RT Journal Article
SR Electronic
T1 Phase I Study of Combination Therapy with S-1 and Weekly Docetaxel for Advanced Gastric Cancer
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 2657
OP 2665
VO 27
IS 4C
A1 OZAKI, TOMOHIRO
A1 TAMURA, KENJI
A1 SATOH, TAROH
A1 KURATA, TAKAYASU
A1 SHIMIZU, TOSHIO
A1 MIYAZAKI, MASAKI
A1 OKAMOTO, ISAMU
A1 NAKAGAWA, KAZUHIKO
A1 FUKUOKA, MASAHIRO
YR 2007
UL http://ar.iiarjournals.org/content/27/4C/2657.abstract
AB Background: The primary objective of this study was to determine the maximum tolerated dose (MTD), the toxicity profile and the recommended dose (RD) for phase II of a combination of S-1 and weekly administration of docetaxel. Patients and Methods: Patients with histologically diagnosed recurrent or unresectable locally advanced gastric cancer were enrolled. A fixed oral dose of 80 mg/m2 S-1 was given for 3 weeks. Docetaxel was infused intravenously on day 1, 8 and 15, repeated every 5 weeks. A pharmacokinetic study was also performed. Results: A total of 14 patients were enrolled. One dose-limiting toxicity (DLT) (grade 3 diarrhea with febrile neutropenia) occurred at level 2. DLTs occurred in 3/5 patients at level 3, (grade 3 stomatitis, with febrile neutropenia or continuous grade 4 neutropenia). The pharmacokinetic study suggested no drug interactions. Overall response and disease control rates were 20% and 80%, respectively. The response rate at the RD (level 2) was 50%. Overall survival was 9.4 months. Conclusion: RD was level 2 (80 mg/m2 of S-1 for 3 weeks and 20 mg/m2 of docetaxel on day 1, 8 and 15, every 5 weeks). Dose intensities of S-1 and docetaxel were 48 mg/m2/week and 12 mg/m2/week, respectively. This regimen showed promising activity for advanced gastric cancer.