Breast metastatic PACLItaxel three weekly and trastuzumab weekly DISCONTINUED

Treatment Schedule Summary

 Frequency: 21 days

Cycles: Continuous until disease progression or unacceptable toxicity (weekly trastuzumab to be continued after completion of paclitaxel chemotherapy)

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Bibliography

Slamon, D.,J., Leyland-Jones, B., Shak, S., et al. 2001. "Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. " N.Engl.J Med. 344(11):783-792

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Background The HER2 gene, which encodes the growth factor receptorHER2, is amplified and HER2 is overexpressed in 25 to 30 percentof breast cancers, increasing the aggressiveness of the tumor. Methods We evaluated the efficacy and safety of trastuzumab,a recombinant monoclonal antibody against HER2, in women withmetastatic breast cancer that overexpressed HER2. We randomlyassigned 234 patients to receive standard chemotherapy aloneand 235 patients to receive standard chemotherapy plus trastuzumab.Patients who had not previously received adjuvant (postoperative)therapy with an anthracycline were treated with doxorubicin(or epirubicin in the case of 36 women) and cyclophosphamidewith (143 women) or without trastuzumab (138 women). Patientswho had previously received adjuvant anthracycline were treatedwith paclitaxel alone (96 women) or paclitaxel with trastuzumab(92 women). Results The addition of trastuzumab to chemotherapy was associatedwith a longer time to disease progression (median, 7.4 vs. 4.6months; P <0.001), a higher rate of objective response (50percent vs. 32 percent, P <0.001), a longer duration of response(median, 9.1 vs. 6.1 months; P <0.001), a lower rate of deathat 1 year (22 percent vs. 33 percent, P=0.008), longer survival(median survival, 25.1 vs. 20.3 months; P=0.046), and a 20 percentreduction in the risk of death. The most important adverse eventwas cardiac dysfunction, which occurred in 27 percent of thegroup given an anthracycline, cyclophosphamide, and trastuzumab;8 percent of the group given an anthracycline and cyclophosphamidealone; 13 percent of the group given paclitaxel and trastuzumab;and 1 percent of the group given paclitaxel alone. Althoughthe cardiotoxicity was potentially severe and, in some cases,life-threatening, the symptoms generally improved with standardmedical management. Conclusions Trastuzumab increases the clinical benefit of first-linechemotherapy in metastatic breast cancer that overexpressesHER2.