Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.

 BACKGROUND

The HER2 gene that encodes a growth factor receptor HER2, is amplified and HER2 is expressed in 25 to 30 percent of breast cancers, increase the aggressiveness of the tumor.

METHOD

We evaluated the efficacy and safety of trastuzumab, a recombinant monoclonal antibody against HER2, in women with metastatic breast cancer which expressed HER2. We randomly assigned 234 patients received standard chemotherapy alone and 235 patients received standard chemotherapy plus trastuzumab. Patients who previously did not receive adjuvant (post-surgery) treatment with anthracycline treated with doxorubicin (or epirubicin in the case of 36 women) and cyclophosphamide alone (138 women) or with trastuzumab (143 women). Patients who had previously received adjuvant anthracycline were treated with paclitaxel alone (96 women) or paclitaxel with trastuzumab (92 women).

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RESULTS

The addition of trastuzumab to chemotherapy was associated with a longer time to disease progression (median, 7.4 vs 4.6 months; P <0.001), a higher rate of objective response (50 percent vs. 32 percent, P <0.001), longer duration of response (median, 9.1 vs 6.1 months; P <0.001), a lower mortality rate at 1 year (22 percent vs. 33 percent, P = 0.008), longer survival (median survival, 25.1 vs 20.3 months; P = 0.01), and a 20 percent reduction in the risk of death. The most important side effects of a dysfunctional heart of New York Heart Association class III or IV, which occurred in 27 percent of the group given an anthracycline, cyclophosphamide, and trastuzumab; 8 percent of the group given an anthracycline and cyclophosphamide alone; 13 percent of the group given paclitaxel and trastuzumab; and 1 percent of the group given paclitaxel alone. Although cardiotoxicity was potentially severe and, in some cases, life-threatening, symptoms generally improved with standard medical management.

CONCLUSION

Trastuzumab improve the clinical benefit of first-line chemotherapy in metastatic breast cancer that overexpresses HER2.