Phase I/II trial of neoadjuvant sunitinib administered with weekly paclitaxel/carboplatin in patients with locally advanced triple-negative breast cancer.

摘要: The purpose of the study is to evaluate feasibility and efficacy adding sunitinib paclitaxel/carboplatin in neoadjuvant therapy patients with triple-negative breast cancer (TNBC). Patients had histologically proven, previously untreated, adenocarcinoma, disease limited axilla (clinical T1–T3, N0–N2, M0; T1N1M0 excluded). Following determination maximum tolerated doses phase I portion, II received paclitaxel 70 mg/m2 IV days 1, 8, 15; carboplatin AUC 5.0 day 1; 25 mg orally daily; treatment was administered for six 28-day cycles followed by definitive surgery. Sunitinib resumed postoperatively complete a 52-week course. Pathologic response (pCR) rate primary endpoint. Fifty-four enrolled; 41 study. Sixteen (39 %) were able therapy; 18 additional surgery after completing 2–5 treatment. pCR these 34 evaluable 35 %. toxicity regimen considerable, myelosuppression resulting numerous dose reductions and/or omissions carboplatin. Eleven (27 discontinued during therapy, (14 completed 52 weeks single-agent sunitinib. In TNBC, combination paclitaxel, carboplatin, difficult administer, produced comparable other less toxic regimens. This not recommended further evaluation. At present, has no defined role cancer.