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Cited by 254

The DOI matches its Crossref record; 23 of the 23 references it cites were found in a registry or an index.

Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: Multicentre, open-label, phase II safety study

Open access
Bruix, Jordi, Tak, Won-Young, Gasbarrini, Antonio, Santoro, Armando, Colombo, Massimo, Lim, Ho-Yeong, Mazzaferro, Vincenzo, Wiest, Reiner, Reig, María, Wagner, Andrea, Bolondi, Luigi·2013·European Journal of Cancer
DOI 10.1016/j.ejca.2013.05.028
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Abstract

PURPOSE: We assessed the safety of the multikinase inhibitor regorafenib in patients with hepatocellular carcinoma (HCC) that had progressed following first-line sorafenib. PATIENTS AND METHODS: Thirty-six patients with Barcelona Clinic Liver Cancer stage B or C HCC and preserved to mildly impaired liver function (Child-Pugh class A) received regorafenib 160 mg once daily in cycles of 3 weeks on/1 week off treatment until disease progression, unacceptable toxicity, death or patient/physician decision to discontinue. The primary end-point was safety; secondary end-points included efficacy (including time to progression and overall survival). RESULTS: The median treatment duration was 19.5 weeks (range 2-103). At data cutoff, three patients remained on treatment. Reasons for discontinuation were adverse events (n=20), disease progression (n=10), consent withdrawal (n=2) and death (n=1). Seventeen patients required dose reductions (mostly for adverse events [n=15]); 35 patients had treatment interruption (mostly for adverse events [n=32] or patient error [n=11]). The most frequent treatment-related adverse events were hand-foot skin reaction (any grade n=19; grade ≥3 n=5), diarrhoea (n=19; n=2), fatigue (n=19; n=6), hypothyroidism (n=15; n=0), anorexia (n=13; n=0), hypertension (n=13; n=1), nausea (n=12; n=0) and voice changes (n=10; n=0). Disease control was achieved in 26 patients (partial response n=1; stable disease n=25). Median time to progression was 4.3 months. Median overall survival was 13.8 months. CONCLUSION: Regorafenib had acceptable tolerability and evidence of antitumour activity in patients with intermediate or advanced HCC that progressed following first-line sorafenib.

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Metadata

Authors
Bruix, J., Tak, W.-Y., Gasbarrini, A., Santoro, A., Colombo, M., Lim, H.-Y., Mazzaferro, V., Wiest, R., Reig, M., Wagner, A., & Bolondi, L.
Venue
European Journal of Cancer
Publisher
Elsevier BV
Published
2013-11
Volume
49
Issue
16
Pages
3412-3419
ISSN
0959-8049 (ISSN-L)
DOI
10.1016/j.ejca.2013.05.028
OpenAlex
W2022665891
Cited by
254
References
23
FWCI
11.93
Type
journal article
Language
en
Open access
hybrid

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