campath], rituximab [Rituxan], and ofatumumab [Arzerra]), and many more drugs ...
Calcium Channel Blockers Linked to Increased Risk of Lobular/Ductal Breast Cancer
Women who are currently using calcium channel blockers and have been doing so for 10 or more years are at increased risk of the two most common histologic types of breast cancer, invasive ductal carcinoma and invasive lobular carcinoma, according to a population-based case control study. “While...
Intralesional Cytokine Therapy in Cutaneous Melanoma: A Call for Clinical Trials
Cutaneous melanomas are mostly an immunogenic group of tumors, but they are also heterogeneous. Therefore, therapeutic specificity and autogenetic approaches are essential to secure beneficial results. The objective of sentinel lymph node biopsy, at the time of diagnosis, is to identify patients...
Better Risk Communication Strategies Needed to Ensure Decision to Have Contralateral Prophylactic Mastectomy Is Evidence-Based
Overestimating the risk that cancer in one breast will affect the other breast may cause many young women with breast cancer to choose contralateral prophylactic mastectomy even though most know it does not clearly improve survival. In a survey of 123 women who were diagnosed with cancer in one...
CancerCare Launches New Edition of Financial Resource Guide for People With Cancer
CancerCare recently announced the launch of a new edition of A Helping Hand: The Resource Guide for People With Cancer, Financial Edition, a reference guide to assist patients with cancer and their families in navigating the financial resources available to them. A Helping Hand is a comprehensive...
Nab-Paclitaxel in Metastatic Pancreas Cancer
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. Indication On September 6, paclitaxel protein-bound particles...
Cabozantinib in Medullary Thyroid Cancer: A Landscape-Shaping New Treatment
Medullary thyroid cancer is derived from parafollicular C cells in the thyroid gland. The disease is sporadic in about 75% of cases and hereditary in the remaining 25%.1 Oncogenic mutations in the gene for tyrosine kinase receptor rearranged during transfection (RET) are driver genetic alterations...
AACR Cancer Progress Report 2013 Highlights Critical Importance of Biomedical Research
On September 17, the American Association for Cancer Research (AACR) presented highlights of its 2013 Cancer Progress Report1 at the National Press Club in Washington, DC. AACR Chief Executive Officer Margaret Foti, PhD, MD (hc), opened the program with a double-edged message, first citing the...
SIDEBAR: 2013 New Drug/Indication Approvals*
1. September 30, 2013: Pertuzumab (Perjeta) Accelerated approval in combination with trastuzumab and docetaxel for the neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer. 2. September 6, 2013: Paclitaxel protein-bound particles (albumin-bound)...
A Look Ahead: How the FDA Is Adapting in the Era of Precision Medicine
Dubbed “Cancer Czar” by the media, Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Office of Hematology and Oncology Products, said he has the “best job in oncology, with a unique vantage point in cancer drug development.” An oncologist for more than 30 years—including...
ASCO President-Elect Candidate Julie M. Vose, MD, MBA, FASCO
Cost of Care and Federal Funding How can ASCO address the high cost of cancer care and diminishing federal resources for basic and translational research? We need to work with the Centers for Medicare & Medicaid Services, private insurers, and health-care systems to encourage evidence-based...
FDA Announces Class-Wide Safety Labeling Changes for Long-Acting Opioid Analgesics to Combat Abuse
The U.S. Food and Drug Administration (FDA) announced class-wide safety labeling changes and new postmarketing study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. “The FDA is invoking its authority to require safety labeling changes and postmarket...
International Cancer Corps Provides Valuable First-Time Volunteer Experience
Even as oncologists try to tackle the changing landscape of health care in the United States, many realize that both physicians and patients in this country are still in a better position than those fighting cancer abroad in low- and middle-income countries. In 2009, ASCO joined with Health...
Options for Management of Bone Health in Patients With Multiple Myeloma
Bone health is critical in patients with multiple myeloma, since up to 85% will suffer bone damage. Options for management include two FDA-approved bisphosphonates—pamidronate and zoledronic acid—and possibly the RANK-L inhibitor denosumab (Xgeva, investigational use). Importance of Supportive ...
