Phase I study of paclitaxel, carboplatin and UFT in chemo-naive patients with advanced non-small cell lung cancer (NSCLC)

Author： Ono Yasushi Hino Mitsunori Ueda Yuka Kamizuru Ryoko Omata Masatoshi Uehara Takashi Tanaka Yosuke Soma Tomoyuki Kudoh Shoji

Publisher： Humana Press, Inc

ISSN： 1357-0560

Source： Medical Oncology, Vol.24, Iss.4, 2007-12, pp. : 402-406

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Abstract

We conducted a phase I study of paclitaxel (PTX), carboplatin (CBDCA), and UFT in chemo-naive patients with advanced non-small cell lung cancer (NSCLC).Twenty-one chemo-naive patients with advanced NSCLC were enrolled. The study was conducted as a phase I dose-escalation study of various doses of systemic PTX followed by CBDCA on day 1 and oral UFT (400 mg/m²) on days 1–5 and 8–12, with the cycle repeated at 21-day intervals. At least three patients were enrolled in each step.The main toxicities were neutropenia and paresthesia, but were tolerable and reversible in all cases. Overall response rate was 57% (12 out of 21). The MTD was not reached at the highest dose level after the first cycle. Given previous recommends of PTX at 225 mg/m² and CBDCA AUC 6 for two-drug therapy, the recommended dose for the phase II study under our regimen was set at PTX 225 mg/m² on day 1, CBDCA AUC 6 on day 1, and UFT 400 mg/m² on days 1–5 and 8–12.The combination of PTX, CBDCA, and UFT showed promising activity and acceptable toxicity in these chemo-naive patients, supporting the development of this combination as a feasible chemotherapeutic option for advanced NSCLC.