Real-world outcomes of regorafenib in metastatic colorectal cancer: a single-center retrospective study

Aims: This study aimed to evaluate the real-world effectiveness and safety of regorafenib in patients with metastatic colorectal cancer (mCRC) treated in routine clinical practice.Methods: A single-center, retrospective, observational study was conducted at the Department of Medical Oncology of the Ordu University Training and Research Hospital. The medical records of 43 patients with mCRC, who received regorafenib after progression on standard systemic therapies between January 2015 and December 2024, were retrospectively reviewed. Overall survival (OS) and progression-free survival (PFS) were analyzed using the Kaplan–Meier method, and treatment-related adverse events and dose modifications were documented.Results: The median OS was 6.1 months (95% confidence interval [CI]: 4.8–7.4), and the median PFS was 3.5 months (95% CI: 0.9–6.1). Dose adjustments were frequent, with dose reductions required in 27.9% of patients and dose escalations in 18.6%. Treatment-related adverse events were primarily mild, including decreased appetite (39.5%), fatigue (34.9%), anemia (27.9%), and rash (20.9%). Serious adverse events were rare; grade ≥3 toxicities were observed in a limited number of patients, specifically fatigue in four patients (9.3%), hypertension in three patients (7.0%), and hand–foot skin reactions in two patients (4.7%). One patient (2.3%) experienced gastrointestinal perforation, leading to treatment discontinuation. Exploratory subgroup analyses, based on sex, age, Eastern Cooperative Oncology Group (ECOG) performance status, primary tumor location, and maintenance dose intensity, revealed no significant differences in survival outcomes. Conclusion: Despite limitations associated with its retrospective and single-center design, this real-world study suggests that regorafenib provides modest, yet clinically meaningful, survival benefits accompanied by a manageable safety profile in heavily pretreated patients with mCRC. These findings support the practical application of regorafenib as a later-line treatment option, particularly when individualized dosing strategies and careful toxicity monitoring are implemented in routine clinical practice.