Orsi C, Bartolozzi B, Messori A, Bosi A
Laboratory of Pharmacoeconomis, Pharmaceutical Service, Azienda Ospedaliera Universitaria, Careggi, Firenze, Italy.
Bone Marrow Transplant. 2007 Oct;40(7):643-9. doi: 10.1038/sj.bmt.1705790. Epub 2007 Jul 30.
Allogeneic transplantation in patients with acute lymphoblastic leukaemia in first remission (ALL-CR1) has been studied in several clinical trials. However, no pooled survival analysis has yet been done. We conducted a survival meta-analysis to compare allogeneic transplantation vs chemotherapy or autologous transplantation using an intention-to-treat approach. Our study included the controlled clinical trials, wherein allocation to allogeneic transplant was based on donor availability. The event-free individual survival data were reconstructed on the basis of published information and Kaplan-Meier graphs. We then generated the meta-analytic event-free survival curves for the two treatments. The mean survival gain per patient was estimated and a simplified cost-effectiveness assessment was carried out. In the allogeneic transplantation group, 293 patients were examined and 479 as controls (four trials). The event-free survival difference was statistically significant (P=0.011). The relative risk for event occurrence was 0.79 for the experimental group vs the controls (95% CI: 0.66-0.96; P=0.017). The mean survival gain was 1 year per patient. The cost per life-year gained was less than the conventional threshold of 50,000 euros. Allogeneic transplantation in ALL-CR1 improves event-free survival as compared to chemotherapy or autologous transplantation. Its cost-effectiveness profile is acceptable.
多项临床试验对首次缓解期急性淋巴细胞白血病(ALL-CR1)患者进行了异基因移植研究。然而,尚未进行汇总生存分析。我们采用意向性分析方法进行了一项生存荟萃分析,以比较异基因移植与化疗或自体移植的效果。我们的研究纳入了对照临床试验,其中异基因移植的分配基于供体可用性。根据已发表的信息和Kaplan-Meier曲线重建了无事件个体生存数据。然后,我们生成了两种治疗方法的荟萃分析无事件生存曲线。估计了每位患者的平均生存获益,并进行了简化的成本效益评估。在异基因移植组中,检查了293例患者,479例作为对照(四项试验)。无事件生存差异具有统计学意义(P = 0.011)。实验组与对照组相比,事件发生的相对风险为0.79(95%CI:0.66 - 0.96;P = 0.017)。每位患者的平均生存获益为1年。获得每生命年的成本低于50,000欧元的传统阈值。与化疗或自体移植相比,ALL-CR1患者进行异基因移植可改善无事件生存。其成本效益情况是可以接受的。