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Showing 24051 - 24100FDA Drug Approvals, January–April 2012
Imatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST). Vismodegib capsules (Erivedge) approved for the treatment of metastatic basal cell carcinoma or locally...
Liposomal Vincristine Receives Positive Vote from ODAC
Talon Therapeutics, Inc, announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit-risk assessment for use of vincristine sulfate liposomes injection (Marqibo). The manufacturer is seeking an indication for the ...
New Data Guide Treatment for Rare Form of Hodgkin Lymphoma
Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) accounts for approximately 5% of Hodgkin lymphoma cases. It is distinguished from classic Hodgkin lymphoma by a variety of clinical and pathologic features, including expression of B-cell associated antigens such as CD20. Given that the...
Erwinia chrysanthemi Asparaginase for Acute Lymphoblastic Leukemia in Patients with Hypersensitivity to E coli–derived Asparaginase
In the Clinic 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. Indication Erwinia chrysanthemi asparaginase (Erwinaze) was...
FDA Approves New Silicone Gel–filled Breast Implant
The FDA recently approved a silicone gel-filled breast implant manufactured by Sientra Inc for breast augmentation in women at least 22 years old and breast reconstruction in women of any age. As a condition of approval, Sientra is required to conduct postapproval studies that will assess long-term ...
FDA Commissioner Statement: Surgeon General’s Report on Youth Smoking
The recent report on “Preventing Tobacco Use Among Youth and Young Adults” by the Surgeon General not only documents the devastating consequences of tobacco use for our nation’s youth, but also represents a clarion call for bold action at every level of government to implement proven strategies to...
ODAC Offers Recommendations on Two Sarcoma Drugs
The FDA’s Oncologic Drugs Advisory Committee (ODAC) recently recommended approval of one drug for sarcoma but rejected another. The panel voted 11 to 2 that clinical studies support a favorable benefit-risk assessment for use of pazopanib (Votrient) in treating patients with advanced soft-tissue...
Update on Novel Anticoagulants: Dabigatran Etexilate
Efficacy and safety of traditional anticoagulants (eg, vitamin K antagonists) are well recognized, given their long-standing use in clinical practice. However, the novel anticoagulants have several potential advantages over the vitamin K antagonists. Even so, in light of their recent introduction...
Treating Acute Promyelocytic Leukemia without Chemotherapy
Throughout the course of medical history, we have witnessed innovations that have initially been met with skepticism but have later revolutionized our management of patients with specific disorders. The recent history of oncology drug development is full of instances where a drug that was...
SIDEBAR: International Study Confirms ACOSOG Z0011
Preliminary findings of the International Breast Cancer Study Group (IBCSG) 23-01 trial1 show no benefit for axillary lymph node dissection in patients with only minimally involved sentinel nodes, thereby supporting the results of the American College of Surgeons Oncology Group (ACOSOG) Z0011...
Advances in Axillary Surgery for Patients with Breast Cancer
Results from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, which found no benefit for completion axillary nodal dissection in patients with breast cancer involving one to two positive sentinel nodes,1 have led to changes in breast cancer management, though points of...
Expert Point of View: New Biomarker Predicts Survival in Advanced Prostate Cancer
“The Bone Scan Index (BSI) is a very important new quantitative imaging biomarker to help us better assess patients with metastatic prostate cancer in a robust and reproducible way, particularly those with bone-dominant disease,” said Lawrence Schwartz, MD, Chair of the Department of Radiology at...
New Biomarker Predicts Survival in Advanced Prostate Cancer
Researchers at Memorial Sloan-Kettering Cancer Center have developed the Bone Scan Index (BSI), which is the first quantitative imaging response biomarker that can assess response to treatment and prognosticates for survival in men with metastatic castration-resistant prostate cancer. Based on Bone ...
AACR Inducts Frank McCormick, PhD, FRS, DSc (hon) as President; Elects Charles L. Sawyers, MD, as President-elect, 2012-2013
Leadership of the American Association for Cancer Research (AACR) inducted Frank McCormick, PhD, FRS, DSc (hon), as President of the society during the AACR Annual Meeting held earlier this month Dr. McCormick is the Director of the University of California, San Francisco (UCSF) Helen Diller Family ...
