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Showing 23401 - 23450FDA Issues Updated Safety Data on Silicone Gel–filled Breast Implants
The FDA has released a report updating the clinical and scientific information for silicone gel–filled breast implants, including preliminary safety data from studies conducted by the manufacturers (Allergan and Mentor) as a condition of their November 2006 approval. While the report confirms...
First Fentanyl Nasal Spray Approved for Cancer Breakthrough Pain
The FDA has approved fentanyl nasal spray (Lazanda) for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. This marks the first FDA product approval for...
A Prominent Oncologist Retraces Her Steps from Baghdad
Maha Hussain, MD, FACP, Professor of Medicine and Urology, is the Associate Director for Clinical Research at the University of Michigan Comprehensive Cancer Center (UMCCC) and Co-leader of its Prostate Cancer/GU Oncology program. Dr. Hussain recently spoke with The ASCO Post about becoming a...
Studies Explore Potential Benefits of Sunitinib before Nephrectomy in Metastatic Clear Cell Renal Cancer
The multitargeted tyrosine kinase inhibitor sunitinib (Sutent) is established as first-line therapy in metastatic clear cell renal cancer. Data supporting use of cytoreductive nephrectomy in metastatic clear cell renal cancer come from the pre–targeted therapy era, when less-effective immune...
Intergroup Study Evaluates Outcomes of Elderly vs Younger Patients Treated for Advanced Hodgkin Lymphoma
The 11th International Conference on Malignant Lymphoma was held June 15–18 in Lugano, Switzerland. Topics of discussion included lymphoma staging in the new millennium, lymphoma and its microenvironment, and lymphoma cure vs control. The ASCO Post summarized several key presentations in the July...
Cancer.Net Mobile App for Patients
Described as “a gem of a freebie,” Cancer.Net’s new app is the mobile companion for patients to stay informed about cancer and to organize important personal data often needed for doctor visits. It includes interactive tools to help patients get answers to important questions, track side effects,...
Stephen Cannistra, MD, Takes Over as Editor-in-Chief of Journal of Clinical Oncology
Since 1989, Stephen Cannistra, MD, has been working to make the Journal of Clinical Oncology (JCO) the most credible, authoritative resource for disseminating significant clinical oncology research while acting as a reviewer, Consultant Editor, Associate Editor, Editorial Board Member, and as of...
Special Award Recipients Honored at 2011 ASCO Annual Meeting
Each year, as a way to recognize enhancements in cancer care, ASCO honors individuals who have made significant contributions to the Society, the practice of oncology, and patients with cancer. At this year’s Annual Meeting, ASCO was pleased to recognize the 2011 Special Award recipients: Kenneth...
ASCO University® Launches New Programs
A couple of convenient new educational opportunities are now available on the ASCO University® website (http://university.asco.org). Cardiac Comorbidity Boards ASCO University® is now offering a pilot series that focuses on cardiovascular disease and cancer treatment–related toxicities. Each module ...
NCI Clinical Investigator Team Leadership Awards: Conversations in Gynecologic Oncology
The National Cancer Institute recognized Cheryl Saenz, MD, and Linda R. Duska, MD, among others, late last year with a Cancer Clinical Investigator Team Leadership Award. The 2-year award includes $50,000 in funding for cancer research programs at NCI-designated cancer centers. The ASCO Post...
Breast Cancer Studies Focus on Tailoring Therapy for Patient Subsets
As part of our ongoing coverage of the 2011 ASCO Annual Meeting, The ASCO Post has provided substantive reports on key breast cancer trials, but others deserve attention. Lapatinib/Capecitabine Controls Brain Metastases Results of the French phase II LANDSCAPE trial found lapatinib (Tykerb) plus...
SIDEBAR: Early Clinical Findings with JAK2 Inhibition
Two small preliminary studies of JAK2 inhibitors CYT387 and SB1518 had encouraging results in patients with myelofibrosis, and these studies were reported in poster presentations at the Annual Meeting.1,2 Both drugs reduced splenomegaly and achieved improvement in constitutional symptoms. SB1518...
