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Showing 28001 - 28050Neoadjuvant Treatment of Early Breast Cancer
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this first installment, FDA Clinical Reviewers Laleh Amiri-Kordestani, MD, and Suparna Wedam, MD, discuss FDA’s recent approval of pertuzumab (Perjeta) for the neoadjuvant treatment of...
SIDEBAR: Brian J. Druker, MD, Discusses Ponatinib
In an interview with The ASCO Post following FDA’s recommendation that sales of ponatinib (Iclusig) be suspended, (see here) Brian J. Druker, MD, Director of Oregon Health & Science University Knight Cancer Institute and JELD-WEN Chair of Leukemia Research, had concerns about obtaining the drug ...
Brivanib Fails to Live Up to the Promise of Early Studies
Hepatocellular carcinoma is a devastating disease worldwide. Although advances in liver transplantation, surgery, and locoregional therapies have made tumor control or even cure possible for a minority of patients, the majority of patients diagnosed with hepatocellular carcinoma will develop...
Brivanib Studied in First- and Second-Line Therapy for Advanced Hepatocellular Carcinoma
The investigational drug brivanib is a dual inhibitor of vascular endothelial growth factor and fibroblast growth factor signaling, both implicated in hepatocellular carcinoma. The agent was recently evaluated in two phase III trials, one comparing first-line brivanib with sorafenib (Nexavar) in...
Pemetrexed Improves Progression-Free Survival vs Gefitinib in Second-Line Setting for EGFR Wild-Type Nonsquamous NSCLC
Both pemetrexed (Alimta) and gefitinib (Iressa) are standard second-line treatments for advanced nonsquamous non–small cell lung cancer (NSCLC) in East Asia. In a phase II trial (CTONG 0806) reported at the International Association for the Study of Lung Cancer’s 15th World Conference on Lung...
Investigational ALK Inhibitor Shows Promise in Patients With Crizotinib-Refractory, ALK-Positive NSCLC
Patients with non–small cell lung cancer (NSCLC) whose tumors have the ALK gene rearrangement usually respond to the drug crizotinib (Xalkori), with a median duration of response of approximately 10 months. In a study reported by Shirish Gadgeel, MD, of Karmanos Cancer Institute in Detroit, and...
Oncogene Addiction and the Rationale for Molecular Targeted Therapy in Lung Cancer
Over the past decade, Fadlo R. Khuri, MD, Professor and Roberto C. Goizueta Distinguished Chair of Hematology and Medical Oncology, and Deputy Director of the Winship Cancer Institute of Emory University, Atlanta, has focused his research and clinical career on investigating novel approaches in the ...
FDA Grants Priority Review to Ramucirumab as a Potential Single-Agent Treatment for Advanced Gastric Cancer
The FDA has assigned Priority Review to the regulatory submission for ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy. Ramucirumab is a human monoclonal antibody that specifically blocks the vascular endothelial growth...
Sale of Ponatinib Suspended Due to Risk of Life-Threatening Blood Clots
The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the tyrosine kinase inhibitor ponatinib (Iclusig) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Ariad Pharmaceuticals has agreed to...
FDA Approves First Extended-Release, Single-Entity Hydrocodone Product
The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate extended-release capsules (Zohydro ER) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. The drug, a Schedule...
Long-Term Colorectal Cancer Incidence and Mortality After Lower Endoscopy
Colonoscopy and sigmoidoscopy have been shown to provide protection against colorectal cancer, but the magnitude and duration of protection, particularly against proximal colon cancer, remain undefined. A study of long-term colorectal cancer incidence and mortality after lower endoscopy reported in ...
One Dose of HPV 16/18 Vaccine Produces Durable Response, Study Finds
Results from the Costa Rica HPV 16/18 Vaccine Trial indicate that 4-year efficacy against 12-month HPV 16/18 persistent infection was similarly high among women who received one, two, or the recommended three doses of the bivalent HPV16/18 L1 virus-like particle vaccine (Cervarix). The findings...
In Mismatch Repair–Deficient Colon Cancer, Side Matters
In general, we have come to think of mismatch repair–deficient colon cancer as having a more favorable prognosis, being less likely to metastasize to regional nodes or distant sites, and being resistant to fluoropyrimidines. Much of our data, however, come from trials combining stage II and III...
