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

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.

Keywords: PD-1 inhibitors; esophageal cancer; oligometastatic disease; radiotherapy.

Grants and funding

This research was supported by the Natural Science Foundation of Shandong Province, (Grant number ZR2019LZL012), Jinan Clinical Medical Science and Technology Innovation Plan (Grant number 202019043), National Natural Science Foundation of China (Grant number 8217102892), The Key Research and Development Program of Shandong (Major Science & Technology Innovation Project) (2021SFGC0501), and Start-up fund of Shandong Cancer Hospital (2022-B14).