Department of Drug Economics, National Health Fund, Central Office, Warsaw, Poland.
Division of Quality Services, Procedures and Medical Standards, Medical University of Łódź, Łódź, Poland.
Med Sci Monit. 2019 May 23;25:3846-3853. doi: 10.12659/MSM.914517.
BACKGROUND This study aimed to undertake an analysis of ten years of real-world evidence (RWE) on overall survival (OS) following treatment of advanced gastrointestinal stromal tumor (GIST) with imatinib, sunitinib, and sorafenib using data from the Polish National Health Fund. MATERIAL AND METHODS Data from the Polish National Health Fund, the sole Polish public payer, identified 1,641 patients with advanced GIST who were treated with imatinib (n=1047), sunitinib (n=457), and sorafenib (n=137). The differences in overall survival (OS) were analyzed. RESULTS For patients with advanced GIST, the median follow-up time for patients treated with imatinib was 71 months (95% CI, 64.8-79.2), the median OS was 56.9 months (95% CI, 50.4-61.2), with survival at 12 months (89.5%), 24 months (77.9%), 36 months (66.9%), and 60 months (48.4%). The median follow-up time for patients treated with sunitinib was 41.4 months (95% CI, 34.6-49.3), the median OS was 22.8 months (95% CI, 19.2-26.8), with survival at 12 months (68.2%), 24 months (47.1%), and 36 months (31%). The median follow-up time for patients treated with sorafenib was 17.4 months (95% CI, 14.6-22.9), the median OS was 16.9 months (95% CI, 13.7-24.3), with survival at 12 months (61.9%), at 24 months (36.2%), and at 36 months (16.8%). CONCLUSIONS Real-world data collected in a ten-year period confirmed the effectiveness of the use of imatinib, sunitinib, or sorafenib for the treatment of advanced GIST and was comparable with the findings from clinical trials.
本研究旨在利用波兰国家卫生基金的数据,对伊马替尼、舒尼替尼和索拉非尼治疗晚期胃肠道间质瘤(GIST)患者的总生存(OS)进行长达十年的真实世界证据(RWE)分析。
波兰国家卫生基金是波兰唯一的公共支付方,其数据涵盖了 1641 名接受伊马替尼(n=1047)、舒尼替尼(n=457)和索拉非尼(n=137)治疗的晚期 GIST 患者。分析了总生存(OS)的差异。
对于晚期 GIST 患者,接受伊马替尼治疗的患者中位随访时间为 71 个月(95%CI,64.8-79.2),中位 OS 为 56.9 个月(95%CI,50.4-61.2),12 个月(89.5%)、24 个月(77.9%)、36 个月(66.9%)和 60 个月(48.4%)的生存率。接受舒尼替尼治疗的患者中位随访时间为 41.4 个月(95%CI,34.6-49.3),中位 OS 为 22.8 个月(95%CI,19.2-26.8),12 个月(68.2%)、24 个月(47.1%)和 36 个月(31%)的生存率。接受索拉非尼治疗的患者中位随访时间为 17.4 个月(95%CI,14.6-22.9),中位 OS 为 16.9 个月(95%CI,13.7-24.3),12 个月(61.9%)、24 个月(36.2%)和 36 个月(16.8%)的生存率。
在长达十年的时间里收集的真实世界数据证实了伊马替尼、舒尼替尼或索拉非尼治疗晚期 GIST 的有效性,与临床试验结果相当。