2012 Annual Meeting to Highlight NCI’s ‘Provocative Questions’ and Offer First-ever Pre–Annual Meeting Seminars
As this year’s ASCO Annual Meeting was being planned, the NCI was developing and releasing its “Provocative Questions” project—an effort to stimulate the cancer community to ask itself 24 key questions in order to advance the treatment of cancer and provide better care. It quickly became clear to...
ASCO Advocates for Solutions to Oncology Drug Shortage Crisis
ASCO continues to call for three specific actions by Congress to help avert shortages of essential treatments for children and adults living with cancer. ASCO President Michael P. Link, MD, outlined the priorities in February at an FDA news briefing on the recent methotrexate and liposomal...
Help Your Patients Understand Cost of Care
Encourage your patients to review ASCO’s newly updated Managing the Cost of Cancer Care booklet, which can help them make informed treatment decisions. This resource explains the various costs associated with cancer treatment, key provisions in the 2010 health-care reform law that are now being...
2012 Breast Cancer Symposium to Expand Tumor Board Session, Add ‘Meet the Professors’ Session
The days of attending the Breast Cancer Symposium, just quietly listening to useful lectures, and then going home are over. In recent years, the meeting’s sponsors and planners have worked to make the 3-day gathering far more interactive and as intimate as a meeting with 1,500 attendees can be....
SIDEBAR: Lessons Learned from caBIG
The Cancer Biomedical Informatics Grid (caBIG) is an NCI program that was launched in 2004 in reaction to a “health information tsunami,” said Daniel R. Masys, MD, Chair of the caBIG Oversight Committee and Affiliate Professor in the Department of Biomedical Informatics and Medical Education,...
Cancer Informatics: A Future Necessity, but Challenges Abound
The National Cancer Policy Forum of the Institute of Medicine (IOM) recently convened a workshop on cancer informatics to examine and discuss needs and challenges facing biomedical researchers, which will in turn affect the way oncology is practiced in the future. “This is a time of huge scientific ...
ACCC Releases Survey on ‘Oncology Medical Home’
The Association of Community Cancer Centers (ACCC) released findings from a survey that explores how community-based cancer care programs view the concept of the “oncology medical home”—a patient-centered model for coordinated care, whereby payers would reimburse physicians for services that keep...
Summary of ASCO Provisional Clinical Opinion on Palliative Care
The ASCO provisional clinical opinion on palliative care recently published1 was based largely on data from seven published randomized controlled trials, including a phase III lung cancer trial by Temel and colleagues, which was the trigger for the new recommendations.2 The trial’s principal...
Not All KRAS Mutations Are Alike in Non–Small Cell Lung Cancer
Mutations in the KRAS oncogene play a critical role in cancer cell growth and resistance to treatment. In colorectal cancer, the presence of any mutant amino acid substitution in the K-Ras protein predicts a poorer response to targeted therapy. In non–small cell lung cancer (NSCLC), however, there...
An Expert Shares Insight into the Future of Lung Cancer Treatment
Despite growing national focus on early detection, prevention, and new molecular-based treatments, lung cancer persistently remains the number 1 cause of cancer death for men and women in the United States. The ASCO Post spoke to lung cancer specialist Paul A. Bunn, Jr, MD, Executive Director,...
SIDEBAR: Major Conclusions of the Surgeon General’s Report on Youth Tobacco Use
Cigarette smoking by youth and young adults has immediate adverse health consequences, including addiction, and accelerates the development of chronic diseases across the full life course. Prevention efforts must focus on both adolescents and young adults because among adults who become daily...
Surgeon General Releases New Report on Youth Smoking
The fight against tobacco use among young people was accelerated recently by Surgeon General Regina M. Benjamin, MD, MBA, with the release of the Surgeon General’s Report, Preventing Tobacco Use Among Youth and Young Adults. This report details the scope, health consequences, and influences that...
Radiation Oncologists Are Discussing Infertility Risks with Young Patients
More than 80% of radiation oncologists discuss the impact of cancer treatments on fertility with their patients of childbearing age. This can lead to improved quality of life for young patients with cancer, according to a study in Practical Radiation Oncology.1 In the past, the clinical focus for...
