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Article: Phase II study of bevacizumab and erlotinib in the treatment of advanced hepatocellular carcinoma patients with sorafenib-refractory disease

TitlePhase II study of bevacizumab and erlotinib in the treatment of advanced hepatocellular carcinoma patients with sorafenib-refractory disease
Authors
KeywordsAdvanced HCC
Bevacizumab
Erlotinib
Sorafenib-refractory
Issue Date2012
PublisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=0167-6997
Citation
Investigational New Drugs, 2012, v. 30 n. 6, p. 2384-2390 How to Cite?
AbstractBackground The combination of bevacizumab (B) and erlotinib (E) has shown promising clinical outcomes as the first-line treatment of advanced HCC patients. We aimed to evaluate the efficacy and safety of using combination of B + E in treating advanced HCC patients who had failed prior sorafenib treatment. Methods Eligible advanced HCC patients with documented radiological evidence of disease progression with sorafenib treatment were recruited. All patients received bevacizumab(B) at 10 mg/kg every 2 weeks with erlotinib(E) at 150 mg daily for a maximum of 6 cycles. Response assessments using both RECIST and modified RECIST criteria were performed after every 6 weeks. The primary endpoint was clinical benefit (CB) rate and a Simon two-stage design was employed. Results The trial was halted in the first stage according to the pre-set statistical criteria with 10 patients recruited. The median age was 47 years (range, 28-61) and all patients were in ECOG performance status 1. Eighty percent of patients were chronic hepatitis B carriers and all patients had Child A cirrhosis. Among these 10 patients, none of the enrolled patients achieved response or stable disease. The median time-to-progression was 1.81 months (95 % confidence interval [C.I.], 1.08-1.74 months) and overall survival was 4.37 months (95 % C.I., 1.08-11.66 months). Rash (70 %), diarrhea (50 %) and malaise (40 %) were the most commonly encountered toxicities. Conclusion The combination of B + E was well tolerated but had no activity in an unselected sorafenib-refractory advanced HCC population. Condensed abstract The combination of bevacizumab and erlotinib had no clinical activity in sorafenib-refractory HCC population. © 2012 The Author(s).
Persistent Identifierhttp://hdl.handle.net/10722/159919
ISSN
2015 Impact Factor: 3.281
2015 SCImago Journal Rankings: 1.376
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorYau, Ten_HK
dc.contributor.authorWong, Hen_HK
dc.contributor.authorChan, Pen_HK
dc.contributor.authorYao, TJen_HK
dc.contributor.authorPang, Ren_HK
dc.contributor.authorCheung, TTen_HK
dc.contributor.authorFan, STen_HK
dc.contributor.authorPoon, RTen_HK
dc.date.accessioned2012-08-16T05:59:31Z-
dc.date.available2012-08-16T05:59:31Z-
dc.date.issued2012en_HK
dc.identifier.citationInvestigational New Drugs, 2012, v. 30 n. 6, p. 2384-2390en_HK
dc.identifier.issn0167-6997en_HK
dc.identifier.urihttp://hdl.handle.net/10722/159919-
dc.description.abstractBackground The combination of bevacizumab (B) and erlotinib (E) has shown promising clinical outcomes as the first-line treatment of advanced HCC patients. We aimed to evaluate the efficacy and safety of using combination of B + E in treating advanced HCC patients who had failed prior sorafenib treatment. Methods Eligible advanced HCC patients with documented radiological evidence of disease progression with sorafenib treatment were recruited. All patients received bevacizumab(B) at 10 mg/kg every 2 weeks with erlotinib(E) at 150 mg daily for a maximum of 6 cycles. Response assessments using both RECIST and modified RECIST criteria were performed after every 6 weeks. The primary endpoint was clinical benefit (CB) rate and a Simon two-stage design was employed. Results The trial was halted in the first stage according to the pre-set statistical criteria with 10 patients recruited. The median age was 47 years (range, 28-61) and all patients were in ECOG performance status 1. Eighty percent of patients were chronic hepatitis B carriers and all patients had Child A cirrhosis. Among these 10 patients, none of the enrolled patients achieved response or stable disease. The median time-to-progression was 1.81 months (95 % confidence interval [C.I.], 1.08-1.74 months) and overall survival was 4.37 months (95 % C.I., 1.08-11.66 months). Rash (70 %), diarrhea (50 %) and malaise (40 %) were the most commonly encountered toxicities. Conclusion The combination of B + E was well tolerated but had no activity in an unselected sorafenib-refractory advanced HCC population. Condensed abstract The combination of bevacizumab and erlotinib had no clinical activity in sorafenib-refractory HCC population. © 2012 The Author(s).en_HK
dc.languageengen_US
dc.publisherSpringer New York LLC. The Journal's web site is located at http://springerlink.metapress.com/openurl.asp?genre=journal&issn=0167-6997en_HK
dc.relation.ispartofInvestigational New Drugsen_HK
dc.rightsThe original publication is available at www.springerlink.com-
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.subjectAdvanced HCCen_HK
dc.subjectBevacizumaben_HK
dc.subjectErlotiniben_HK
dc.subjectSorafenib-refractoryen_HK
dc.titlePhase II study of bevacizumab and erlotinib in the treatment of advanced hepatocellular carcinoma patients with sorafenib-refractory diseaseen_HK
dc.typeArticleen_HK
dc.identifier.emailYau, T: tyaucc@hku.hken_HK
dc.identifier.emailYao, TJ: tjyao@hkucc.hku.hken_HK
dc.identifier.emailPang, R: robertap@hku.hken_HK
dc.identifier.emailFan, ST: stfan@hku.hken_HK
dc.identifier.emailPoon, RT: poontp@hku.hken_HK
dc.identifier.authorityYau, T=rp01466en_HK
dc.identifier.authorityYao, TJ=rp00284en_HK
dc.identifier.authorityPang, R=rp00274en_HK
dc.identifier.authorityFan, ST=rp00355en_HK
dc.identifier.authorityPoon, RT=rp00446en_HK
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1007/s10637-012-9808-8en_HK
dc.identifier.pmid22402942-
dc.identifier.pmcidPMC3484314-
dc.identifier.scopuseid_2-s2.0-84875543408en_HK
dc.identifier.hkuros202715en_US
dc.identifier.volume30en_US
dc.identifier.issue6-
dc.identifier.spage2384en_HK
dc.identifier.epage2390en_HK
dc.identifier.isiWOS:000310470100031-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridYau, T=23391533100en_HK
dc.identifier.scopusauthoridWong, H=23089414000en_HK
dc.identifier.scopusauthoridChan, P=7403497715en_HK
dc.identifier.scopusauthoridYao, TJ=7401886444en_HK
dc.identifier.scopusauthoridPang, R=7004376659en_HK
dc.identifier.scopusauthoridCheung, TT=7103334165en_HK
dc.identifier.scopusauthoridFan, ST=7402678224en_HK
dc.identifier.scopusauthoridPoon, RT=7103097223en_HK
dc.identifier.citeulike10463697-

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