Abstract:

Objective To analyze and compare the short-term efficacy and safety of sintilimab and tislelizumab in neoadjuvant therapy for advanced esophageal squamous cell carcinoma. Methods The clinical data of 95 patients with esophageal squamous cell carcinoma who received neoadjuvant chemotherapy （paclitaxel + nedaplatin） combined with immunotherapy in the Department of Thoracic Surgery of the Affiliated Hospital of North Sichuan Medical College from January 2021 to October 2022 were collected. According to the different use of immune drugs， they were divided into the sintilimab group （n=58） and the tislelizumab group （n=37）. The objective remission rate （ORR）， adverse reactions， R0 resection rate， pathological complete response （pCR） rate， etc. were analyzed and compared between the two groups after neoadjuvant therapy. Results After 2 cycles of neoadjuvant therapy， the sintilimab group and the tislelizumab group had a similar ORR [72.4% （42/58） vs. 56.8% （21/37）， χ²=2.48， P=0.115]. The main adverse reactions of the two groups of patients included gastrointestinal reactions （nausea， vomiting， diarrhea）， hematological toxicity， hypothyroidism， alopecia， liver and kidney dysfunction， pneumonia， etc. The incidence of grade 3 adverse reactions was less than 15%， with no grade 4 adverse reactions. The incidence of hypothyroidism in the sintilimab group was significantly higher than that in the tislelizumab group [56.9% （33/58） vs. 16.2% （6/37）]， with a statistically significant difference （χ²=15.45， P<0.001）； There was no statistically significant difference in surgical resection （χ²=1.26， P=0.661） and pCR rate [31.0% （18/58） vs. 32.4% （12/37）， χ²=0.02， P=0.886] between the two groups of patients. In terms of postoperative complications， both groups of patients experienced partial pulmonary infections and anastomotic fistulas， but the incidence was relatively low [19.0% （11/58） vs. 24.3% （9/37）， 3.4% （2/58） vs. 2.7% （1/37）]， with no statistically significant difference （χ²=0.39， P=0.532； χ²<0.01， P>0.999）. Conclusion For preoperative neoadjuvant therapy of advanced esophageal squamous cell carcinoma， the use of either sintilimab or tislelizumab in addition to chemotherapy has good short-term efficacy and safety. Thyroid function should be monitored carefully when using sintilimab.

Key words: Immunotherapy, Esophageal squamous cell carcinoma, Drug-related side effects and adverse reactions, Short-term efficacy