Efficacy and Safety of Regorafenib in Patients with Characteristics of Good Prognosis in the Treatment of Metastatic Colorectal Cancer: Subgroup Analysis of CORRECT Study
DOI:
https://doi.org/10.32635/2176-9745.RBC.2022v68n4.2727Keywords:
protein kinase inhibitors, colorectal neoplasms, neoplasm metastasis, survival analysisAbstract
Introduction: Colorectal cancer (CRC) is the second most common and when metastatic, it has a five-year survival rate of 14%. Regorafenib is an approved TKI for metastatic colorectal cancer (mCRC) with a proven increase in overall survival (OS). Objective: To investigate the efficacy and safety results of regorafenib in patients with mCRC and good prognostic characteristics (GPC). Method: Subgroup analysis of the CORRECT study, with participants divided according to GPC, following the criteria: Eastern Cooperative Oncology Group (ECOG) 0, duration of metastatic disease greater than 18 months, up to three metastatic sites and absence of liver metastasis. Efficacy compared with stratified log-rank test and hazard ratios (HR) calculated with the Cox model. Results: Of the 760 participants randomized, 292 (34.5%) had GPC; 185 (63.4%) received regorafenib; and 107 (35.6%) received placebo. For the GPC group, the median OS was 10.9 months (95%CI:8.8-12.3) for regorafenib and 7.3 months (95%CI:5.6-9.1) for placebo, with 39% of reduction of the risk of death (HR 0.61; 95% CI:0.43-0.88; p=0.0069). The median progression-free survival (PFS) was 3.5 months (95%CI:3.0-3.9) versus 1.8 months (95%CI:1.7-1.8) respectively, with 61% of reduced risk of disease progression or death (HR 0.39; 95%CI:0.30-0.52; p<0.0001). Grade 3 and 4 adverse events were more frequent for regorafenib. After setting baseline for quality of life scores (EQ-5D), these declined less for regorafenib compared to placebo (0.687 versus 0.592) with a significant difference of 0.09. Conclusion: GPC patients who received regorafenib improved OS and PFS with less deterioration of quality-of-life compared to placebo.
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