Clinical outcomes and safety of PD-1 inhibitors in combination with chemotherapy in patients with recurrent cervical cancer

Background Clinical trials have shown that the combination of PD-1 inhibitors and chemotherapy is effective in treating recurrent cervical cancer (rCC), but there are relatively few real-world studies on the combination of PD-1 inhibitors and chemotherapy for rCC. Objective To explore the actual clinical effects of PD-1 inhibitors combined with chemotherapy in rCC patients. Methods Patients with rCC who received PD-1 inhibitors with chemotherapy in the First Medical Center of Chinese PLA General Hospital from July 2014 to July 2022 were served as the observation group, and rCC patients who received the same chemotherapy regimen during the same period as the control group. The objective response rate (ORR), disease control rate (DCR), median overall survival (mOS), 1-year survival rate, 2-year survival rate, and the degree of decline in squamous cell carcinoma antigen (SCCAg) in patients with squamous cell carcinoma and adverse reactions were compared between the two groups. Results A total of 88 patients were enrolled in the study, with 39 in the observation group and 49 in the control group. The general information and clinical baseline data of the two groups were comparable (P>0.05). The ORR of the observation group was higher than that of the control group (59.0% vs 32.7%, P=0.014), while the DCR showed no significant difference between the two groups (89.7% vs 83.7%, P=0.410). The mOS in the observation group was 16.0 months (95% CI: 13.66-39.70), which was higher than the 15.0 months (95% CI: 12.70-18.58) in the control group, but the difference was not statistically significant (P=0.176). The 1-year survival rate of the observation group was higher than that of the control group (84.6% vs 67.3%, P=0.047), and the 2-year survival rate was also higher than that of the control group (69.2 % vs 46.9 %, P = 0.024). For patients with squamous cell carcinoma, compared with before treatment, the sera SCCAg level decreased after treatment in the observation group (P<0.001), and the SCCAg level in the observation group was lower than that in the control group after treatment (P=0.046). There was no significant difference in the main adverse reactions between the two groups (P>0.05). The incidence of myelosuppression in the observation group was higher than that in the control group (92.3% vs 71.4%, P=0.014), but there was no difference in severe III-IV degree myelosuppression (20.5% vs 16.3%, P=0.613).Conclusion PD-1 inhibitors combined with chemotherapy are more effective in controlling the progression of rCC than chemotherapy alone. Although the incidence of myelosuppression is higher, it does not increase the incidence of severe myelosuppression, and the safety is controllable.