Weekly Oraxol for Second-Line Treatment of Metastatic, Recurrent Gastric Cancer

the Cancer Therapy Advisor take:

Moderate efficacy and favorable toxicity levels of Oraxol as a second-line chemotherapy treatment were observed in patients with metastatic or recurrent gastric cancer (GC), according to an article published online in the journal The Oncologist.

This study included two phases: phase I was to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of Oraxol (a chemotherapy drug consisting of paclitaxel and HM30181A, a P-glycoprotein inhibitor) and phase II was to evaluate efficacy and safety of Oraxol.

In phase I of the study, paclitaxel was orally administered in increasing doses of 90, 120, or 150 mg/m2 per day along with a fixed dose of 15mg per day of HM30181A. Oraxol was issued on days 1, 2, 8, 9, 15, and 16 (six times per cycle) every four weeks. In phase II of the study, the authors evaluated the efficacy and toxicity of Oraxol in the patients.

Results showed that the MTD could not be determined from phase I; however, the RP2D of oral paclitaxel was found to be 150 mg/m2 using toxicity and pharmacokinetic data.

In phase II, it was found that 9.3% of patients (4 out of 43) achieved a partial response level from treatment. The most common adverse effects (grade ≥ 3) caused by the drug were neutropenia and diarrhea.

The median progression-free survival was determined to be 2.6 months, while overall survival was calculated to be 10.7 months.