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


METHODS
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.


CONCLUSIONS
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.
Ono
Yasushi
Y
Respiratory Disease Center, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inba-mura, Chiba, Japan. y-ono@nms.ac.jp
Hino
Mitsunori
M
Ueda
Yuka
Y
Kamizuru
Ryoko
R
Omata
Masatoshi
M
Uehara
Takashi
T
Tanaka
Yosuke
Y
Soma
Tomoyuki
T
Kudoh
Shoji
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D005641:Tegafur / Q000009:adverse effects; D016896:Treatment Outcome; D014498:Uracil / Q000009:adverse effects
D005641:Tegafur; D014498:Uracil; D016190:Carboplatin; D017239:Paclitaxel