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A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC)

Journal of Clinical Oncology Feb 02, 2019

Cecchini M, et al. - The safety and effectiveness of oxaliplatin combined with TAS-102 (an alternative and non-cross-resistant anti-metabolite) for refractory metastatic colorectal cancer (mCRC) was determined in phase 1 of TAS-OX, a 3+3 dose-escalating study with a starting dose of TAS-102 25 mg/m2 and oxaliplatin 85 mg/m2 with three dose levels. Researchers identified 12 patients that were able to be evaluated for dose-limiting toxicity (DLT). As per outcomes, the recommended phase 2 dose (RP2D) of TAS-102 is 35 mg/m2in combination with oxaliplatin 85 mg/m2. They observed no DLTs and no unexpected AEs. This heavily pretreated patient population displayed encouraging disease control rate. Researchers are enrolling for phase 2 at this dose.

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