Ardin Camille, Humez Sarah, Leroy Vincent, Ampere Alexandre, Bordier Soraya, Escande Fabienne, Turlotte Amélie, Stoven Luc, Nunes David, Cortot Alexis, Gauvain Clément
Service de Pneumologie-Oncologie Thoracique, Institut Cœur Poumon, Lille University Hospital, Boulevard du Professeur Jules Leclercq, Lille 59037, France.
Service d'anatomo-pathologie, Lille University Hospital, Lille, France.
Ther Adv Med Oncol. 2023 Sep 13;15:17588359231195600. doi: 10.1177/17588359231195600. eCollection 2023.
The optimal duration of immune checkpoint inhibitor (ICI) treatment for patients with advanced non-small cell lung cancer (NSCLC) remains to be determined. Treatment durations in cornerstone phase 3 clinical trials vary between a fixed 2-year duration and pursuit until disease progression. Clinical practices may thus differ according to the attending physician.
Here we provide real-world data about treatment decisions at 2 years, with subsequent clinical outcomes.
This multicentric observational study included patients with advanced NSCLC whose disease was controlled after 2 years of pembrolizumab or nivolumab. The primary outcome was the decision to discontinue ICI treatment or not, along with factors motivating this decision. Secondary outcomes included progression-free survival (PFS) (according to treatment continuation or not) and adverse events.
A total of 91 patients were included, of which 60 (66%) had been pre-treated. The programmed death-ligand 1 expression level was ⩾50% in 43 patients (47%). In 61 patients (67%), ICI was continued after 2 years of treatment. This decision was significantly associated with the care center ( < 0.001) but neither with the tumor response at 2 years, as evaluated by CT scan or PET scan, nor with clinical status, immune-related adverse events, or previous locally treated oligo-progressive disease under ICI. Two years after the 2-year decision, PFS was 68.5%, [95% confidence interval (CI) (53.3-88.0)] in the 'ICI discontinuation' group and 64.1% [95% CI (51.9-79.2)] in the 'ICI pursuit' group; hazard ratio for relapse was 1.14 [95% CI (0.54-2.30), = 0.77]. The overall survival rate at 24 months after discontinuation was 89.2% [95% CI (78.4-100)] for the 'discontinuation' group and 93.1% [95% CI (85.8-100)] for the 'pursuit' group. Given insufficient power, overall survival could not be compared.
The decision to continue ICI or not after 2 years of treatment depends mainly on the care center and does not seem to impact survival. Larger, randomized data sets are required to confirm this result.
晚期非小细胞肺癌（NSCLC）患者免疫检查点抑制剂（ICI）治疗的最佳持续时间仍有待确定。关键的3期临床试验中的治疗持续时间在固定的2年和直至疾病进展之间有所不同。因此，临床实践可能因主治医生而异。
在此，我们提供关于2年时治疗决策及后续临床结果的真实世界数据。
这项多中心观察性研究纳入了在接受帕博利珠单抗或纳武利尤单抗治疗2年后疾病得到控制的晚期NSCLC患者。主要结局是是否决定停止ICI治疗以及促使该决定的因素。次要结局包括无进展生存期（PFS）（根据是否继续治疗）和不良事件。
共纳入91例患者，其中60例（66%）曾接受过预处理。43例患者（47%）程序性死亡配体1表达水平≥50%。61例患者（67%）在治疗2年后继续接受ICI治疗。这一决定与护理中心显著相关（<0.001），但与通过CT扫描或PET扫描评估的2年时肿瘤反应无关，也与临床状态、免疫相关不良事件或先前在ICI治疗下局部治疗的寡进展性疾病无关。在做出2年决策后的2年，“ICI停药”组的PFS为68.5%，[95%置信区间（CI）（53.3 - 88.0）]，“ICI继续治疗”组为64.1% [95% CI（51.9 - 79.2）]；复发风险比为1.14 [95% CI（0.54 - 2.30），P = 0.77]。停药后24个月时，“停药”组的总生存率为89.2% [95% CI（78.4 - 100）]，“继续治疗”组为93.1% [95% CI（85.8 - 100）]。由于检验效能不足，无法比较总生存率。
治疗2年后是否继续ICI治疗的决定主要取决于护理中心，且似乎不影响生存率。需要更大规模的随机数据集来证实这一结果。
