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

Kopečková, Kateřina; Büchler, Tomáš; Bortlíček, Zbyněk; Hejduk, Karel; Chloupková, Renata; Melichar, Bohuslav; Pokorná, Petra; Tomášek, Jiří; Linke, Zdeněk; Petruželka, Luboš; Kiss, Igor; Prausová, Jana

doi:10.1007/s11523-016-0458-1

Cited by 21 publications

(18 citation statements)

References 15 publications

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“…Median PFS was 3.9 months (95% CI 3.3 to 4.5 months) and median OS was 7.6 month (95% CI 4.2 to 11.1 months). Interestingly, in a comparative European study, survival data was also higher than that found in the original CORRECT trial [4]: in that 2017 Czech registry study, Kopeckova K. et al [12] also report PFS of 3.5 months and median OS of 9.3 months in 148 patients; and these results are similar to our findings (PFS 2.9 months, Table 3, Figure 1B). Even if our data is retrospective, it remains consistent with other regorafenib studies [13].…”

Section: Discussionsupporting

confidence: 90%

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Regorafenib therapy in metastatic colorectal cancer patients: markers and outcome in an actual clinical setting

Unseld

Filip

Seirl

et al. 2018

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The oral multikinase inhibitor regorafenib had beneficial effects in randomized clinical phase III trials compared to the placebo in patients with metastatic colorectal cancer (mCRC) who progressed on standard therapies. The factors which influence regorafenib response and therapy sequence during treatment history are still highly discussed, and herein we analyzed the therapy algorithm, outcome and clinical markers following regorafenib application in a single center register study. Clinical data for 48 metastatic colorectal cancer patients were collected from 01.01.2013 to 31.12.2016. Treatment effects according to various patient and tumor characteristics were evaluated using univariate and multivariate Cox proportional hazard regression models. The 48 patients comprised 14 (29%) females and 34 (71%) males, with mean age 64.2±9 and ECOG 0-1. Progression free survival under regorafenib therapy was 2.9 months (quartiles 2.2; 4.4) and the overall response rate was 2 (4%) and disease control rate was 19 (40%). Overall survival (OS) and progression free survival (PFS) were investigated under regorafenib in the chemotherapy regimen given immediately before and afterthis treatment. Variables including tumor localization, Ras status, CEA and CA 19-9 plasma levels were analyzed for their impact on PFS, and the regorafenib-related adverse events were also observed. Our study confirms the efficacy of regorafenib in a real-life setting. We established that response rate and PFS in regorafenib treatment are independent of tumor localization, Ras status or biomarkers such as CEA and CA 19-9. Trifluridin/tripacil application or re-induction of chemotherapy +/- target therapy was effective following regorafenib therapy.

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Section: Discussionsupporting

confidence: 90%

“…Retrospective data on regorafenib real-life use seeks to address therapy response and cost effectiveness, but little data is available [10][11][12]. In this single center registry study, we analyzed treatment response after regorafenib administration in different therapy lines and compared clinical outcomes with those achieved in previous studies.…”

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confidence: 99%

Regorafenib therapy in metastatic colorectal cancer patients: markers and outcome in an actual clinical setting

Unseld

Filip

Seirl

et al. 2018

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“…In fact, both urinary neopterin and CRP correlated with baseline CEA concentration, a parameter that, despite some limitations, approximates the tumor mass. The findings of the present study may have obvious implications for the management of patients presenting for second or higher line of therapy although the algorithm of the treatment of metastatic colorectal carcinoma has changed, and with anti-EGFR therapy moving to the front-line [22] other treatments, including combination of chemotherapy with aflibercept or bevacizumab, regorafenib or different chemotherapy regimens are being used and the search for new active agents continues [28][29][30]. In this population of, sometimes heavily, pretreated patients, the potential benefit of the therapy should be carefully weighted against its complications.…”

Section: Discussionmentioning

confidence: 93%

Association of peripheral blood cell count-derived ratios, biomarkers of inflammatory response and tumor growth with outcome in previously treated metastatic colorectal carcinoma patients receiving cetuximab

et al. 2017

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Abstract:The aim of the present study was to investigate the association of peripheral-blood cell count (PBC)-derived ratios, other biomarkers of inflammation and biomarkers of tumor growth with outcome in a cohort of patients presenting for the next line of therapy after the failure of prior systemic treatment. The data of 51 patients with advanced/metastatic colorectal carcinoma treated with cetuximab in the second or higher line of therapy were retrospectively analyzed. The median duration of cetuximab therapy and the median survival were 5.1 and 12.1 months, respectively. C-reactive protein (CRP), but not urinary neopterin correlated significantly with PBC-derived ratios. Both CRP and urinary neopterin correlated positively with carcinoembryonic antigen (CEA) concentrations and biomarkers of liver dysfunction. Although a number of parameters predicted overall survival in univariate analysis, only hemoglobin, CEA change and serum bilirubin were independent predictors of survival. In conclusion, in patients with metastatic colorectal carcinoma and predominantly liver metastases, the outcome of therapy in the advanced line setting was associated with initial hemoglobin level, a decrease of CEA concentration and initial presence of liver dysfunction. Urinary neopterin did not correlate with PBC-derived ratios, in contrast to CRP, but both urinary neopterin and serum CRP concentrations correlated with laboratory parameters of liver dysfunction.

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“…Thirty-two retrieved articles were clinical trials or series. After exclusion of 12 reports describing phase I, II and III trials and eight case reports or series with few patients, 12 retrospective series remained to be included in the current analysis (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). These reports were published between 2015 and 2017 and described a total of 702 patients (Table I).…”

Section: Resultsmentioning

confidence: 99%

“…The preponderance of reports came from Asian populations, thus making the relevance of results for other populations debatable. Nevertheless, two out of the three most extensive series (22,25) accounting for more than half of the total patients analyzed were from Europe.…”

Section: Discussionmentioning

confidence: 99%

A Systematic Review and Meta-analysis of Retrospective Series of Regorafenib for Treatment of Metastatic Colorectal Cancer

Mercier

Voutsadakis

2017

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Colorectal cancer is the most common gastrointestinal malignancy in the Western world and remains a prominent cause of cancer morbidity and mortality, despite progress in its management. It affects approximately 746,000 men and 614,000 women yearly and it is the 3rd most common cancer in the former and the 2nd most common in the latter (1). About one fourth of newly-diagnosed colorectal cancers are already in a metastatic stage and of those that are diagnosed in a localized stage nearly 50% will go on to develop metastatic disease, in most cases becoming unresectable. Metastatic colorectal cancer treatment options have been broadened to include regimens of oxaliplatin or irinotecan added to a fluoropyrimidine backbone, as well as targeted treatments with bevacizumab and, for KRAS wild-type tumors, cetuximab or panitumumab (2-4). These treatments have extended the median survival of patients with metastatic colorectal cancer to over 2 years. Nevertheless, the disease remains incurable in most patients and when the above drug options have been exhausted, there is a paucity of other options. This therapeutic vacuum has been partially filled recently with the approval of the tyrosine kinase inhibitor regorafenib, a fluorinated derivative of sorafenib, for the third line treatment of metastatic colorectal cancer patients (5).Regorafenib (formerly known as BAY 73-4506; chemical formula: C 21 H 17 CIF 4 N 4 O 4 ) is a small molecule multi-kinase inhibitor of fms-related tyrosine kinase 1 (FLT1, also known as vascular endothelial growth factor receptor 1, VEGFR1), 5925

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

Abstract: 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.

Cited by 21 publications

References 15 publications

Regorafenib therapy in metastatic colorectal cancer patients: markers and outcome in an actual clinical setting

Regorafenib therapy in metastatic colorectal cancer patients: markers and outcome in an actual clinical setting

Association of peripheral blood cell count-derived ratios, biomarkers of inflammatory response and tumor growth with outcome in previously treated metastatic colorectal carcinoma patients receiving cetuximab

A Systematic Review and Meta-analysis of Retrospective Series of Regorafenib for Treatment of Metastatic Colorectal Cancer

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