JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.
THIS WEEK'S CONTENT
JAMA NEWS RELEASES
PLEASE NOTE: The Following JAMA Releases Have Various Embargo Dates And Times Because Of This Week’s American College Of Cardiology Conference.
JAMA NEWS RELEASES
Embargoed for Early Release: 1 p.m. CT, Tuesday, April 1, 2008
DRUG DOES NOT APPEAR TO REDUCE RISK OF HEART ATTACK OR DEATH FOLLOWING CORONARY ARTERY BYPASS GRAFT SURGERY
INTEGRATING GENETIC INFORMATION WITH BREAST CANCER RISK FACTORS MAY HELP REFINE PROGNOSIS
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
TV Note: This week's JAMA Video News Report has an early embargo of 10 a.m. CT Tuesday, April 1. The report is on the results of use of a weight loss drug for people with heart disease. The report will be fed Tuesday, April 1, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 26 (formerly Intelsat America 6) C-Band, Transponder 14, downlink frequency: 3880 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.
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Embargoed for Early Release: 1:00 p.m. CT, Tuesday, April 1, 2008
Media Advisory: To contact John H. Alexander, M.D., M.H.S., call Michelle Gailiun at 919-724-5343.
DRUG DOES NOT APPEAR TO REDUCE RISK OF HEART ATTACK OR DEATH FOLLOWING CORONARY ARTERY BYPASS GRAFT SURGERY
CHICAGO—Use of MC-1 (a naturally occurring metabolite of vitamin B6) before and for 30 days after coronary artery bypass graft surgery did not reduce the risk of heart attack or cardiovascular death, according to a JAMA study being released early online April 1 to coincide with its presentation at the annual conference of the American College of Cardiology. The study will be published in the April 16 issue of JAMA.
“Coronary artery bypass graft (CABG) surgery is one of the most important therapeutic options for relieving angina and improving survival and quality of life in patients with multivessel coronary artery disease. It is the most commonly performed cardiac surgical procedure in the world, and in 2005, more than 250,000 CABG procedures were performed in the United States,” the authors write. Serious complications can include heart attack, recurrent angina, kidney insufficiency, stroke, and death. Phase 2 trial data suggest that MC-1 may reduce death or heart attack in high-risk patients undergoing CABG surgery.
John H. Alexander, M.D., M.H.S., of Duke University Medical Center, Duke Clinical Research Institute, Durham, N.C., and colleagues with MEND-CABG II, a phase 3, multicenter, randomized trial, assessed the cardioprotective effect of MC-1 administered before and continued for 30 days after CABG surgery, compared with placebo, in 3,023 intermediate- to high-risk patients undergoing CABG surgery with cardiopulmonary bypass.
The researchers found that the primary efficacy outcome, cardiovascular death or nonfatal heart attack at 30 days, occurred in 140 of 1,510 patients (9.3 percent) in the MC-1 group and 133 of 1,486 patients (9.0 percent) in the placebo group. All-cause death was higher among patients assigned to MC-1 than placebo at 4 days (1.0 percent vs. 0.3 percent) but was similar at 30 days (1.9 percent vs. 1.5 percent). There was no beneficial effect of MC-1 seen in any prespecified subgroup or on other outcomes.
There was no difference in the incidence of postoperative stroke, atrial fibrillation, or kidney function between the two groups. Patients assigned to receive MC-1 and placebo had similar intensive care unit and hospital lengths of stay.
“MEND-CABG II demonstrates that among intermediate- to high-risk patients undergoing CABG surgery, MC-1, 250 mg/d, given immediately before and for 30 days following surgery did not reduce cardiovascular death or nonfatal [heart attack]. Myocardial injury remains a significant problem following CABG surgery. Effective therapies to reduce perioperative morbidity and mortality are needed but remain elusive,” the authors conclude.
(JAMA. 2008;299[15]:doi:10.1001/jama.299.15.joc80027. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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Embargoed for Early Release: 1:00 p.m. CT, Tuesday, April 1, 2008
Media Advisory: To contact corresponding author Anil Potti, M.D., call Lauren Shaftel at 919-684-4148. To contact editorial co-author Chiang-Ching Huang, Ph.D., call Marla Paul at 312-503-8928.
INTEGRATING GENETIC INFORMATION WITH BREAST CANCER RISK FACTORS MAY HELP REFINE PROGNOSIS
CHICAGO—Incorporating genetic information known as gene expression signatures with clinical and other risk factors for breast cancer may help refine estimates of relapse-free survival and predicted response to chemotherapy, according to a study in the April 2 issue of JAMA.
“The advent of genomic technology for the analysis of human tumor samples has now added an additional source of information to aid prognosis and clinical decisions. In particular, the development of genomic profiles that accurately assess risk of recurrence offers the hope that this information will more precisely define clinical outcomes in breast cancer. The dimension and complexity of such data provide an opportunity to uncover clinically valid trends that can distinguish subtle phenotypes [physical manifestations] in ways that traditional methods cannot,” the authors write. Few studies have examined the value in integrating genomic information with the traditional clinical risk factors to provide a more detailed assessment of clinical risk and an improved prediction of response to therapy.
Chaitanya R. Acharya, M.S., of the Duke Institute for Genome Sciences and Policy, Duke University, Durham, N.C., and colleagues conducted a study to determine the value in incorporating genomic information with clinical and pathological risk factors to refine prognosis and to improve therapeutic strategies for early stage breast cancer. The study included patients with early stage breast cancer who were candidates for supplemental chemotherapy; 964 breast tumor samples were used. All patients were assigned relapse risk scores based on their respective clinicopathological features. Genetic testing was performed and gene expression signatures (characteristic profiles) were applied to these samples to obtain patterns of deregulation that correspond with relapse risk scores to refine prognosis with the clinicopathological prognostic model alone. Predictors of chemotherapeutic response were also applied to further characterize clinically relevant heterogeneity (diversity) in early stage breast cancer.
The researchers found that integrating gene expression signatures into clinical risk stratification could refine prognosis for patients in three risk subgroups (low, intermediate, and high) and help predict relapse-free survival and response to chemotherapy.
“Pending future prospective clinical validation, these results provide preliminary evidence that the profusion of gene expression signatures in defining breast cancer, if used appropriately, represent less of a paradox and should be viewed as an important complementary approach to current clinicopathological risk stratification systems. Furthermore, knowledge of increased likelihood of sensitivity to specific chemotherapeutic agents from a repertoire of drugs that are commonly used to treat breast cancer is something that could be more immediately used in current clinical practice, once issues regarding cost and accessibility are addressed, in instances wherein multiple chemotherapeutics or chemotherapeutic combinations are Food and Drug Administration approved, as in early stage breast cancer, and are considered the standard of care,” the authors conclude.
(JAMA. 2008;299[13]:1574-1587. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: USE OF GENE SIGNATURES TO IMPROVE RISK ESTIMATION IN CANCER
In an accompanying editorial, Chiang-Ching Huang, Ph.D., and Markus Bredel, M.D., Ph.D., of the Feinberg School of Medicine, Northwestern University, Chicago, write that these findings are promising.
“In essence, the study by Acharya et al demonstrates the potential value of using microarray-based gene signatures to refine outcome predictions. ...In an attempt to tailor risk estimation, these investigators shy away from pure metagene predictors but instead focus on genes with mechanistic implication in breast cancer. Because these genes represent potential targets for specific molecular therapy, this approach represents an advance in the changing landscape of oncology toward individualized patient management.”
(JAMA. 2008;299[13]:1605-1606. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
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