Calpe-Armero Pablo, Ferriols-Lisart Rafael, Ferriols-Lisart Francisco, Pérez-Pitarch Alejandro
Pharmacy Department, University Clinical Hospital of Valencia, Valencia, Spain.
Chemotherapy. 2017;62(6):374-380. doi: 10.1159/000475803. Epub 2017 Oct 19.
To evaluate the effectiveness of nivolumab as second-line treatment compared to standard therapy with docetaxel in adult patients with non-small cell lung cancer (NSCLC) in clinical practice.
This is an observational, retrospective cohort study of adult patients diagnosed with NSCLC, stage III-IV, treated with docetaxel or nivolumab as second-line treatment. The end points evaluated were overall survival (OS) and progression-free survival (PFS). PFS and OS were described using the Kaplan-Meier method. The Cox proportional hazards model was applied to identify independent prognostic and predictive factors related to disease progression or death.
Thirty-three patients were included in this study (i.e., 14 in the nivolumab group and 19 in the docetaxel group). Nonsquamous NSCLC was the most frequent histological subtype. Cohorts were homogeneous. The follow-up time was 116 ± 87.3 days. The median PFS was 84 days (95% CI 39-300) for patients treated with nivolumab and 61 days (95% CI 48-76) for patients treated with docetaxel. The risk of progression was 60% lower for patients treated with nivolumab (HR 0.40; 95% CI 0.16-0.97; p = 0.043) compared to patients receiving docetaxel. Among the patients treated with docetaxel, the median OS was 129 days (95% CI 106-300). More than 50% of the patients treated with nivolumab were alive at the end of the follow-up period; nevertheless, the risk difference was not statistically significant (HR 0.55; 95% CI 0.20-1.51; p = 0.244).
NSCLC patients treated with nivolumab as second-line therapy had a longer PFS compared to patients treated with docetaxel in a health care environment.
在临床实践中，评估与多西他赛标准治疗相比，纳武单抗作为二线治疗在成年非小细胞肺癌（NSCLC）患者中的有效性。
这是一项针对诊断为Ⅲ-Ⅳ期NSCLC的成年患者的观察性、回顾性队列研究，这些患者接受多西他赛或纳武单抗作为二线治疗。评估的终点为总生存期（OS）和无进展生存期（PFS）。采用Kaplan-Meier方法描述PFS和OS。应用Cox比例风险模型来识别与疾病进展或死亡相关的独立预后和预测因素。
本研究纳入了33例患者（即纳武单抗组14例，多西他赛组19例）。非鳞状NSCLC是最常见的组织学亚型。各队列具有同质性。随访时间为116±87.3天。接受纳武单抗治疗的患者中位PFS为84天（95%CI 39-300），接受多西他赛治疗的患者中位PFS为61天（95%CI 48-76）。与接受多西他赛治疗的患者相比，接受纳武单抗治疗的患者疾病进展风险降低60%（HR 0.40；95%CI 0.16-0.97；p = 0.043）。在接受多西他赛治疗的患者中，中位OS为129天（95%CI 106-300）。超过50%接受纳武单抗治疗的患者在随访期结束时仍存活；然而，风险差异无统计学意义（HR 0.55；95%CI 0.20-1.51；p = 0.244）。
在医疗环境中，与接受多西他赛治疗的患者相比，接受纳武单抗二线治疗的NSCLC患者PFS更长。
