Open-Label, Randomized, Multicenter, Phase III Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients With Metastatic Breast Cancer

    July 2022 in “ Journal of Clinical Oncology ”
    Hope S. Rugo, Gerardo Umanzor, Feliciano Barrios, Rosa H. Vasallo, Marco A. Chivalan, Suyapa Bejarano, J. Ramírez, Luis Fein, Rubén Dario Kowalyszyn, E Douglas Kramer, Hui Wang, Min-Fun Rudolf Kwan, David L. Cutler
    The study compared oral paclitaxel plus encequidar (oPac + E) to intravenous paclitaxel (IVpac) in 402 women with metastatic breast cancer. The confirmed tumor response was higher for oPac + E (36%) compared to IVpac (23%). Progression-free survival was 8.4 months for oPac + E versus 7.4 months for IVpac, and overall survival was 22.7 months versus 16.5 months, respectively. Grade 3-4 adverse reactions were similar between the groups, but oPac + E had lower rates of neuropathy and alopecia, though it caused more gastrointestinal issues and neutropenic complications, especially in patients with elevated liver enzymes. The study concluded that oPac + E increased tumor response and had a different side effect profile compared to IVpac.
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