The Food and Drug Administration and Genentech Inc. are notifying physicians of new data demonstrating a significant increase in cardiotoxicity in patients randomized to receive Herceptin (trastuzumab) along with standard adjuvant chemotherapy, compared with patients who received chemotherapy alone.
The data come from the National Surgical Adjuvant Breast and Bowel Project (NSABP) study (B-31), a phase III trial involving 2,043 women with operable HER2 overexpressing breast cancer (immunohistochemistry test score of 3 or greater or a positive fluorescence in situ hybridization test score).
Preliminary analysis of safety data from this trial and the North Central Cancer Treatment Group (NCCTG) study (N9831) revealed a statistically significant increase in the 3-year cumulative incidence of New York Hospital Association class III and IV congestive heart failure and cardiac death observed in patients who received the Herceptin-containing regimen (4.1%), compared with the chemotherapy-alone group (0.8%). No cardiac deaths were observed in patients who received the Herceptin-containing regimen; one cardiac death occurred in the control arm. Final analysis of the cardiac safety data collected in these two studies is ongoing.
Herceptin as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens. Herceptin in combination with Taxol (paclitaxel) is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy.
For additional information, contact Genentech Inc.'s medical communication department by calling 800-821-8590 or by visiting www.gene.com/gene/contact/