A letter has been sent to oncologists and others caring for cancer patients about new data on cardiotoxicity related to the use of trastuzumab (Herceptin) by the drug's manufacturer, Genentech. The data come from a phase III clinical trial being conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) testing trastuzumab in women with operable, HER2-expressing breast cancer. The study, NSABP B-31, is evaluating the addition of trastuzumab to standard adjuvant chemotherapy compared with adjuvant chemotherapy alone.
The data show a significant increase in cardiotoxicity in 18.6 percent of patients in the trastuzumab arm of the study, including an asymptomatic decrease in left ventricular ejection fraction, or LVEF (a measure of how well the heart is pumping), and in symptomatic cardiac dysfunction or other cardiac toxicity. In addition, there was a statistically significant increase in advanced cases of heart failure (New York Heart Association Class III and IV) compared with those in the control arm (4.1 percent vs. 0.8 percent).
Final analysis of the study's cardiac safety data - as well as data from a similar trial being conducted by the North Central Cancer Treatment Group (NCCTG), N9831 - is ongoing, the letter explains. "Risk factors for cardiac dysfunction will be analyzed with data from both the NSABP B-31 and NCCTG N9831 trials, when available," the letter continues. "A preliminary exploratory analysis performed by NSABP investigators suggests that age and LVEF following AC chemotherapy may identify patients at greatest risk for symptomatic cardiac dysfunction."
For more information, go to the FDA's MedWatch site.
NCI Hosts Translational Immunology Conference
The sixth annual principal investigator's (PI) meeting of NCI's Innovative Molecular Analysis Technologies (IMAT) program was held September 7-9 in Washington, D.C. Dr. Erkki Ruoslahti presented the keynote address, and representatives from FDA, the venture capital community, and large and small businesses provided their perspectives to more than 100 PIs and NCI program managers who attended the meeting. Investigators shared research progress and discussed potential collaborations with a broad range of scientific, multidisciplinary, and cross-sector experts. The next receipt date for IMAT applications is October 18, 2005. See http://otir.cancer.gov for more information on the meeting and the IMAT program.
Science Writers' Seminar to Focus on Behavioral Aspects of Cancer
The event will begin at 11:00 a.m. and will be webcast simultaneously at http://videocast.nih.gov. The webcast will be archived for later viewing. For additional information, contact the NCI Press Office at (301) 496-6641 or at firstname.lastname@example.org.
Weinberg to Lecture on Tumor Formation
A professor of biology at Massachusetts Institute of Technology and a founding member of the Whitehead Institute, Dr. Weinberg is a pioneer in cancer research, most widely known for his discoveries of the first human oncogene and the first tumor-suppressor gene.