Assié Jean-Baptiste, Grumberg Valentine, Reynaud Dorothée, Gaudin Anne-Françoise, Batisse Alexandre, Jolivel Ronan, Jouaneton Baptiste, Cotté François-Emery, Chouaïd Christos
Functional Genomics of Solid Tumors Laboratory, Centre de Recherche des Cordeliers, INSERM, Sorbonne Université, Université de Paris, Paris, France; Centre Hospitalier Intercommunal Créteil, Créteil, France.
Bristol Myers Squibb France, 3 rue Joseph Monier, Rueil-Malmaison 92500, France; Oncostat - U1018, INSERM, Paris Saclay University, "Ligue Contre le Cancer" Labeled Team, Villejuif, France.
Respir Med Res. 2023 Nov;84:101051. doi: 10.1016/j.resmer.2023.101051. Epub 2023 Oct 6.
Data on long-term survivors with advanced non-small-cell lung cancer (NSCLC) treated with nivolumab are available from randomized trials. Characteristics, management, and healthcare resources of those patients need to be confirmed with real-world data.
The UNIVOC retrospective observational study included all patients with advanced NSCLC recorded in the French national hospital database starting nivolumab in 2015 and followed them until December 2020. The Kaplan-Meier method estimated the overall survival (OS). A machine learning approach identified patients with similar treatment sequences.
Within the 3,050 patients who had nivolumab initiation,5-year OS rate was 14.6 % (95 %CI 13.3 %-16.2 %). In total, data covering at least 5 years of follow-up were retrieved for 231 surviving patients. Survivors were younger, often female and had fewer comorbidities than non-survivors. Three clusters of patients with different nivolumab treatment durations were identified: 1/ Continuous nivolumab treatment; 2/ Long period of nivolumab treatment followed by chemotherapy or no treatment; 3/ Short period of nivolumab treatment then chemotherapy or no treatment. At 5 years, 61.0 % of survivors were no longer receiving systemic therapy, 26.4 % were treated with nivolumab, 8.7 % chemotherapy, and 3.9 % other immunotherapies. Among 5-y survivor patients, the average number of hospitalisations per patient decreased from 23.4 to 12.8 between the 1st and the 5th year. In the 5th year, 46 % of patients had no more hospitalization for lung cancer.
This large nationwide study confirms the long-term benefit of nivolumab treatment for advanced NSCLC patients in the real-world setting, with a 5-year survival rate similar to that reported in clinical trials.
关于接受纳武利尤单抗治疗的晚期非小细胞肺癌（NSCLC）长期幸存者的数据可从随机试验中获得。这些患者的特征、管理和医疗资源需要通过真实世界数据来证实。
UNIVOC回顾性观察研究纳入了2015年开始在法国国家医院数据库中记录的所有开始使用纳武利尤单抗的晚期NSCLC患者，并对他们进行随访直至2020年12月。采用Kaplan-Meier方法估计总生存期（OS）。一种机器学习方法识别出具有相似治疗序列的患者。
在3050例开始使用纳武利尤单抗的患者中，5年总生存率为14.6%（95%CI 13.3%-16.2%）。总共为231例存活患者检索到了至少5年的随访数据。与未存活者相比，存活者更年轻，女性居多，合并症较少。识别出了三组纳武利尤单抗治疗持续时间不同的患者：1/持续使用纳武利尤单抗治疗；2/长时间使用纳武利尤单抗治疗后进行化疗或不进行治疗；3/短时间使用纳武利尤单抗治疗后进行化疗或不进行治疗。5年时，61.0%的存活者不再接受全身治疗，26.4%接受纳武利尤单抗治疗，8.7%接受化疗，3.9%接受其他免疫治疗。在5年存活患者中，每位患者的平均住院次数在第1年至第5年期间从23.4次降至12.8次。在第5年，46%的患者因肺癌不再住院。
这项大型全国性研究证实了在真实世界中纳武利尤单抗治疗晚期NSCLC患者的长期益处，5年生存率与临床试验报告的相似。
