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Showing 8201 - 8250FDA Announces Strategic Plan to Prevent Drug Shortages
The U.S. Food and Drug Administration (FDA) is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages. The FDA has released a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the...
Neoadjuvant 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...
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...
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 ...
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...
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,” ...
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...
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...
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...
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...
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 ...
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, ...
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 ...
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...
No Survival Benefit of Adjuvant Ibandronate in High-Risk Early Breast Cancer: Potential Activity in Low-Estrogen Patients
The effect of bisphosphonate treatment in early breast cancer is controversial, with some data indicating survival benefit in the adjuvant setting. In a study reported in the Journal of Clinical Oncology (German Adjuvant Intergroup Node-Positive Study, GAIN), Gunter von Minckwitz, MD, PhD, Chairman ...
German Analysis in Diffuse Large B-Cell Lymphoma: Hypothesis-Generating Rather Than Definitive?
In their retrospective analysis of German High-Grade Non-Hodgkin Lymphoma Study Group trials reported in the Journal of Clinical Oncology and reviewed in this issue of The ASCO Post, Held and colleagues assessed the effects of rituximab (Rituxan) and radiotherapy in patients with aggressive B-cell...
Rituximab Does Not Improve Outcome in B-Cell Lymphoma With Skeletal Involvement, but Radiotherapy Benefit Found
In a retrospective analysis of German High-Grade Non-Hodgkin Lymphoma Study Group trials reported in the Journal of Clinical Oncology, Gerhard Held, MD, of Saarland University Medical School in Homburg, and colleagues assessed the impact of rituximab (Rituxan) and radiotherapy on outcome in...
ASCO Launches Formal Development of CancerLinQ™ System
ASCO recently announced that it has initiated development of the full CancerLinQ™ system, a groundbreaking health information technology (HIT) initiative to achieve higher-quality, higher-value cancer care with better outcomes for patients. The announcement was made at a White House Office of...
University of Chicago Names Ernst Lengyel, MD, PhD, Chair of Obstetrics and Gynecology
Ernst Lengyel, MD, PhD, was recently named Chair of the Department of Obstetrics and Gynecology at the University of Chicago. He succeeds Arthur Haney, MD, who served as Chair of the Department of Obstetrics and Gynecology since April 2003. Under the leadership of Dr. Haney, the Department...
Sunshine Act Reporting: ASCO Encourages Members to Get Prepared, Stay Educated
On August 1 of this year, requirements of the Physician Payments Sunshine Act, or Open Payments, went into effect. The legislation, passed as part of the Patient Protection and Affordable Care Act, was designed to create greater transparency around financial relationships between physicians,...
National Human Genome Research Institute Names First Director of Division of Genomics and Society
Lawrence C. Brody, PhD, has been selected to be the first Director of the newly established Division of Genomics and Society at the National Human Genome Research Institute (NHGRI). Dr. Brody, a genetics and genomics researcher, is currently Chief of the Genome Technology Branch within NHGRI’s...
Gastric Cancer: Time to Revisit Angiogenesis
Progress in the treatment of gastric cancer has lagged behind advances in other solid tumor malignancies. A modest but clear survival benefit with the use of adjuvant therapy combined with surgery has been achieved, including the use of postoperative adjuvant chemotherapy as shown in large-scale...
Anti–VEGFR-2 Antibody Ramucirumab Prolongs Survival in Previously Treated Advanced Gastric or Gastroesophageal Cancer
Vascular endothelial growth factor (VEGF)– and VEGF receptor-2 (VEGFR-2)–mediated signaling and angiogenesis seem to have an important role in the pathogenesis of gastric cancer. In the phase III REGARD trial reported in Lancet, Charles S. Fuchs, MD, MPH, of Dana-Farber Cancer Institute, Boston,...
Benefits and Controversies in Survivorship Care Plans
Since the Institute of Medicine’s (IOM’s) 2005 report, From Cancer Patient to Cancer Survivor: Lost in Translation,1 survivorship plans have received growing attention. In short, a survivorship care plan is the record of a patient’s cancer history and recommendations for follow-up care. At ASCO’s...
Two Studies Highlight Communication Challenges Facing Medical Oncology
In one study presented at ASCO’s second annual Quality Care Symposium in San Diego, patients receiving chemotherapy with palliative care intent were at high risk of side-effect–related hospitalization, which defeats the clinical purpose and adds preventable costs to health care.1 “There is an...
