The efficacy and safety of neoadjuvant sintilimab combined with chemotherapy in elderly patients with locally advanced esophageal squamous cell carcinoma.

378 Background: Neoadjuvant PD-1 inhibitor combined with chemotherapy has been reported to improve the pathologic response of locally advanced esophageal squamous cell carcinoma (ESCC). However, systematic report of efficacy and safety data in elderly Chinese patients is lacking. This study we report the efficacy and safety outcomes of neoadjuvant sintilimab combined with chemotherapy in elderly patients with locally advanced ESCC. Methods: Elderly patients (70 years or older) with locally advanced ESCC received neoadjuvant sintilimab combined with albumin-bound paclitaxel and nedaplatin in our institution between July 2019 and September 2022 were reviewed. Efficacy including pathologic response, short-term survival outcomes, and safety profile retrospectively were evaluated. Results: Thirty-one eligible patients were included in the analysis, with median age 72 years (range 70-78 years), male 18 (58.1%), Upper/middle/lower tumors 2(6.5%)/15(48.4%) /14(45.2%), ECOG PS 0/1-2 15 (48.4%)/16 (51.6%), clinical stage II/III 14 (45.2%)/17 (54.8%). The median number of neoadjuvant cycles was 3 (range 2-4). All 31 patients achieved R0 resection. Postoperative pathology showed pCR rate was 45.2% (95CI 27.3%-64.0%), MPR rate was 58.1% (95CI 39.1%-75.5%), tumor down-staging rate was 90.3% (95CI 74.2%-98.0%). With a median follow-up of 15.9 months (range 3.0-32.3), 1 (4.2%) patient had disease recurrence and died. The median DFS and median OS had not been reached yet, 2-year DFS rate was 95.0% (95%CI 85.9%-100.0%). Grade 3-4 Surgical complications occurred in 1 (4.2%) patient, with a grade 3 pulmonary infection. The median operation time was 332 min (range, 142–470 min), and the median intraoperative blood loss was 150 ml (range, 80–300 ml). The median hospital stay was 12.5 days (range 7-22). There was no perioperative death. Grade 3-4 TRAEs were Neutropenia (9.7%), leukopenia (9.7%), abnormal liver function (6.5%), anemia (6.5%), sensory neuropathy (3.2%), pneumonia (3.2%). Conclusions: Our results preliminarily confirms that Chinese elderly patients with locally advanced ESCC can benefit from neoadjuvant sintilimab combined with chemotherapy, similarly with this combination treatment in all age patients.