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门诊环境下S-1与低剂量顺铂每周两次联合化疗用于晚期和复发性胃癌的回顾性研究

Combination chemotherapy of S-1 and low-dose twice-weekly cisplatin for advanced and recurrent gastric cancer in an outpatient setting: a retrospective study.

作者信息

Tsuji Akihito, Shima Yasuo, Morita Sojiro, Uchida Mizuki, Okamoto Koichi, Morita Masanori, Horimi Tadashi, Shirasaka Tetsuhiko

机构信息

Department of Clinical Oncology, Kochi Health Science Center, Kochi, Japan.

出版信息

Anticancer Res. 2008 Mar-Apr;28(2B):1433-8.

Abstract

BACKGROUND

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.

PATIENTS AND METHODS

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).

RESULTS

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).

CONCLUSION

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.

摘要

背景

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。

患者与方法

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)。

结果

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)。

结论

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。

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