Oral paclitaxel shows similar efficacy to IV paclitaxel in phase II metastatic breast cancer trial

PURPOSE: DHP107 is an oral paclitaxel enabling administration of paclitaxel without Cremophor EL, a vehicle used to improve the solubility of intravenous (IV) paclitaxel. The randomized phase II OPERA study investigated the efficacy and safety of DHP107 versus IV paclitaxel in patients with HER2-negative breast cancer. METHODS: OPERA was conducted in the USA and Czech Republic. Patients were ≥ 18 years, with measurable disease, and histologically or cytologically confirmed recurrent or metastatic breast cancer with any tumor hormone receptor status. Patients were randomized 2:1 to DHP107 (200 mg/m po bid with premedication if needed on days 1, 8, and 15, every 28 days) or IV paclitaxel (80 mg/m with standard premedication on days 1, 8, and 15 every 28 days). The primary objective was DHP107 efficacy; secondary objectives included DHP107 safety and tolerability. RESULTS: 72 patients were randomized, 48 to DHP107 and 24 to IV paclitaxel. There was one complete response and 11 partial responses with DHP107 (objective response rate [ORR 25.0%; 90% CI 15.1-37.3), and six partial responses with IV paclitaxel (objective response rate [ORR] 28.6%; 90% CI 13.2-48.7; p = 0.7559). Median progression-free survival (PFS) was 5.5 months for DHP107 and 4.7 months for IV paclitaxel (p = 0.8018); median overall survival (OS) was 17.1 and 13.2 months, respectively (p = 0.7629). Common all-grade adverse events were diarrhea (68.8%), nausea (64.6%), and fatigue (52.1%) for DHP107 and fatigue (47.6%), peripheral neuropathy (42.9%), and alopecia (42.9%) for IV paclitaxel. CONCLUSION: DHP107 is a tolerable and feasible treatment for patients with recurrent or metastatic HER2-negative breast cancer, with similar efficacy and safety to IV paclitaxel. CLINICALTRIALS: gov no: NCT03326102; date of registration October 19, 2017.