A phase II nonrandomized study of nab-paclitaxel plus carboplatin in patients with recurrent platinum-sensitive ovarian or primary peritoneal cancer.

Abstract

5011 Background: Paclitaxel in combination with carboplatin is effective salvage therapy for the treatment of recurrent ovarian cancer. The purpose of this study was to evaluate the antitumor activity of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin in patients with recurrent platinum-sensitive ovarian or primary peritoneal carcinoma. Methods: Patients with measurable disease received nab-paclitaxel 100 mg/m2 on days 1, 8, and 15 of each 28-day cycle and carboplatin AUC 5 intravenously on day 1. Patients were to be treated for at least 6 cycles. Efficacy was measured by objective response rate (ORR) per RECIST, progression-free survival (PFS), and overall survival (OS). Patients were followed every 3 months for 2 years. Results: Forty eligible patients with median age of 62 years (range 43 - 81) were enrolled; 28 patients had ovarian cancer stage IIIC, 9 had stage IIB/IIIB or IIC, and 3 had stage IV disease. Most were Caucasian (83%), most had ECOG status of 0 (88%), and all had received prior taxane/platinum chemotherapies. The median (standard deviation [STDV]) platinum-free interval was 13 (8) months. The median number of cycles with nab-paclitaxel plus carboplatin was 6 (range 3-48). Of 38 patients who were evaluable (2 did not receive treatment), 15 (39%) had a complete response (CR), 15 (39%) had a partial response (PR) for an ORR of 79%. Seven (18%) patients had stable disease (SD), 1 (3%) patient had disease progression (PD). The median (STDV) PFS was 13 (11) months and median (STDV) OS was 30 (13) months. The most common grade ≥ 3 adverse events were neutropenia (43%), fatigue (33%), hypersensitivity reaction to carboplatin (18%), anemia (10%), thrombocytopenia (5%), and nausea (5%). Of the 40 patients enrolled, 11 patients have completed 2 years of follow-up, 15 patients have died, 13 patients are still being followed, and 1 patient is still receiving treatment after more than 2 years. Conclusions: With a 97% disease control rate (CR + PR + SD), the combination of nab-paclitaxel plus carboplatin had significant antitumor activity and was reasonably tolerated in patients with platinum-sensitive recurrent ovarian cancer. No significant financial relationships to disclose.