Efficacy and safety of sintilimab in patients with advanced colorectal cancer

doi:10.19803/j.1672-8629.2022.02.11

Abstract

Abstract: Objective To study the efficacy and adverse reaction of sintilimab combined with chemotherapy in patients with advanced colorectal cancer. Methods 82 patients with advanced colorectal cancer who had failed first-line chemotherapy with oxaliplatin in Bayinguoleng Mongolian Autonomous Prefecture Hospital between January 1, 2018 and July 31, 2020 were randomly divided into group A and group B. Patients in group A underwent second-line chemotherapy involving irinotecan and capecitabine (referred to as XELIRI regimen), while those in group B were given sintilimab combined with XELIRI chemotherapy. The short-term efficacy, long-term efficacy and adverse reactions were compared between the two groups. Results As of February 28, 2021, the clinical efficacy among the 82 patients with advanced colorectal cancer could be evaluated. The Objective response rate (ORR) was 20.00% in group A and 21.42% in group B. The disease control rate (DCR) was 65.00% in group A and 71.43% in group B. There was no significant difference in ORR or DCR between the two groups (P>0.05). The median PFS of group B was superior to that of group A, with statistically significant significance (P<0.05). As for adverse reactions, there was no significant difference between the two groups in blood toxicity, gastrointestinal tract reactions (nausea/vomiting), diarrhea or elevation of transaminase (P > 0.05). However, the incidence of such adverse reactions (mainly mild reactions of grade I to II) as rash, hypothyroidism and proteinuria was higher in group B than in group A, which were considered to be related to sintilimab. One patient developed grade III rash reaction, but the rash was completely relieved one month after withdrawal and after one week of symptomatic treatment. Overall adverse reactions were tolerable in both groups. Conclusions intilimab combined with second-line XELIRI chemotherapy is of potential benefit for patients with advanced colorectal cancer, with generally tolerable adverse reactions and controllable safety.

Key words: sintilimab, colorectal cancer, curative effect, safety

CLC Number:

R994.11

CAI Jiangxia, CHEN Siying, DONG Kai, QIN Jianpin, ZHANG Yue, QI Ruifeng, YE Yinmei. Efficacy and safety of sintilimab in patients with advanced colorectal cancer[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 164-168.

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