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Showing 13901 - 13950First 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...
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...
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...
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,...
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...
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...
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...
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...
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...
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 ...
Intermittent or Continuous Androgen Suppression Produces Comparable Survival after Radical Therapy in Prostate Cancer
Men with prostate cancer who receive intermittent courses of androgen-suppressing therapy can live as long as those who are treated with continuous therapy, according to results of a recently concluded study. Until now, standard treatment has consisted of continuous therapy, but this is expected to ...
Rising Costs of Cancer Care: It's More Than Drugs
All parties—the government, payers, and consumers—agree that, left unchecked, rising health-care costs will eventually hamstring vital portions of our delivery system. For example, Medicare, which covers more than 50% of the nation’s patients with cancer, is marching headlong toward insolvency....
A Landmark Lung Screening Trial: What Does It Mean for Clinicians and Their Patients?
The NCI-funded National Lung Screening Trial (NLST), published recently in The New England Journal of Medicine,1 was heralded as a landmark study in lung cancer detection. This study is the first comprehensive clinical trial to find that screening high-risk individuals with low-dose CT reduces lung ...
Surgical Site Infections after Colectomy More Likely in Obese Patients
Obese patients appear to have a significantly increased risk of developing a surgical site infection after segmental or total colectomy for colon cancer, diverticulitis, or inflammatory bowel disease, and the presence of infection increases the cost associated with the procedure, according to a...
Neoadjuvant Chemotherapy with CMV Improves Outcome for Invasive Bladder Cancer
Long-term results from a phase III trial show that neoadjuvant chemotherapy with CMV (cisplatin, methotrexate, and vinblastine) improves the outcome for patients with muscle-invasive urothelial cancer of the bladder treated by cystectomy and/or radiotherapy. “Three cycles of CMV before cystectomy...
Androgen Deprivation Therapy plus Radiotherapy Increases Survival in Men with Localized Prostate Cancer
The addition of short-term androgen deprivation therapy to radiotherapy for men with stage T1b, T1c, T2a, or T2b prostate adenocarcinoma and a prostate-specific antigen (PSA) level of 20 ng/mL or less “conferred a modest but significant increase in the 10-year rate of overall survival, from 57 to...
Identifying Genetic Factors That Predict Response to Chemotherapy in NSCLC
A genetic variation in the chemokine-like receptor 1 (CMKLR1) gene was statistically significantly associated with poor overall survival in patients with non–small cell lung cancer (NSCLC) who were treated with platinum-based chemotherapy with or without radiation. The variation was identified by a ...
Updated Drug Label Approved for Pioglitazone after Safety Review
The FDA recently approved updated drug labels for pioglitazone (Actos) and other pioglitazone-containing medicines (in combination with metformin, Actoplus Met and Actoplus Met XR; and with glimepiride, Duetact) to include safety information that the use of pioglitazone for more than 1 year may be...
At 5 Years, Brachytherapy Shows Quality-of-life Advantages over Radical Prostatectomy for Favorable-risk Prostate Cancer
Five years after treatment for favorable-risk prostate cancer, men who either chose or were randomly assigned to receive brachytherapy reported quality-of-life advantages in urinary and sexual domains and in patient satisfaction compared to men who received radical prostatectomy, according to a...
Experts Address Cancer-related Distress—the ‘Sixth Vital Sign’
More research is needed to investigate the effects of screening and treatment for distress in cancer care, according to a recent issue of the international journal Psycho‑Oncology. This special edition of the journal includes a review of screening for distress and depression over 40 years in cancer ...
Cancer Care in the UK: A Conversation with Chris Parker, MD
In the contentious debate over rising health-care spending, the cancer care policies of the British National Health Service (NHS) are often cited by U.S. policymakers as an example of how health-care rationing denies patients life-prolonging treatments based on costs. The ASCO Post recently spoke...
ASCO Connection Adds New Columnists, Launches Group Creation Option
ASCO’s professional networking site, ASCOconnection.org, continues to build depth in areas of interest to the oncology community, adding as its newest commentator ASCO President Michael P. Link, MD, the Lydia J. Lee Professor in Pediatric Oncology at Stanford University School of Medicine, as well...
A Conversation with Constance M. Chen, MD, MPH
Although incidence data vary widely, breast cancer–related lymphedema may affect as many as 54% of the 2.3 million survivors of breast cancer in the United States. The condition is often disabling and can result in both long-term devastating physical consequences for survivors, including the loss...
Adjuvant Immunotherapy Provides No Clinical Benefit in Patients with High‑risk Renal Cell Carcinoma
For renal cell carcinoma patients at high risk of relapse following nephrectomy, adjuvant therapy with the combination of interleukin-2 (Proleukin), interferon alfa, and fluorouracil (5-FU) provides no survival benefit over observation alone, according to a phase III trial conducted by the European ...
A Conversation with Samuel Silver, MD, PhD
Over the past 2 decades, significant therapeutic advances have led to greater survival rates and quality of life for patients with cancer. During the same period there has been a transformation in the way oncology services are both perceived and delivered. In a recent conversation with The ASCO...
Increased Use of Hospital Services Boosts Oncology Spending
For our ongoing series on the rising costs of cancer care, The ASCO Post spoke with Lee N. Newcomer, MD, Senior Vice President of Oncology for UnitedHealthcare. Dr. Newcomer is responsible for improving cost-effective cancer care at the nation’s largest health insurer. He shed light on areas of...
Expert Point of View: World Conference on Lung Cancer
The EURTAC study provides additional evidence of the efficacy of the oral EGFR inhibitors in the first-line treatment of patients with mutated EGFR—and, importantly, in Western patients, rather than Asians, for whom data are more abundant. “The findings speak to the fact that all patients with...
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 ...
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...
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...
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...
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...
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...
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 ...
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...
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...
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,...
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...
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...
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...
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 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...
