Article: A randomized, controlled trial of postoperative adjuvant interferon therapy after resection of hepatocellular carcinoma

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TitleA randomized, controlled trial of postoperative adjuvant interferon therapy after resection of hepatocellular carcinoma
AuthorsLo, CM1
Liu, CL1
Chan, SC1
Lam, CM1
Poon, RTP1
Ng, IOL1
Fan, ST1
Wong, J1
Issue Date2007
PublisherLippincott Williams & Wilkins. The Journal's web site is located at http://www.annalsofsurgery.com
CitationAnnals Of Surgery, 2007, v. 245 n. 6, p. 831-842 [How to Cite?]
DOI: http://dx.doi.org/10.1097/01.sla.0000245829.00977.45
AbstractOBJECTIVE: We conducted a randomized controlled trial of adjuvant interferon therapy in patients with predominantly hepatitis B-related hepatocellular carcinoma (HCC) to investigate whether the prognosis after hepatic resection could be improved. SUMMARY BACKGROUND DATA: Recurrence is common after hepatic resection for HCC. Interferon possesses antiviral, immunomodulatory, antiproliferative, and antiangiogenic effects and may be an effective form of adjuvant therapy. PATIENTS AND METHODS: Since February 1999, patients with no residual disease after hepatic resection for HCC were randomly assigned with stratification by pTNM stage to receive no treatment (control group), interferon alpha-2b 10 MIU/m (IFN-I group) or 30 MIU/m (IFN-II group) thrice weekly for 16 weeks. Enrollment to the IFN-II group was terminated from January 2000 because adverse effects resulted in treatment discontinuation in the first 6 patients. By June 2002, 40 patients each had been enrolled into the control group and IFN-I group. The baseline clinical, laboratory, and tumor characteristics of both groups were comparable. RESULTS: The 1- and 5-year survival rates were 85% and 61%, respectively, for the control group and 97% and 79%, respectively, for the IFN-I group (P = 0.137). After adjusting for the confounding prognostic factors in a Cox model, the relative risk of death for interferon treatment was 0.42 (95% CI, 0.17-1.05; P = 0.063). Exploratory subset analysis showed that adjuvant interferon had no survival benefit for pTNM stage I/II tumor (5-year survival 90% in both groups; P = 0.917) but prevented early recurrence and improved the 5-year survival of patients with stage III/IVA tumor from 24% to 68% (P = 0.038). CONCLUSION: In a group of patients with predominantly hepatitis B-related HCC, adjuvant interferon therapy showed a trend for survival benefit, primarily in those with pTNM stage III/IVA tumors. Further larger randomized trials stratified for stage are needed. © 2007 Lippincott Williams & Wilkins, Inc.
ISSN0003-4932
2011 Impact Factor: 7.492
2011 SCImago Journal Rankings: 0.617
DOIhttp://dx.doi.org/10.1097/01.sla.0000245829.00977.45
ISI Accession Number IDWOS:000246873000001
PubMed Central IDPMC1876947
ReferencesReferences in Scopus
DC Field
Value
dc.contributor.authorLo, CM
dc.contributor.authorLiu, CL
dc.contributor.authorChan, SC
dc.contributor.authorLam, CM
dc.contributor.authorPoon, RTP
dc.contributor.authorNg, IOL
dc.contributor.authorFan, ST
dc.contributor.authorWong, J
dc.date.accessioned2010-09-06T09:45:18Z
dc.date.available2010-09-06T09:45:18Z
dc.date.issued2007
dc.description.abstractOBJECTIVE: We conducted a randomized controlled trial of adjuvant interferon therapy in patients with predominantly hepatitis B-related hepatocellular carcinoma (HCC) to investigate whether the prognosis after hepatic resection could be improved. SUMMARY BACKGROUND DATA: Recurrence is common after hepatic resection for HCC. Interferon possesses antiviral, immunomodulatory, antiproliferative, and antiangiogenic effects and may be an effective form of adjuvant therapy. PATIENTS AND METHODS: Since February 1999, patients with no residual disease after hepatic resection for HCC were randomly assigned with stratification by pTNM stage to receive no treatment (control group), interferon alpha-2b 10 MIU/m (IFN-I group) or 30 MIU/m (IFN-II group) thrice weekly for 16 weeks. Enrollment to the IFN-II group was terminated from January 2000 because adverse effects resulted in treatment discontinuation in the first 6 patients. By June 2002, 40 patients each had been enrolled into the control group and IFN-I group. The baseline clinical, laboratory, and tumor characteristics of both groups were comparable. RESULTS: The 1- and 5-year survival rates were 85% and 61%, respectively, for the control group and 97% and 79%, respectively, for the IFN-I group (P = 0.137). After adjusting for the confounding prognostic factors in a Cox model, the relative risk of death for interferon treatment was 0.42 (95% CI, 0.17-1.05; P = 0.063). Exploratory subset analysis showed that adjuvant interferon had no survival benefit for pTNM stage I/II tumor (5-year survival 90% in both groups; P = 0.917) but prevented early recurrence and improved the 5-year survival of patients with stage III/IVA tumor from 24% to 68% (P = 0.038). CONCLUSION: In a group of patients with predominantly hepatitis B-related HCC, adjuvant interferon therapy showed a trend for survival benefit, primarily in those with pTNM stage III/IVA tumors. Further larger randomized trials stratified for stage are needed. © 2007 Lippincott Williams & Wilkins, Inc.
dc.description.naturelink_to_OA_fulltext
dc.identifier.citationAnnals Of Surgery, 2007, v. 245 n. 6, p. 831-842 [How to Cite?]
DOI: http://dx.doi.org/10.1097/01.sla.0000245829.00977.45
dc.identifier.doihttp://dx.doi.org/10.1097/01.sla.0000245829.00977.45
dc.identifier.epage842
dc.identifier.hkuros127612
dc.identifier.isiWOS:000246873000001
dc.identifier.issn0003-4932
2011 Impact Factor: 7.492
2011 SCImago Journal Rankings: 0.617
dc.identifier.issue6
dc.identifier.openurl
dc.identifier.pmcidPMC1876947
dc.identifier.pmid17522506
dc.identifier.scopuseid_2-s2.0-34249316548
dc.identifier.spage831
dc.identifier.urihttp://hdl.handle.net/10722/88584
dc.identifier.volume245
dc.languageeng
dc.publisherLippincott Williams & Wilkins. The Journal's web site is located at http://www.annalsofsurgery.com
dc.publisher.placeUnited States
dc.relation.ispartofAnnals of Surgery
dc.relation.referencesReferences in Scopus
dc.rightsThis is a non-final version of an article published in final form in Annals of Surgery, 2007, v. 245 n. 6, p. 831-842
dc.subject.meshAntineoplastic Agents - adverse effects - therapeutic use
dc.subject.meshCarcinoma, Hepatocellular - drug therapy - pathology - surgery - virology
dc.subject.meshInterferon-alpha - adverse effects - therapeutic use
dc.subject.meshLiver Neoplasms - drug therapy - pathology - surgery - virology
dc.subject.meshProportional Hazards Models
dc.titleA randomized, controlled trial of postoperative adjuvant interferon therapy after resection of hepatocellular carcinoma
dc.typeArticle
Author Affiliations
  1. The University of Hong Kong