Expert Point of View: Novel JAK Inhibitor May Be an Option for Patients with Myelofibrosis
Ross Levine, MD, of Memorial Sloan-Kettering Cancer Center, New York, was the discussant of the COMFORT-I and COMFORT-II trials.1 He explained that 70% to 90% of patients with myelofibrosis have JAK2 mutations, which appear to be endemic. “This is a driver mutation, although not the only mutation...
Novel JAK Inhibitor May Be an Option for Patients with Myelofibrosis
A new approach to treating myelofibrosis appears to be paying off, according to several studies presented at the 2011 ASCO Annual Meeting. Treatment with a novel JAK inhibitor called ruxolitinib demonstrated significant and sustained improvement in splenomegaly and overall quality of life,...
Expert Point of View: Maintenance Therapy Prolongs Progression-free Survival in Advanced NSCLC but Produces No Overall Survival Benefit
Maintenance therapy in NSCLC is an ever-contentious issue,” stated formal discussant of these trials, Martin Edelman, MD, University of Maryland Greenebaum Cancer Center, Baltimore, at the ASCO Annual Meeting. “The maintenance approach is based on two observations: limited benefit from more than...
Maintenance Therapy Prolongs Progression-free Survival in Advanced NSCLC but Produces No Overall Survival Benefit
Maintenance therapy with either pemetrexed (Alimta) or gefitinib (Iressa) achieved modest improvements in progression-free survival in patients with advanced non–small cell lung cancer (NSCLC). The magnitude of improved progression-free survival was 1.3 months and 2.2 months, respectively, in the...
Emerging Targeted Therapies Offer Glimmer of Hope for NSCLC but Biomarkers for Response Needed
Among the newer approaches to treatment of non–small cell lung cancer (NSCLC) are heat-shock protein 90 (Hsp90) inhibitors, toll-like receptor 2 (TLR2) agonists, and vascular-disrupting agents. So far, none appears to be a “home run,” but Hsp90 inhibition may be the most promising of the three...
ODAC Again Recommends FDA Withdraw Its Approval of Bevacizumab for Metastatic Breast Cancer
In June 2011, a public hearing was convened to consider an appeal of the December 2010 recommendation by FDA to remove the breast cancer indication for bevacizumab (Avastin). FDA’s recommendation late last year was in accordance with a July 2010 recommendation by the Oncologic Drugs Advisory...
Final Decision on Sipuleucel-T
The Centers for Medicare & Mediaid Services (CMS) issued a final decision to cover FDA-approved indications of sipuleucel-T (Provenge) in prostate cancer, calling the treatment “reasonable and necessary.” The CMS final decision assures provider reimbursement of sipuleucel-T for Medicare...
Expert Point of View: Axitinib Improves Progression-free Survival over Sorafenib in Advanced Renal Cell Carcinoma
According to Eric Jonasch, MD, of The University of Texas MD Anderson Cancer Center, “These data show that treatment with a potent and specific antiangiogenic agent after immunotherapy does provide significant prolongation of progression-free survival, and that axitinib is clearly superior to...
Axitinib Improves Progression-free Survival over Sorafenib in Advanced Renal Cell Carcinoma
A randomized comparative effectiveness phase III trial demonstrated significantly superior efficacy for the tyrosine kinase inhibitor axitinib compared to sorafenib (Nexavar) in patients with advanced renal cell carcinoma (RCC). These data suggest that axitinib may become a new standard of care for ...
Conflicts of Interest in Health-care Reform?
Last year’s health-care reform legislation, the Patient Protection and Affordable Care Act, was designed to incrementally roll out major new bureaucratic entities, oversight, and mandates for the practice of medicine between its enactment and 2013, after the next presidential election. A new...
Are Clinical Pathways Inevitable in Oncology’s Future?
Our health-care system is undergoing a gradual but inevitable sea change, shifting from traditional fee-for-service to fee-for-value. A session at this year’s Association of Community Cancer Centers meeting in Washington, DC, shed light on how this trend will reshape incentives and the clinical...
