1529P - Tislelizumab plus chemotherapy sequential neo-chemoradiotherapy therapy as total neoadjuvant therapy in locally advanced esophageal squamous cell carcinoma (ETNT)

Background

High recurrence and metastasis rates remain the main factors leading to the failure of the current standard treatment of neoadjuvant chemoradiotherapy plus surgery for resectable locally advanced ESCC. Improving the pathological complete response (pCR) rate may significantly benefit the survival of patients with resectable locally advanced ESCC after neoadjuvant therapy.

Methods

Patients aged 18-75 years with untreated, resectable, stage III-IVA ESCC, adequate organ and bone marrow function were eligible for inclusion. patients received neoadjuvant chemoradiotherapy (paclitaxel 135 mg/m2 d1 + carboplatin AUC = 3–5 d1, q3w × 2 cycles + 65 simultaneous radiotherapy (40 Gy/4 W/20F)) treatment, after the end of chemoradiotherapy, Tislelizumab (200 mg intravenously every 3 weeks for 2 cycles, and all patients undergo surgery after 4–6 weeks. The primary outcomes of the pCR rate and the incidence of adverse events will be analyzed completely within months, the secondary endpoints will include major pathological response rate, objective response rate, R0 resection rate, event-free survival, and overall survival. All enrolled patients were included in the activity and safety analyses.

Results

Thirty-two patients were enrolled in the study, among 8 patients are waiting for a surgery, with 24 patients undergoing surgical resection at a 100% R0 resection rate. All patients had stage III-IVA disease. Patients who received tislelizumab plus chemotherapy sequential nCRT achieved 13(54.2%) patients had a pathologic complete response, 16 (66.7%) patients achieved major pathologic response, and 21(87.5%) objective remission rate. Within 30 days after surgery, anastomotic fistula was found in 4 (16.7%) patients, but no deaths occurred, the most common grade 2 or 3 adverse event was leukopenia, hypothyroidism and lymphopenia. The analysis of survival was immature, and patients are still being followed up.

Conclusions

This study explored the safety and efficacy of tislelizumab plus chemotherapy sequential neo-chemoradiotherapy therapy for ESCC patients and provided a total neoadjuvant therapy model that can benefit patients with locally advanced ESCC.

Clinical trial identification

NCT05189730.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.