OPTIMAL: A Multinational Phase III Study of Oral Paclitaxel (DHP107) versus Intravenous Weekly Paclitaxel in HER2-Negative Recurrent or Metastatic Breast Cancer

Key Points

• To evaluate the effectiveness and safety of oral paclitaxel compared to intravenous paclitaxel in HER2-negative breast cancer.
• Conducted a Phase 3 multinational trial
• Compared progression-free survival and overall survival between DHP107 and IV paclitaxel
• Monitored adverse effects including neutropenia and GI toxicity
• Assessed tumor response rates
• Median progression-free survival was 10.0 months for DHP107 versus 8.5 months for IV paclitaxel
• Median overall survival was comparable at 32.6 months for DHP107 and 31.8 months for IV paclitaxel
• Tumor response rates were 43.3% for DHP107 compared to 38.8% for IV paclitaxel
• DHP107 resulted in more cases of neutropenia and GI toxicity but fewer hypersensitivity reactions and neuropathy
• No treatment-related deaths were reported