A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601)

被引:70
作者
Koizumi, Wasaburo [1 ]
Nakayama, Norisuke [2 ]
Tanabe, Satoshi [1 ]
Sasaki, Tohru [1 ]
Higuchi, Katsuhiko [1 ]
Nishimura, Ken [2 ]
Takagi, Seiichi [2 ]
Azuma, Mizutomo [1 ]
Ae, Takako [1 ]
Ishido, Kenji [1 ]
Nakatani, Kento [3 ]
Naruke, Akira [1 ]
Katada, Chikatoshi [3 ]
机构
[1] Kitasato Univ, East Hosp, Dept Gastroenterol Gastrointestinal Oncol, Sagamihara, Kanagawa 2288520, Japan
[2] Kanagawa Canc Ctr, Div Gastroenterol, Yokohama, Kanagawa, Japan
[3] Kitasato Univ Hosp, Dept Gastroenterol, Sagamihara, Kanagawa, Japan
关键词
Docetaxel; Cisplatin; S-1 (combination); Gastric cancer; Phase II; ADENOCARCINOMA; FLUOROURACIL; THERAPY; TRIAL;
D O I
10.1007/s00280-011-1701-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
We conducted a phase II study to evaluate the efficacy and safety of a triplet regimen of docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer. Docetaxel (40 mg/m(2)) and cisplatin (70 or 60 mg/m(2)) were given on day 1 of a 28-day cycle. S-1 (40 mg/m(2)) was given twice daily on days 1-14. Treatment with this regimen was continued for a maximum of 6 cycles. Subsequently, patients with no disease progression received a combination of docetaxel and S-1. Fifty-nine patients were enrolled. The median number of administered cycles was 8 (range, 1-25). Because some patients had serious myelosuppression and renal dysfunction with 70 mg/m(2) of cisplatin, dose of cisplatin was reduced to 60 mg/m(2) after 19 patients had been treated. Common severe toxic effects of grade 3 or 4 were leukocytopenia (44%), neutropenia (72%), anemia (15%), and febrile neutropenia (14%). The overall response rate of this group was 81% (95% confidence interval (CI), 71-91%). The median overall survival and progression-free survival were 18.5 (95% CI, 15.6-21.5) and 8.7 (95% CI, 6.7-10.7) months, respectively. Triplet of docetaxel, cisplatin, and S-1 is a well-tolerated and highly active regimen for advanced or recurrent gastric cancer. A 60 mg/m(2) of cisplatin is as effective as 70 mg/m(2) of cisplatin.
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收藏
页码:407 / 413
页数:7
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