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A feasibility study of outpatient chemotherapy with S-1 + cisplatin in patients with advanced gastric cancer

机译:S-1 +顺铂门诊化疗治疗晚期胃癌的可行性研究

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Background: Regimens of standard-dose cisplatin have usually been administered as inpatient chemotherapy in Japan. This prospective study evaluated the feasibility of outpatient chemotherapy with standard-dose cisplatin in Japanese patients with advanced gastric cancer. Methods: Advanced gastric cancer patients received an S-1 + cisplatin regimen (S-1: 80-120 mg days 1-21; cisplatin: 60 mg/m2 day 8, every 4-5 weeks), either as outpatient chemotherapy with oral hydration on days 9-10, or as inpatient chemotherapy with intravenous hydration on days 9-10, based on the results of an oral hydration test during days 1-7 of the first cycle. The primary endpoint was the completion rate of two cycles in the outpatient group. Results: A total of 36 patients were enrolled: 32 were allocated to the outpatient group and 4 to the inpatient group. The completion rate of two cycles in the outpatient group was 78% [90% confidence interval (CI): 63-89]. The median of the total number of treatment cycles of S-1 + cisplatin and the median progression-free survival in the outpatient group were 5 (range 1-11) and 10.6 months (95% CI 4.2-16.9), respectively. Although seven patients in the outpatient group discontinued treatment, mainly owing to gastrointestinal toxicity, most of them could continue S-1 + cisplatin by switching to inpatient chemotherapy from the next cycle. Conclusion: Outpatient chemotherapy with S-1 + cisplatin in advanced gastric cancer patients can be safely and effectively administered in Japan with appropriate patient selection and supportive treatment.
机译:背景:在日本,标准剂量的顺铂方案通常作为住院化疗的药物。这项前瞻性研究评估了日本晚期胃癌患者使用标准剂量顺铂进行门诊化疗的可行性。方法:晚期胃癌患者接受S-1 +顺铂方案(S-1:1-21天80-120 mg;顺铂:第8天,每4-5周60 mg / m2第8天),或者口服口服门诊化疗根据第一个周期1-7天的口服水合测试结果,在第9-10天进行水合作用,或在第9-10天进行静脉水合作用的住院化疗。主要终点是门诊组两个周期的完成率。结果:共纳入36例患者:门诊组32例,住院组4例。门诊组两个周期的完成率为78%[90%置信区间(CI):63-89]。门诊治疗组中S-1 +顺铂治疗总次数的中位数和无进展生存期的中位数分别为5(1-11)和10.6个月(95%CI 4.2-16.9)。尽管门诊组中有7名患者由于胃肠道毒性而中止治疗,但他们中的大多数可以通过从下一个周期改用住院化疗继续使用S-1 +顺铂。结论:在日本,通过适当的患者选择和支持治疗,可以安全有效地对晚期胃癌患者进行门诊S-1 +顺铂化疗。

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