A phase II evaluation of nab-paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer: A Gynecologic Oncology Group (GOG) study.

Abstract

5010 Background: Nab-paclitaxel (Abraxane, ABX) is a novel cremophor-free nanoparticle of albumin-stabilized paclitaxel, which has favorable efficacy and toxicity characteristics relative to other solvent-based taxanes, such as paclitaxel and docetaxel, and is currently approved for recurrent breast cancer. This is the first report of weekly abraxane in patients with recurrent ovarian, fallopian tube or peritoneal cancer (OC). Methods: Eligible patients had OC, that was persistent (n = 5) or progressed within 6 months of completion (n = 42) of primary platinum and taxane-based chemotherapy. All patients were required to have measurable disease, no prior therapy for recurrent disease and GOG performance status of ≤ 2. Treatment was ABX 100 mg/m2 days 1,8,15 on a 28-day schedule. The primary endpoint was RECIST response rate (RR), evaluated in a 2-stage design (with power of 0.90 for a RR of 25% and with alpha of 0.05 for RR of 10%). Results: 51 patients were enrolled, of which 47 are evaluable; median time from frontline therapy completion to registration was just 21 days. Patient demographics include median age: 59 (34-78) years, primary site ovary: 87%, serous histology: 72%, and high-grade: 81%. All patients had measurable disease, one prior chemotherapy regimen and prior surgery. Efficacy: partial response was confirmed in 11 patients (23%); 17 patients (36%) had stable disease. The median progression-free survival (PFS) was 4.5 months (95%CI: 2.1-6.7); overall survival was 17.4 months (95%CI: 12.5, not estimable). 17 patients (36%) had PFS > 6 months. Toxicity: there were no grade 4 events; grade 3 events were neutropenia (6), anemia (3), GI (2), metabolic (2), pain (2), and leukopenia (1); neurosensory toxicity was observed as grade 2: 5; and grade 3: 1. Conclusions: ABX appears to have substantial single-agent activity and to be tolerable in this cohort of highly refractory ovarian cancer patients previously treated with paclitaxel, and further investigation is warranted. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Abraxis BioScience Abraxis BioScience