Metastatic Melanoma: Encouraging Data Keep Coming
Excitement continues to build in the metastatic melanoma arena, as novel agents keep upping the ante for efficacy. The following news from the 2013 European Cancer Congress has added to the buzz. New MEK Inhibitor In the phase IB BRIM7 study, cobimetinib, a novel MEK inhibitor, when combined with...
Early Evidence Supports Novel ALK Inhibitor in Patients with Non–Small Cell Lung Cancer With Brain Metastases
Identifying ALK rearrangements as a cancer target in patients with lung cancer led to the development and FDA approval of crizotinib (Xalkori) to treat ALK-positive non–small cell lung cancer (NSCLC). Several second-generation ALK inhibitors are in development, and these agents appear to work in...
What Does ‘Myeloma’ Mean?
Over the centuries it has become clear that, as physicians, what we say and how we say it can have a major impact on those who seek our help. Our pronouncement that a patient is in remission or harbors a serious illness carries with it a large number of spoken and unspoken implications. So when we...
Response-Guided Neoadjuvant Therapy for Breast Cancer: A Promising Model Warranting Additional Investigation
GeparTrio was an innovative phase III trial conducted by the German Breast Group, enrolling over 2,000 women with early breast cancer who were candidates for neoadjuvant chemotherapy. Patients with evidence of early response, defined as reduction in clinical tumor size by 50% or more, following two ...
GeparTrio Long-Term Data Show Response-Guided Neoadjuvant Therapy for Breast Cancer Improves Survival
In an exploratory analysis of long-term survival data from the GeparTrio trial reported in the Journal of Clinical Oncology, Gunter von Minckwitz, MD, PhD, of the German Breast Group in Neu-Isenburg and the University of Frankfurt, Germany, and colleagues found that response-guided neoadjuvant...
Peter Jacobs, MD, Storied South African Hematology Pioneer, Dies
“We make a living by what we get. We make a life by what we give.” —Winston S. Churchill The remarkable medical career of Peter Jacobs, MD, in large part, traces the oncologic history of South Africa. During the decades of political and social unrest that engulfed his native land, Dr. Jacobs...
Promoting Timely Referral to Reproductive Specialists for Patients Concerned About Fertility
Updated clinical guidelines published this year by ASCO “give oncology care providers an opportunity to partner with their reproductive specialist colleagues to ensure that the clinical and psychosocial needs of patients with cancer are addressed as close to the time of diagnosis as possible,”...
Oncologists Need to Inform Primary Care Physicians About Late and Long-Term Effects of Chemotherapy
A nationally representative survey of 1,130 oncologists and 1,072 primary care physicians found that primary care physicians had limited awareness of late or long-term effects of chemotherapy agents. This was attributed to primary care physicians not typically encountering chemotherapy agents...
Three-Drug Regimen Produces High Response Rate in Relapsed/Refractory Myeloma
A phase II trial to evaluate the combination of bendamustine (Treanda) with bortezomib (Velcade) and dexamethasone in patients with relapsed/refractory multiple myeloma “showed a remarkable response rate of 60.9%,” and when minor responses were included, 75.9%,” researchers reported in Blood. “The...
SIDEBAR: Expect Questions From Patients
Not discussing the costs of medical interventions could result in “financial toxicity” for patients who have trouble paying out-of-pocket costs, as well as problems adhering to expensive treatment regimens. “The problem is perhaps starkest in cancer care, but it applies to all complex illness,”...
The Quest to Optimize Personalized Therapies for Cancer
In the late 1980s, Brian J. Druker, MD, was investigating the BCR-ABL tyrosine kinase as a target for therapeutic intervention for chronic myeloid leukemia (CML) in a laboratory at Dana-Farber Cancer Institute in Boston. By 1993, Dr. Druker had moved to Oregon Health & Science University in...
Patient-Reported Outcomes, a Central Component to Value and Rapid-Learning Systems
With the passage of the Patient Protection and Affordable Care Act in 2010, value became the operative word in assessing the success of health care, from outcomes to cost. To drive more value, the Affordable Care Act seeks to implement initiatives such as comparative effectiveness research that...
Oncology Drug Dosing: Can an Optimal Dose Be Fine-Tuned for Each Patient?
