Prognostic factors for regorafenib treatment in patients with refractory metastatic colorectal cancer: A real-life retrospective multi-center study

Authors

  • Sabin Goktas Aydin Department of Medical Oncology, Medical Faculty, Medipol University, Istanbul, Turkey https://orcid.org/0000-0002-0077-6971
  • Engin Eren Kavak Department of Medical Oncology, Medical Faculty, Ankara University, Ankara, Turkey
  • Atakan Topcu Department of Medical Oncology, Medical Faculty, Bezmialem Vakif University, Istanbul, Turkey https://orcid.org/0000-0002-3634-4820
  • Ayberk Bayramgil Department of Medical Oncology, Medical Faculty, Medipol University, Istanbul, Turkey
  • Fahri Akgul Department of Medical Oncology, Medical Faculty, Trakya University, Edirne, Turkey https://orcid.org/0000-0003-1422-1093
  • Seda Kahraman Department of Medical Oncology, Medical Faculty, Ankara Yildirim Beyazit University, Ankara, Turkey https://orcid.org/0000-0002-5328-6554
  • Musa Baris Aykan Department of Medical Oncology, Gulhane Education and Research Hospital, Ankara, Turkey https://orcid.org/0000-0001-7538-9119
  • Yunus Emre Altıntas Department of Medical Oncology, Medical Faculty, Koc University, Istanbul, Turkey
  • Kaan Helvaci Department of Medical Oncology, Memorial Ankara Hospital, Ankara, Turkey https://orcid.org/0000-0002-8394-8168
  • Yuksel Urun Department of Medical Oncology, Medical Faculty, Ankara University, Ankara, Turkey
  • Ahmet Bilici Department of Medical Oncology, Medical Faculty, Medipol University, Istanbul, Turkey https://orcid.org/0000-0002-0443-6966
  • Mesut Seker Department of Medical Oncology, Medical Faculty, Bezmialem Vakif University, Istanbul, Turkey
  • Mehmet Ali Nahit Sendur Department of Medical Oncology, Medical Faculty, Ankara Yildirim Beyazit University, Ankara, Turkey https://orcid.org/0000-0001-7021-6139
  • Omer Fatih Olmez Department of Medical Oncology, Medical Faculty, Medipol University, Istanbul, Turkey https://orcid.org/0000-0001-7934-7039
  • Ozgur Acikgoz Department of Medical Oncology, Medical Faculty, Medipol University, Istanbul, Turkey https://orcid.org/0000-0003-2715-4002
  • Irfan Cicin Department of Medical Oncology, Medical Faculty, Trakya University, Edirne, Turkey https://orcid.org/0000-0002-7584-3868

DOI:

https://doi.org/10.17305/bb.2023.9253

Keywords:

Regorafenib, metastatic colorectal cancer (mCRC), dose escalation, dose interruption, progression-free survival (PFS), overall survival (OS)

Abstract

Regorafenib, an oral multikinase inhibitor, has improved survival in metastatic colorectal cancer (mCRC) patients who have progressed on standard therapies. Our study aimed to evaluate prognostic factors influencing regorafenib treatment and assess the optimal dosing regimen in a real-life setting. We retrospectively analysed 263 patients with mCRC from multiple medical oncology clinics in Turkey. Treatment responses and prognostic factors for survival were evaluated using univariate and multivariate analysis. Of the patients, 120 were male, and 143 were female; 28.9% of tumors were located in the rectum. RAS mutations were present in 3.0% of tumors, while BRAF, K-RAS, and N-RAS mutations were found in 3.0%, 29.7%, and 25.9% of tumor tissues, respectively. Dose escalation was preferred in 105 (39.9%) patients. The median treatment duration was 3.0 months, with an objective response rate (ORR) of 4.9%. Grade ≥ 3 treatment-related toxicity occurred in 133 patients, leading to discontinuation, interruption, and modification rates of 50.6%, 43.7%, and 79.0%, respectively. Median progression-free survival (PFS) and overall survival (OS) were 3.0 and 8.1 months, respectively. RAS/RAF mutation (hazard ratio [HR] 1.5, 95% confidence interval [CI] 1.1-2.3; P = 0.01), pretreatment carcinoembryonic antigen (CEA) levels (HR 1.6, 95% CI 1.1-2.3; P = 0.008), and toxicity-related treatment interruption or dose adjustment (HR 1.6, 95% CI 1.1-2.4; P = 0.01) were identified as independent prognostic factors for PFS. Dose escalation had no significant effect on PFS but was associated with improved OS (P < 0.001). Independent prognostic factors for OS were the initial TNM stage (HR 1.3, 95% CI 1.0-1.9; P = 0.04) and dose interruption/adjustment (HR 0.4, 95% CI 0.2-0.9; P = 0.03). Our findings demonstrate the efficacy and safety of regorafenib. Treatment line influences the response, with dose escalation being more favorable than adjustment or interruption, thus impacting survival.

Prognostic factors for regorafenib treatment in patients with refractory metastatic colorectal cancer: A real-life retrospective multi-center study

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Published

03-11-2023

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Translational and Clinical Research

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How to Cite

1.
Prognostic factors for regorafenib treatment in patients with refractory metastatic colorectal cancer: A real-life retrospective multi-center study. Biomol Biomed [Internet]. 2023 Nov. 3 [cited 2024 Mar. 3];23(6):1089–1095. Available from: https://www.bjbms.org/ojs/index.php/bjbms/article/view/9253