NCCN Announces New Guidelines for Adolescent and Young Adult Oncology
The National Comprehensive Cancer Network (NCCN) announced that it has issued new NCCN Clinical Practice Guidelines in Oncology for Adolescent and Young Adult (AYA) Oncology.1 Adolescent and young adult patients are defined in the guidelines as individuals 15 to 39 years of age at initial cancer...
SELECT Trial Update: Vitamin E Fails to Prevent Prostate Cancer in Healthy Men, Appears to Increase Risk
Supplements touted as preventing prostate cancer may turn out to be dangerous, as is evident from updated results of the largest long-term prevention trial, called the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Final analysis of SELECT showed that, compared to placebo, vitamin E alone ...
Expert Point of View: Short-term Hormone Therapy Did Not Increase Risk of Cardiovascular Death in Men with Localized Prostate Cancer, RTOG 94-08 Trial Finds
Oliver Sartor, MD, Medical Director of Tulane Cancer Center, New Orleans, said that in his opinion, RTOG 94-08 had some flaws because outdated radiotherapy doses were employed. “The utility of hormone therapy is questionable with today’s doses,” Dr. Sartor said. “Using standard radiation doses at...
Short-term Hormone Therapy Did Not Increase Risk of Cardiovascular Death in Men with Localized Prostate Cancer, RTOG 94-08 Trial Finds
Short-term androgen deprivation therapy does not appear to increase cardiovascular mortality in men with clinically localized prostate cancer, according to a post hoc analysis of a large Radiation Therapy Oncology Group (RTOG)-sponsored clinical trial.1 “Our study analyzes data from a large...
Expert Point of View: Study Shows Concurrent Chemoradiation Therapy to be a Viable Strategy for Muscle-invasive Bladder Cancer
According to Seth P. Lerner, MD, Professor in the Scott Department of Urology at Baylor College of Medicine, Houston, and Co-chair of the session at the Genitourinary Cancers Symposium where the study by Mak and colleagues was presented, the data clearly demonstrate proof of principle that the...
Study Shows Concurrent Chemoradiation Therapy to be a Viable Strategy for Muscle-invasive Bladder Cancer
Combined-modality therapy provides a bladder-sparing alternative to radical cystectomy with comparable outcomes in patients with muscle-invasive bladder cancer, according to a pooled analysis of six Radiation Therapy Oncology Group (RTOG) trials.1 The study included 468 patients and showed that...
George Kovach, MD, Named as President of the Association of Community Cancer Centers
George Kovach, MD, became President of the Association of Community Cancer Centers (ACCC) at its 38th Annual National Meeting in March 2012. Dr. Kovach is the medical director of the Genesis Cancer Center, Davenport, Iowa, and one of the founding members of the Iowa Oncology Society (IOS). “I am...
Expert Point of View: Controlled Study Links ‘Chemobrain’ to Longitudinal Changes in Brain
Commenting on the study by Deprez et al, Patricia Ganz, MD, noted the importance of the finding for clinicians. “This study tells us that self-reported complaints mapped onto the neuropsychologic tasks; this has not been shown very often,” said Dr. Ganz, who is Director of the Division of Cancer...
Controlled Study Links ‘Chemobrain’ to Longitudinal Changes in Brain
The phenomenon called “chemobrain”—impaired cognitive functioning following chemotherapy—correlates with longitudinal changes in the brain’s white matter, according a recent study in the Journal of Clinical Oncology.1 Structural changes in the white matter, measured by magnetic resonance diffusion...
Survival Analysis by Gastric Cancer Subtypes in AVAGAST Phase III Trial
Subset analysis of the AVAGAST trial, which evaluated the benefit of bevacizumab (Avastin) in advanced gastric cancer, has demonstrated distinct differences in outcomes according to disease subtype, reported Manish A. Shah, MD, of Weill Cornell Medical College and New York Presbyterian Hospital, at ...
Targeting KRAS in GI Cancers: The Hunt for the Holy Grail in Cancer Research
The RAS oncogenes are the most frequently mutated class of oncogenes in human cancers, and this has prompted a search for Ras inhibitors to effectively treat tumors with these mutations. Despite intensive efforts, however, none has materialized clinically because K-Ras is proving to be a very...
