Li Pengxiang, Wong Yu-Ning, Armstrong Katrina, Haas Naomi, Subedi Prasun, Davis-Cerone Margaret, Doshi Jalpa A
Division of General Internal Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Leonard Davis Institute of Health Economics, Philadelphia, Pennsylvania.
Cancer Med. 2016 Feb;5(2):169-81. doi: 10.1002/cam4.574. Epub 2015 Dec 8.
Between December 2005 and October 2009, FDA approved six targeted therapies shown to significantly extend survival for advanced renal cell carcinoma (RCC) patients in clinical trials. This study aimed to examine changes in survival between the pretargeted and targeted therapy periods in advanced RCC patients in a real-world setting. Utilizing the 2000-2010 SEER Research files, a pre-post study design with a contemporaneous comparison group was employed to examine differences in survival outcomes for patients diagnosed with advanced RCC (study group) or advanced prostate cancer (comparison group, for whom no significant treatment innovations happened during this period) across the pretargeted therapy era (2000-2005) and the targeted therapy era (2006-2010). RCC patients diagnosed in the targeted therapy era (N = 6439) showed improved survival compared to those diagnosed in the pretargeted therapy era (N = 7231, hazard ratio (HR) for all-cause death: 0.86, P < 0.01), while the change between the pre-post periods was not significant for advanced prostate cancer patients (HR: 0.97, P = 0.08). Advanced RCC patients had significantly larger improvements in overall survival compared to advanced prostate cancer patients (z = 4.31; P < 0.01). More detailed year-to-year analysis revealed greater survival improvements for RCC in the later years of the posttargeted period. Similar results were seen for cause-specific survival. Subgroup analyses by nephrectomy status, age, and gender showed consistent findings. Patients diagnosed with advanced RCC during the targeted therapy era had better survival outcomes than those diagnosed during the pretargeted therapy era. Future studies should examine the real-world survival improvements directly associated with targeted therapies.
2005年12月至2009年10月期间,美国食品药品监督管理局(FDA)批准了6种靶向疗法,这些疗法在临床试验中显示可显著延长晚期肾细胞癌(RCC)患者的生存期。本研究旨在探讨在现实环境中晚期RCC患者在靶向治疗前和靶向治疗期间的生存变化。利用2000 - 2010年监测、流行病学和最终结果(SEER)研究文件,采用带有同期对照组的前后研究设计,以检验在靶向治疗前时代(2000 - 2005年)和靶向治疗时代(2006 - 2010年)被诊断为晚期RCC的患者(研究组)或晚期前列腺癌患者(对照组,在此期间没有重大治疗创新)的生存结局差异。与在靶向治疗前时代被诊断的患者(N = 7231)相比,在靶向治疗时代被诊断的RCC患者(N = 6439)生存期有所改善(全因死亡风险比(HR):0.86,P < 0.01),而晚期前列腺癌患者前后期间的变化不显著(HR:0.97,P = 0.08)。与晚期前列腺癌患者相比,晚期RCC患者的总生存期改善显著更大(z = 4.31;P < 0.01)。更详细的逐年分析显示,在靶向治疗后时期的后期,RCC患者的生存期改善更大。特定病因生存期也观察到类似结果。按肾切除术状态、年龄和性别进行的亚组分析显示结果一致。在靶向治疗时代被诊断为晚期RCC的患者比在靶向治疗前时代被诊断的患者有更好的生存结局。未来的研究应考察与靶向疗法直接相关的现实环境中的生存期改善情况。