Ohtsu Atsushi
Division of Digestive Endoscopy/Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Gan To Kagaku Ryoho. 2006 Jun;33 Suppl 1:52-6.
The aim of this survey was to confirm the safety and efficacy of S-1 for advanced gastric cancer after market release.
All patients had to be registered with the manufacturer for a post-marketing survey, according to the government recommendation. All patients were monitored for safety and survival.
During this survey, a total of 4,177 patients with advanced gastric cancer were registered. The incidences of all adverse events and of grade 3 or worse events in the 3,808 patients evaluable for safety were 74% and 25%, respectively. In patients with lower creatinine clearance at baseline, the incidences of adverse reactions were higher for all grades combined, as well as for grade 3 or worse. There were 90 (2.4%) early deaths (within 30 days of the initiation of the treatment) and 5 (0.1%) deaths possibly related to the treatment. The median survival time and the 1-year survival rate for all patients evaluable for efficacy (n=3,801) were 8.3 months (95% CI: 8.0-8.6 months) and 33.3% (95% CI: 31.8-34.9%), respectively.
This nationwide survey confirmed that the safety and efficacy profiles of S-1 were similar to those seen in the registration study.
本调查旨在确认S-1在上市后用于晚期胃癌的安全性和有效性。
根据政府建议，所有患者必须向制造商登记以进行上市后调查。对所有患者进行安全性和生存情况监测。
在本次调查期间，共有4177例晚期胃癌患者登记。在可评估安全性的3808例患者中，所有不良事件的发生率以及3级或更严重事件的发生率分别为74%和25%。基线时肌酐清除率较低的患者，所有级别不良事件的综合发生率以及3级或更严重不良事件的发生率均较高。有90例（2.4%）早期死亡（在治疗开始后30天内），5例（0.1%）可能与治疗相关的死亡。可评估疗效的所有患者（n=3801）的中位生存时间和1年生存率分别为8.3个月（95%CI：8.0 - 8.6个月）和33.3%（95%CI：31.8 - 34.9%）。
这项全国性调查证实，S-1的安全性和有效性概况与注册研究中的情况相似。
