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Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer
New England Journal of Medicine, 01/09/2012
Clinical Article
Baselga J et al. – The combination of pertuzumab plus trastuzumab plus docetaxel, as compared with placebo plus trastuzumab plus docetaxel, when used as first–line treatment for HER2–positive metastatic breast cancer, significantly prolonged progression–free survival (PFS), with no increase in cardiac toxic effects.
Methods- Randomly assigned 808 patients with HER2–positive metastatic breast cancer to receive placebo plus trastuzumab plus docetaxel (control group) or pertuzumab plus trastuzumab plus docetaxel (pertuzumab group) as first–line treatment until the time of disease progression or the development of toxic effects that could not be effectively managed
- Primary end point independently assessed PFS
- Secondary end points included overall survival, PFS as assessed by the investigator, objective response rate, and safety
- Median PFS 12.4 months in control group, as compared with 18.5 months in the pertuzumab group (HR for progression or death, 0.62; 95% CI, 0.51 to 0.75; P<0.001)
- Interim analysis of OS showed strong trend in favor of pertuzumab plus trastuzumab plus docetaxel
- Safety profile was generally similar in the 2 groups, with no increase in left ventricular systolic dysfunction; the rates of febrile neutropenia and diarrhea of grade 3 or above were higher in pertuzumab group than in control group