https://scholars.lib.ntu.edu.tw/handle/123456789/521286
Title: | Long-term results of a randomized, observation-controlled, phase III Trial of Adjuvant Interferon alfa-2b in hepatocellular carcinoma after curative resection | Authors: | Chen L.-T. Chen M.-F. Li L.-A. PO-HUANG LEE Jeng L.-B. Lin D.-Y. Wu C.-C. Mok K.-T. Chen C.-L. Lee W.-C. Chau G.-Y. Chen Y.-S. Lui W.-Y. Hsiao C.-F. Whang-Peng J. PEI-JER CHEN |
Issue Date: | 2012 | Publisher: | Lippincott Williams and Wilkins | Journal Volume: | 255 | Journal Issue: | 1 | Start page/Pages: | 8-17 | Source: | Annals of Surgery | Abstract: | OBJECTIVE: To investigate the clinical efficacy of adjuvant interferon alfa-2b (IFNα-2b) therapy on recurrence-free survival (RFS) of patients with postoperative viral hepatitis-related hepatocellular carcinoma (HCC). BACKGROUND: Despite most individual trials have failed to meet their primary endpoint, recent pooled-data meta-analyses suggest that adjuvant IFN therapy may significantly reduce the incidence of recurrence in curatively ablated HCC. METHODS: Patients with curative resection of viral hepatitis-related HCC were eligible, and were stratified by underlying viral etiology and randomly allocated to receive either 53 weeks of adjuvant IFNα-2b treatment or observation alone. The primary endpoint of this study was RFS. RESULTS: A total of 268 patients were enrolled with 133 in the IFNα-2b arm and 135 in the control arm. Eighty percent of them were hepatitis B surface antigen seropositive. At a median follow-up of 63.8 months, 154 (57.5%) patients had tumor recurrence and 84 (31.3%) were deceased. The cumulative 5-year recurrence-free and overall survival rates of intent-to-treat cohort were 44.2% and 73.9%, respectively. The median RFS in the IFNα-2b and control arms were 42.2 (95% confidence interval [CI], 28.1-87.1) and 48.6 (95% CI, 25.5 to infinity) months, respectively (P = 0.828, log-rank test). Adjuvant IFNα-2b treatment was associated with a significantly higher incidence of leucopenia and thrombocytopenia. Thirty-four (24.8%) of treated patients required dose reduction, and 5 (3.8%) of these patients subsequently withdrew from therapy because of excessive toxicity. Adjuvant IFNα-2b only temporarily suppressed viral replication during treatment period. CONCLUSIONS: In this study, adjuvant IFNα-2b did not reduce the postoperative recurrence of viral hepatitis-related HCC. More potent antiviral therapy deserves to be explored for this patient population. This study is registered at ClinicalTrials.gov and carries the identifier NCT00149565. Copyright ? 2011 by Lippincott Williams & Wilkins. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84984555585&doi=10.1097%2fSLA.0b013e3182363ff9&partnerID=40&md5=3dc0b738ac30b6b2ea6490ceb6455773 https://scholars.lib.ntu.edu.tw/handle/123456789/521286 |
ISSN: | 0003-4932 | DOI: | 10.1097/SLA.0b013e3182363ff9 | SDG/Keyword: | alpha fetoprotein; alpha2b interferon; hepatitis B surface antibody; recombinant alpha2b interferon; virus DNA; virus RNA; abdominal radiography; adult; anemia; anorexia; article; blood cell count; cancer adjuvant therapy; cancer surgery; cancer survival; computer assisted tomography; controlled study; disease association; disease free survival; drug dose escalation; drug dose reduction; drug efficacy; drug withdrawal; fatigue; female; fever; follow up; granulocytopenia; human; infection; leukocyte count; leukopenia; liver cell carcinoma; liver function test; liver toxicity; major clinical study; male; mental disease; multimodality cancer therapy; nausea; neurologic disease; neutrophil count; outcome assessment; overall survival; phase 3 clinical trial; physical examination; priority journal; randomized controlled trial; recurrence risk; respiratory tract disease; risk reduction; serology; side effect; thrombocyte count; thrombocytopenia; treatment duration; tumor recurrence; virus hepatitis; virus load; virus replication; vomiting; weight reduction |
Appears in Collections: | 醫學系 |
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