Abstract 163P
Background
This study aimed to evaluate the safety and efficacy of neoadjuvant chemoradiotherapy (nCRT) combined with sequential tislelizumab followed by surgery for resectable thoracic esophageal squamous cell carcinoma (TESCC).
Methods
Patients with pathologically confirmed TESCC and clinical T1-2N1-3M0 or T3-4aN0-3M0 were allocated to receive neoadjuvant radiotherapy (41.4 Gy in 23 fractions) with concurrent chemotherapy (albumin-bound paclitaxel, 50-100 mg/m2, once weekly for five weeks; carboplatin, area under the curve of 2 mg/mL/min, once weekly for five weeks) plus sequential tislelizumab (200 mg every three weeks for three cycles, beginning within the first to 14th day after completion of radiotherapy) followed by subtotal esophagectomy with two-field lymphadenectomy. The primary endpoints were safety and pCR rate after surgery. The second endpoints included radical (R0) resection and major pathological response (MPR) rate.
Results
From January 2021 to June 2022, 26 eligible patients were enrolled. Eighteen patients completed neoadjuvant Tislelizumab and 15 underwent planed surgery. R0 resection rate was 100%. pCR rate for primary tumor and resected lymph nodes was 46.7% (7/15). MPR rate for primary tumor was 86.7% (13/15). During neoadjuvant Tislelizumab, no ≥ grade 3 adverse events (AEs) occurred and grade 1–2 AEs developed in 88.9% (16/18) of the patients, including weakness (66.7%, 12/18), chest pain (61.1%, 11/18), pulmonary infection (PI) (33.3%, 6/18) and radiation-induced lung injury (33.3%, 6/18). Grade 3 postoperative complications occurred in 20.0% (3/15) of the patients, including anastomotic fistula (20.0%, 3/15), injury of recurrent laryngeal nerve (6.7%, 1/15) and pleural effusion (PE) (6.7%, 1/15). And grade 1-2 postoperative complications occurred in 80.0% (12/15) of the patients, including anemia (46.7%, 7/15), PI (26.7%, 4/15), PE (26.7%, 4/15) and liver malfunction (13.3%, 2/15).
Conclusions
nCRT combined with sequential tislelizumab followed by surgery may be safe and effective for resectable TESCC and be worthy of further study.
Clinical trial identification
NCT04776590.
Legal entity responsible for the study
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Funding
BeiGene, Ltd
Disclosure
All authors have declared no conflicts of interest.