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Showing 13451 - 13500Doxorubicin/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...
FDA Commissioner Announces Decision on Bevacizumab
On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will still remain on the market as an...
Rates of Surgery and Survival Increasing for Early-stage Cancers
Surgery is increasingly being used to treat patients with early-stage laryngeal cancer in the United States, and chemotherapy in combination with radiation therapy is being used increasingly to treat patients in an advanced stage of the disease, according to a report in the October issue of...
Alternative Treatment for Advanced Ovarian Cancer Reduces Neurotoxicity and Alopecia
A randomized phase III clinical trial found that carboplatin/pegylated liposomal doxorubicin (Doxil) was not superior in prolonging progression compared to the standard carboplatin/paclitaxel as first-line therapy of patients with advanced ovarian cancer. The carboplatin/liposomal doxorubicin...
Fewer False-positives, Small Increased Risk of Late Diagnosis with Biennial Mammography
Screening mammography every other year reduced false-positive recalls by about one-third compared to annual screening, but was associated with a small increase in the probability of late-stage cancer diagnosis, according to a study funded by the NCI and published in Annals of Internal Medicine. To...
Low-level Expression of ESR1 Tied to Tamoxifen Resistance
Data from a retrospective analysis of two pivotal breast cancer studies suggest that the low-level expression of the estrogen receptor (ER) gene ESR1 “is a determinant of tamoxifen resistance in ER-positive breast cancer,” reported researchers in the Journal of Clinical Oncology. “We performed...
Oxaliplatin Improved Overall Survival in Patients under 70
The addition of oxaliplatin to fluorouracil (5-FU) plus leucovorin improved overall survival in patients younger than 70 years old participating in the National Surgical Adjuvant Breast and Bowel Project (NSABP) C-07 trial. Patients eligible for the trial had either stage II or III colon cancer and ...
Should Age at Initial Screening Colonoscopy Be Younger for Men?
A study to investigate the most appropriate age for initial screening colonoscopy to improve detection of adenomas, advanced adenomas, and colorectal cancer, and lower colorectal cancer mortality found that the most appropriate age might be different for men and women. “In our study, analysis of...
MRI Helps Predict Survival Outcomes in Patients with Rectal Cancer
Magnetic resonance imaging (MRI) can be used after neoadjuvant therapy for rectal cancer to predict survival outcomes for good and poor responders and offer patients additional treatment options before definitive surgery, according to a study conducted at 11 specialist colorectal cancer units in...
Adjuvant Trastuzumab in Nonanthracycline Regimen Studied
One of four large, randomized trials to evaluate adjuvant trastuzumab (Herceptin) in early-stage HER2-positive breast cancer—and the only study to include a nonanthracycline chemotherapy regimen—found that regimen had similar efficacy to anthracycline-containing regimens, but with lower rates of...
Challenging Perceptions about Treatment Options for Younger Women with Early-stage Breast Cancer
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. “There is a perception out there...
A Conversation with Craig B. Thompson, MD
In November 2010, Craig B. Thompson, MD, was named President and CEO of Memorial Sloan-Kettering Cancer Center (MSK) in New York, succeeding Harold Varmus, MD, who is now Director of the NCI. A cancer clinician and researcher, before coming to Memorial Sloan-Kettering Dr. Thompson was Director of...
Expert Point of View: Lessening Patients’ Suffering at the End of Life
In her interview with The ASCO Post, Judith Redwing Keyssar, RN, sheds light on easing the suffering of patients facing the end of life. Although what she says is appropriate for patients who are clearly dying, I would emphasize that palliative care is also pertinent to patients who are not...
A Conversation with Judith Redwing Keyssar, RN
The number of patients seeking hospice and palliative care has grown significantly since 1974, when the NCI funded the first hospice facility in Branford, Connecticut. Nevertheless, according to the National Center for Health Statistics, 85% of Americans still die in hospitals or nursing homes....
FDA Approves Cetuximab to Treat Metastatic Head and Neck Cancer
On November 7, the FDA approved cetuximab (Erbitux) in combination with platinum-based therapy plus fluorouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck. The approval was based primarily on...
Geriatric Oncology, a Much Needed Discipline for Future Cancer Care
The U.S. health-care system, with its rapidly aging population, faces a multitude of difficult clinical and financial challenges in caring for its burgeoning population of older patients with cancer. Moreover, age-related social and medical issues among older patients need to be addressed by a...
American Society of Hematology Recognizes Christoph Klein, MD, PhD, with William Dameshek Prize
The American Society of Hematology (ASH) will honor Christoph Klein, MD, PhD, of Children’s Hospital, Ludwig-Maximilians University in Munich, Germany, with the 2011 William Dameshek Prize, at the upcoming Annual Meeting in San Diego. Dr. Klein is being recognized by ASH for his many...
Biosimilars in Cancer Treatment: What Should the Oncology Community Expect?
Alternative versions of biologic agents, ie, “biosimilars,” will presumably be getting the green light by the FDA, giving oncologists more choices for treatments that come at lower costs to patients and society. The FDA plans to issue its guidance on biosimilars by the end of this year, paving the...
Test for AML Prognosis Cleared by FDA
Abbott announced today it has received 510(k) clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukemia (AML) Abbott’s Vysis EGR1 FISH Probe Kit, the third Abbott fluorescence in situ hybridization (FISH) assay approved or...
VGX-100 Investigational New Drug Application Approved
The Australian biotechnology company Circadian Technologies announced that its subsidiary, Vegenics Pty Ltd, has received approval for its investigational new drug (IND) application from the FDA to initiate clinical trials of VGX-100. The first phase I trial will study VGX-100 in patients with a...
FDA Approves Molecular Test to Detect HPV
Gen-Probe recently announced that the FDA has approved its APTIMA HPV assay, an amplified nucleic acid test that detects high-risk strains of human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions. The test has been approved to run on Gen-Probe’s fully...
Tamoxifen vs Surgery Study Shows Older Patients with Breast Cancer Can Achieve a ‘Personal Cure’
A truly final review—when all the patients in the trial have died and the cause of death is known for each—of a randomized trial comparing tamoxifen to surgery in patients over the age of 70 with operable breast cancer found no differences in the survival rates or deaths attributable to breast...
Global Trials: Do Benefits Outweigh Pitfalls?
Global clinical trials have many advantages and are essential in many disease settings, but there are also challenges that confront global industry-sponsored research, said Sandra Horning, MD, Senior Vice President and Global Head of Clinical Development in Hematology/Oncology for Genentech (Table...
Sunitinib and Everolimus: New Indications in Pancreatic Neuroendocrine Tumors
With In the Clinic, The ASCO Post 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. Sunitinib Indication—The oral kinase inhibitor...
NCCN Guidelines® for Lung Cancer Screening Now Available
The new NCCN Guidelines for Lung Cancer Screening primarily refer to non–small cell lung cancer, the most common type of lung cancer, and recommend helical low-dose computed tomography (LDCT) screening for select patients at high risk for the disease. In addition to outlining the appropriate use of ...
SIDEBAR: White House Issues Executive Order on Drug Shortage
On October 31, President Barack Obama issued an executive order instructing the FDA to broaden reporting of potential drug shortages, expedite reviews of applications to begin or modify production of these drugs, and provide more information to the Justice Department about possible cases of...