SIDEBAR: ASCO PCO Expert Panel
Members of the Ad hoc Expert Panel included co-chairs Jamie H. Von Roenn, MD, Northwestern University, and Thomas J. Smith, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine, in addition to: Amy P. Abernethy, MD, Erin R. Alesi, MD, Tracy A. Balboni, MD, MPH, Ethan M. Basch,...
ASCO Releases Palliative Care Provisional Clinical Opinion
ASCO has released a provisional clinical opinion (PCO) addressing the integration of palliative care services into standard oncology care.1 The ASCO Post recently spoke with one of the PCO’s lead authors, Thomas J. Smith, MD, Director of Palliative Care for Johns Hopkins Medicine and the Johns...
‘We Need an Index of Biologic Aging’
As a retired elderly (soon to be 83-year-old) oncologist, I read the recent article on the subject of geriatric oncology, in the March 15 issue of The ASCO Post, with great interest ("Moving the Field of Geriatric Oncology Forward," by Stuart M. Lichtman, MD, FACP, FASCO.) This was particularly so...
ACCC Meeting Focuses on Affordable Care Act: Its Future, and What It Might Accomplish
The Association of Community Cancer Centers (ACCC) mid-March Annual Meeting devoted several sessions to the Patient Protection and Affordable Care Act: Will it still be here after the Supreme Court decides its fate? If so, how much of it will survive, and how will it affect oncology practice? In...
Our Patients, Our Teachers
There is no greater professional satisfaction than the knowledge that you have cared for a patient and the care brought an improvement in the patient's health. Regardless of the level of appreciation, whether the patient is cured or not, and even if the patient's sense of well-being may be...
Neoadjuvant Aromatase Inhibitor Therapy Converts Many Patients to Candidates for Breast-conserving Surgery
The American College of Surgeons Oncology Group (ACOSOG) Z1031 trial examined the effect of neoadjuvant aromatase inhibitor therapy on clinical response and breast-conservation rates in postmenopausal women with estrogen receptor (ER)-rich stage II or III breast cancer. An update of the surgical...
2012 Oncology Meetings
May 4th IMPAKT Breast Cancer Conference May 3-5 • Brussels, Belgium For more information: www.esmo.org ONS 37th Annual Congress May 3-6 • New Orleans, Louisiana For more information: www.ons.org State of the Art Techniques in IMRT, IGRT, SBRT, Proton and Brachytherapy May 4-6 • Las Vegas, Nevada...
Adding Cetuximab to Adjuvant Therapy with Modified FOLFOX6 Does Not Improve Survival
Adding cetuximab (Erbitux) to adjuvant treatment with mFOLFOX6, the modified sixth version of FOLFOX (leucovorin, fluorouracil, oxaliplatin) did not improve disease-free survival among patients with resected stage III colon cancer, even those with wild-type KRAS, according to a phase III study in...
Nearly 800,000 Lung Cancer Deaths Averted during 1975–2000 Due to Decline in Smoking Rates
The cumulative impact of changes in smoking behavior that started in the mid-1950s averted approximately 795,851 U.S. lung cancer deaths, 552,574 among men and 243,277 among women from 1975 to 2000, according to a report in the Journal of the National Cancer Institute. The researchers also...
Quality of Life Is What’s Most Important to Me
For me, getting a cancer diagnosis has been more annoying than frightening. Mainly, I’m annoyed at myself for not taking care of an anal skin tag sooner. (I’d had it since birth.) The growth hadn’t been a problem until I got pregnant with my first child and it became temporarily engorged with...
SIDEBAR: Expect Questions from Your Patients: Cervical Cancer Screening Guidelines
Changes in the cervical cancer screening guidelines, as recommended by the U.S. Preventive Services Task Force (USPSTF), mainly concern longer intervals between screening tests and recommended ages when women should start and stop being screened. USPSTF Co-Vice Chair Michael L. LeFevre, MD, MSPH,...
SIDEBAR: Women Who Received HPV Vaccine Still Need Cervical Cancer Screening
The updated cervical cancer screening guidelines from the the U.S. Preventive Services Task Force (USPSTF) note that women who receive the HPV vaccine still need to be screened for cervical cancer because the vaccine does not protect against all strains of HPV that can cause cervical cancer. “The...
