What question did this study set out to answer?

To evaluate the effectiveness and safety of oral paclitaxel compared to intravenous paclitaxel in HER2-negative breast cancer.

March 16, 2026Open Access

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

Abstract

Highlights In this Phase 3 trial, DHP107 (oral paclitaxel) was compared with weekly IV paclitaxel in HER2(-) metastatic breast cancer. DHP107 showed non-inferior PFS compared with paclitaxel (median 10.0 vs. 8.5 months; HR 0.869, 95% CI, 0.707-1.068). OS (median 32.6 months vs. 31.8months) and tumor response rates (43.3% vs. 38.8%) were also comparable. DHP107 had more neutropenia and GI toxicity and less hypersensitivity and neuropathy, with no treatment-related deaths. DHP107 may be a convenient, non-inferior, and safe alternative to IV paclitaxel in HER2-negative breast cancer.

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Cite This Study

Xu et al. (Sun,) studied this question.

synapsesocial.com/papers/69b79da78166e15b153aae28 https://doi.org/https://doi.org/10.1016/j.annonc.2026.03.002

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