Regorafenib is a multikinase inhibitor approved for the therapy of patients with metastatic colorectal carcinoma (mCRC) previously treated with a fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF therapy, and (in wild-type RAS tumours) anti-EGFR therapy. The aim of the present study was to analyse the outcomes of treatment with regorafenib in real-world clinical practice based on data from a national registry.
The CORECT registry (http://corect.registry.cz) is a non-interventional database of patients with colorectal cancer treated with targeted agents. The analysis included 451 evaluable patients treated with regorafenib for mCRC.
The median age at diagnosis was 61.1 years. The primary tumor was in the left colon or rectum in 343 patients (76.1%), right colon in 81 patients (18.0%), data on location were not available for 27 patients (6.0%). KRAS mutation was detected in 202 patients (44.8%) and NRAS mutation in 40 patients (8.9%). The median duration of treatment was 2.7 months (range 0.0-23.4 months). Partial response was seen in 12 patients (3.2%). Progression of the disease was reported in 170 patients (44.7%) and disease stabilisation for at least 6 weeks in 110 patients (28.9%). Progression-free and overall survival data are shown in the table. Improved outcomes were observed in patients with longer interval from diagnosis of mCRC and in those without liver metastases. Age, tumor sidedness, and RAS status were not associated with outcome of regorafenib therapy. The main cause of treatment discontinuation was disease progression (71.3%) followed by general deterioration in the absence of radiological progression in 93 patients (24.5%), and adverse events related to regorafenib in (4.2%).Table: 468P
Progression-free survival and overall survival of patients treated with regorafenib
|Median (95% CI)||3-month survival (95% CI)||6-month survival (95% CI)|
|Progression-free survival||3.5 months (3.2–3.7)||57.6% (52.5–62.4)||25.2% (20.9–29.9)|
|Overall survival||9.3 months (7.9–10.7)||88.8% (85.2–91.5)||68.7% (63.6–73.3)|
Overall survival of patients treated with regorafenib in real-world clinical practice exceeded that achieved in randomised trials.
Clinical trial identification
Legal entity responsible for the study
Katerina Kopeckova and Tomas Buchler.
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. Supported by Grant AZV 15-26535A from the Czech Health Research Council.
K. Kopeckova: Research support: Bayer. B. Melichar: Consulting fees: Roche, Novartis, Astellas, Bristol-Myers Squibb, MSD, Merck, Pfizer, Janssen; Travel: Roche, Novartis, Astellas, Bristol-Myers Squibb; Provision of writing assistance: Roche, Bristol-Myers Squibb Payment for lectures: Roche, Novartis, Astellas, Bristol-Myers Squibb, MSD, Merck, Pfizer, Janssen. J. Finek: Lecture honoraria, travel grants: Roche, Merck, Pfizer, Novartis, Amgen. O. Fiala, T. Buchler: Research funding, travel grants, honoraria: Roche, Merck, Bayer, Servier, BMS, MSD, Sanofi, Amgen. J. Tomasek: Grants, consulting fees, travel: Bayer. I. Kiss: Speakers’ honoraria: Roche, Merck, Amgen. All other authors have declared no conflicts of interest.