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同步或序贯放疗联合(PD - 1)抑制剂治疗寡转移性食管癌的安全性和有效性

Safety and Efficacy of Concurrent or Sequential Radiotherapy Plus (PD-1) Inhibitors in Oligometastatic Esophageal Cancer.

作者信息

Duan Yanan, Qin Wenru, Yang Linlin, Zou Bing, Qie Wenting, Song Ruiting, Xue Lu, Wang Linlin

机构信息

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, People's Republic of China.

Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan, Shandong, People's Republic of China.

出版信息

Cancer Manag Res. 2023 Jan 14;15:55-65. doi: 10.2147/CMAR.S391529. eCollection 2023.

Abstract

PURPOSE

We assess real-world outcomes, including safety and efficacy, of concurrent or sequential treatment with radiotherapy plus programmed cell death protein 1 (PD-1) inhibitors in patients with oligometastatic esophageal cancer (OMEC).

METHODS

This cohort study retrospectively collected clinical data of patients with synchronous or metachronous OMEC. All patients underwent concurrent or sequential treatment with radiotherapy plus PD-1 inhibitors. Each patient had up to five measurable metastatic lesions and up to three organs involved. Study endpoints were progression-free survival (PFS), treatment-related toxicities, locoregional progression-free survival (LRPFS), objective response rate (ORR), and disease control rate (DCR). Description statistics and Kaplan-Meier models were used for statistical analysis.

RESULTS

A total of 86 patients were included, most of whom were diagnosed with squamous cell carcinoma histology (98%) and presented with synchronous OMEC (64%). The median follow-up period was 17 months (range: 6-32 months), the median PFS was 15.2 months (95% confidence interval: 12.1-18.2 months); and the 1- and 2-year PFS rates were 61.4% and 26.7%, respectively. The 1- and 2-year LRPFS were 91.3% and 57.3%, respectively. The ORR and DCR were 46.5% and 91.8%, respectively. Forty-two patients (48.8%) experienced grade 3 or higher treatment-related adverse events (TRAEs); a grade 5 treatment-related adverse event was observed in one patient (1.2%) who died of immune-related pneumonitis.

CONCLUSION

Combining radiotherapy with PD-1 inhibitors is a safe and effective treatment option for patients with OMEC. No new safety concerns were identified in this study. However, due to the potential risk of cumulative toxicity, an individual risk-benefit assessment for each patient is required prior to treatment initiation.

摘要

目的

我们评估寡转移性食管癌(OMEC)患者接受放疗联合程序性细胞死亡蛋白1(PD-1)抑制剂同步或序贯治疗的真实世界疗效及安全性。

方法

本队列研究回顾性收集了同步或异时性OMEC患者的临床数据。所有患者均接受了放疗联合PD-1抑制剂的同步或序贯治疗。每位患者最多有5个可测量的转移病灶,累及器官最多3个。研究终点为无进展生存期(PFS)、治疗相关毒性、局部区域无进展生存期(LRPFS)、客观缓解率(ORR)和疾病控制率(DCR)。采用描述性统计和Kaplan-Meier模型进行统计分析。

结果

共纳入86例患者,其中大多数为鳞状细胞癌组织学类型(98%),且为同步OMEC(64%)。中位随访期为17个月(范围:6 - 32个月),中位PFS为15.2个月(95%置信区间:12.1 - 18.2个月);1年和2年PFS率分别为61.4%和26.7%。1年和2年LRPFS分别为91.3%和57.3%。ORR和DCR分别为46.5%和91.8%。42例患者(48.8%)发生3级或更高等级的治疗相关不良事件(TRAEs);1例患者(1.2%)发生5级治疗相关不良事件,死于免疫相关性肺炎。

结论

放疗联合PD-1抑制剂对OMEC患者是一种安全有效的治疗选择。本研究未发现新的安全问题。然而,由于存在累积毒性的潜在风险,在开始治疗前需要对每位患者进行个体化的风险效益评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ba0/9849787/6f450a304e3e/CMAR-15-55-g0001.jpg

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