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Showing 13701 - 13750FDA 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...
Important Lessons for Oncology from the Front Lines of the AIDS Pandemic
On June 5, 1981, the CDC issued a warning about a rare type of pneumonia discovered among a small group of young gay men in Los Angeles, later determined to be AIDS-related, ushering in the HIV/AIDS epidemic. Early on, AIDS-related malignancies brought the oncology community into this formidable...
Neural Stem Cell Transplantation May Improve Cognitive Function in Brain Cancer
The potentially devastating long-term consequences on cognitive function in patients with brain cancer following cranial irradiation led Charles L. Limoli, PhD, Professor of Radiation Oncology, University of California, Irvine, to study neural stem cell transplantation and how the procedure may...
Medicare Reimbursement to Physicians: Déjà Vu All Over Again
In February 2011, The ASCO Post published an opinion piece (“Congress and the ‘Doctor Fix’: Looking Back, Looking Ahead”) about the ping-pong of legislative continuing resolutions to avert a 21.3% cut in physician reimbursement. These continuing resolutions were necessary because the Affordable...
SIDEBAR: Expect Questions from Your Patients
Patients concerned about an increased risk of cancer among recipients of organ transplantation need to know that “in the great majority of cases, patients don’t get cancer,” according to Eric Engels, MD, MPH, lead author of the Transplant Cancer Match Study report and Senior Investigator, Division...
Solid Organ Transplant Recipients Have Increased Risk for Broad Range of Malignancies
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. The Transplant Cancer Match Study, a ...
Evidence of Improved Survival for Lobectomy vs Limited Resection in Early-stage Lung Cancer
“Evidence is statistically inconclusive but suggestive that lobectomy, compared with limited resection, is associated with increased long-term survival for early-stage lung cancer,” according to a study reported in the Journal of the National Cancer Institute. The study analyzed data from 679...
Significant Neurologic and Executive Function Impairment among Breast Cancer Survivors
Women who survive breast cancer show significant neurologic impairment, with outcomes appearing to be significantly poorer for those treated with chemotherapy, according to a report in the Archives of Neurology. Investigators at Stanford University School of Medicine in California conducted an...
Significantly Longer Survival with Axitinib Compared to Sorafenib in Patients with Renal Cell Carcinoma
A phase III study comparing the vascular endothelial growth factor receptor (VEGFR) inhibitors axitinib and sorafenib (Nexavar) as second-line therapy in patients with metastatic renal cell carcinoma found that axitinib produced significantly longer progression-free survival. Published in The...
Twitter Dominates Social Media Buzz at Stockholm Meeting
There was a time when clinical trial results were disseminated mainly through peer-reviewed journals that appeared in your mailbox. Computers and prompt reporting from medical conferences changed that, and same-day postings on medical websites brought “breaking news” a step closer. But the...
Reflections from The ASCO Post
The editors gratefully acknowledge all contributors to The ASCO Post and thank the columnists who contributed to Volume 2, January–December 2011: Al B. Benson III, MD, FACP Richard Boxer, MD, FACS Carlton G. Brown, RN, PhD, AOCN Barrie R. Cassileth, PhD E. David Crawford, MD Emil J. Freireich, MD, ...
American Society of Hematology Elects New Officers
The American Society of Hematology announced the election of three new members to its Executive Committee, the governing body of the organization, for terms to begin in January 2012. Linda J. Burns, MD, will serve a 1-year term as Vice President, followed by successive terms as President-Elect and...
510(k) Clearance Granted for OncoTrac
Translational Sciences Corporation announced that it has received FDA 510(k) clearance for commercialization of its OncoTrac medical imaging software. OncoTrac is designed for efficient quantitative assessment of treatment response of metastatic tumors including those of the breast, lung,...
FDA Approves First Drug to Treat Myelofibrosis
The FDA has approved ruxolitinib (Jakafi), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis. Myelofibrosis is a disease in which the bone marrow is replaced by scar tissue resulting in blood cells being made in organs such as the liver and the...
Lessons from a Northern Neighbor: A Conversation with Joseph M. Connors, MD
Policy analysts searching for a better understanding of health-care models often compare the cancer delivery systems of Canada and the United States. The ASCO Post recently spoke with Joseph M. Connors, MD, Clinical Professor and Director of the BC Cancer Agency’s Centre for Lymphoid Cancer,...
Important Briefs from the 2011 European Multidisciplinary Cancer Congress
Nearly 16,000 people from 16 countries attended this year’s European Multidisciplinary Cancer Congress, held recently in Stockholm. The ASCO Post has featured several key reports from the meeting and will offer further coverage in upcoming issues. Additional noteworthy studies presented at the...
ASH Honors Janet Rowley, MD, and Brian Druker, MD
The American Society of Hematology (ASH) recognized Janet Rowley, MD, of the University of Chicago Medical Center, and Brian Druker, MD, of Oregon Health & Science University with the 2011 Ernest Beutler Lecture and Prize for their significant advances in the diagnosis and treatment of chronic...
New Drug Approved to Treat Acute Lymphoblastic Leukemia
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze) to treat patients with acute lymphoblastic leukemia who have developed hypersensitivity to Escherichia coli–derived asparaginase (Elspar) and pegaspargase (Oncaspar). Acute lymphoblastic leukemia is the most commonly diagnosed...
2011 in Review: Oncology Drugs/Indications Newly Approved by FDA
At press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2011. Asparaginase Erwinia chrysanthemi (Erwinaze) as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in patients who have...
Optimizing HER2-directed Therapy in the Clinic
Seminal research in the treatment of HER2-positive breast cancer has been led by Edith A. Perez, MD, the Serene M. and Frances C. Durling Professor of Medicine at the Mayo Clinic, Jacksonville, Florida. The ASCO Post asked Dr. Perez to share her approach to HER2-directed therapy. Testing...
A Conversation with Ezekiel J. Emanuel, MD, PhD
Last September, Ezekiel J. Emanuel, MD, PhD, a leading scholar in bioethics and health-care policy, was named the Diane v.S. Levy and Robert M. Levy University Professor and Vice Provost for Global Initiatives at the University of Pennsylvania in Philadelphia. His appointment will be shared between ...
Breast Cancer Experts Voice Opinion and Express ‘Disappointment’ over FDA Decision
Gabriel N. Hortobagyi, MD, Chair of Medical Breast Oncology at The University of Texas MD Anderson Cancer Center, Houston, said he was “disappointed but not surprised” at the FDA decision to withdraw the bevacizumab (Avastin) indication in breast cancer. “Once the FDA put this in the hands of ODAC, ...
FDA Announces Bevacizumab Decision: Agency Will Revoke Breast Cancer Indication
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 remain on the market as an...
SIDEBAR: Expect Questions from Your Patients
“The message” of a meta-analysis of 17 randomized trials of breast-conserving surgery with or without radiation, “should be that the benefits of radiation are not temporary, that it provides an increased chance of cure,” Thomas A. Buchholz, MD, told The ASCO Post. The meta-analysis was conducted by ...
Benefits of Radiation after Breast-conserving Surgery Cut Risk of Recurrence in Half
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. “After breast-conserving surgery,...
MD Anderson Cancer Center’s New President Has a Bold Vision
On September 1, 2011, Ronald A. DePinho, MD, became only the fourth President in the 70-year history of The University of Texas MD Anderson Cancer Center in Houston. Dr. DePinho spent the previous 14 years as head of Dana-Farber’s Belfer Institute for Applied Cancer Science. In a recent interview...
