OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer - PubMed
8 hours ago
- #Oral Paclitaxel
- #Metastatic Breast Cancer
- #Phase II Trial
- DHP107 is an oral paclitaxel formulation, allowing taxane delivery without Cremophor EL, used for solubility in IV paclitaxel.
- The OPERA phase II trial compared DHP107 (200 mg/m² orally, days 1, 8, 15 every 28 days) to IV paclitaxel (80 mg/m², same schedule) in 72 HER2-negative metastatic/recurrent breast cancer patients, randomized 2:1.
- Objective response rates were similar: 25.0% with DHP107 (1 complete response, 11 partial) and 28.6% with IV paclitaxel (6 partial responses; p=0.7559).
- Median progression-free survival was 5.5 months for DHP107 vs 4.7 months for IV paclitaxel (p=0.8018), and overall survival was 17.1 vs 13.2 months (p=0.7629).
- Common adverse events: DHP107 primarily caused diarrhea (68.8%), nausea (64.6%), and fatigue (52.1%); IV paclitaxel caused fatigue (47.6%), neuropathy (42.9%), and alopecia (42.9%).
- The study concluded DHP107 is a tolerable and feasible option with comparable efficacy and safety to IV paclitaxel in this patient population.