Abstract: Objective To analyze the efficacy, safety and prognostic factors of immune checkpoint inhibitors in the treatment of recurrent and metastatic cervical cancer. Methods A total of 87 patients with recurrent and metastatic cervical cancer admitted to the First Affiliated Hospital of Soochow University from January 2018 to June 2022 were retrospectively analyzed. They were divided into non immunotherapy group n=32 and immunotherapy group n=55 according to whether immune checkpoint inhibition was applied after recurrence and metastasis. The disease control rate DCR, progression free survival PFS, overall survival 1 OS1, date of pathology diagnosis to the end of follow-up or time of death, overall survival 2 OS2, time of first immunotherapy/non-immunotherapy to the end of follow-up or time of death, safety and prognostic factors of the two groups were analyzed and compared. Results In 87 patients with recurrent and metastatic cervical cancer, the DCR of the non immunotherapy group and immunotherapy group were 53.1% 17/32 and 72.7% 40/55 respectively χ²=3.44, P=0.064. The median OS1 of the non immunotherapy group was 51.0 months, while the immunotherapy group did not reach the median OS1, with a statistically significant difference χ²=7.50, P=0.006. The median OS2 of the non immunotherapy group was 28.0 months, while the immunotherapy group did not reach the median OS2, with a statistically significant difference χ²=7.07, P=0.008. The median PFS of the non immunotherapy group and immunotherapy group were 18.0 months and 23.0 months respectively, with no significant difference χ²=0.01, P=0.915. In the immunotherapy group, 70.9% 39/55 of patients received immune checkpoint inhibitors as first-line treatment and 29.1% 16/55 received as second-line and above treatment. Both groups of patients did not achieve median OS2, with median PFS of 23.0 and 17.0 months respectively, and there were no statistically significant differences χ²=0.94, P=0.333； χ²=2.00, P=0.158； 38.2% 21/55 of patients received immune checkpoint inhibitor combined with local radiotherapy, 61.8% 34/55 patients did not receive radiotherapy. And neither group of patients achieved median OS2, with median PFS of 19.0 and 25.0 months respectively, with no statistically significant differences χ²=0.62, P=0.432； χ²=0.01, P=0.906. The incidences of grade 1-2 hematuria and hypothyroidism in the non immunotherapy group and immunotherapy group were 53.1% 17/32 vs. 27.3% 15/55, χ²=5.82, P=0.016, 3.1% 1/32 vs. 21.8% 12/55, χ²=4.19, P=0.041 respectively. The incidence of myelosuppression in the non immunotherapy group [grade 1-2: 59.4% 19/32, grade 3-4: 34.4% 11/32] was significantly different from that in the immunotherapy group [grade 1-2: 80.0% 44/55, grade 3-4: 3.6% 2/55； Z=3.50, P<0.001]. There were no statistically significant differences between creatinine increase, glutamic-oxaloacetic transaminase and glutamic-pyruvic transaminase increase, lymphocyte decrease, hypoproteinemia, proteinuria, rash, fatigue all P>0.05. Univariate regression analysis showed that the use of immune checkpoint inhibitor was an independent protective factor affecting the prognosis of patients HR=0.31, 95%CI: 0.12-0.77, P=0.012. Conclusion Whether used as first-line or second-line or above treatment, the use of immune checkpoint inhibitors in patients with recurrent and metastatic cervical cancer prolongs their OS1, OS2, and has good safety. The application of immune checkpoint inhibitors is an independent protective factor affecting the prognosis of patients.

Key words: Uterine cervical neoplasms, Recurrence, Neoplasm metastasis, Immune checkpoint inhibitors