Oral paclitaxel with encequidar improves overall survival and progression-free survival in breast cancer
USA: Compared to intravenous paclitaxel (IVpac), oral paclitaxel plus Encequidar (oPac + E) improved the confirmed tumor response while showing trends in overall survival (OS) and progression-free survival (PFS), says an article published in the Journal of Clinical Oncology.
Neuropathy makes intravenous paclitaxel more difficult to administer; therefore, premedication is necessary to avoid hypersensitivity-like symptoms. The new P-glycoprotein pump inhibitor encequidar (E), which is used to treat paclitaxel, improves oral absorption. In order to compare the effectiveness and safety of oPac + E once daily for three consecutive days per week with IVpac at the authorized dose and schedule, 175 mg/m2 once every three weeks in patients with mBC, Hope S. Rugo and colleagues conducted a phase III study.
With balanced demographics and past treatments, 400 Latin American patients (265 oPac + E, 137 IVpac) were included. The primary endpoint was determined by blinded independent central review and was confirmed by radiographic response using RECIST 1.1. Progression-free survival and overall survival were secondary endpoints.
The key findings of this study were as follows:
1. In comparison to 23% for IVpac, the confirmed response (intent-to-treat) for oPac + E was 36%.
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