Regorafenib with or without chemotherapy/immunotherapy in second-line treatment of metastatic colorectal cancer during the COVID-19 pandemic: a single-center retrospective analysis.

Background: Regorafenib, approved in China for the third-line treatment of patients with metastatic colorectal cancer (mCRC), targets multiple tyrosine kinases. We retrospectively evaluated the efficacy and safety of regorafenib, both as monotherapy and in combination with capecitabine or immune checkpoint inhibitors (ICIs), as a second-line treatment for patients unable to access hospital-based care due to limited hospital visits during the coronavirus disease 2019 (COVID-19) pandemic.

Methods: Retrospective analysis was conducted on individual patient data from Peking University Third Hospital, covering the period from January 2020 to September 2023. The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS) and safety.

Results: The study comprised 31 patients with a median age of 65 years. The median PFS (mPFS) was 6.0 months, while the median OS (mOS) was 20.0 months. Compared to those treated with regorafenib alone, patients treated with regorafenib plus capecitabine/ICIs tended to have a longer PFS (8.0 4.0 months) and OS (27.0 15.0 months). Liver metastases [hazard ratio (HR) =2.515, 95% confidence interval (CI): 1.037-6.100; P=0.04] and prior bevacizumab treatment (HR =2.613, 95% CI: 1.168-5.846; P=0.02) were identified as independent prognostic factors for PFS. Frequent grade 3/4 adverse drug reactions (ADRs) included hand-foot skin reactions (HFSRs), fatigue, hypertension, and proteinuria.

Conclusions: This single-center, retrospective study indicates that regorafenib, alone or combined with chemotherapy/immunotherapy, is a feasible and safe second-line treatment for mCRC for situations where hospital access is limited, such as during the COVID-19 pandemic. Additional prospective studies are required to investigate the advantages of combination therapies.