Japanese nationwide post-marketing survey of S-1 in patients with advanced gastric cancer.
Japanese nationwide post-marketing survey of S-1 in patients with advanced gastric cancer.
复制标题
DOI：
10.1007/s10120-004-0306-3
复制
发表时间：
2005-01-01
期刊：
影响因子：
--
通讯作者：
Ito, Kunio
中科院分区：
文献类型：
--
作者：
Nagashima, Fumio;Ohtsu, Atsushi;Ito, Kunio
背景：在申请批准的注册研究和上市后的临床实践中显示的抗癌药物的安全性和有效性结果可能存在一些差异。本调查的目的是确认S-1上市后治疗晚期胃癌的安全性和有效性。方法：根据政府建议，1999年S-1获批后，所有患者必须在制造商处注册，进行上市后调查。对所有患者进行安全和生存监测。所有登记患者的数据在每次登记1年后更新。结果：本次调查共纳入4177例晚期胃癌患者。在3808例可评估安全性的患者中，所有不良事件和3级或更严重不良事件的发生率分别为74.3%和25.0%。在基线时肌酐清除率较低的患者中，所有级别的不良反应发生率都较高，3级或更差的患者也是如此。有90例（2.4%）早期死亡（开始治疗后30天内）和5例（0.1%）可能与治疗有关的死亡。所有可评估疗效的患者（n = 3801）的中位生存时间和1年生存率分别为8.3个月（95%可信区间[CI]， 8.0-8.6个月）和33.3% （95% CI, 31.8-34.9%）。结论：这项全国范围的调查证实了S-1的安全性和有效性与注册研究中看到的相似。这些结果证明了上市后调查在评估先前临床研究获得的安全性和有效性结果的可重复性方面的效用。
BACKGROUND: It is likely that there are some discrepancies in the safety and efficacy results for anticancer agents between those shown in registration studies for approval and those shown in clinical practice after market release. The aim of this survey was to confirm the safety and efficacy of S-1 for advanced gastric cancer after market release.METHODS: After the approval of S-1 in 1999, 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. The data for all registered patients were updated 1 year after each registration.RESULTS: During this survey, a total of 4177 patients with advanced gastric cancer were registered. The incidences of all adverse events and of grade 3 or worse adverse events in the 3808 patients evaluable for safety were 74.3% and 25.0%, respectively. In patients with lower creatinine clearance at baseline, the incidences of adverse reactions were higher for all grades combined, as well as for grades 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 = 3801) were 8.3 months (95% confidence interval [CI], 8.0-8.6 months) and 33.3% (95% CI, 31.8-34.9%), respectively.CONCLUSION: This nationwide survey confirmed that the safety and efficacy profiles of S-1 were similar to those seen in the registration study. These results have proven the utility of this post-marketing survey in assessing the reproducibility of the safety and efficacy results obtained from prior clinical studies.