Barlesi Fabrice, Dixmier Adrien, Debieuvre Didier, Raspaud Christophe, Auliac Jean-Bernard, Benoit Nicolas, Bombaron Pierre, Moro-Sibilot Denis, Audigier-Valette Clarisse, Asselain Bernard, Egenod Thomas, Rabeau Audrey, Fayette Jérôme, Sanchez Myriam Locatelli, Labourey Jean-Luc, Westeel Virginie, Lamoureux Pauline, Cotte François-Emery, Allan Victoria, Daumont Melinda, Dumanoir Juliette, Reynaud Dorothée, Calvet Christophe Yannick, Ozan Nicolas, Pérol Maurice
CNRS, INSERM, CRCM, Assistance Publique Hôpitaux de Marseille, Hopital Nord, Pavillon Mistral, 6ème Étage A, Chemin des Bourrely, Aix Marseille University, Marseille, France.
Department of Pulmonology, Centre Hospitalier Régional d'Orléans, Orléans, France.
Oncoimmunology. 2020 Apr 12;9(1):1744898. doi: 10.1080/2162402X.2020.1744898.
EVIDENS is an ongoing, prospective, non-interventional study evaluating the effectiveness and safety of nivolumab in lung cancer patients in France (ClinicalTrials.gov NCT03382496). Adults with a pathologically confirmed diagnosis of lung cancer and initiating treatment with nivolumab were recruited from 146 sites in France. This analysis included only patients with non-small cell lung cancer (NSCLC) who received ≥1 nivolumab infusion, and evaluated patient characteristics at the time of nivolumab initiation and its effectiveness and safety after a median follow-up of 18 months. A total of 1,420 patients with NSCLC were included, most of whom had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 (82.9%), non-squamous histology (69.2%) and stage IV disease (91.4%). Brain metastases were present in 19.9% of patients. Nivolumab was a second-line or ≥third-line regimen in 73.6% and 26.1% of patients, respectively. Almost all patients had prior chemotherapy (99.7%). Median overall survival was 11.2 months (95% confidence interval [CI]: 10.0-12.4). ECOG PS, smoking status, corticosteroids at baseline, epidermal growth factor receptor mutation status, presence of symptomatic brain metastases and treatment-related adverse events (TRAEs) were independent predictors of survival. Grade 3 and 4 TRAEs were reported in 105 (7.4%) and 12 (0.8%) patients, respectively; no treatment-related deaths were reported. Preliminary results of the EVIDENS study confirm the effectiveness and safety of nivolumab, mostly in pre-treated advanced NSCLC patients, with similar benefits to those observed in the phase III randomized clinical trials, despite a broader study population.
EVIDENS是一项正在进行的前瞻性非干预性研究，旨在评估纳武利尤单抗在法国肺癌患者中的有效性和安全性（ClinicalTrials.gov标识符：NCT03382496）。在法国的146个地点招募了经病理确诊为肺癌并开始接受纳武利尤单抗治疗的成年人。该分析仅纳入接受了≥1次纳武利尤单抗输注的非小细胞肺癌（NSCLC）患者，并评估了纳武利尤单抗开始使用时的患者特征及其在中位随访18个月后的有效性和安全性。总共纳入了1420例NSCLC患者，其中大多数患者的东部肿瘤协作组体能状态（ECOG PS）为0 - 1（82.9%），非鳞状组织学类型（69.2%），疾病分期为IV期（91.4%）。19.9%的患者存在脑转移。纳武利尤单抗分别是73.6%和26.1%患者的二线或≥三线治疗方案。几乎所有患者都接受过先前的化疗（99.7%）。中位总生存期为11.2个月（95%置信区间[CI]：10.0 - 12.4）。ECOG PS、吸烟状态、基线时的皮质类固醇使用情况、表皮生长因子受体突变状态、有症状脑转移的存在以及治疗相关不良事件（TRAEs）是生存的独立预测因素。分别有105例（7.4%）和12例（0.8%）患者报告了3级和4级TRAEs；未报告与治疗相关的死亡。EVIDENS研究的初步结果证实了纳武利尤单抗的有效性和安全性，主要体现在先前接受过治疗的晚期NSCLC患者中，尽管研究人群更广泛，但与III期随机临床试验中观察到的益处相似。
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