Sunitinib improved objective response, but did not extend PFS or OS compared with docetaxel monotherapy for patients with HER-2–negative advanced breast cancer.
In a randomized, phase 3 study, patients were randomly assigned to either 37.5 mg daily sunitinib (Sutent, Pfizer) and 75 mg/m2 docetaxel once every 3 weeks (n=296) or 100 mg/m2 docetaxel once every 3 weeks (n=297) as first-line therapy.
There were 107 deaths in the combination arm and 91 deaths in monotherapy arm. Median PFS was 8.6 months with the combination and 8.3 months with docetaxel alone (HR=0.92). Median OS was 24.8 months with the combination and 25.5 months with docetaxel.
Objective response rate favored the combination (55% vs. 42%), but duration of response was similar in both arms (7.5 months with the combination vs. 7.2 months with docetaxel).
Additionally, patients in the combination arm experienced adverse events more frequently and were more likely to discontinue treatment due to adverse events. Patients in the combination arm experienced a 16% absolute increase in grade-3/grade-4 hand-foot syndrome.