Impact of Deficient DNA Mismatch Repair on Disease-Free Survival in Stage III Colon Cancer
In an analysis reported in the Journal of Clinical Oncology, Frank A. Sinicrope, MD, of the Mayo Clinic and North Central Cancer Treatment Group (NCCTG), and colleagues investigated the association of deficient DNA mismatch repair with prognosis in patients with stage III colon cancer treated with...
Erratum
In the October 15, 2013 issue of The ASCO Post, production instructions were inadvertently placed on an advertisement for Tafinlar® (page 4) and printed in the final version of the advertisement. Harborside Press, publisher of The ASCO Post, regrets this error and accepts full responsibility for...
Important News Briefs: New Data Reported in Breast, Renal Cell, Head and Neck, and Lung Cancer
The 2013 European Cancer Congress (ECC), held September 27 to October 1 in Amsterdam, was jointly sponsored by the European Society of Medical Oncology, the European Cancer Organization, and the European Society of Radiation Oncology. With the Congress theme being “Reinforcing Multidisciplinarity,” ...
Institute of Medicine Elects New Members, Foreign Associates
The Institute of Medicine (IOM) recently announced the names of 70 new members and 10 foreign associates during its 43rd Annual Meeting. “It is an honor to welcome our highly distinguished colleagues to the Institute of Medicine,” said IOM President Harvey V. Fineberg. “These individuals have...
Expert Point of View: Rebecca Kristeleit, MD
Formal discussant of the AURELIA and ICON7 presentations, Rebecca Kristeleit, MD, University College London Hospital, London, said that a consistent message in both trials was the benefit of bevacizumab (Avastin) in high-risk disease. “Angiogenesis seems to be a particular driver of advanced...
Two Trials Explore the Evolving Role of Bevacizumab in Ovarian Cancer
The optimal use of bevacizumab (Avastin) in ovarian cancer appears to be in high-risk subgroups and in patients with platinum-resistant ovarian cancer, according to results of two phase III trials presented at the 2013 European Cancer Congress (ECC) in Amsterdam. AURELIA investigated the safety and ...
Expert Point of View: Antonio Casado, MD
Formal discussant of the TRINOVA-1 presentation, Antonio Casado, MD, Hospital Universitario San Carlos, Madrid, said that the study showed a clinically meaningful benefit with the addition of trebananib in this pretreated group of patients with recurrent epithelial ovarian cancer. Also, the drug...
Trebananib Improves Progression-Free Survival in Recurrent Ovarian Cancer
Trebananib, an investigational antiangiogenesis inhibitor with a different mechanism of action than bevacizumab (Avastin), significantly improved progression-free survival in recurrent platinum-resistant and partially platinum-sensitive ovarian cancer in the phase III TRINOVA-1 trial. The addition...
Expert Point of View: Cora N. Sternberg, MD
Press conference moderator Cora N. Sternberg, MD, Chief of Medical Oncology at San Camillo and Forlanini Hospitals, Rome, called the 2- to 3-month improvement in overall survival “worthwhile, and clinically meaningful.” She said this should be viewed in the context of manageable toxicity....
Cediranib Achieves 'Groundbreaking' Results in Relapsed Ovarian Cancer
The investigational oral vascular endothelial growth factor (VEGF) inhibitor cediranib extended progression-free survival when given with platinum-based chemotherapy and improved overall survival when given as maintenance therapy in patients with recurrent ovarian cancer. Experts are hopeful that...
Expert Point of View: Clifford Hudis, MD
Formal discussant Clifford Hudis, MD, ASCO President and Chief of the Breast Cancer Service at Memorial Sloan-Kettering Cancer Center in New York, commented that the findings were not surprising. “The results of TH3RESA nicely reflect the EMILIA trial and are consistent with those of anti-HER2...
Strong Showing for Ado-Trastuzumab Emtansine in Advanced HER2-Positive Heavily Pretreated Breast Cancer
Results of the phase III TH3RESA trial show that the antibody-conjugate ado-trastuzumab emtansine (Kadcyla), formerly known as T-DM1, extends progression-free survival in women with advanced HER2-positive breast cancer that progressed on two or more previous HER2-directed therapies including...
