The objective of this treatment was to evaluate the effectiveness and safety of administering topical sintilimab alongside concurrent chemoradiotherapy (CRT) and californium-252 neutron brachytherapy for first-line treatment in patients with advanced gynecological squamous cell carcinoma.

Following the treatment regimen, 19 patients achieved complete response (CR), and one patient attained partial response (PR). The time taken for the longest interval from treatment to CR was 6 months. Both the objective response rate (ORR) and disease control rate (DCR) were 100%. Over a median follow-up period of 19 months, no instances of disease progression were observed, and only one patient succumbed during the study due to heart failure. The two-year cancer-specific survival rate reached 100%. The median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were still indeterminate. Notably, only 15% of patients experienced immune-mediated adverse events, specifically Grade II thyroid dysfunction in two cases and Grade III thyroid dysfunction in one case.

Conclusion

The clinical application of PD-1 immunotherapy faces challenges due to limited patient response rates and high rates of immune-related adverse effects. Radiation therapy has shown potential in enhancing PD-1 efficiency by inducing tumor antigens, modifying the tumor microenvironment, and increasing PD-L1 expression on tumors. The optimal sequence for this combined treatment strategy remains uncertain.

Typically, PD-1 inhibitors are administered intravenously, but tumors often exhibit neovascular malformations and poor blood perfusion, leading to reduced drug concentration and diminished antitumor activity. To overcome these limitations, intratumoral or locoregional administration of PD-1 antibodies has been proposed. This clinical trial represents the first investigation into the combination of PD-1 antibody topical injection with chemoradiotherapy for cervical cancer. The results demonstrate superior antitumor effects and a lower risk of immunotherapy-related adverse effects compared to published data. However, being a single-center study, the sample size remains limited, and a more extended follow-up duration is necessary to confirm the long-term efficacy and potential toxicities. 

For more insight into the patient's burden/epidemiology, treatment, and changing market landscape-related advancements of other related indications, refer to the following reports:

• Ovarian Cancer Market Insight, Epidemiology, and Market Forecast
• Cervical Cancer Market Insight, Epidemiology, and Market Forecast