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Showing 13651 - 13700Pathways 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...
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...
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...
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...
Susan G. Komen for the Cure® Announces 2011 Brinker Award Winners for Scientific Distinction
Armando Giuliano, MD, and Carlos Arteaga, MD, are being honored as this year’s winners of the Susan G. Komen for the Cure® Brinker Awards for Scientific Distinction in basic science and clinical research. The awards will be presented on December 7 at the 34th Annual San Antonio Breast Cancer...
LETTER TO THE EDITOR: ‘Unrealistic Optimism’ or Losing Sight of the Forest for the Trees?
The article: “Unrealistic Optimism Poses Ethical Challenges, May Affect Informed Consent Process” (The ASCO Post, September 1, 2011, page 35) seems to be delving into a subject with an intent that is unclear. I agree fully with Dr. Jimmie Holland that discrimination between “optimism” and...
LETTER TO THE EDITOR: Treating Cancer or Fear?
I read the article by Deb Stewart, “Acting on Fear” (The ASCO Post, August 15, 2011, page 1) with interest, disappointment, and empathy. “Acting on fear” in cancer treatment generally, and particularly in breast cancer, is not uncommon. Hence, I was most interested in the article’s major thrust, as ...
Cancer Information on Wikipedia as Accurate as on PDQ but Harder to Understand
A comparison of cancer information on Wikipedia and the patient version of information on the NCI’s Physician Data Query (PDQ) “found that although Wikipedia had similar accuracy and depth to the PDQ, the written style was more complex and thus might be less understandable to patients.” According...
Hepatic Resection Remains Preferred Strategy for Colorectal Liver Metastases
Hepatic resection was shown to be superior to radiofrequency ablation (RFA) for the treatment of colorectal liver metastases, according to a model used to stimulate a randomized controlled trial. Researchers from the Hepatobiliary and Pancreatic Surgery Program at the Providence Portland Medical...
Replacing Epirubicin with Docetaxel for Three Cycles Improved Outcomes for Node-positive Breast Cancer
Substituting docetaxel for epirubicin in the final three cycles of chemotherapy resulted in improvement in disease-free and overall survival in a trial among postmenopausal women with node-positive early breast cancer. Following complete excision, women enrolled in the Docetaxel Epirubicin Adjuvant ...
Comparing Therapies for Managing Hot Flashes in Women with Breast Cancer
In a double-blind, placebo-controlled trial, two often-prescribed treatments recommended in clinical guidelines for the management of hot flashes were found to be effective in managing hot flashes in patients with breast cancer. Patient-reported hot flash scores showed that venlafaxine, a selective ...
Doxorubicin/Cyclophosphamide with Docetaxel Equally Effective in Combination or Sequentially
Five-year disease-free survival and overall survival rates were “indistinguishable” in patients with operable, node-positive, HER2-nonamplified breast cancer treated with the sequential or combination regimens of doxorubicin/cyclophosphamide (AC) and docetaxel (T). The Breast Cancer International...
Elderly Patients with Ovarian Cancer Least Likely to Receive Chemotherapy
An analysis of data for 4,617 women aged 65 years or older diagnosed with epithelial ovarian cancer found that those in the oldest age group, 80 and up, were least likely to receive any chemotherapy. While 53% of patients 80 and older received no chemotherapy, the rate was less than half (22%) for...
‘Hot Chemotherapy’ Generates Heated Debate about Its Use with Cytoreductive Surgery to Manage Peritoneal Metastases
"Hot chemotherapy” has become the common term for hyperthermic intraperitoneal chemotherapy (HIPEC), which together with cytoreductive surgery is being used by some surgeons to treat patients with carcinomatosis from colorectal cancer. While HIPEC is not considered the most important component of...
Oncology Community Faces Complex Challenges in Evolving Policy Arena
As the political environment heats up in advance of the upcoming presidential campaign season, many issues crucial to the oncology community are being placed on the political chopping block as policymakers seek ways to reduce the mounting debt and soaring health-care spending. To help clarify some...
FDA Announces Changes in Drug Center’s Oncology Office
The FDA recently announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and...
Improvements Highlighted in Treatment of Leukemias and Preleukemias
Certain preleukemic conditions and leukemia in high-risk patients have remained challenging to treat despite advances in hematology, according to Wendy Stock, MD, of the University of Chicago. But studies reported at the Best of ASCO® Annual Meeting ‘11 in Seattle show progress even in these ...
Newly Elected ASTRO Officers Installed at Annual Meeting
Recently elected officers for the American Society for Radiation Oncology (ASTRO) began their terms at ASTRO’s 53rd Annual Meeting in Miami Beach, which was held October 2-6, 2011. The new Board of Directors members are: President-elect: Colleen A. Lawton, MD, FASTRO, Medical College of Wisconsin, ...
Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma
In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel...
New Biomarker Test Cleared to Evaluate Ovarian Cancer Likelihood
Fujirebio Diagnostics announced that it has received 510(k) clearance from the FDA to market the company’s HE4 Test in an algorithm called ROMA to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding...