Standardizing the Interpretation of PET Scans: An INR Equivalent
Since its introduction, the positron-emission tomography (PET) scan has shown great potential to improve our ability to care for patients with lymphoma. By demonstrating which masses seen on a computed tomography (CT) scan represent viable tumor, and by identifying viable tumor in places that were...
IOM Report Illuminates U.S. Cancer Care Crisis and Offers Framework for Change
In September, the Institute of Medicine (IOM) of the National Academies issued its report, Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis,1 published more than a decade after its first study on the quality of cancer care in the United States. The authors of the...
Ipilimumab Conveys Long-Term Survival Benefit in Pooled Analysis of Metastatic Melanoma Patients
In the treatment of metastatic or locally advanced unresectable melanoma, the anti–CTLA-4 monoclonal antibody ipilimumab (Yervoy) conveys long-term survival benefits, with some patients alive out to 10 years, according to the largest survival analysis of the immunomodulating agent, presented at the ...
Impact of Pelvic Radiotherapy and Lymphadenectomy on Endometrial Cancer Mortality
Analysis of data from 58,172 patients identified from Surveillance, Epidemiology, and End Results (SEER) registries as having stage I or II endometrial adenocarcinoma found that pelvic radiotherapy and lymphadenectomy were associated with statistically significantly reduced noncancer mortality,...
Nodal Status and Tumor Size Predicted Late Recurrences of ER-Positive Breast Cancer in Postmenopausal Women
Only nodal status and tumor size provided statistically significant prognostic information for predicting recurrences 5 to 10 years after diagnosis for postmenopausal women with early estrogen receptor–positive breast cancer enrolled in the monotherapy arms of the ATAC (Arimidex, Tamoxifen, Alone...
One in Three American Adults Do Not Comply With Screening Guidelines for Colorectal Cancer
The percentage of American adults aged 50 to 75 who are up-to-date with recommended screening for colorectal cancer “increased from 54% in 2002 to 65% in 2010, primarily driven by increased use of colonoscopy,” according to data from the 2012 Behavioral Risk Factor Surveillance System survey....
It Sounds Crazy, but Cancer Has Made Me a Better Chef
I was diagnosed with stage IVB squamous cell carcinoma of the tongue in 2007, when I was just 33 years old, but the cancer had started to show itself long before then. I first noticed a white dot on the left side of my tongue in 2002, and as time went on, the sore became annoying and hurt when it...
ASH as Part of 'NDD United' Releases Report on Effects of Sequestration
A new report recently released and supported by the American Society of Hematology (ASH) details the crippling effects of sequestration on programs that rely on discretionary federal funding, including the National Institutes of Health (NIH). In “Faces of Austerity: How Budget Cuts Have Made Us...
SIDEBAR: Expect Questions From Your Patients
Risk-reducing salpingo-oophorectomy “is an important strategy for reducing both breast and gynecologic cancer risk for women with BRCA1 or BRCA2 mutations and is proven to improve life expectancy,” Noah D. Kauff, MD, told The ASCO Post. Questions persist, however, about whether women undergoing...
'Reasonable but Not Required' for Women With BRCA Mutations to Have Hysterectomy Concurrent With Salpingo-Oophorectomy
For women with BRCA1 or BRCA2 mutations who choose to have salpingo-oophorectomy to reduce their risks of ovarian and breast cancer, also choosing to have a hysterectomy is “reasonable but not required,” noted Noah D. Kauff, MD, Director of the Ovarian Cancer Screening and Prevention Program and...
Evaluation of Breast Cancer MRI Screening Strategies
Recent years have witnessed much heated debate about the benefits of breast cancer screening and optimal screening strategies. Unlike with mammography, no randomized data are available to determine whether screening with magnetic resonance imaging (MRI) reduces mortality from breast cancer....
Cost-Effectiveness of MRI Screening for Women With Familial Risk of Breast Cancer in the Netherlands
Annual screening for breast cancer with magnetic resonance imaging (MRI) has been found to be cost-effective in women aged 30 to 60 years who are BRCA1 or BRCA2 carriers or who have a 50% chance of being a carrier, and such screening is recommended in these women by many authorities. It is unclear...
Phospho-cMET Inhibition in Multiple Myeloma
In a study reported in Clinical Cancer Research, Moschetta and colleagues characterized the involvement of the cMet oncogene in drug resistance and the activity of a novel selective inhibitor of cMET/phospho-cMET (SU11274) in multiple myeloma cells sensitive (RPMI-8226 and MM.1S) and resistant (R5...
