Objectives: Metastatic colorectal cancer (mCRC) remains a major cause of cancer-related mortality, with limited therapeutic options available after the failure of standard treatments. Regorafenib, an oral multichines inhibitor, has shown a survival advantage in treatment refractory mCRC. This research aims to evaluate the real-world effectiveness of regorafenib and to investigate the prognostic significance of inflammatory and nutritional indicators, specifically the Pan-Immune-Inflammation Value (PIV) and Prognostic Nutritional Index (PNI).
Methods: We conducted a retrospective analysis of 166 mCRC patients who received regorafenib 2014 to 2024. Demographic, clinical, and pathological data, treatment responses, and laboratory indicators were gathered. Survival outcomes were evaluated by Kaplan–Meier analysis, whereas prognostic variables were analyzed using Cox regression.
Results: The average age was 58 years, and 59% of patients were male. The overall disease control rate with regorafenib was 33%, and the objective response rate was 11%. The median progression-free survival (PFS) was 3.8 months, and the median overall survival (OS) was 9.1 months. A high PIV (≥309.1) was associated with significantly shorter overall survival (7.1 vs. 11.8 months, P=0.001), whereas a high PNI (≥47.9) was correlated with longer overall survival (10.7 vs. 6.7 months, P=0.02). Multivariate analysis confirmed PIV and PNI as independent prognostic indicators.
Conclusions: Regorafenib provides a modest survival advantage and disease stabilization in previously treated mCRC patients. PIV and PNI are independent prognostic biomarkers that may assist in patient stratification and therapy optimization. Further studies are warranted to refine predictive markers and dosing strategies.
Regorafenib metastatic colorectal cancer Prognostic nutritional index pan-immune-inflammation value prognostic biomarkers
This study was approved by the Kartal Dr. Lütfi Kırdar City Hospital Scientific Research Ethics Committee (Decision No.: 2024/010.99/3/1 and dated 29.04.2023). All procedures performed during data collection, review of patient records, and study implementation complied with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its subsequent amendments. Informed consent was waived because of the retrospective nature of the study and the analysis used anonymous clinical data.
Primary Language | English |
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Subjects | Clinical Oncology, Cancer Therapy (Excl. Chemotherapy and Radiation Therapy) |
Journal Section | Original Articles |
Authors | |
Early Pub Date | October 3, 2025 |
Publication Date | October 10, 2025 |
Submission Date | August 25, 2025 |
Acceptance Date | September 27, 2025 |
Published in Issue | Year 2025 Volume: 11 Issue: 6 |