Effectiveness and Safety of Neoadjuvant Immunochemotherapy with and without Surgery in Patients with Resectable Esophageal Squamous Cell Carcinoma: A Retrospective Cohort Study

Xuqiang Liao,1,* Xianshan Chen,1,* Wenyuan Hong,1,2,* Fengxia Chen,1 Gao Li,1 Liang Li1 1Department of Thoracic Surgery, Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University, Haikou, Hainan, People’s Republic of China; 2Hainan Medical University, Haikou, Hainan, People’s Republic of China*These authors contributed equally to this workCorrespondence: Gao Li, Email [email protected] Liang Li, Email [email protected]: This study aimed to retrospectively compare the effectiveness and safety of neoadjuvant immunochemotherapy with and without surgery for locally advanced esophageal squamous cell carcinoma (ESCC).Methods: This study included patients with ESCC who received neoadjuvant immunochemotherapy from May 2021 to July 2023. Patients were divided into a surgery cohort and a non-surgery cohort. Outcomes included R0 resection rate, pathological complete response (pCR), major pathological response (MPR), objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety.Results: Among the 61 patients undergoing neoadjuvant immunochemotherapy, 33 received subsequent surgery, and 28 did not undergo surgery due to unsuitability or refusal. Totally, 8 (13.1%) achieved complete response, and 38 (62.3%) had partial response, resulting in an overall ORR of 75.4%. In the surgery cohort, the R0 resection rate was 87.9% (29/33), with 24.2% (8/33) achieving pCR and 66.7% (22/33) achieving MPR. The EFS was 23.0 months (95% CI 16.8-NA) for the surgery cohort and 9.2 months (95% CI 6.1– 12.8) for the non-surgery cohort. The 2-year OS rates were 65.4% (95% CI 48.7– 82.1) and 41.3 (95% CI 22.3– 60.3) in the surgery and non-surgery cohorts, respectively. Common adverse events included vomiting (70.5%), nausea (45.9%), and fatigue (19.7%). Common postoperative complications included anastomotic leakage (11.8%) and pulmonary infection (11.8%).Conclusion: Neoadjuvant immunochemotherapy represents a promising treatment strategy for patients with locally advanced resectable ESCC, with high rates of R0 resection, pCR and MPR. The subsequent surgery leads to several postoperative complications which can be well-managed, and surgery contributes to improved survival.Keywords: neoadjuvant therapy, locally advanced esophageal squamous cell carcinoma, surgery, immunotherapy, tislelizumab