一种旨在减轻不良反应并通过在每2周给药疗程后引入1周无药间隔来延长用药时间的S-1治疗新方案：临床实践中的疗效和可行性。
A new regimen for S-1 therapy aiming at adverse reaction mitigation and prolonged medication by introducing a 1-week drug-free interval after each 2-week dosing session: efficacy and feasibility in clinical practice.
作者信息
Kimura Yutaka, Kikkawa Nobuteru, Iijima Shohei, Kato Takeshi, Naoi Yasuto, Hayashi Taro, Tanigawa Takahiko, Yamamoto Hitoshi, Kurokawa Eiji
机构信息
Department of Surgery and Clinical Oncology, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka 568-0871, Japan.
出版信息
Gastric Cancer. 2003;6 Suppl 1:34-9. doi: 10.1007/s10120-003-0230-y.
BACKGROUND
The response rate of advanced or recurrent gastric cancer to S-1 (TS-1) is 46.5%, which is higher than the response rate of this type of cancer to any other anticancer agent. However, the incidence of adverse reactions to this drug has also been reported to be as high as 83.2%. According to a postmarketing survey, adverse reactions to this drug begin to appear 2-3 weeks after the start of drug administration. With these findings in mind, we recently devised a new dosing regimen for the drug, by which the drug is administered for 2-week periods separated by 1-week drug-free intervals (the 2-week regimen). The aim of this retrospective study was to evaluate the efficacy and feasibility of the 2-week regimen in comparison with a 4-week dosing regimen with a 2-week interval between sessions (the 4-week regimen) as the historical control.
METHODS
The subjects were 27 patients with advanced or recurrent gastric cancer who received S-1 therapy at our center between September 1999 and November 2001. Of these patients, 14 who received the 4-week regimen before January 2001 served as historical controls, and the results in these patients were compared with those of the remaining 13 patients, who received the 2-week regimen after February 2001. Patient backgrounds, adverse reactions, compliance, and efficacy were investigated retrospectively.
RESULTS
The incidence of adverse reactions tended to be lower in the 2-week-regimen group (77%) than in the 4-week-regimen group (93%). The percentage of patients who received the drug for 6 months in complete compliance with the dosing schedule, as calculated by the Kaplan-Meier method, was 85% in the 2-week-regimen group and 40% in the 4-week-regimen group. The response rate to the drug was 23% in the 2-week-regimen group and 21% in the 4-week-regimen group.
CONCLUSION
These results suggest that this 2-week regimen may mitigate adverse reactions and prolong the medication period.
背景
晚期或复发性胃癌对S-1（替吉奥）的缓解率为46.5%，高于该类型癌症对任何其他抗癌药物的缓解率。然而，据报道该药物不良反应的发生率也高达83.2%。根据一项上市后调查，该药物的不良反应在开始给药2至3周后开始出现。考虑到这些发现，我们最近为该药物设计了一种新的给药方案，即给药2周，间隔1周停药（2周方案）。这项回顾性研究的目的是评估2周方案与作为历史对照的4周给药方案（疗程间隔2周，4周方案）相比的疗效和可行性。
方法
研究对象为1999年9月至2001年11月在本中心接受S-1治疗的27例晚期或复发性胃癌患者。其中，2001年1月前接受4周方案治疗的14例患者作为历史对照，将这些患者的结果与2001年2月后接受2周方案治疗的其余13例患者的结果进行比较。对患者的背景、不良反应、依从性和疗效进行回顾性调查。
结果
2周方案组不良反应的发生率（77%）倾向于低于4周方案组（93%）。根据Kaplan-Meier方法计算，完全按照给药计划接受药物治疗6个月的患者百分比，2周方案组为85%，4周方案组为40%。该药物的缓解率在2周方案组为23%，在4周方案组为21%。
结论
这些结果表明，这种2周方案可能减轻不良反应并延长用药期。
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