(ChemotherapyAdvisor) – The combination of sunitinib plus docetaxel improved the objective response rate (ORR) but did not prolong progression-free survival (PFS) or overall survival (OS) vs. docetaxel alone for the first-line treatment of HER2/neu–negative advanced breast cancer, a Phase 3 randomized study concluded in the Journal of Clinical Oncology online February 13.

The study randomly assigned patients to sunitinib 37.5mg/day (days 2–15) plus docetaxel 75mg/m2 (day 1) every 3 weeks (n=296) or docetaxel 100mg/m2 alone every 3 weeks (n=297).

The ORR was 55% for the sunitinib plus docetaxel vs. 42% for docetaxel alone; however, PFS, the primary end point, was not met: median PFS was 8.6 months for sunitinib plus docetaxel vs. 8.3 months for docetaxel alone. Response duration was 7.5 months for the combination vs. 7.2 months for monotherapy; median OS was 24.8 and 25.5 months, respectively.

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In the sunitinib plus docetaxel arm, there were 107 deaths and, in the docetaxel alone arm, 91 deaths. Patients receiving the combination regimen had more adverse events (AEs) — specifically, a 16% increase in grade 3 to 4 hand-foot syndrome compared with monotherapy — and a higher number of treatment discontinuations due to AEs.

“The sunitinib-docetaxel regimen evaluated in this study is not recommended for further use in advanced breast cancer,” the authors wrote.