Take-Home Messages From the NCCN Hematologic Malignancies Conference
As the National Comprehensive Cancer Network (NCCN) 8th Annual Congress: Hematologic Malignancies was drawing to a close, The ASCO Post spoke with Andrew D. Zelenetz, MD, PhD, about the themes of the meeting and the take-home messages for attendees and for our readers. Dr. Zelenetz is Vice Chair...
New Strategies for Relapsed/Refractory Multiple Myeloma Explored
Although upfront therapy can achieve remission in multiple myeloma, most patients will ultimately relapse. Newer targeted therapies and genomic analysis are moving the management of relapsed/refractory multiple myeloma forward, according to Kenneth C. Anderson, MD, Director, Jerome Lipper Multiple...
The AVEX Trial
As reported in The Lancet Oncology by Cunningham and colleagues and reviewed in this issue of The ASCO Post, the AVEX trial was an open-label randomized phase III trial limited to patients over the age of 70 years with previously untreated, unresectable metastatic colorectal cancer who were not...
Bevacizumab/Capecitabine Improves Progression-Free Survival in Older Patients With Treatment-Naive Metastatic Colorectal Cancer
Elderly patients are often underrepresented in clinical trials of metastatic colorectal cancer. In the phase III AVEX trial reported in The Lancet Oncology,1 David Cunningham, MD, of Royal Marsden Hospital in London and colleagues assessed the addition of bevacizumab (Avastin) to capecitabine in...
Aspirin Protects Against Colorectal Cancer Recurrence in PIK3CA-Mutant Tumors
At the 2013 European Cancer Congress, two investigative teams attempted to explain how aspirin may protect against colorectal cancer recurrences, with one study showing PIK3CA mutations associated with protection from aspirin, but not a COX-2 inhibitor, and the other study implicating HLA class I...
Optimizing Anti-HER2 Treatment for Metastatic Breast Cancer in 2013
The good news about HER2-positive breast cancer is that recurrent disease is plummeting, owing to the impact of adjuvant trastuzumab [Herceptin]. Hopefully, first-line metastatic treatment is becoming a thing of the past,” said Harold Burstein, MD, PhD, of Dana-Farber Cancer Institute, Boston....
FDA Approves Obinutuzumab for Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva) for use in combination with chlorambucil (Leukeran) to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab is the first drug with Breakthrough Therapy designation to receive FDA...
COMMENTARY: Choosing Wisely: Good Care With Efficiency
Is more care better care? It is often said, by Americans, that the United States has the best care in the world. However, there are many population-based statistics that do not support that humble opinion. We certainly spend more money than any other nation by far. In fact, we may spend more money ...
ASCO's 2013 Top Five List in Oncology for Choosing Wisely Campaign
ASCO recognizes the importance of evidence-based cancer care and making wise choices in the diagnosis and management of patients with cancer. After careful consideration by experienced oncologists, ASCO annually highlights five categories of tests, procedures and/or treatments annually whose common ...
Patient Assistance Programs Provide Psychosocial but Not Practical Help
“Patients with breast cancer who connect to relevant patient assistance programs receive useful informational and psychosocial but not practical help,” concluded Nina A. Bickell, MD, MPH, of Mount Sinai School of Medicine in New York, and colleagues who conducted a randomized trial among 374 women...
Impact of Hormone Replacement Therapy on Breast Cancer Risk Varies by Race, Weight, and Breast Density
The impact of hormone replacement therapy on breast cancer risk varies according to the patient’s to race/ethnicity, body mass index, and breast density. An analysis of 1,642,824 screening mammograms with 9,300 breast cancer cases in postmenopausal women aged 45 years or older found that hormone...
CancerCare Launches New Edition of Financial Resource Guide for People With Cancer
CancerCare recently announced the launch of a new edition of A Helping Hand: The Resource Guide for People With Cancer, Financial Edition, a reference guide to assist patients with cancer and their families in navigating the financial resources available to them. A Helping Hand is a comprehensive...
Omega-3
Common Name: Polyunsaturated fatty acids (PUFAs) Brand Names: Omegaven, Max-EPA 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...
SIDEBAR: Five Proposals for the FDA
At a forum convened by Friends of Cancer Research in September 2013, a panel of experts presented five proposals outlining how sponsors and FDA may be able to improve and expedite the process for the codevelopment and review of a companion diagnostic designed for use with a drug that has received...
