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.
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.
Authors: Joan H Schiller; David Harrington; Chandra P Belani; Corey Langer; Alan Sandler; James Krook; Junming Zhu; David H Johnson Journal: N Engl J Med Date: 2002-01-10 Impact factor: 91.245
Authors: P J Souquet; E H Tan; J Rodrigues Pereira; R Van Klaveren; A Price; U Gatzemeier; M Jaworski; J P Burillon; D Aubert Journal: Ann Oncol Date: 2002-12 Impact factor: 32.976
Authors: V Alberola; C Camps; M Provencio; D Isla; R Rosell; C Vadell; I Bover; A Ruiz-Casado; P Azagra; U Jiménez; J L González-Larriba; P Diz; F Cardenal; A Artal; A Carrato; S Morales; J J Sanchez; R de las Peñas; E Felip; G López-Vivanco Journal: J Clin Oncol Date: 2003-09-01 Impact factor: 44.544
Authors: F Anthony Greco; James R Gray; Dana S Thompson; Howard A Burris; Joan B Erland; John H Barton; Sharlene Litchy; Gerry A Houston; James A Butts; Charles Webb; Charles Scott; John D Hainsworth Journal: Cancer Date: 2002-09-15 Impact factor: 6.860