Real world effectiveness of regorafenib in heavily pretreated patients with metastatic colorectal cancer.

Abstract

141 Background: Metastatic colorectal cancer (mCRC) remains a challenge with a significant impact on patient survival and quality of life. Over the past decade, targeted therapies have emerged as promising treatment options for mCRC, including regorafenib. While clinical trials have established efficacy and safety of regorafenib in mCRC, based on the CORRECT and ReDos trials, the real-world utilization and outcomes associated with this therapy have gained increasing importance. This abstract presents a real-world data analysis focused on the use of regorafenib in patients with metastatic colorectal cancer in a community based comprehensive cancer center in Moscow, Russia. The data were collected from 2 outpatient medical oncology departments from 2018-2022 and we evaluated the real world patterns of use, effectiveness and safety. Methods: We evaluated all patients who were issued Regorafenib at a medical pharmacy of our cancer center. We evaluated all Regorafenib issued from 2018-2022 in our center – 348 patients received Regorafenib and 311 of them were patients with metastatic colorectal cancer and identified patterns of use, toxicity and outcomes in this patient population. Results: The median age was 61.2 and 49.5% were female (50.5 – were male%) Primary tumor was right sided in 20.9% of all patients, left sided – 49.1% and rectum in 29.9% De novo metastatic colorectal cancer was in 208 patients and 103 patients were those who progressed after initial treatment. Mutation status was identified in 91% of all patients. 46% had KRAS mutation, 3.8% were BRAF mutated and 4.2% were NRAS mutated. MSI status was known for 71% of the patients and it was negative. We understand the selection bias, because most of MSI-h patients would have gone on to receive immunotherapy rather than a TKI. The patients identified in our practice were more heavily pretreated (93.5% of them received more than 3 lines of prior therapy) and 1/3 of all patients were ECOG 2-3 performance status. Toxicity data were available only in 61% of the patients which reveals data caveats when using real world data outside of a clinical trial. Any grade toxicity was noted in 53% of all patients. Using Kaplan Myer Survival Analysis, the median PFS was 2 months and median OS was 5.3 months in the evaluated population. Conclusions: The real world data analysis shows that while Regorafenib is another treatment option, and our data confirm the results of clinical trial, its utilization and use provides only modest clinical benefit for patients.[Table: see text]