Efficacy of regorafenib combined with PD-1 inhibitors in elderly patients with advanced metastatic colorectal cancer

Objective: This is the first trial that wants to investigate the treatment patterns, clinical outcomes and prognostic factors of regorafenib plus PD-1 inhibitors therapy to Chinese elderly patients with advanced colorectal cancer. Methods: : A cohort of metastatic colorectal cancer patients with 60 years or older received treatment of regorafenib combined with PD-1 inhibitors was included in our analysis. The endpoints included overall survival (OS), progression free survival (PFS), and prognostic factors. Results: : In total, 24 patients were enrolled. The median age was 68 years; 62.5% were female. The median OS and PFS were 15.03 months (95% CI 7.0-23.0) and 4.0 months (95% CI 1.8-6.2), respectively. The objective response rate was 8.3% and disease control rate was 70.8%. When compared with PFS and OS in different initial daily doses group of regorafenib (such as 40, 80, 120 or 160 mg), we concluded that there were no significantly difference between these groups. And similar results were found in final daily doses groups. However, in terms of final daily doses, it showed a trend toward better PFS in > 80mg group compared to ≤80 mg group (median PFS was 10.0 months in >80mg group versus 3.5 months in ≤80mg group) . Patients with previous treated with regorafenib had longer median PFS than those without it (6.3 versus 2.8 months). Conclusions: : This real-world evidence confirms that Chinese elderly patients with advanced colorectal cancer may benefit from treatment of regorafenib combined with PD-1 inhibitors, similarly with this combination therapy strategies in all age patients.