Phase I study of paclitaxel,carboplatin and UFT in chemo-naive patients with advanced non-small cell lung cancer (NSCLC) |
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Authors: | Yasushi Ono Mitsunori Hino Yuka Ueda Ryoko Kamizuru Masatoshi Omata Takashi Uehara Yosuke Tanaka Tomoyuki Soma Shoji Kudoh |
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Institution: | (1) Respiratory Disease Center, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inba-mura, Chiba 270-1694, Japan;(2) Fourth Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan |
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Abstract: | Objective 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).
Method 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.
Results 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.
Conclusion 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. |
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Keywords: | Non-small-cell lung carcinoma Paclitaxel Carboplatin UFT |
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