Objective  To investigate the clinical efficacy and safety of sintilimab in combination with intensity-modulated radiotherapy (IMRT) and chemotherapy in patients with advanced cervical cancer (ACC).

Methods  The clinical data of ACC patients diagnosed and treated in the Department of Obstetrics and Gynecology of Xi'an Ninth Hospital from January 2019 to June 2020 were retrospectively collected. According to the treatment regimen, ACC patients were divided into Sintilimab group (sintilimab + IMRT combined with cisplatin and taxane) and control group (IMRT combined with cisplatin and paclitaxel). Serum tumor markers [squamous cell carcinoma antigen (SCCA), carcinoembryonic antigen (CEA), carbohydrate antigen 724 (CA724) and carbohydrate antigen 199 (CA199)], immune function [CD3+, CD4+ and CD8+] and quality of life [quality of life (QOL) scale assessment] were observed and compared before and after treatment. The short-term efficacy [objective response rate (ORR) and disease control rate (DCR)] and long-term efficacy [mortality, local recurrence rate, distant metastasis rate, and overall survival (OS)] in patients with ACC were compared. The occurrence of adverse drug reactions were assessed according to the American Radiation Oncology Collaboration (RTOG) and Common Terminology Criteria for Adverse Events.

Results  A total of 118 ACC patients were included in the study, including 59 patients in the sintilimab group and 59 in the control group. Before treatment, there were no significant differences in serum SCCA expression level, serum CEA expression level, serum CA724 expression level, serum CA199 expression level, CD3+, CD4+, CD8+/CD4+ and quality of life between the two groups (P>0.05). After treatment, the serum SCCA level, CEA expression level, CA724 expression level, serum CA199 expression level, CD3+, CD4+ and CD8+/CD4+ levels in the Sintilimab group were significantly lower than those in the control group (P<0.05), the quality of life and the ORR were significantly higher than that in the control group (P<0.05), while there was no significant difference in DCR between the two groups (P>0.05). The mortality rate, local recurrence rate and distant metastasis rate of ACC patients in the Sintilimab group were significantly lower than those in the control group (P<0.05). Kaplan-Meier analysis showed that the OS of ACC patients in the Sintilimab group was significantly higher than that in the control group (P<0.05). In addition, there was no statistically significant difference in adverse drug reactions between the Sintilimab group and the control group (P>0.05).

Conclusion  Sintilimab combined with IMRT and chemotherapy has significant efficacy in ACC patients, which can reduce the level of tumor markers, improve quality of life, reduce mortality, local recurrence rate and distant metastasis rate, and improve total OS, with high safety.

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