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

Aykut Turhan; Neslihan Özyurt

doi:10.47582/jompac.1855426

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

Abstract

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.

Keywords

Thanks

We sincerely thank the Editor-in-Chief and the Editorial Board for considering our manuscript. We appreciate the time and effort devoted to the evaluation of our work.

References

Tarpgaard LS, Winther SB, Pfeiffer P. Treatment options in late-line colorectal cancer: lessons learned from recent randomized studies. Cancers (Basel). 2023;16(1):126. doi:10.3390/cancers16010126
Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10. 3322/caac.21834
Garcia-Alfonso P, Vera R, Aranda E, Elez E, Rivera F. Delphi consensus for the third-line treatment of metastatic colorectal cancer. Clin Transl Oncol. 2024;26(6):1429-1437. doi:10.1007/s12094-023-03369-1
Walter T, Hawkins NS, Pollock RF, Colaone F, Shergill S, Ross PJ. Systematic review and network meta-analyses of third-line treatments for metastatic colorectal cancer. J Cancer Res Clin Oncol. 2020;146(10): 2575-2587. doi:10.1007/s00432-020-03315-6
Steup C, Kennel KB, Neurath MF, Fichtner-Feigl S, Greten FR. Current and emerging concepts for systemic treatment of metastatic colorectal cancer. Gut. 2025;74(12):2070-2095. doi:10.1136/gutjnl-2025-335412
Barzi A, Bekaii-Saab T. Sequencing considerations in the third-line treatment of metastatic colorectal cancer. Am J Manag Care. 2024;30(2 Suppl):S31-S35. doi:10.37765/ajmc.2024.89546
Fadlallah H, El Masri J, Fakhereddine H, et al. Colorectal cancer: recent advances in management and treatment. World J Clin Oncol. 2024;15(9): 1136-1156. doi:10.5306/wjco.v15.i9.1136
Grothey A, Van Cutsem E, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381(9863):303-312. doi:10.1016/S0140-6736(12)61900-X

Dane F, Ozgurdal K, Yalcin S, et al. Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD study. BMJ Open. 2020; 10(3):e027665. doi:10.1136/bmjopen-2018-027665
Hopirtean C, Nagy V. Optimizing the use of anti VEGF targeted therapies in patients with metastatic colorectal cancer: review of literature. Clujul Med. 2018;91(1):12-17. doi:10.15386/cjmed-881
L Zygulska A. Further therapeutic options in heavily pretreated colorectal cancer patients. In: Jeong K-Y, ed. Multidisciplinary Approach for Colorectal Cancer. IntechOpen; 2019:chap Chapter 6.
Li J, Qin S, Xu R, et al. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015;16(6):619-629. doi:10.1016/S1470-2045(15)70156-7
Van Cutsem EJD, Grothey A, Sobrero A, et al. Phase 3 correct trial of regorafenib in metastatic colorectal cancer (MCRC): overall survival update. Ann Oncol. 2012;23:ixe10. doi:10.1016/s0923-7534(20)34319-2
Krishnamoorthy SK, Relias V, Sebastian S, Jayaraman V, Saif MW. Management of regorafenib-related toxicities: a review. Therap Adv Gastroenterol. 2015;8(5):285-297. doi:10.1177/1756283X15580743
Azoulay L. Rationale, strengths, and limitations of real-world evidence in oncology: a Canadian review and perspective. Oncologist. 2022;27(9): e731-e738. doi:10.1093/oncolo/oyac114
Mitchell AP, Harrison MR, Walker MS, George DJ, Abernethy AP, Hirsch BR. Clinical trial participants with metastatic renal cell carcinoma differ from patients treated in real-world practice. J Oncol Pract. 2015;11(6):491-497. doi:10.1200/JOP.2015.004929
Zauderer MG. Practical application of real-world evidence in developing cancer therapies. JCO Clin Cancer Inform. 2019;3:1-2. doi:10.1200/CCI. 19.00071
Skovlund E, Leufkens HGM, Smyth JF. The use of real-world data in cancer drug development. Eur J Cancer. 2018;101:69-76. doi:10.1016/j.ejca.2018.06.036
Booth CM, Karim S, Mackillop WJ. Real-world data: towards achieving the achievable in cancer care. Nat Rev Clin Oncol. 2019;16(5):312-325. doi:10.1038/s41571-019-0167-7
George G, Russell B, Rigg A, Coolen ACC, Van Hemelrijck M. Real world data studies of antineoplastic drugs: how can they be improved to steer everyday use in the clinic? Pragmat Obs Res. 2023;14:95-100. doi: 10.2147/POR.S395959
Nakashima M, Li K, Chen Q, et al. Appropriate dose of regorafenib based on body weight of colorectal cancer patients: a retrospective cohort study. BMC Cancer. 2023;23(1):1268. doi:10.1186/s12885-023-11720-6
Bekaii-Saab T, Khan N, Ostojic H, et al. Real-world dosing of regorafenib and outcomes among patients with metastatic colorectal cancer: a retrospective analysis using US claims data. BMC Cancer. 2024;24(1): 939. doi:10.1186/s12885-024-12421-4
Van Cutsem E, Sobrero AF, Siena S, et al. Phase III CORRECT trial of regorafenib in metastatic colorectal cancer (mCRC). J Clin Oncol. 2012; 30(15_suppl):3502-3502. doi:10.1200/jco.2012.30.15_suppl.3502
Tang M, Pearson SA, Simes RJ, Chua BH. Harnessing real-world evidence to advance cancer research. Curr Oncol. 2023;30(2):1844-1859. doi:10.3390/curroncol30020143
Khozin S, Stein RM. A novel approach to reducing disparities in health outcomes by enhancing interpretation of cancer clinical trials for underrepresented patient groups. Biochim Biophys Acta Rev Cancer. 2022;1877(6):188825. doi:10.1016/j.bbcan.2022.188825
Loupakis F, Antonuzzo L, Bachet JB, et al. Practical considerations in the use of regorafenib in metastatic colorectal cancer. Ther Adv Med Oncol. 2020;12:1758835920956862. doi:10.1177/1758835920956862
Beom SH, Bae KB, Zang DY, et al. Real-world experience of safety and effectiveness of regorafenib for treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumors, and hepatocellular carcinoma: a post-marketing surveillance study in Korea. Research paper. J Cancer. 2022;13(13):3396-3403. doi:10.7150/jca.74107
Sastre J, Argiles G, Benavides M, et al. Clinical management of regorafenib in the treatment of patients with advanced colorectal cancer. Clin Transl Oncol. 2014;16(11):942-953. doi:10.1007/s12094-014-1212-8

