Regorafenib for Metastatic Colorectal Cancer: An Analysis of a Registry-Based Cohort of 555 Patients

Alena Novakova-Jiresova; Katerina Kopeckova; Ludmila Boublikova; Renata Chloupkova; Bohuslav Melichar; Lubos Petruzelka; Jindrich Finek; Ondrej Fiala; Peter Grell; Stanislav Batko; Zdenek Linke; Igor Kiss; Jana Prausova; Tomas Buchler

doi:10.2147/CMAR.S255332

Regorafenib for Metastatic Colorectal Cancer: An Analysis of a Registry-Based Cohort of 555 Patients

Cancer Manag Res. 2020 Jul 3:12:5365-5372. doi: 10.2147/CMAR.S255332. eCollection 2020.

Authors

Affiliations

¹ Department of Oncology, First Faculty of Medicine and Thomayer Hospital, Charles University, Prague, Czech Republic.
² Department of Oncology, University Hospital in Motol, Charles University, Prague, Czech Republic.
³ Institute of Biostatistics and Analysis, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
⁴ Department of Oncology, Palacky University Medical and Teaching Hospital, Olomouc, Czech Republic.
⁵ Department of Oncology, General Faculty Hospital, Charles University, Prague, Czech Republic.
⁶ Department of Oncology and Radiotherapy, Medical School and University Hospital in Pilsen, Charles University, Pilsen, Czech Republic.
⁷ Biomedical Center, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czech Republic.
⁸ Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, Brno, Czech Republic.

Abstract

Purpose: Regorafenib is an oral multikinase inhibitor approved for the therapy of previously treated metastatic colorectal carcinoma (mCRC). The aim of the present study was to analyze the outcomes of treatment with regorafenib in real-world clinical practice based on data from a national registry.

Methods: The CORECT registry, the Czech non-interventional database of patients with mCRC treated with targeted agents, searched for patients with metastatic CRC treated with regorafenib. In total, 555 evaluable patients were identified.

Results: The median age at diagnosis was 61.7 years. All patients had disease progression on or after previous systemic treatment. Most patients were treated with an initial dose of 160 mg daily (n = 463; 83.6%). The median duration of treatment was 2.7 months (range 0.0-23.4 months). By the data cut-off date, 472 patients (85%) had completed treatment with regorafenib and were evaluable for treatment response evaluation. Partial response was reported in 13 patients (2.8%) and disease stabilization in 130 patients (27.5%). Median progression-free survival (PFS) and overall survival (OS) were 3.5 months (95% confidence interval [CI] 3.2-3.7 months) and 9.3 months (95% CI 8.3-10.3 months), respectively. The 6-month OS rate was 67.7% (95% CI 63.4-72.1%). Multivariable analysis showed that female gender, longer interval from diagnosis of metastatic disease, M0 stage at diagnosis, and Eastern Cooperative Oncology Group performance status (ECOG PS) 0 were associated with longer PFS, while higher body-mass index (BMI), longer interval from diagnosis of metastatic disease, and ECOG PS of 0 were associated with longer OS.

Conclusion: OS of patients treated with regorafenib in the real-world clinical practice in this cohort exceeded that reported in randomized trials. Regorafenib is a safe and active treatment option for a subgroup of patients with mCRC who are progressing after other systemic therapies and maintain good performance status.

Keywords: colorectal cancer; outcome analysis; registry; regorafenib; survival.

Grants and funding

The Institute of Biostatistics and Analysis, Faculty of Medicine, Masaryk University, Brno received financial support for the CORECT registry from Bayer, Amgen Merck and Roche.