Phase I/II study of a combination of S-1 and weekly paclitaxel in patients with advanced or recurrent gastric cancer.
OBJECTIVE
A phase I/II study of a combination of S-1 and weekly paclitaxel was conducted to determine the maximum tolerated dose (MTD), recommended dose (RD), dose-limiting toxicities (DLTs) and objective response rate (RR) in patients with advanced or recurrent gastric cancer.


METHODS
S-1 was administered orally at a fixed dose of 80 mg/m(2) per day on days 1-14. Paclitaxel was injected intravenously on days 1, 8, and 15, starting with a dose of 50 mg/m(2). The dose was increased in a stepwise manner.


RESULTS
In phase I, level 2 (60 mg/m(2)) was considered the MTD, because 2 of 3 patients in level 2 developed DLTs (grade 3 neutropenia and anemia, and grade 4 diarrhea and stomatitis). Therefore, the RD was determined to be level 1 (50 mg/m(2)). In phase II, efficacy and safety were assessed in 18 patients treated with the RD. The RR was 64.7% and the median survival time was 13.5 months. The most severe toxicities were grade 3 leukopenia (5.5%) and grade 3 neutropenia (5.5%).


CONCLUSIONS
Our study showed that S-1 combined with 50 mg/m(2) paclitaxel is effective and safe in patients with advanced or recurrent gastric cancer.
Kawabata
Ryohei
R
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Fujiwara
Yoshiyuki
Y
Doki
Yuichiro
Y
Fujita
Junya
J
Tsukahara
Yasuo
Y
Yamasaki
Makoto
M
Miyata
Hiroshi
H
Takiguchi
Shuji
S
Monden
Morito
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage
D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel