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Published in: Targeted Oncology 1/2017

01-02-2017 | Original Research Article

Regorafenib in the Real-Life Clinical Practice: Data from the Czech Registry

Authors: Katerina Kopeckova, Tomas Buchler, Zbynek Bortlicek, Karel Hejduk, Renata Chloupkova, Bohuslav Melichar, Petra Pokorna, Jiri Tomasek, Zdenek Linke, Lubos Petruzelka, Igor Kiss, Jana Prausova

Published in: Targeted Oncology | Issue 1/2017

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Abstract

Objective

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.

Results

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 %).

Conclusions

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.
Literature
1.
go back to reference Van Cutsem E, Cervantes A, Nordlinger B, Arnold D. Metastatic colorectal cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(suppl 3):iii1–9. Van Cutsem E, Cervantes A, Nordlinger B, Arnold D. Metastatic colorectal cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(suppl 3):iii1–9.
2.
go back to reference Schmieder R. Regorafenib (BAY 73-4506): antimetastatic activity in a mouse model of colorectal. Cancer Res 2012;72(8 Suppl):Abstract nr 2337. Schmieder R. Regorafenib (BAY 73-4506): antimetastatic activity in a mouse model of colorectal. Cancer Res 2012;72(8 Suppl):Abstract nr 2337.
3.
go back to reference Strumberg D, Scheulen ME, Schultheis B, et al. Regorafenib (BAY 73-4506) in advanced colorectal cancer: a phase I study. Br J Cancer. 2012;106:1722–7.CrossRefPubMedPubMedCentral Strumberg D, Scheulen ME, Schultheis B, et al. Regorafenib (BAY 73-4506) in advanced colorectal cancer: a phase I study. Br J Cancer. 2012;106:1722–7.CrossRefPubMedPubMedCentral
4.
go back to reference Wilhelm SM, Dumas J, Adnane L, et al. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer. 2011;129:245–55.CrossRefPubMed Wilhelm SM, Dumas J, Adnane L, et al. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer. 2011;129:245–55.CrossRefPubMed
6.
go back to reference Wilhelm SM, Carter C, Tang L, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004;64:7099–109.CrossRefPubMed Wilhelm SM, Carter C, Tang L, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004;64:7099–109.CrossRefPubMed
7.
go back to reference 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;381:303–12.CrossRefPubMed 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;381:303–12.CrossRefPubMed
8.
go back to reference Slavicek L, Pavlik T, Tomasek J, et al. Efficacy and safety of bevacizumab in elderly patients with metastatic colorectal cancer: results from the Czech population-based registry. BMC Gastroenterol. 2014;14:53.CrossRefPubMedPubMedCentral Slavicek L, Pavlik T, Tomasek J, et al. Efficacy and safety of bevacizumab in elderly patients with metastatic colorectal cancer: results from the Czech population-based registry. BMC Gastroenterol. 2014;14:53.CrossRefPubMedPubMedCentral
9.
go back to reference Tougeron D, Desseigne F, Etienne PL et al. REBECCA: a large cohort study of regorafenib (REG) in the real-life setting in patients previously treated for metastatic colorectal cancer (mCRC). Ann Oncol. 2014;25(suppl_4): iv167–iv209. Tougeron D, Desseigne F, Etienne PL et al. REBECCA: a large cohort study of regorafenib (REG) in the real-life setting in patients previously treated for metastatic colorectal cancer (mCRC). Ann Oncol. 2014;25(suppl_4): iv167–iv209.
10.
go back to reference Van Cutsem E, Ciardiello F, Seitz J-F, et al. LBA-05 Results from the large, open-label phase 3b CONSIGN study of regorafenib in patients with previously treated metastatic colorectal cancer. Ann Oncol. 2015;26(suppl_9):42–70. Van Cutsem E, Ciardiello F, Seitz J-F, et al. LBA-05 Results from the large, open-label phase 3b CONSIGN study of regorafenib in patients with previously treated metastatic colorectal cancer. Ann Oncol. 2015;26(suppl_9):42–70.
11.
go back to reference 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;16:619–29.CrossRefPubMed 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;16:619–29.CrossRefPubMed
12.
go back to reference Garcia-Alfonso P, Feliu J, Garcia-Carbonero R, et al. Is regorafenib providing clinically meaningful benefits to pretreated patients with metastatic colorectal cancer? Clin Transl Oncol. 2016;1:1. Garcia-Alfonso P, Feliu J, Garcia-Carbonero R, et al. Is regorafenib providing clinically meaningful benefits to pretreated patients with metastatic colorectal cancer? Clin Transl Oncol. 2016;1:1.
13.
go back to reference Chun YS, Vauthey JN, Boonsirikamchai P, et al. Association of computed tomography morphologic criteria with pathologic response and survival in patients treated with bevacizumab for colorectal liver metastases. JAMA. 2009;302:2338–44.CrossRefPubMedPubMedCentral Chun YS, Vauthey JN, Boonsirikamchai P, et al. Association of computed tomography morphologic criteria with pathologic response and survival in patients treated with bevacizumab for colorectal liver metastases. JAMA. 2009;302:2338–44.CrossRefPubMedPubMedCentral
14.
go back to reference Hofheinz RD, Arnold D, Kubicka S, et al. Improving patient outcomes with regorafenib for metastatic colorectal cancer - patient selection, dosing, patient education, prophylaxis, and management of adverse events. Oncol Res Treat. 2015;38:300–8.CrossRefPubMed Hofheinz RD, Arnold D, Kubicka S, et al. Improving patient outcomes with regorafenib for metastatic colorectal cancer - patient selection, dosing, patient education, prophylaxis, and management of adverse events. Oncol Res Treat. 2015;38:300–8.CrossRefPubMed
15.
go back to reference Tabernero J, Lenz HJ, Siena S, et al. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol. 2015;16:937–48.CrossRefPubMed Tabernero J, Lenz HJ, Siena S, et al. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol. 2015;16:937–48.CrossRefPubMed
16.
go back to reference NCCN. NCCN Clinical Practice Guidelines in Oncology. Colon Cancer. Version3. 2011. NCCN. NCCN Clinical Practice Guidelines in Oncology. Colon Cancer. Version3. 2011.
Metadata
Title
Regorafenib in the Real-Life Clinical Practice: Data from the Czech Registry
Authors
Katerina Kopeckova
Tomas Buchler
Zbynek Bortlicek
Karel Hejduk
Renata Chloupkova
Bohuslav Melichar
Petra Pokorna
Jiri Tomasek
Zdenek Linke
Lubos Petruzelka
Igor Kiss
Jana Prausova
Publication date
01-02-2017
Publisher
Springer International Publishing
Published in
Targeted Oncology / Issue 1/2017
Print ISSN: 1776-2596
Electronic ISSN: 1776-260X
DOI
https://doi.org/10.1007/s11523-016-0458-1

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