A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601)
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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/m2) and cisplatin (70 or 60 mg/m2) were given on day 1 of a 28-day cycle. S-1 (40 mg/m2) 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/m2 of cisplatin, dose of cisplatin was reduced to 60 mg/m2 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/m2 of cisplatin is as effective as 70 mg/m2 of cisplatin.
KeywordsDocetaxel Cisplatin S-1 (combination) Gastric cancer Phase II
The Authors thank Nobutaka Samejima, Satoshi Matsumoto and Ryouta Seto for their helpful advices.
Conflict of interest
- 3.Ministry of Health Law. Vital Statistics of Japan (2009)Google Scholar
- 4.Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K et al (1996) Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs 7(5):548–557PubMedCrossRefGoogle Scholar
- 7.Ajani JA, Rodriguez W, Bodoky G, Moiseyenko V, Lichinitser M, Gorbunova V et al (2010) Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: the FLAGS trial. J Clin Oncol 28(9):1547–1553PubMedCrossRefGoogle Scholar
- 8.Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C et al (2006) Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 study group. J Clin Oncol 24(31):4991–4997PubMedCrossRefGoogle Scholar
- 13.Sato Y, Takayama T, Sagawa T, Takahashi Y, Ohnuma H, Okubo S et al (2010) Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Cancer Chemother Pharmacol 66:721–728Google Scholar