Tsuji Akihito, Shima Yasuo, Morita Sojiro, Uchida Mizuki, Okamoto Koichi, Morita Masanori, Horimi Tadashi, Shirasaka Tetsuhiko
Department of Clinical Oncology, Kochi Health Science Center, Kochi, Japan.
Anticancer Res. 2008 Mar-Apr;28(2B):1433-8.
We have reported the efficacy and safety of S-1 combined with low-dose consecutive cisplatin therapy for advanced and recurrent gastric cancer, but the regimen was difficult because daily cisplatin administration was necessary. We have already confirmed that cisplatin of 6 mg/m2 twice-weekly maintained the same protein-bound Pt concentration as that of 3 mg/m2 of cisplatin daily. In the present study, the efficacy and safety of a combination of S-1 and low-dose twice-weekly cisplatin were investigated.
The participants were 32 patients treated at our hospital, and all were admitted for the first 2 weeks of therapy. S-1 at 80 mg/m2 daily was administered orally in two divided doses. Cisplatin at 6 mg/m2 was administered by intravenous drip infusion over 30 minutes on 2 days each week, day 1 and day 4. Each treatment cycle consisted of 4 weeks of drug administration followed by a 2-week drug-free period (6 weeks in total).
A total of 146 cycles were administered, with a median of three cycles (range: 1-24) per patient. The results were rated as a complete response in 1 case, partial response in 24 cases and stable disease in 5 cases. The response rate was 78.1% (25/32) and the median survival time was 12.0 months (95% confidence interval (CI) 8.9-15.1 months). The response rate did not differ between previously treated and untreated patients. The one-year survival rate was 48.2% (95% CI 30.3-66.0%). The major adverse reactions were myelosuppression and gastrointestinal symptoms. The total incidence of grade 3 or greater adverse reactions was 15.6% (5/32).
The combination of S-1 and low-dose twice-weekly cisplatin therapy appears to be highly efficacious and safe and shows promise as a useful treatment strategy, even in outpatient clinics.
我们已报道了S-1联合小剂量连续顺铂疗法治疗晚期和复发性胃癌的疗效及安全性，但该方案实施困难，因为需要每日给予顺铂。我们已证实，每周两次给予6mg/m²顺铂可维持与每日给予3mg/m²顺铂相同的蛋白结合铂浓度。在本研究中，我们对S-1与小剂量每周两次顺铂联合治疗的疗效及安全性进行了研究。
研究对象为在我院接受治疗的32例患者，所有患者均在治疗的前2周入院。S-1每日80mg/m²，分两次口服给药。顺铂6mg/m²，每周2天（第1天和第4天）静脉滴注30分钟。每个治疗周期包括4周的药物给药期，随后是2周的无药期（共6周）。
共进行了146个周期的治疗，每位患者的中位周期数为3个（范围：1 - 24个）。结果评定为完全缓解1例，部分缓解24例，病情稳定5例。缓解率为78.1%（25/32），中位生存时间为12.0个月（95%置信区间（CI）8.9 - 15.1个月）。既往接受过治疗的患者与未接受过治疗的患者之间缓解率无差异。一年生存率为48.2%（95%CI 30.3 - 66.0%）。主要不良反应为骨髓抑制和胃肠道症状。3级或更高级别不良反应的总发生率为15.6%（5/32）。
S-1与小剂量每周两次顺铂联合治疗似乎高效且安全，即使在门诊环境下，也有望成为一种有效的治疗策略。
