Uedo Noriya, Narahara Hiroyuki, Ishihara Ryu, Takiuchi Hiroya, Goto Masahiro, Fujitani Kazumasa, Hirao Motohiro, Tsujinaka Toshimasa, Imano Motohiro, Furukawa Hiroshi, Tsukuma Hideaki, Taguchi Tetsuo
Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka,
Oncology. 2007;73(1-2):65-71. doi: 10.1159/000120630. Epub 2008 Mar 12.
BACKGROUND/AIMS: To investigate the efficacy and safety of the combination therapy of irinotecan (CPT-11) plus S-1 in patients with advanced gastric cancer at the dose recommended by a previous phase I study.
A total of 23 patients received 80 mg/m(2) of CPT-11 on days 1 and 15, and S-1 at a dose level set on the basis of the body surface area (BSA): 40 (BSA <1.25 m(2)), 50 (BSA > or =1.25 to <1.5 m(2)) or 60 mg (BSA > or =1.5 m(2)) b.i.d. was given from days 1-21.
The overall response rate was 47.8% (11 of 23, 95% confidence interval, CI: 27.4-68.2%). The median time to progression (TTP) was 210 days (95% CI: 145-322 days) and the median survival time was 394 days (95% CI: 241-484 days). The incidence of grade 3 or 4 hematological and non-hematological toxicity was 17.4 and 8.7%. The most common hematological toxicity was anemia and the most common non-hematological toxicity was diarrhea.
The combination therapy of CPT-11 and S-1 provided prolonged TTP with low toxicity, and the results warrant a further phase III study to define the efficacy in improvement of survival in patients with advanced gastric cancer.
背景/目的：按照先前一项I期研究推荐的剂量，研究伊立替康（CPT-11）联合S-1治疗晚期胃癌患者的疗效和安全性。
总共23例患者在第1天和第15天接受80mg/m²的CPT-11，并根据体表面积（BSA）设定S-1的剂量水平：40mg（BSA＜1.25m²）、50mg（BSA≥1.25至＜1.5m²）或60mg（BSA≥1.5m²），每天两次，从第1至21天给药。
总缓解率为47.8%（23例中的11例，95%置信区间，CI：27.4 - 68.2%）。中位疾病进展时间（TTP）为210天（95%CI：145 - 322天），中位生存时间为394天（95%CI：241 - 484天）。3级或4级血液学和非血液学毒性的发生率分别为17.4%和8.7%。最常见的血液学毒性是贫血，最常见的非血液学毒性是腹泻。
CPT-11与S-1联合治疗可延长TTP且毒性较低，该结果值得进一步开展III期研究以明确其对晚期胃癌患者生存改善的疗效。
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