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Article: A phase I/II trial of chemoembolization for hepatocellular carcinoma using a novel intra-arterial drug-eluting bead

TitleA phase I/II trial of chemoembolization for hepatocellular carcinoma using a novel intra-arterial drug-eluting bead
Authors
Issue Date2007
PublisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/cgh
Citation
Clinical Gastroenterology And Hepatology, 2007, v. 5 n. 9, p. 1100-1108 How to Cite?
AbstractBackground & Aims: To assess the safety and efficacy of transarterial chemoembolization (TACE) using doxorubicin-eluting beads (DEB) for hepatocellular carcinoma (HCC). Methods: Patients with incurable HCC and Child-Pugh class A cirrhosis were considered eligible for this phase I/II trial. Two courses of TACE using DEB were given at an interval of 2 months, and tumor response was assessed by computerized tomography scan. The phase I trial was a dose-escalating study starting from 25 mg to 150 mg doxorubicin in cohorts of 3 patients. The 150-mg doxorubicin dose was used for the phase II study. Primary end points were treatment-related complications and deaths. Secondary end points included tumor response and pharmacokinetics of doxorubicin. Results: In the phase I study involving 15 patients, no dose-limiting toxicity was observed for up to 150 mg doxorubicin, which was used for 20 patients in the phase II study. The pharmacokinetic study showed a low peak plasma doxorubicin concentration (49.4 ± 23.7 ng/ mL), and no systemic toxicity was observed. The treatmentrelated complication rate was 11.4%. There was no treatmentrelated death. Among 30 patients who completed 2 courses of TACE, the partial response rate and the complete response rates were 50% and 0%, respectively, by response evaluation criteria in solid tumors (RECIST) criteria at computerized tomography scan 1 month after the second TACE. By modified RECIST criteria, taking into account the extent of tumor necrosis, 19 (63.3%) patients had a partial response and 2 (6.7%) had a complete response. Conclusions: This study shows that TACE using DEB is a safe and effective treatment for HCC, supporting a phase III randomized trial to compare this novel treatment with conventional TACE using doxorubicin-Lipiodol emulsion. © 2007 by the AGA Institute.
Persistent Identifierhttp://hdl.handle.net/10722/77217
ISSN
2015 Impact Factor: 7.68
2015 SCImago Journal Rankings: 2.744
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorPoon, RTPen_HK
dc.contributor.authorTso, WKen_HK
dc.contributor.authorPang, RWCen_HK
dc.contributor.authorNg, KKCen_HK
dc.contributor.authorWoo, Ren_HK
dc.contributor.authorTai, KSen_HK
dc.contributor.authorFan, STen_HK
dc.date.accessioned2010-09-06T07:29:31Z-
dc.date.available2010-09-06T07:29:31Z-
dc.date.issued2007en_HK
dc.identifier.citationClinical Gastroenterology And Hepatology, 2007, v. 5 n. 9, p. 1100-1108en_HK
dc.identifier.issn1542-3565en_HK
dc.identifier.urihttp://hdl.handle.net/10722/77217-
dc.description.abstractBackground & Aims: To assess the safety and efficacy of transarterial chemoembolization (TACE) using doxorubicin-eluting beads (DEB) for hepatocellular carcinoma (HCC). Methods: Patients with incurable HCC and Child-Pugh class A cirrhosis were considered eligible for this phase I/II trial. Two courses of TACE using DEB were given at an interval of 2 months, and tumor response was assessed by computerized tomography scan. The phase I trial was a dose-escalating study starting from 25 mg to 150 mg doxorubicin in cohorts of 3 patients. The 150-mg doxorubicin dose was used for the phase II study. Primary end points were treatment-related complications and deaths. Secondary end points included tumor response and pharmacokinetics of doxorubicin. Results: In the phase I study involving 15 patients, no dose-limiting toxicity was observed for up to 150 mg doxorubicin, which was used for 20 patients in the phase II study. The pharmacokinetic study showed a low peak plasma doxorubicin concentration (49.4 ± 23.7 ng/ mL), and no systemic toxicity was observed. The treatmentrelated complication rate was 11.4%. There was no treatmentrelated death. Among 30 patients who completed 2 courses of TACE, the partial response rate and the complete response rates were 50% and 0%, respectively, by response evaluation criteria in solid tumors (RECIST) criteria at computerized tomography scan 1 month after the second TACE. By modified RECIST criteria, taking into account the extent of tumor necrosis, 19 (63.3%) patients had a partial response and 2 (6.7%) had a complete response. Conclusions: This study shows that TACE using DEB is a safe and effective treatment for HCC, supporting a phase III randomized trial to compare this novel treatment with conventional TACE using doxorubicin-Lipiodol emulsion. © 2007 by the AGA Institute.en_HK
dc.languageengen_HK
dc.publisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/cghen_HK
dc.relation.ispartofClinical Gastroenterology and Hepatologyen_HK
dc.titleA phase I/II trial of chemoembolization for hepatocellular carcinoma using a novel intra-arterial drug-eluting beaden_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=1542-3565&volume=5&issue=9&spage=1100&epage=1108&date=2007&atitle=A+phase+I/II+trial+of+chemoembolization+for+hepatocellular+carcinoma+using+a+novel+intra-arterial+drug-eluting+beaden_HK
dc.identifier.emailPoon, RTP: poontp@hkucc.hku.hken_HK
dc.identifier.emailPang, RWC: robertap@hkucc.hku.hken_HK
dc.identifier.emailFan, ST: stfan@hku.hken_HK
dc.identifier.authorityPoon, RTP=rp00446en_HK
dc.identifier.authorityPang, RWC=rp00274en_HK
dc.identifier.authorityFan, ST=rp00355en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/j.cgh.2007.04.021en_HK
dc.identifier.pmid17627902-
dc.identifier.scopuseid_2-s2.0-35748960546en_HK
dc.identifier.hkuros139480en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-35748960546&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume5en_HK
dc.identifier.issue9en_HK
dc.identifier.spage1100en_HK
dc.identifier.epage1108en_HK
dc.identifier.isiWOS:000249642400020-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridPoon, RTP=7103097223en_HK
dc.identifier.scopusauthoridTso, WK=7006905486en_HK
dc.identifier.scopusauthoridPang, RWC=7004376659en_HK
dc.identifier.scopusauthoridNg, KKC=35248894000en_HK
dc.identifier.scopusauthoridWoo, R=22955009500en_HK
dc.identifier.scopusauthoridTai, KS=7101738949en_HK
dc.identifier.scopusauthoridFan, ST=7402678224en_HK

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