Expert Point of View: Daniel Zips, MD
Formal discussant of the Danish Head and Neck Cancer Group (DAHANCA) 19 trial at the European Cancer Congress, Daniel Zips, MD, University Hospital for Radiation Oncology, Tübingen, Germany, said that the DAHANCA trial program is impressive and conducted with stringent quality assurance....
Novel EGFR Inhibitor Added to Radiotherapy Fails to Improve Outcomes in Head and Neck Cancer
The addition of zalutumumab, an investigational epidermal growth factor receptor (EGFR) inhibitor, to primary chemoradiotherapy did not increase locoregional control or improve survival at 3 years in patients with squamous cell carcinoma of the head and neck compared with chemoradiotherapy alone,...
Spanning a Spectrum of Issues Related to Head and Neck Cancers
Five recent articles in JAMA Otolaryngology–Head & Neck Surgery1-5 span a spectrum of issues related to head and neck cancers. These include risk factors, concentration of care to teaching hospitals, avoiding venous thromboembolism, and encouraging patients to eat and do swallowing exercises to ...
Oncology Meetings
December Sixth AACR International Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically UnderservedDecember 6-9 • Atlanta, GeorgiaFor more information: www.aacr.org 55th ASH Annual MeetingDecember 7-10 • New Orleans, LouisianaFor more information:...
Improving Quality Measurement in Cancer Care: Policy Recommendations
Quality measurement—how we assess cost and effectiveness of cancer care—cannot be separated from policy decisions that have a profound influence on the overall health-care system. At the recent ASCO Quality Care Symposium, Jennifer L. Malin, MD, PhD, Medical Director for Oncology at WellPoint, Inc, ...
University of Michigan Cancer Center Founding Director to Step Down
Max S. Wicha, MD, has announced he will step down as Director of the University of Michigan Comprehensive Cancer Center where he has served for the past 27 years. Dr. Wicha founded University of Michigan’s Cancer Center in 1986 and shepherded it to its first National Cancer Institute Cancer Center ...
Expert Point of View: Monica Morrow, MD, and Chau T. Dang, MD
In an editorial accompanying the article by Boughey et al, Monica Morrow, MD, and Chau T. Dang, MD, of Memorial Sloan-Kettering Cancer Center, New York, question whether sentinel lymph node biopsy can be considered a part of standard management in patients with initial clinically node-positive...
Alliance Trial Evaluates Sentinel Node Surgery After Neoadjuvant Chemotherapy for Node-Positive cN1 Breast Cancer
Sentinel lymph node surgery provides reliable nodal staging information and is associated with less morbidity than axillary lymph node dissection in patients with clinically node-negative (cN0) breast cancer. The American College of Surgeons Oncology Group (ACOSOG) Z1071 (Alliance) trial examined...
Living With Cancer: The Role of Palliative Care in Long-Term Survivorship Care
According to data from the Surveillance, Epidemiology, and End Results Program (SEER) and the U.S. Census Bureau registries,1 there are currently about 13.7 million cancer survivors in the United States, and that number is projected to grow to 18 million by 2022. In addition, 64% of this population ...
NewYork-Presbyterian/Columbia University Medical Center Opens Irving Radiation Oncology Center
NewYork-Presbyterian/Columbia University Medical Center has opened its new Irving Radiation Oncology Center, part of the medical center’s Herbert Irving Comprehensive Cancer Center. The 12,500-square-foot facility provides precision radiation therapies and advanced diagnostic imaging for children...
Ocular Melanoma Research Fellowship Opportunity Announced
The American Association for Cancer Research (AACR) and the Ocular Melanoma Foundation (OMF) are pleased to announce a new partnership to provide a grant opportunity for researchers focused on ocular melanoma, which is diagnosed in approximately 2,000 adults in the United States each year....
Where Is Adjuvant Bisphosphonate Therapy Now?
The adjuvant use of bisphosphonates in breast cancer continues to yield seemingly contradictory data despite a sound biologic basis and smaller pilot studies suggesting that dampening bone turnover with bisphosphonates can lessen the bone reservoir of micrometastases.1,2 Early adjuvant trials with...