FDA Approves Denosumab to Increase Bone Mass in Patients with Cancer
Denosumab (Prolia) recently received FDA approval as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. Pivotal Trials The approvals were based...
Can Bayesian Design Streamline Our Sluggish Clinical Trial System?
The randomized controlled clinical trial has long been the gold standard for new cancer drugs to demonstrate worthiness of FDA approval; however, many experts contend that that our method of bringing drugs to the market is plagued by undue costs, long delays, and overregulation. According to Donald ...
Novel Management Strategies Assessed in Renal Cell and Prostate Cancers
At the Best of ASCO Miami meeting, William Oh, MD, of the Tisch Cancer Institute, Mount Sinai School of Medicine, New York, described new trends and remaining questions in the management of renal cell and prostate cancers. Axitinib vs Sorafenib in Second-line RCC Axitinib, a potent and selective...
SIDEBAR: Is G13D KRAS Mutational Status Ready for Prime Time?
Individual oncologists will have to decide for themselves whether the results from the pooled analysis of cetuximab trials regarding G13D KRAS mutational status are ready for clinical application, according to Axel Grothey, MD, of the Mayo Clinic in Rochester, Minnesota. “We still need...
Standards of Care Confirmed in Latest Group of Colorectal Cancer Trials
Colorectal cancer studies reported at this year’s ASCO meeting offered little in the way of practice-changing information, according to Axel Grothey, MD, of the Mayo Clinic in Rochester, Minnesota. But they did confirm existing standards of care, he noted at the Best of ASCO® meeting in Seattle....
SIDEBAR: Stay Tuned for More Information on Neuropathy-related Genes
According to Daniel F. Hayes, MD, of the University of Michigan, Ann Arbor, who moderated the Best of ASCO® Miami conference, taxane-induced neuropathy is a more complicated story than the study by Schneider and colleagues may suggest. “There are now three observations regarding inherited germline ...
Special Supplement: Reports from Best of ASCO® Annual Meeting '11
The ASCO Post is pleased to present this special supplement with a focused review of more than 50 key abstracts from the Annual Meeting of the American Society of Clinical Oncology (ASCO), as presented and discussed at the Best of ASCO ’11 meetings (July 29-30, 2011, Miami, Florida, and August 5-6, ...
BRCA Mutation Has Little Effect on Outcome with Neoadjuvant Therapy
A retrospective analysis to determine the efficacy of neoadjuvant systemic therapy for breast cancer patients with and without BRCA mutations found the overall prognosis was similar in both groups of patients. “No significant differences were noted in survival outcomes with respect to BRCA status...
Physicians Can Help Patients Set Realistic Expectations for Sexual Functioning after Treatment for Prostate Cancer
Models that can be personalized to predict erectile function of individual patients following treatment for early-stage prostate cancer have been developed and validated in a study involving a total of 2,940 men, and are ready for use in clinical practice, according to Martin G. Sanda, MD, the...
Bevacizumab Labeling Revised to Include New Risks
The FDA recently announced changes made to the bevacizumab (Avastin) package insert regarding new safety concerns. These changes include the following: A new Warning subsection describing the increased risk of ovarian failure in premenopausal patients receiving bevacizumab and chemotherapy and...
Gel for Blood Vessel Surgery Approved
The FDA has approved LeGoo (PluroMed Inc, Woburn, Mass), a gel that allows surgeons to temporarily stop blood flow during surgery so that they can join blood vessels without clamps or elastic loops. LeGoo has been shown to minimize blood flow into the surgical area without damaging blood vessels....
FDA Issues Safety Announcement on Dasatinib
The FDA is warning the public that the leukemia drug dasatinib (Sprycel) may increase the risk of pulmonary arterial hypertension (PAH). Information about this risk has been added to the Warnings and Precautions section of the dasatinib drug label. In reported cases, patients developed PAH after...
Expert Point of View: Panitumumab Is Not Beneficial in KRAS Mutations: No Exceptions
Axel Grothey, MD, of the Mayo Clinic, Rochester, Minnesota, found the findings presented by Marc Peeters, MD, PhD,1 at the 2011 European Multidisciplinary Cancer Congress to be of great interest, from both clinical and research perspectives. “We have two discrepant analyses now for G13D. When we...
New Technologies Are Driving Up Costs: Are They Worth the Price?
Expensive new cancer therapies and technologies are alluring for both physicians and their patients. Prostate cancer, because of the sheer volume of cases and the variability of treatment options, serves as a dynamic disease model in the ongoing debate over how to curb spending and maintain...
GI Symposium Helps Oncologists Stay Abreast of Fast-moving Research
Gastrointestinal cancers are a key therapeutic area in research, and science is moving forward in that arena at a fast clip. But how are those who focus on gastrointestinal malignancies in the clinic supposed to stay on top of it all? One great way is to attend the annual Gastrointestinal Cancers...
A Conversation with Richard J. Gilbertson, MD, PhD
St. Jude Children’s Research Hospital, Memphis, the country’s first and only NCI-designated Comprehensive Cancer Center devoted solely to children, recently appointed internationally regarded pediatric brain tumor researcher, Richard J. Gilbertson, MD, PhD, as its new Cancer Center Director. In a...
