CECOG NEWS ISSUE #1/1998 
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Addition of Herceptin (Humanized antiHER2 antibody) to first line chemotherapy for HER2 overexpressing metastatic breast cancer; markedly increases anticancer activity: A randomized multinational controlled phase III trial.
D. Slamon, ASCO 1998

469 female patients received chemotherapy for metastatic breast cancer expressing HER2 antigen. Of this group of women half received additional therapy with Herceptin, a humanized anti HER2 antibody. At a median follow up of 10.5 months, assessments of time to disease progression and response rates show a significant augmentation of chemotherapy effect by Herceptin, without increase in overall severe adverse effects. In summary, the data indicates that addition of Herceptin to chemotherapy markedly increases clinical benefit, as assessed by response rates and time to disease progression. Preliminary analysis of both risk and benefit favors the regimen of Herceptin and paclitaxel.