Department of Medical Oncology, Centre Hospitalier Universitaire Nantes, Nantes University, Nantes, France.
Nantes Université, CHU Nantes, Pôle Hospitalo-Universitaire 11: Santé Publique, Clinique des données, INSERM, Nantes, France.
Clin Lung Cancer. 2024 Mar;25(2):e101-e111.e2. doi: 10.1016/j.cllc.2023.11.009. Epub 2023 Nov 23.
First-line chemotherapy plus immunotherapy (CT-IO) has recently demonstrated survival benefits over CT alone in extensive-stage small-cell lung cancer (ES-SCLC), based on randomized phase III studies. This retrospective multicenter study assessed the real-world use and effectiveness of CT-IO in ES-SCLC patients.
All newly diagnosed ES-SCLC patients from 4 French hospitals treated with CT alone or CT-IO between May 2020 and December 2021 were included. Overall survival (OS) and real-world progression-free survival (rwPFS) were estimated using the Kaplan-Meier method. Cox proportional hazard models were performed to estimate hazard ratios (HRs) with 95 % confidence intervals (CIs) in univariate and multivariate models. The aim was not to compare efficacy between groups.
Among 104 patients, 75 (72.1%) received CT-IO. Brain metastases were diagnosed in 28.3% of patients, and 29.8% were performance status (PS) ≥ 2. At a median follow-up of 16.8 months (95%CI, 14.9-23.4), the median OS was 11.4 months (95%CI, 7.7-14.7) in the CT-IO group, and the 12-month OS rate was 43.6% (95%CI, 33.3-57.2). In the CT group, the median OS was 7.8 months (95%CI, 5.4-11.8) and the 12-month OS rate was 15.3% (95%CI, 5.7-41.0). In multivariate analyses, baseline brain and liver metastases were associated with a shorter OS for patients treated in the CT-IO group (HR, 3.80 [95%CI, 1.90-7.60] and 3.12 [95%CI, 1.60-6.08] respectively; P < 0.001 for both).
We showed that clinicians have chosen to use IO beyond the specific criteria defined in guidelines. Survival data appeared promising with a median OS comparable to the one previously demonstrated in clinical trials.
基于随机 III 期研究,一线化疗联合免疫治疗(CT-IO)在广泛期小细胞肺癌(ES-SCLC)中较单独化疗显示出生存获益。本回顾性多中心研究评估了 CT-IO 在 ES-SCLC 患者中的真实世界应用和疗效。
纳入了 2020 年 5 月至 2021 年 12 月期间,4 家法国医院接受单独化疗或 CT-IO 治疗的所有新诊断的 ES-SCLC 患者。采用 Kaplan-Meier 法估计总生存期(OS)和真实世界无进展生存期(rwPFS)。使用单因素和多因素模型中的 Cox 比例风险模型估计风险比(HR)及其 95%置信区间(CI)。本研究的目的不是比较两组之间的疗效。
在 104 例患者中,75 例(72.1%)接受了 CT-IO。28.3%的患者诊断为脑转移,29.8%的患者表现状态(PS)≥2。在中位随访 16.8 个月(95%CI,14.9-23.4)时,CT-IO 组的中位 OS 为 11.4 个月(95%CI,7.7-14.7),12 个月 OS 率为 43.6%(95%CI,33.3-57.2)。在 CT 组中,中位 OS 为 7.8 个月(95%CI,5.4-11.8),12 个月 OS 率为 15.3%(95%CI,5.7-41.0)。在多因素分析中,基线脑和肝转移与 CT-IO 组患者的 OS 更短相关(HR,3.80 [95%CI,1.90-7.60]和 3.12 [95%CI,1.60-6.08];均 P<0.001)。
我们表明,临床医生已经选择在指南中定义的特定标准之外使用 IO。生存数据似乎很有希望,中位 OS 与临床试验中先前证明的结果相当。