ASCO Chief Medical Officer Richard L. Schilsky, MD, and other oncology drug experts presented a panel on drug dosing at a recent meeting, cosponsored by the Friends of Cancer Research and the Brookings Institution, in Washington, DC.1 The presentations made it clear that issues surrounding drug...
Conquer Cancer Foundation–Funded Research Identified Among Top Cancer Advances of 2013
The recently released Clinical Cancer Advances 2013: ASCO’s Annual Report on Progress Against Cancer, highlights the most impactful advances in clinical cancer research of the year, and this year’s report identifies two studies that were funded by the Conquer Cancer Foundation. Advances in Targeted ...
NCI-Led Scientists Develop Criteria for 'Omics' Tests Used in Clinical Investigations
High-throughput “omics” technologies that generate molecular profiles on tumor specimens are increasingly being incorporated into clinical trials, but some of these assays have not been well validated, leading many in the research community to question their fitness for use in patient-care...
No Apparent Benefit of Adjuvant Gefitinib in Resected NSCLC in Prematurely Closed Trial
As reported in Journal of Clinical Oncology by Glenwood D. Goss, MD, of the Ottawa Hospital Cancer Center, and colleagues, the prematurely closed NCIC CTG BR19 study showed no apparent survival benefit of adjuvant gefitinib (Iressa, withdrawn from U.S. market) vs placebo in patients with completely ...
Adjuvant Trastuzumab Duration: When Is Enough, Enough?
The duration of adjuvant systemic chemotherapy for breast cancer has been a subject of investigation, scrutiny, and meta-analysis.1,2 With the appreciation that prolonged regimens of cytotoxic chemotherapy of, for example, 1 to 2 years in duration were not superior in reducing breast cancer...
Long-Term Follow-up of the HERA Trial Shows No Benefit of 2 Years vs 1 Year of Trastuzumab in Early Breast Cancer
As reported in The Lancet by Aron Goldhirsch, MD, of the European Institute of Oncology in Milan, Italy, and colleagues from the Breast International Group (BIG), the comparison of 1 vs 2 years of trastuzumab (Herceptin) in patients with HER2-positive early breast cancer in the phase III HERA trial ...
Breast Cancer Vaccines for Primary Prevention Move Toward Clinical Use
The first candidate vaccine to prevent recurrence of breast cancer entered clinical trials about 8 years ago, and since then, the idea of a vaccine for secondary prevention has gained traction; more such vaccines are now in development. But this fall, it was vaccines for primary prevention that had ...
Treating Earlier to Avoid Progression to Multiple Myeloma
With an expanded list of drugs to treat multiple myeloma, experts are interested in whether treating precursor diseases to multiple myeloma can prevent progression to full-blown myeloma. In addition, new drugs are entering the armamentarium for treating multiple myeloma, noted Ruben Niesvizky, MD,...
PIK3CA-Mutant Tumors Not Likely to Respond to Neoadjuvant HER2 Blockade
In early breast cancer patients receiving anti-HER2 therapy in the NeoALTTO trial, mutations in PIK3CA were associated with lower rates of pathologic complete response, according to a study reported at the 2013 European Cancer Congress by José Baselga, MD, Physician-in-Chief at Memorial...
Transplant Now or Later for High-Risk Aggressive Non-Hodgkin Lymphoma?
The use of high-dose chemotherapy and autologous hematopoietic blood or marrow transplantation for high-risk aggressive non-Hodgkin lymphoma has been extensively evaluated over the past few decades. This treatment was originally used only for patients with relapsed aggressive lymphoma. However, as...
Autologous Transplantation as Consolidation Improves Progression-Free Survival in Aggressive Non-Hodgkin Lymphoma
The strategy of autologous stem-cell transplantation as consolidation in high-intermediate– or high-risk diffuse aggressive non-Hodgkin lymphoma (NHL) has not been specifically examined in the rituximab (Rituxan) era. In the phase III Southwest Oncology Group (SWOG)-led intergroup 9704 trial...
Call for Expanded Genetic Profiling in Colorectal Cancer
Testing for codons 12 and 13 on the KRAS gene and BRAF testing can predict whether patients with colorectal cancer will respond to anti–epidermal growth factor receptor (EGFR) therapies. However, genetic alterations not captured by testing for KRAS codon 12 and 13 mutations may play an important...