FDA Hears Proposals on Codevelopment of Companion Diagnostics for Breakthrough Therapies
A companion diagnostic developed for use with a drug that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) should automatically be eligible for priority review, according to an expert panel that presented this proposal and four others to the FDA in...
NIH Awards $17 Million in Grants to Augment Genomics Research in Africa
The National Institutes of Health has awarded 10 new grants totaling up to $17 million over the next 4 years to support genomics research in Africa, as part of the Human Heredity and Health in Africa (H3Africa) program. This set of grants is the second disbursement of H3Africa awards and brings the ...
FDA Approves Transducer Array Layout System for Use in Patients With Recurrent Glioblastoma Multiforme
Novocure recently announced that it has received FDA approval for its NovoTAL (Transducer Array Layout) System through a Premarket Approval supplement. The NovoTAL System allows certified physicians to use the individual magnetic resonance imaging data of recurrent glioblastoma multiforme patients...
IOM Presents 2013 Lienhard Award to Leader of Smoking Cessation and Tobacco Prevention Efforts
The Institute of Medicine has (IOM) presented the 2013 Gustav O. Lienhard Award to Steven A. Schroeder, MD, whose pioneering efforts to control tobacco use have helped save millions from premature, smoking-related deaths. The award also recognizes Dr. Schroeder’s leadership in general medicine as...
Focus on the Texas Society of Clinical Oncology
The second largest state in the nation (after Alaska), Texas covers a total area of 268,581 square miles and has a diverse population of over 26 million people. In 1987, the Texas Society of Medical Oncology, now the Texas Society of Clinical Oncology (TxSCO), was formed to address the oncology...
Yoga to Manage Sleep Disruption in Cancer Survivors: A Low-Risk Intervention With High Potential for Benefit
Impaired sleep quality is a concerning problem for many patients with cancer, and pharmacologic treatments come with many negative effects. Several small studies indicate that yoga improves persistent fatigue, sleep disturbance, anxiety, and quality of life, in addition to reducing the need for...
Yoga Improves Sleep Quality in Patients With Cancer Suffering From Sleep Disruption
It is estimated that 30% to 90% of patients with cancer experience impairment of sleep quality post-treatment, and such impairment can be severe enough to increase morbidity and mortality. Preliminary evidence indicates that yoga may improve sleep in cancer patients. In a study reported in the...
No Progression-Free Survival Difference for Cediranib or Cediranib/Lomustine vs Lomustine in Recurrent Glioblastoma
In a phase III study (REGAL trial) reported in the Journal of Clinical Oncology, Tracy T. Batchelor, MD, MPH, of the Massachusetts General Hospital Cancer Center, and colleagues compared oral monotherapy with the investigational pan–vascular endothelial growth factor (VEGF) receptor tyrosine kinase ...
In International Study, Patients Prefer Subcutaneous Over Intravenous Trastuzumab for Breast Cancer
Subcutaneous trastuzumab (not available in the United States) has been shown to have noninferior efficacy and similar pharmacokinetic and safety profiles compared with intravenous trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer. In the PrefHer trial reported in...
Evidence-Based Opportunity to Personalize Breast Cancer Risk: The Data Are Building
The worldwide data from prospective studies of the relationship between levels of endogenous sex hormones and breast cancer risk in postmenopausal women show multiple and complex relationships.1 Nine prospective studies (different from those reported here) of women not taking exogenous sex hormones ...
Advancing Psychosocial Oncology Care Over the Next Decade
A psychiatrist for more than 40 years, Jimmie C. Holland, MD, Attending Psychiatrist and Wayne E. Chapman Chair at Memorial Sloan-Kettering Cancer Center and Professor of Psychiatry, Weill Medical College of Cornell University in New York, is internationally recognized as the founder of the...
New Report Examines Trends in End-of-Life Care
Although fewer Medicare patients with cancer died in the hospital in 2010 than in the years 2003–2007, aggressive treatment continues at the end of life, according to a new report from the Dartmouth Atlas Project.1 The findings also show that a significant number of patients were likely to receive...
Illness Is Personal!
For clinicians and health service researchers striving to improve care for people living with life-threatening conditions, September was a sobering month. The Dartmouth Atlas group released a brief report on Trends in Cancer Care Near the End of Life1 showing that while the proportion of patients...