Details

Primary Language

English

Subjects

Clinical Oncology

Journal Section

Research Article

Authors

Aykut Turhan ^*
0000-0002-2535-9816
Türkiye

Neslihan Özyurt
0000-0002-1404-8983
Türkiye

Publication Date

February 20, 2026

Submission Date

January 3, 2026

Acceptance Date

February 19, 2026

Published in Issue

Year 2026 Volume: 7 Number: 1

DOI

https://doi.org/10.47582/jompac.1855426

IZ

https://izlik.org/JA47DK34WY

Cite

RIS / Bibtex

APA

Turhan, A., & Özyurt, N. (2026). Real-world outcomes of regorafenib in metastatic colorectal cancer: a single-center retrospective study. Journal of Medicine and Palliative Care, 7(1), 182-188. https://doi.org/10.47582/jompac.1855426

AMA

1.Turhan A, Özyurt N. Real-world outcomes of regorafenib in metastatic colorectal cancer: a single-center retrospective study. J Med Palliat Care / JOMPAC / jompac. 2026;7(1):182-188. doi:10.47582/jompac.1855426

Chicago

Turhan, Aykut, and Neslihan Özyurt. 2026. “Real-World Outcomes of Regorafenib in Metastatic Colorectal Cancer: A Single-Center Retrospective Study”. Journal of Medicine and Palliative Care 7 (1): 182-88. https://doi.org/10.47582/jompac.1855426.

EndNote

Turhan A, Özyurt N (February 1, 2026) Real-world outcomes of regorafenib in metastatic colorectal cancer: a single-center retrospective study. Journal of Medicine and Palliative Care 7 1 182–188.

IEEE

[1]A. Turhan and N. Özyurt, “Real-world outcomes of regorafenib in metastatic colorectal cancer: a single-center retrospective study”, J Med Palliat Care / JOMPAC / jompac, vol. 7, no. 1, pp. 182–188, Feb. 2026, doi: 10.47582/jompac.1855426.

ISNAD

Turhan, Aykut - Özyurt, Neslihan. “Real-World Outcomes of Regorafenib in Metastatic Colorectal Cancer: A Single-Center Retrospective Study”. Journal of Medicine and Palliative Care 7/1 (February 1, 2026): 182-188. https://doi.org/10.47582/jompac.1855426.

JAMA

1.Turhan A, Özyurt N. Real-world outcomes of regorafenib in metastatic colorectal cancer: a single-center retrospective study. J Med Palliat Care / JOMPAC / jompac. 2026;7:182–188.

MLA

Turhan, Aykut, and Neslihan Özyurt. “Real-World Outcomes of Regorafenib in Metastatic Colorectal Cancer: A Single-Center Retrospective Study”. Journal of Medicine and Palliative Care, vol. 7, no. 1, Feb. 2026, pp. 182-8, doi:10.47582/jompac.1855426.

Vancouver

1.Aykut Turhan, Neslihan Özyurt. Real-world outcomes of regorafenib in metastatic colorectal cancer: a single-center retrospective study. J Med Palliat Care / JOMPAC / jompac. 2026 Feb. 1;7(1):182-8. doi:10.47582/jompac.1855426