Expert Point of View: Exemestane Prevents Invasive and Preinvasive Breast Cancers in MAP.3 Trial
According to Andrea De Censi, MD, of the E.O. Ospedali Galliera in Genoa, Italy, the invited discussant of the paper presented by Paul Goss, MD, PhD, at the 2011 ASCO Annual Meeting, “MAP.3 provides a paradigm shift for breast cancer prevention. Avoiding breast cancer with manageable toxicity is...
Exemestane Prevents Invasive and Preinvasive Breast Cancers in MAP.3 Trial
The aromatase inhibitor exemestane, taken for 5 years, significantly reduced invasive and preinvasive breast cancers in postmenopausal women at increased risk for the disease, in the large Canadian NCIC CTG MAP.3 randomized trial. Results of the trial were presented at the recent ASCO Annual...
Higher Risk of Recurrence for Triple-negative Breast Cancer after Modified Radical Mastectomy without Radiation
“The paucity of therapeutic options” for women with triple-negative breast cancer “emphasizes the urgent need to optimize the current locoregional management of patients with [triple-negative breast cancer] and reduce their risk of locoregional recurrence,” noted the authors of a Canadian study...
Endoscopic Excision May Be Viable Alternative to Surgical Resection of Large Colorectal Polyps
A retrospective review of 104 consecutive patients with large colorectal lesions, including 39 with carcinoma, found that “endoscopic excision of large colorectal polyps is a viable alternative to surgical resection in a select group of patients and can be performed safely with a good success...
Venous Thromboembolism More Frequent after Open Colorectal Surgery than Post-laparoscopy
The risk of developing venous thromboembolism (VTE) may be nearly twice as high for patients undergoing open colorectal procedures as for those undergoing laparoscopic colorectal resections, according to a report in the Archives of Surgery. The authors also “identified malignancy, obesity, and...
Conventional Induction Chemotherapy Beneficial in Only a Subset of Older Adults with AML
Over the past several decades, progress in the treatment of acute myeloid leukemia (AML) in the older population (generally considered to be older than 60 years) has been limited (Fig. 1). In particular, the outcome of patients over age 70 has been poor, with few long-term survivors. Although AML...
Despite Advances, Little Overall Improvement Seen in Treatment of Older Adults with AML
The outcome of treatment of older adults with acute myeloid leukemia (AML) remains unsatisfactory, although certainly not a totally futile exercise. Patients satisfying the entry criteria for cooperative group clinical trials can be expected to have complete remission rates of 50% to 55%, with...
Point of View: Should Patients Over 70 Receive Aggressive Therapy for Acute Myeloid Leukemia?
Despite Advances, Little Overall Improvement Seen in Treatment of Older Adults with AMLBy Charles A. Schiffer, MD The outcome of treatment of older adults with acute myeloid leukemia (AML) remains unsatisfactory, although certainly not a totally futile exercise. Patients satisfying the entry...
SIDEBAR: First International Conference on Integrative Care
Last March, nearly 250 oncology professionals and representatives of patient organizations, insurance companies, and government agencies from 12 countries attended the First International Conference on Integrative Care for the Future held in Amsterdam. Barrie R. Cassileth, PhD, chaired the event....
SIDEBAR: Making Evidence-based Integrative Medicine Part of Mainstream Cancer Care
During the 1960s and 1970s, the concept of a holistic approach to treating disease that took into account the body, mind, and spirit grew in patient popularity and morphed into two basic categories: alternative and complementary, which later became known by its acronym CAM (complementary and...
A Conversation with Barrie R. Cassileth, PhD
Barrie R. Cassileth, PhD, Chief, Integrative Medicine Service at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York, recently spoke with The ASCO Post about her quest to stamp out the illegitimate use of alternative medicine in cancer care and the results from her latest research. A...
SIDEBAR: Timing of Prostate Cancer Drugs: Earlier But Not Too Early?
While sipuleucel-T, abiraterone, and cabazitaxel have been approved for patients with advanced disease, they might also be used in patients with earlier-stage disease, according to Christopher J. Logothetis, MD, of MD Anderson Cancer Center. “I think it is fair to say that they will be used better...
SIDEBAR: Expect Questions from Your Patients
Drugs for the treatment of prostate cancer have been in the news because of recent approvals by the FDA, the costs connected with their use, and associated improvements in survival.1 More recently reported was the decision to allow Medicare coverage of sipuleucel-T treatment for men who met the FDA ...
