Regorafenib in the Real-Life Clinical Practice: Data from the Czech Registry
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To describe the use of regorafenib for the treatment of metastatic colorectal cancer (mCRC) in clinical practice in the Czech Republic, and to describe the clinical outcomes of patients in terms of safety and survival.
Patients and Methods
The data of patients treated with regorafenib were extracted from the national CORECT registry. The CORECT registry is a non-interventional post-marketing database, gathering information about patients with CRC and treated with targeted agents. Twenty oncology centres in the Czech Republic contributed to this registry. Collected data included patients’ characteristics, disease history, cancer treatments, response to treatments and safety.
A total of 148 patients treated with regorafenib in clinical practice were analysed. At regorafenib initiation, almost all patients were fully active or slightly restricted in physical activity. Regorafenib was not administered as first-line treatment in any patient. Median progression-free survival was 3.5 months and median overall survival was 9.3 months. One-year survival rate was 44.6 %. Four partial responses were observed and 51 stable diseases. Progression was observed in 66 patients (44.6 %). The main reported adverse events were skin toxicity (5.4 %) and fatigue (2.0 %).
Regorafenib is a well-established treatment for pretreated patients with mCRC, however real-life data are scarce. Our results demonstrated slightly better efficacy of regorafenib and better safety profile in patients with mCRC compared to the randomised trials.
KeywordsOverall Survival Bevacizumab Sorafenib Cetuximab Metastatic Colorectal Cancer
Fifteen comprehensive oncology centres, approved by the authorities and payers, contributed to the registry.
The authors thank Abir Tadmouri, PhD (ClinSerach) for providing editorial assistance in the preparation of the manuscript.
Compliance with Ethical Standards
The institute of Biostatistics and Analysis, Faculty of Medicine, Masaryk University, Brno received financial support for the CORRECT registry from Bayer, Amgen Merck and Roche.
Conflict of Interest
Katerina Kopeckova received grants and payment for lectures from Bayer.
Tomas Buchler received grants, consulting fees and support for travel from Bayer.
Zbynek Bortlicek has no conflict of interest to declare.
Karel Hejduk has no conflict of interest to declare.
Renta Chloupkova has no conflicts of interest to declare.
Bohuslav Melichar received consulting fees from Roche, Novartis, Astellas, Bristol-Myers Squibb, MSD, Merck, Pfizer, Janssen, support for travel from Roche, Novartis, Astellas, Bristol-Myers Squibb, provision of writting assistance from Roche, Bristol-Myers Squibb, payment for lectures Roche, Novartis, Astellas, Bristol-Myers Squibb, MSD, Merck, Pfizer, Janssen.
Petra Pokorna has no conflicts of interest to declare.
Jiri Tomasek has no conflicts of interest to declare.
Zdenek Linke has no conflicts of interest to declare.
Lubos Petruzelka has no conflicts of interest to declare.
Igor Kiss has no conflicts of interest to declare.
Jana Prausova has no conflicts of interest to declare.
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