Department of Hematology and Medical Oncology, Emory University, Atlanta, Georgia 30322, USA.
Oncologist. 2013;18(5):600-10. doi: 10.1634/theoncologist.2012-0480. Epub 2013 May 1.
Disparity exists between patients with lung cancer enrolled in clinical trials and patients treated in the community setting. This study assessed the real-world effectiveness of cytotoxic agents that became available for the treatment of non-small cell lung cancer (NSCLC) in the last 2 decades.
We employed the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database for patients diagnosed with stage IIIB/IV NSCLC between 1988 and 2005 to assess the effectiveness of newly approved agents. Effectiveness of specific agents was assessed at time periods immediately following the approval of the agent for NSCLC: baseline, 1988-1994; platinum, 1995-1999; docetaxel, 1999-2003; pemetrexed and bevacizumab, 2004-2005. Significant associations between specific drug treatment and survival improvement were determined using the Kaplan-Meier method, Cox proportional hazard model, and propensity score analyses. Significant differences were established by log-rank test.
This analysis employed data from 143,548 patients by sex (58% male, 42% female), cancer stage (35% stage IIIB, 65% stage IV), and age (12% 20-64 years, 22% 65-69 years, 45% 70-79 years, 22% 80 years and older). There was temporal improvement in survival for patients treated with newly approved chemotherapy (1-year survival rates: 32.41% in 1988-1994, 32.95% in 1995-1998, 37.40% in 1999-2003, and 39.55% in 2004-2005). Patients treated with a newly approved drug during the relevant treatment era had a significant reduction in the risk of death when compared with patients treated with chemotherapy other than the newly approved agent (hazard ratios [95% confidence interval] were 0.76 [0.71-0.81] for platinum, 0.73 [0.70-0.75] for docetaxel, 0.40 [0.37-0.44] for pemetrexed, and 0.33 [0.27-0.40] for bevacizumab; p < .001). Propensity score adjustment did not significantly alter these results.
Currently approved drugs for the treatment of advanced NSCLC are associated with improved survival in the U.S. Medicare patient population. Our findings support the effectiveness of these agents in the real-world oncology practice.
在临床试验中入组的肺癌患者与在社区环境中接受治疗的患者之间存在差异。本研究评估了过去 20 年中可用于治疗非小细胞肺癌（NSCLC）的细胞毒性药物的真实世界疗效。
我们利用了链接的监测、流行病学和最终结果（SEER）-医疗保险数据库，对 1988 年至 2005 年间诊断为 IIIB/IV 期 NSCLC 的患者进行了评估，以评估新批准药物的疗效。在药物获得 NSCLC 批准后的特定时间段内评估特定药物的有效性：基线期，1988-1994 年；铂类药物，1995-1999 年；多西他赛，1999-2003 年；培美曲塞和贝伐单抗，2004-2005 年。使用 Kaplan-Meier 方法、Cox 比例风险模型和倾向评分分析确定特定药物治疗与生存改善之间的显著关联。通过对数秩检验确定显著差异。
本分析通过性别（58%为男性，42%为女性）、癌症分期（35%为 IIIB 期，65%为 IV 期）和年龄（12%为 20-64 岁，22%为 65-69 岁，45%为 70-79 岁，22%为 80 岁及以上）对来自 143548 名患者的数据进行了评估。接受新批准化疗的患者的生存时间有所延长（1 年生存率：1988-1994 年为 32.41%，1995-1998 年为 32.95%，1999-2003 年为 37.40%，2004-2005 年为 39.55%）。与接受新批准药物以外的化疗药物治疗的患者相比，在相关治疗期间接受新批准药物治疗的患者的死亡风险显著降低（风险比[95%置信区间]分别为 0.76 [0.71-0.81] 用于铂类药物，0.73 [0.70-0.75] 用于多西他赛，0.40 [0.37-0.44] 用于培美曲塞，0.33 [0.27-0.40] 用于贝伐单抗；p<0.001）。倾向评分调整并没有显著改变这些结果。
目前批准用于治疗晚期 NSCLC 的药物在美国医疗保险患者人群中与生存改善相关。我们的发现支持这些药物在真实世界肿瘤学实践中的有效性。
