Cardiotoxicity information updated for trastuzumab
Cardiotoxicity information updated for trastuzumab
Genentech and the FDA have notified health care professionals of updated cardiotoxicity information related to the use of trastuzumab (Herceptin). This information was obtained from the National Surgical Adjuvant Breast and Bowel Project (NSABP) study (B-31), a randomized, Phase III trial that was conducted in 2,043 women with operable, human epidermal growth factor receptor 2 (HER2) overexpressing breast cancer [(immunohistochemical test) IHC 3+ or (fluorescence in situ hybridization test) FISH+]. This study demonstrated a significant increase in cardiotoxicity in patients who were randomized to the trastuzumab-containing arm as compared to patients who received chemotherapy alone.
Preliminary analysis of safety data from Study NSABP B-31 and the North Central Cancer Treatment Group study (NCCTG N9831) revealed a statistically significant increase in the three-year cumulative incidence of New York Heart Association Class III and IV congestive heart failure and cardiac death observed in patients who received the trastuzumab-containing regimen (4.1%) compared with control (0.8%). No cardiac deaths were observed in patients who received the trastuzumab-containing regimen, and one cardiac death was observed in the control arm. Final analysis of the cardiac safety data collected in Studies NSABP B-31 and NCCTG N9831 is ongoing.
For more information, see www.fda.gov/medwatch/safety/2005/safety05.htm# Herceptin.
Genentech and the FDA have notified health care professionals of updated cardiotoxicity information related to the use of trastuzumab (Herceptin).Subscribe Now for Access
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