Optimizing Treatment for Advanced Prostate Cancer Requires Shifting Focus from Individual Drugs to Integrated Therapies
Newer drugs, including sipuleucel-T (Provenge), cabazitaxel (Jevtana), and abiraterone (Zytiga), can extend survival modestly and ease symptoms for men with advanced prostate cancer. Maximizing the benefit to patients will require shifting the focus from developing individual drugs to developing...
Combined Therapy Produces Good Outcomes in Primary Testicular Diffuse Large B-cell Lymphoma
Final results of an international phase II trial of first-line treatment for primary testicular diffuse large B-cell lymphoma show that using a combined treatment strategy including chemotherapy and central nervous system and testicular prophlaxis “was associated with a good outcome.” The results...
Evaluating Risk for Suicide in People Diagnosed or Living with Cancer
The challenges of life-threatening physical illness can sometimes lead to suicide. In fact, given the critical stressors that a person with cancer faces, we might expect suicide to be a more common reaction. Patients with cancer are at increased risk of completed suicide, though the prevalence of...
FDA Outlines Oversight of Mobile Medical Applications
The FDA is seeking input on its proposed oversight approach for mobile medical applications (“apps”) designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications, and will not regulate the...
New Safety Information Reported for 5-alpha Reductase Inhibitors
The FDA announced that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor class of drugs has been revised to include new safety information about the increased risk of being diagnosed with high-grade prostate cancer. This risk appears to be low, but health-care...
Help Your Patients Manage the Cost of Cancer Care
Because the cost of cancer care can be high, it is important for your patients to understand what to expect before starting treatment so that they can manage the financial effect of cancer in the most effective way possible. To that end, Cancer.Net, ASCO’s patient information website, offers a...
ASCO’s Oncology Slide Library Functions as a Share‑and‑Exchange Forum
ASCO’s Oncology Slide Library—which allows ASCO meeting attendees to upload and share their ASCO meeting presentation slides with slide-library subscribers—may only be a year old, but participation is already very high. This year’s Annual Meeting in June marked the first time ASCO gave each speaker ...
Oncology Community Briefs Members of Congress and Calls for Action
ASCO and seven other oncology organizations held a Capitol Hill briefing in July and explained to nearly 200 members of Congress and their staffs how widespread cancer drug shortages are creating “a crisis in care.” According to the University of Utah Drug Information Service, the number of drug...
ASCO’s International Cancer Corps Launches Initiatives in Ethiopia and Vietnam
Imagine just four oncologists attempting to provide care for a population of 82 million people living in a country covering twice the territory of Texas. That’s the state of cancer care in Ethiopia. And imagine a country of more than 90 million people—more than twice the population of...
ODAC Recommends Accelerated Approval for Brentuximab
Seattle Genetics, Inc, announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend that the agency grant accelerated approval of brentuximab vedotin (ADCETRIS) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant...
FDA Issues Guidance for Diagnostic Tests Used with Targeted Therapies
The FDA issued a new draft guidance to facilitate the development and review of “companion diagnostics”—tests used to help health-care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft ...
SIDEBAR: Child-Pugh Score
The Child-Pugh score, a prognostic measure used in patients with chronic liver disease, is determined by five clinical measures, including total bilirubin level; serum albumin level; prothrombin time expressed by international normalized ratio (INR), presence of ascites (none, mild, severe); and...
Expert Point of View: Sorafenib Acceptable in Child-Pugh B Patients with Hepatocellular Carcinoma
The GIDEON trial “can provide us with important information on safety and single-arm efficacy in the Child-Pugh B population,” said Bert H. O’Neil, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill. “The results suggest that safety is similar between...
Sorafenib Acceptable in Child-Pugh B Patients with Hepatocellular Carcinoma
Patients with hepatocellular carcinoma and moderate liver dysfunction can derive benefit from, and be treated safely with, sorafenib (Nexavar), according to the second interim analysis of the GIDEON trial, presented at the 2011 ASCO Annual Meeting by Jorge A. Marrero, MD, of the University of...
