一项针对不可切除 III 期非小细胞肺癌患者在同期放化疗后行巩固性帕博利珠单抗治疗的 2 期临床试验：Hoosier Cancer Research Network LUN 14-179。
A phase 2 trial of consolidation pembrolizumab following concurrent chemoradiation for patients with unresectable stage III non-small cell lung cancer: Hoosier Cancer Research Network LUN 14-179.
机构信息
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana.
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.
出版信息
Cancer. 2020 Oct 1;126(19):4353-4361. doi: 10.1002/cncr.33083. Epub 2020 Jul 22.
BACKGROUND
Five-year overall survival (OS) for patients with unresectable stage III non-small cell lung cancer (NSCLC) is poor. Until recently, a standard of care was concurrent chemoradiation alone. Patients with metastatic NSCLC treated with anti-programmed death 1 antibodies have demonstrated improved OS. This trial evaluated pembrolizumab as consolidation therapy after concurrent chemoradiation in patients with unresectable stage III disease.
METHODS
Patients with unresectable stage III NSCLC received concurrent chemoradiation with cisplatin and etoposide, cisplatin and pemetrexed, or carboplatin and paclitaxel and 59.4 to 66.6 Gy of radiation. Patients with nonprogression of disease were enrolled and received pembrolizumab (200 mg intravenously every 3 weeks for up to 12 months). The primary endpoint was the time to metastatic disease or death (TMDD). Secondary endpoints included progression-free survival (PFS) and OS.
RESULTS
The median follow-up for 93 patients (92 for efficacy) was 32.2 months (range, 1.2-46.6 months). The median TMDD was 30.7 months (95% confidence interval [CI], 18.7 months to not reached), which was significantly longer than the historical control of 12 months (P < .0001). The median PFS was 18.7 months (95% CI, 12.4-33.8 months), and the median OS was 35.8 months (95% CI, 24.2 months to not reached). The 1-, 2-, and 3-year OS estimates were 81.2%, 62.0%, and 48.5%, respectively. Forty patients (43.5%) completed 12 months of treatment (median number of cycles, 13.5). Symptomatic pneumonitis (grade 2 or higher) was noted in 16 patients (17.2%); these cases included 4 grade 3 events (4.3%), 1 grade 4 event (1.1%), and 1 grade 5 event (1.1%).
CONCLUSIONS
Consolidation pembrolizumab after concurrent chemoradiation improves TMDD, PFS, and OS in comparison with historical controls of chemoradiation alone. Rates of grade 3 to 5 pneumonitis were similar to those reported with chemoradiation alone.
背景
不可切除的 III 期非小细胞肺癌（NSCLC）患者的 5 年总生存率（OS）较差。直到最近，标准治疗方法仍是单纯同步放化疗。接受抗程序性死亡 1 抗体治疗的转移性 NSCLC 患者的 OS 得到改善。本试验评估了帕博利珠单抗作为不可切除 III 期疾病患者同步放化疗后的巩固治疗。
方法
不可切除的 III 期 NSCLC 患者接受顺铂和依托泊苷、顺铂和培美曲塞或卡铂和紫杉醇联合放化疗，放射剂量为 59.4 至 66.6 Gy。疾病无进展的患者被纳入并接受帕博利珠单抗（每 3 周静脉注射 200 mg，持续 12 个月）。主要终点是转移疾病或死亡的时间（TMDD）。次要终点包括无进展生存期（PFS）和 OS。
结果
93 例患者（92 例用于疗效评估）的中位随访时间为 32.2 个月（范围为 1.2-46.6 个月）。TMDD 的中位时间为 30.7 个月（95%置信区间[CI]，18.7 个月至未达到），明显长于历史对照的 12 个月（P<.0001）。中位 PFS 为 18.7 个月（95%CI，12.4-33.8 个月），中位 OS 为 35.8 个月（95%CI，24.2 个月至未达到）。1、2 和 3 年 OS 估计值分别为 81.2%、62.0%和 48.5%。40 例患者（43.5%）完成了 12 个月的治疗（中位治疗周期数为 13.5 个）。16 例（17.2%）患者出现了有症状的肺炎（2 级或更高）；其中包括 4 例 3 级事件（4.3%）、1 例 4 级事件（1.1%）和 1 例 5 级事件（1.1%）。
结论
与单纯同步放化疗的历史对照相比，同步放化疗后使用帕博利珠单抗巩固治疗可改善 TMDD、PFS 和 OS。3 至 5 级肺炎的发生率与单纯同步放化疗报告的发生率相似。
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