Four-year follow-up from the phase 2 study TD-NICE: neoadjuvant treatment of tislelizumab combined with chemotherapy in resectable esophageal squamous cell carcinoma.

Background: The efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy have been presented and evaluated in previously published TD-NICE study. However, the long-term impacts of patients who received tislelizumab plus chemotherapy followed by surgery were not observed in the study.

Methods: From September 2020 to March 2021, a total of 45 patients were enrolled in the TD-NICE trial. The 4 -year follow-up data of the TD-NICE ITT population were collected by investigators. The primary endpoint was OS, and the secondary endpoint was EFS. Kaplan-Meier method and cox proportional hazards model were used to proceed statistical analysis.

Results: The median OS and EFS were not reached in all patients. The OS was 82.2% (95%CI:67.6-90.7) at 12 months, 73.3%(95%CI:57.8-83.9) at 24 months, 66.7%(95%CI:50.9-78.4) at 36 months and simulated 66.2% (95%CI:46.5-74.6) at 48 months. There were statistically significant differences between surgery and non-surgery patients(P = 0.046). And patients with R0 resection had a higher improvement in OS than those with R1&R2 resection (P = 0.041). The differences in EFS in surgery and non-surgery group (P = 0.046) as well as in R0 resection and R1&R2 resection group (P = 0.045) were significant, respectively.

Discussion: Our study identified that chemoimmunotherapy plus surgery could improve overall survival in resectable ESCC, and patients had significant benefits from surgery and R0 tumor resection.

Trial registration: TD-NICE study was registered in the August 28, 2020, and the registration number was ChiCTR2000037488 (Chinese Clinical Trial Registry (ChiCTR) identifier).