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Objective: We performed this meta-analysis to compare the efficacy and toxicity of regorafenib and TAS-102.
Methods: Electronic databases were searched to identify studies comparing the efficacy and safety of regorafenib and TAS-102 in patients with chemotherapy-refractory metastatic colorectal cancer using pooled analyses.
Results: Three clinical trials were included in this analysis. Regarding the reasons for treatment discontinuation, regorafenib was significantly associated with disease progression (odds ratio [OR] = 0.33, 95% confidence interval [CI] = 0.21-0.50) and adverse events (OR = 4.38, 95% CI = 2.69-7.13). However, overall (OR = 0.97, 95% CI = 0.81-1.17) and progression-free survival (OR = 1.01, 95% CI = 0.86-1.18) did not significantly differ between the groups. The most common treatment-related adverse events in the regorafenib group were neutropenia (OR = 0.06, 95% CI = 0.03-0.11), hand-foot syndrome (OR = 50.34, 95% CI = 10.44-242.84), and liver dysfunction (OR = 34.51, 95% CI = 8.30-143.43). Conversely, the incidence of thrombocytopenia did not differ between the two groups.
Conclusions: Regorafenib and TAS-102 have similar efficacy but different adverse event profiles. Differences in the toxicity profiles of the two drugs will help guide treatment selection.
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http://dx.doi.org/10.1177/0300060520926408 | DOI Listing |
Lancet Oncol
September 2025
Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Background: In the phase 3 CodeBreaK 300 study, sotorasib (KRAS inhibitor) plus panitumumab (EGFR inhibitor) significantly prolonged progression-free survival versus investigator's choice of trifluridine-tipiracil or regorafenib (standard of care) in patients with KRAS-mutated chemorefractory metastatic colorectal cancer. This analysis evaluated patient-reported outcomes (PROs) as secondary and exploratory endpoints.
Methods: In this open-label, randomised clinical trial, adult (aged ≥18 years) patients from 67 centres in 13 countries in Asia, Australia, Europe, and North America with KRAS-mutated chemorefractory metastatic colorectal cancer (as assessed by central molecular testing of tumour biopsy specimens) who were KRAS inhibitor-naive, had progressed to recurrence after previous therapy with fluoropyrimidine, oxaliplatin, and irinotecan, with measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.
Oncologist
June 2025
Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan 250012, People's Republic of China.
Background: Both regorafenib and trifluridine/tipiracil (TAS-102) monotherapies have shown significant but limited survival benefits in metastatic colorectal cancer (mCRC) cases who progress after standard treatments. This study aimed to evaluate the efficacy and safety of regorafenib plus biweekly TAS-102 in refractory mCRC.
Methods: In this single-arm multicenter phase II trial (ChiCTR2300071752), eligible patients received regorafenib at 120 mg/day for 21 days in a 4-week cycle or were treated with a dose-escalation strategy (80 mg/day, followed by weekly increase of 40 mg to 120 mg/day).
J Gastrointest Oncol
April 2025
Department of Oncology Digestive, First Hospital of Shanxi Medical University, Taiyuan, China.
Background: Metastatic colorectal cancer (mCRC) is associated with poor prognosis and limited options for later-line treatment. Regorafenib and TAS-102 have shown significant benefit and are recommended as later-line treatment for mCRC. This study aimed to investigate the progression-free survival (PFS) and overall survival (OS) of patients with mCRC treated with TAS-102 sequentially after regorafenib progression.
View Article and Find Full Text PDFFuture Oncol
July 2025
Real World Research, Ontada, Boston, MA, USA.
Aim: To assess biomarker testing utilization, treatment patterns, and clinical outcomes in previously treated proficient mismatch repair deficient (pMMR) or non-microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) patients.
Materials & Methods: Using the iKnowMed electronic health record database, this study included pMMR/non-MSI-H adult mCRC patients previously treated with standard-of-care (SoC) chemotherapies between 1 January 2016 and 31 December 2021. Patients were censored for overall survival (OS) and real-world progression-free survival (rwPFS) at their last visit date or the end of study period, 31 August 2022.
J Med Econ
December 2025
Analysis Group, Boston, MA, USA.
Background: New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.
Materials And Methods: A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs).