一项关于度伐利尤单抗用于不可切除的 III 期非小细胞肺癌同步或序贯放化疗后的真实世界、多中心、观察性回顾性研究。
A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer.
作者信息
Bruni Alessio, Scotti Vieri, Borghetti Paolo, Vagge Stefano, Cozzi Salvatore, D'Angelo Elisa, Giaj Levra Niccolò, Fozza Alessandra, Taraborrelli Maria, Piperno Gaia, Vanoni Valentina, Sepulcri Matteo, Trovò Marco, Nardone Valerio, Lattanzi Elisabetta, Bou Selman Said, Bertolini Federica, Franceschini Davide, Agustoni Francesco, Jereczek-Fossa Barbara Alicja, Magrini Stefano Maria, Livi Lorenzo, Lohr Frank, Filippi Andrea Riccardo
机构信息
Radiotherapy Unit, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.
Department of Oncology, Radiation Therapy Unit, Careggi University Hospital, Florence, Italy.
出版信息
Front Oncol. 2021 Sep 28;11:744956. doi: 10.3389/fonc.2021.744956. eCollection 2021.
INTRODUCTION
For unresectable stage III non-small cell lung cancer (NSCLC), the standard therapy consists of chemoradiotherapy (CRT) followed by durvalumab maintenance for responding patients. The present study reports on the safety and outcome of durvalumab use after CRT in a real-world, multicenter, retrospective cohort.
METHODS
Two hundred thirty-eight patients have been included. We collected data on systemic therapy, radiation therapy, the timing between CRT and durvalumab, number of durvalumab cycles, reasons for non-starting or discontinuation, incidence and grade of adverse events (AEs), and progression-free survival (PFS) and overall survival (OS).
RESULTS
One hundred fifty-five patients out of 238 (65.1%) received at least one durvalumab dose: 91 (58.7%) after concomitant CRT (cCRT) and 64 (41.3%) after sequential CRT (sCRT). Programmed-death ligand 1 (PD-L1) status was unknown in 7/155 (4.5%), negative in 14 (9.1%), and positive ≥1% in 134/155 (86.4%). The main reasons for non-starting durvalumab were progression (10.1%), PD-L1 negativity (7.5%), and lung toxicity (4.6%). Median follow-up time was 14 months (range 2–29); 1-year PFS and OS were 65.5% (95%CI: 57.6-74.4) and 87.9% (95%CI: 82.26.6-93.9), respectively. No significant differences in PFS or OS were detected for cCRT vs. sCRT, but the median PFS was 13.5 months for sCRT vs. 23 months for cCRT. Potentially immune-related AEs were recorded in 76/155 patients (49.0%). Pneumonitis was the most frequent, leading to discontinuation in 11/155 patients (7.1%).
CONCLUSIONS
Durvalumab maintenenace after concurrent or sequential chemoradiation for unresectable, stage III NSCLC showed very promising short-term survival results in a large, multicenter, restrospective, real-world study. Durvalumab was the first drug obtaining a survival benefit over CRT within the past two decades, and the present study contributes to validating its use in clinical practice.
引言
对于不可切除的 III 期非小细胞肺癌（NSCLC），标准治疗方案包括放化疗（CRT），随后对有反应的患者进行度伐利尤单抗维持治疗。本研究报告了在真实世界、多中心、回顾性队列中 CRT 后使用度伐利尤单抗的安全性和结果。
方法
纳入了 238 例患者。我们收集了关于全身治疗、放射治疗、CRT 与度伐利尤单抗之间的时间间隔、度伐利尤单抗周期数、未开始或停用的原因、不良事件（AE）的发生率和分级，以及无进展生存期（PFS）和总生存期（OS）的数据。
结果
238 例患者中有 155 例（65.1%）接受了至少一剂度伐利尤单抗：91 例（58.7%）在同步 CRT（cCRT）后接受，64 例（41.3%）在序贯 CRT（sCRT）后接受。155 例患者中有 7 例（4.5%）程序性死亡配体 1（PD-L1）状态未知，14 例（9.1%）为阴性，134 例（86.4%）为阳性≥1%。未开始使用度伐利尤单抗的主要原因是疾病进展（10.1%）、PD-L1 阴性（7.5%）和肺部毒性（4.6%）。中位随访时间为 14 个月（范围 2 - 29 个月）；1 年 PFS 和 OS 分别为 65.5%（95%CI：57.6 - 74.4）和 87.9%（95%CI：82.2 - 93.9）。cCRT 与 sCRT 之间在 PFS 或 OS 方面未检测到显著差异，但 sCRT 的中位 PFS 为 13.5 个月，而 cCRT 为 23 个月。155 例患者中有 76 例（49.0%）记录到潜在的免疫相关 AE。肺炎是最常见的，导致 11/155 例患者（7.1%）停药。
结论
在一项大型、多中心、回顾性、真实世界研究中，对于不可切除的 III 期 NSCLC，同步或序贯放化疗后使用度伐利尤单抗维持治疗显示出非常有前景的短期生存结果。度伐利尤单抗是过去二十年来首个在生存获益方面优于 CRT 的药物，本研究有助于验证其在临床实践中的应用。
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