1. The overall response rate was 54.8% in the intention-to-treat group while it was 59.0% in the efficacy-evaluable group.
2. Common treatment-related adverse events in patients receiving sintilimab plus anlotinib were hypothyroidism, elevated aspartate aminotransferase levels and hypertension.
Evidence Rating Level: 2 (Good)
Study Rundown: Cervical cancer is known as the 4th leading cause of cancer related deaths worldwide. Currently, the standard of care for recurrent or metastatic cervical cancer is platinum-based chemotherapy plus antiangiogenic therapy. However, there is scarce knowledge on the treatment for patients who are refractory or intolerant to the first line therapy. Sintilimab (selective anti-PD-L1 monoclonal) and anlotinib (multikinase inhibitor) as a combination therapy have been studied in other tumour types such as advanced non-small cell lung cancer. Therefore, this study aimed to explore the efficacy and safety of sintilimab plus anlotinib as second line or later treatment for PD-L1–positive (Combined Positive Score [CPS] ³1) recurrent or metastatic cervical cancer. CPS is a PD-L1 scoring method for multiple tumour types, including advanced cervical cancer. In the intention-to-treat group, 54.8% of the patients achieved investigator-confirmed complete response (CR) or partial response (PR). In the efficacy-evaluable group, the ORR was 59.0%. Hypothyroidism, elevated aspartate aminotransferase levels and hypertension were common treatment-related adverse events that were reported. 7 patients experienced grade 3 and above treatment-related adverse events and there were no treatment-related deaths. The main limitation of the analyses included enrollment of a limited number of patients and the inability to compare its efficacy with currently available treatments. Overall, this study demonstrated that sintilimab plus anlotinib could be a potential treatment for advanced cervical cancer. However, further investigation is required to examine the long-term efficacy and safety profile of the treatments.
In-Depth [prospective cohort]: This was an open-label, single-arm, phase II study. Patients were enrolled if they had previously received at least one type of systemic treatment or were intolerable to chemotherapy. A total of 42 patients were enrolled to receive the study treatment. 3 patients discontinued treatment [adverse events (n=2), withdrawal (n=1)] and therefore, 39 patients were included as part of the efficacy-evaluable population. The median follow-up period was 10.9 months (range: 0.03-19.2) and the median treatment duration was 7.0 months (range: 0.03-19.2). The overall response rate (ORR) for the intention-to-treat population was 54.8% (95% confidence interval [CI]: 38.7 to 70.2). In the efficacy-evaluable patient groups, the ORR was 59.0% (95% CI: 82.7-99.4). Common treatment-related adverse events of any grade included hypothyroidism (33%), elevated aspartate aminotransferase levels (21%) and hypertension (19%). Seven patients experienced grade 3 and above treatment-related adverse events. These included 3 cases of fistula, and one case of each of the following treatment-related adverse events: hypertension, diarrhea, fatigue, immune pneumonitis, immune myocarditis.
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