Phase II study of 2-week TS-1 administration followed by 1-week rest for gastric cancer.
Phase II study of 2-week TS-1 administration followed by 1-week rest for gastric cancer.
复制标题
治疗胃癌的 II 期研究是给予 2 周 TS-1，然后休息 1 周。
作者：
H. Imamura;H. Furukawa;T. Kishimoto;S. Nakae;Kentaro Inoue;Y. Tsukahara;M. Imano;K. Yamazaki;S. Okano;T. Morimoto;Seiichi Sugihara;T. Shimokawa
背景/目的
TS-1单药治疗（给药4周，停药2周）在日本被用作转移性胃癌的社区标准治疗。然而，根据上市后调查，接受三个或三个以上疗程的患者比例仅为44.6%;原因是第一个或第二个疗程期间症状加重或不良反应导致停药。因此，我们针对转移性胃癌进行了TS-1给药2周，然后停药1周的II期研究，旨在减轻不良反应而不降低抗肿瘤作用。
方法
2001年至2003年期间，在日本的9个研究所招募了35名患者。剂量为80 mg/m2/天的TS-1治疗的一个周期包括给药2周，然后停药1周。主要终点为总缓解率，次要终点为安全性和可行性。
结果
有6例PR，13例NC，11例PD，5例患者不可评价（NE），缓解率为17%。所有患者的中位生存期为290天。在8例（23%）患者中观察到3级或4级重度不良反应。接受6个或6个以上疗程的患者比例为43%。相对总给药天数的累积率为93%。
结论
我们得出结论，TS-1给药2周，然后停药1周的方案在抗肿瘤作用、不良反应和延长用药时间方面可能并不上级传统方案（给药4周，停药2周），尽管从生存率的角度来看是可以接受的。
BACKGROUND/AIMS
TS-1 monotherapy with 4-week administration followed by 2-week rest is used as the community standard treatment for metastatic gastric cancer in Japan. However, according to a postmarketing survey, the percentage of patients who received three or more courses was only 44.6%; for the reasons of discontinuation due to exacerbation of symptoms or adverse reactions during the first or second course. Therefore, we conducted the phase II study of 2-weeks administration with TS-1 followed by a 1-week rest against metastatic gastric cancer, aiming for mitigation of adverse reactions without reduction of antitumor effect.
METHODOLOGY
Thirty-five patients were enrolled between 2001 and 2003 at nine institutes in Japan. One cycle of TS-1 treatment whose dosage was 80 mg/m2/day consisted of administration for 2 weeks followed by a 1-week rest. The primary endpoint was overall response rate and the secondary endpoints were safety and feasibility.
RESULTS
There were 6 PRs, 13 NCs, 11 PDs, and 5 patients were not evaluable (NE), yielding a response rate of 17%. The median survival time of all patients was 290 days. Severe adverse Grade 3 or 4 reactions were observed in 8 (23%) patients. The rate of patients who received six or more courses was 43%. The cumulative rate of the relative total administration days was 93%.
CONCLUSIONS
We concluded that the schedule of TS-1 administration for 2 weeks followed by a 1-week rest might not be superior to the conventional schedule (4 weeks on and 2 weeks off) with regard to the antitumor effect, adverse reactions and prolonged medication, although it was acceptable from the point of view of survival.