Immunochemotherapy Plus Radiotherapy Versus Immunochemotherapy Alone as First-Line Treatment for Treatment-Naïve, Advanced Esophageal Squamous Cell Carcinoma (Aec-Icr-1st): A Multi-Center Cohort Study

Currently, immunochemotherapy is the standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). However, the prognosis remains unsatisfactory. We aimed to evaluate the efficacy and safety of immunochemotherapy plus radiotherapy (ICR) compared to immunochemotherapy (IC) alone as first-line treatment for advanced ESCC. This was a multicenter cohort study across 5 cancer centers (NCT06190652). We evaluated outcomes in patients with advanced ESCC who received first-line therapy of IC with or without radiotherapy (RT) between 2018 and 2023. Overall, 23,641 patients were screened and 702 patients were eligible finally. Both before and after PSM, the ICR cohort had a longer median OS compared to IC alone cohort (14.5 versus 10.8 months, P =0.001; 14.2 versus 11.0 months, P =0.008; respectively); multivariate analysis further supported that RT was associated with a better OS (HR: 0.695, P =0.001; HR: 0.729, P =0.018; respectively). Exploratory analysis revealed that the survival benefits were most pronounced in the subgroup who received IC concurrently combined with definitive dose RT to the primary tumor, with a median OS of 15.4 months (HR: 0.515, P =0.011) and PFS of 11.1 months (HR: 0.567, P =0.009). The grade ≥ 3 TEAEs were esophagitis (4.10% versus 0.41%; P =0.006), anemia (6.97% versus 1.64%; P =0.004), leukopenia (12.70% versus 6.56%; P =0.021) and lymphopenia (38.52% versus 4.92%, P < 0.001) in ICR and IC cohort. The addition of RT to IC as a first-line treatment for advanced ESCC could bring benefits, and was well-tolerated. RCTs are warranted to validate the benefits.

Note:
Funding declaration: This study was funded by the National Natural Science Foundation of China (No. 82272733 and 82102840).

Conflict of Interests: We have no conflicts of interests.

Ethical Approval: This study was approved by the Ethics Committees of each institution (NO. bc2023043) and conducted according to the tenets of the Declaration of Helsinki.

Keywords: advanced esophageal squamous cell carcinoma, first-line treatment, immunotherapy, chemotherapy, Radiotherapy

Suggested Citation: Suggested Citation

Li, Jiacheng and Wang, Xiaofeng and Cao, Jianzhong and Fan, Chengcheng and Xiao, Qin and Zheng, Zhunhao and Gao, Wenyan and Liu, Xiao and Feng, Peixin and Liu, Fang and Ouyang, Shuyu and Zhang, Tian and Chen, Xi and Yuan, Zhiyong and Pang, Qingsong and Wang, Ping and Wang, Qifeng and ZHANG, WENCHENG, Immunochemotherapy Plus Radiotherapy Versus Immunochemotherapy Alone as First-Line Treatment for Treatment-Naïve, Advanced Esophageal Squamous Cell Carcinoma (Aec-Icr-1st): A Multi-Center Cohort Study. Available at SSRN: https://ssrn.com/abstract=4863162 or http://dx.doi.org/10.2139/ssrn.4863162