Meyers Daniel E, Pasternak Meghann, Dolter Samantha, Grosjean Heidi A I, Lim Chloe A, Stukalin Igor, Goutam Siddhartha, Navani Vishal, Heng Daniel Y C, Cheung Winson Y, Morris Don G, Pabani Aliyah
Department of Oncology, University of Calgary, Calgary, Alberta, Canada.
Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
JTO Clin Res Rep. 2023 Feb 24;4(4):100482. doi: 10.1016/j.jtocrr.2023.100482. eCollection 2023 Apr.
Landmark trials testing immune checkpoint inhibitors (ICIs) in advanced NSCLC are difficult to extrapolate to real-world practice given the exclusion of patients with poor (i.e., ≥2) Eastern Cooperative Oncology Group performance status (ECOG PS). We sought to evaluate the impact of ECOG PS on clinical outcomes and health care utilization in patients with NSCLC treated with ICIs in real-world practice.
Patients with advanced NSCLC who received at least one dose of pembrolizumab or nivolumab were retrospectively identified from the Alberta Immunotherapy Database. The primary outcome was median overall survival, as stratified by ECOG PS. Secondary outcomes included median time-to-treatment failure and metrics of health care utilization, including emergency department visits, hospitalizations, and death in hospital.
A total of 790 patients were included, with 29.2% having poor ECOG PS at initiation of ICI. These patients had significantly lower median overall survival (3.3 versus 13.4 mo) and median time-to-treatment failure (1.4 versus 4.9 mo) compared with those with favorable ECOG PS ( < 0.0001 for both outcomes). Patients with poor ECOG PS were also more likely to present to the emergency department, be admitted to the hospital, and die in the hospital during their first admission (risk ratio = 1.6, 2.3-2.7, < 0.001).
Patients with NSCLC with poor ECOG PS treated with ICI had significantly worse survival outcomes and were significantly more likely to use health care services than those with favorable ECOG PS. The large proportion of patients with poor ECOG PS further justifies the urgent need for randomized trials evaluating the efficacy of ICI in this high-risk population.
鉴于排除了东部肿瘤协作组体能状态(ECOG PS)较差(即≥2)的患者,在晚期非小细胞肺癌(NSCLC)中测试免疫检查点抑制剂(ICI)的里程碑式试验难以外推至实际临床实践。我们试图评估ECOG PS对在实际临床实践中接受ICI治疗的NSCLC患者临床结局和医疗资源利用的影响。
从艾伯塔省免疫治疗数据库中回顾性识别接受至少一剂派姆单抗或纳武单抗的晚期NSCLC患者。主要结局为按ECOG PS分层的中位总生存期。次要结局包括中位治疗失败时间和医疗资源利用指标,包括急诊就诊、住院和院内死亡。
共纳入790例患者,29.2%在开始ICI治疗时ECOG PS较差。与ECOG PS良好的患者相比,这些患者的中位总生存期(3.3个月对13.4个月)和中位治疗失败时间(1.4个月对4.9个月)显著更短(两个结局均P<0.0001)。ECOG PS较差的患者在首次住院期间也更有可能前往急诊、入院和在院内死亡(风险比分别为1.6、2.3至2.7,P<0.001)。
与ECOG PS良好的患者相比,接受ICI治疗的ECOG PS较差的NSCLC患者生存结局显著更差,且使用医疗服务的可能性显著更高。ECOG PS较差的患者比例很大,这进一步证明迫切需要开展随机试验来评估ICI在这一高危人群中的疗效。