Background: In patients with metastatic cancer of the breast that’s positive for human epidermal growth factor receptor 2 (HER2), progression-free survival was considerably improved after first-line therapy with pertuzumab, trastuzumab, and docetaxel, compared to placebo, trastuzumab, and docetaxel. Overall survival was considerably improved with pertuzumab within an interim analysis with no median being arrived at. We report final prespecified overall survival results having a median follow-from 50 several weeks.
Methods: We at random assigned patients with metastatic cancer of the breast who’d not received previous chemotherapy or anti-HER2 therapy for his or her metastatic disease to get the pertuzumab combination or even the placebo combination. The secondary finish points of overall survival, investigator-assessed progression-free survival, individually assessed time period of response, and safety are reported. Sensitivity analyses were adjusted for patients who entered over from placebo to pertuzumab following the interim analysis.
Results: The median overall survival was 56.5 several weeks (95% confidence interval [CI], 49.3 not to arrived at) within the group finding the pertuzumab combination, compared to 40.8 several weeks (95% CI, 35.8 to 48.3) within the group finding the placebo combination (hazard ratio favoring the pertuzumab group, .68 95% CI, .56 to .84 P<0.001), a difference of 15.7 months. This analysis was not adjusted for crossover to the pertuzumab group and is therefore conservative. Results of sensitivity analyses after adjustment for crossover were consistent. Median progression-free survival as assessed by investigators improved by 6.3 months in the pertuzumab group (hazard ratio, 0.68 95% CI, 0.58 to 0.80). Pertuzumab extended the median duration of response by 7.7 months, as independently assessed. Most adverse events occurred during the administration of docetaxel in the two groups, with long-term cardiac safety maintained.
Conclusions: In patients with HER2-positive metastatic breast cancer, the addition of pertuzumab to trastuzumab and docetaxel, as compared with the addition of placebo, significantly improved the median overall survival to 56.5 months and extended the results of previous analyses showing the efficacy of this drug combination. (Funded by F. Hoffmann-La Roche and Genentech CLEOPATRA ClinicalTrials.gov number, NCT00567190.).