Phase 2 Trial of Combination Radiotherapy and Pembrolizumab Plus Chemotherapy in Patients With Previously Untreated Metastatic NSCLC: NJLCG 1902

IF 3 Q2 ONCOLOGY
Yoko Tsukita MD, PhD , Rei Umezawa MD, PhD , Taku Nakagawa MD, PhD , Akira Anbai MD, PhD , Tomonori Makiguchi MD, PhD , Hisashi Tanaka MD, PhD , Yosuke Horii MD, PhD , Aya Suzuki MD , Ryo Morita MD, PhD , Hitomi Nogawa MD , Hiroshi Yokouchi MD, PhD , Nozomu Kimura MD, PhD , Keiichi Jingu MD, PhD , Akira Inoue MD, PhD , Hisatoshi Sugiura MD, PhD , Eisaku Miyauchi MD, PhD
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Abstract

Introduction

Treatment strategies that enhance the efficacy of immunotherapy are desired. Radiotherapy can enhance immunity, but the utility of adding radiotherapy to immunotherapy plus platinum-doubled chemotherapy in patients with metastatic NSCLC has not been explored.

Methods

This multicenter, single-arm phase 2 trial evaluated the efficacy and safety of combining radiotherapy with pembrolizumab plus chemotherapy in patients with previously untreated metastatic NSCLC. Patients begin receiving pembrolizumab plus platinum-doublet chemotherapy within 1 week of starting radiotherapy (30 Gy in 10 fractions). The primary end point was the 12-month progression-free survival (PFS) rate. The secondary end points included PFS, overall survival, and toxicity profiles.

Results

Forty patients were enrolled. In total, 37 and 38 patients were analyzed for efficacy and safety, respectively. The 12-month PFS rate was 44.3% (90% confidence interval [CI]: 30.3–57.3), which met the primary end point. The median PFS was 8.4 months (95% CI: 5.7–22.2), and the median overall survival was 30.1 months (95% CI: 22.3–not reached). Grade 3 or 4 adverse events occurred in 25 patients (65.8%), and one treatment-related death was reported. Pneumonitis was reported in 10 patients (26.3%), including two cases of grade 3 pneumonitis and one case of grade 5.

Conclusions

Adding radiotherapy to pembrolizumab plus platinum-doublet chemotherapy led to promising efficacy in patients with previously untreated metastatic NSCLC. Although caution should be exercised with regard to pneumonitis, adverse events were tolerable. Further research is needed to confirm the efficacy and safety of this strategy.
联合放疗和派姆单抗加化疗治疗先前未治疗的转移性NSCLC患者的2期试验:NJLCG 1902
需要提高免疫治疗疗效的治疗策略。放疗可增强免疫功能,但转移性NSCLC患者在免疫治疗加铂双化疗的基础上加放疗的效用尚未探讨。该多中心、单臂2期临床试验评估了放疗联合派姆单抗联合化疗治疗既往未治疗的转移性NSCLC患者的有效性和安全性。患者在开始放疗后1周内开始接受派姆单抗加铂双药化疗(30 Gy,分10次)。主要终点为12个月无进展生存期(PFS)。次要终点包括PFS、总生存期和毒性概况。结果共纳入40例患者。共对37例和38例患者进行疗效和安全性分析。12个月PFS率为44.3%(90%置信区间[CI]: 30.3-57.3),达到主要终点。中位PFS为8.4个月(95% CI: 5.7-22.2),中位总生存期为30.1个月(95% CI: 22.3 -未达到)。25例患者(65.8%)发生3级或4级不良事件,1例治疗相关死亡。肺炎10例(26.3%),包括2例3级肺炎和1例5级肺炎。结论在派姆单抗加铂双药化疗的基础上增加放疗对既往未治疗的转移性NSCLC患者有很好的疗效。尽管对肺炎应谨慎对待,但不良事件是可以容忍的。需要进一步的研究来证实这一策略的有效性和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.20
自引率
0.00%
发文量
145
审稿时长
19 weeks
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