(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.
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.