Juergens R A, Mariano C, Jolivet J, Finn N, Rothenstein J, Reaume M N, Faghih A, Labbé C, Owen S, Shepherd F A, Villeneuve J, Romeyer F, Pettersson F, Butts C
Juravinski Cancer Centre, Hamilton, ON.
Royal Columbian Hospital, New Westminster, BC.
Curr Oncol. 2018 Dec;25(6):384-392. doi: 10.3747/co.25.4287. Epub 2018 Dec 1.
Nivolumab was the first immuno-oncology agent available for the treatment of lung cancer in Canada. In the present study, we evaluated the real-world benefit of nivolumab in Canadian patients with lung cancer.
Patients included in the cohort were identified from a registry of patients treated through expanded access to nivolumab before and after Health Canada approval. Demographics were collected from the application forms. Outcome data for the duration of treatment and survival were collected retrospectively.
In contrast to the randomized clinical trial populations, our study cohort included patients who were older (median age: 66 years; range: 36-92 years) and who had an Eastern Cooperative Oncology Group performance status of 2 (8.9%). Despite the poorer-prognosis cohort, median overall survival was 12.0 months, which is comparable to the survival demonstrated in the randomized phase iii trials of nivolumab in lung cancer. Median time to treatment discontinuation was 3.45 months and was similar for all patient subgroups, including poorer-prognosis groups such as those with a performance status of 2, those 75 years of age and older, and those with brain metastases.
Nivolumab given in a real-world clinical setting was associated with results similar to those reported in the phase iii clinical trial setting.
纳武单抗是加拿大首个可用于治疗肺癌的免疫肿瘤药物。在本研究中，我们评估了纳武单抗在加拿大肺癌患者中的实际疗效。
队列中的患者来自加拿大卫生部批准前后通过扩大纳武单抗使用范围进行治疗的患者登记册。人口统计学数据从申请表中收集。治疗持续时间和生存的结局数据进行回顾性收集。
与随机临床试验人群不同，我们的研究队列包括年龄较大的患者（中位年龄：66岁；范围：36 - 92岁）以及东部肿瘤协作组体能状态为2的患者（8.9%）。尽管该队列预后较差，但中位总生存期为12.0个月，这与纳武单抗治疗肺癌的随机III期试验中显示的生存期相当。治疗中断的中位时间为3.45个月，所有患者亚组均相似，包括预后较差的组，如体能状态为2的患者、75岁及以上的患者以及有脑转移的患者。
在实际临床环境中使用纳武单抗的结果与III期临床试验环境中报告的结果相似。
