Department of Internal Medicine, Indiana University, Indianapolis, IN.
Department of Biostatistics, Indiana University, Indianapolis, IN.
Clin Lung Cancer. 2020 May;21(3):288-293. doi: 10.1016/j.cllc.2019.06.009. Epub 2019 Jul 8.
The Hoosier Cancer Research Network (HCRN) LUN 14-179 is a phase II trial of consolidation pembrolizumab after concurrent chemoradiation for the treatment of patients with stage III non-small-cell lung cancer (NSCLC). Time to metastatic disease or death (TMDD), progression-free survival (PFS), and overall survival (OS) appear to be superior to that in historical controls of chemoradiation alone. Unfortunately, not all patients benefit from consolidation immunotherapy. We performed a univariate analysis to evaluate variables associated with PFS, metastatic disease, and OS.
We conducted a retrospective analysis of patients enrolled in HCRN LUN 14-179. Data collected included age, sex, stage, smoking status, programmed death ligand 1 status, Grade (G) ≥ 2 versus G ≤ 1 adverse event, G ≤ 2 versus G ≥ 3 pneumonitis, duration of pembrolizumab (< 4 vs. ≥ 4 cycles), chemotherapy regimen, performance status 0 versus 1, time to start pembrolizumab (4-6 vs. 6-8 weeks from radiation), volume of lung receiving at least 20 Gy of radiation (V; < 20% vs. ≥ 20%). Univariable Cox regression was performed to determine the variables associated with 3 end points: TMDD, PFS, and OS.
From April 2015 to December 2016, 93 patients were enrolled and 92 were included in the efficacy analysis (1 patient was ineligible). For TMDD, improved outcomes might be associated (P < .1) with stage IIIA and ≥ 4 cycles of pembrolizumab. For PFS, improved outcomes (P < .1) might be seen for ≥ 4 cycles of pembrolizumab, stage IIIA and V < 20%. For OS, improved outcomes (P < .1) might be seen for stage IIIA and ≥ 4 cycles of pembrolizumab.
Stage IIIA and longer duration of pembrolizumab treatment might be associated with prolonged TMDD, PFS, and OS for patients with stage III NSCLC treated with chemoradiation followed by pembrolizumab.
Hoosier 癌症研究网络（HCRN）LUN14-179 是一项针对 III 期非小细胞肺癌（NSCLC）患者同步放化疗后巩固性 pembrolizumab 治疗的 II 期试验。转移性疾病或死亡时间（TMDD）、无进展生存期（PFS）和总生存期（OS）似乎优于单纯放化疗的历史对照。不幸的是，并非所有患者都能从巩固性免疫治疗中获益。我们进行了单变量分析，以评估与 PFS、转移性疾病和 OS 相关的变量。
我们对 HCRN LUN14-179 入组的患者进行了回顾性分析。收集的数据包括年龄、性别、分期、吸烟状态、程序性死亡配体 1 状态、≥ 2 级与≤ 1 级不良事件、≤ 2 级与≥ 3 级肺炎、pembrolizumab 持续时间（< 4 与≥ 4 个周期）、化疗方案、体能状态 0 与 1、开始 pembrolizumab 的时间（放疗后 4-6 与 6-8 周）、至少接受 20Gy 放疗的肺体积（V；< 20%与≥ 20%）。进行单变量 Cox 回归分析以确定与 3 个终点相关的变量：TMDD、PFS 和 OS。
从 2015 年 4 月至 2016 年 12 月，共纳入 93 例患者，92 例患者纳入疗效分析（1 例患者不符合入组条件）。对于 TMDD，改善结果可能与 IIIA 期和≥ 4 个周期 pembrolizumab 相关（P<.1）。对于 PFS，改善结果（P<.1）可能与≥ 4 个周期 pembrolizumab、III 期和 V<20%相关。对于 OS，改善结果（P<.1）可能与 IIIA 期和≥ 4 个周期 pembrolizumab 相关。
III 期和更长时间的 pembrolizumab 治疗可能与 III 期 NSCLC 患者同步放化疗后接受 pembrolizumab 治疗的 TMDD、PFS 和 OS 延长相关。
