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Clinical Study

Low-Dose Thalidomide Treatment for Advanced Hepatocellular Carcinoma

Hsu C.a,c,d · Chen C.-N.b · Chen L.-T.f,g · Wu C.-Y.a · Yang P.-M.c · Lai M.-Y.c,d · Lee P.-H.b · Cheng A.-L.a,c,e,f

Author affiliations

Departments of aOncology, bSurgery, and cInternal Medicine, National Taiwan University Hospital; dGraduate Institute of Clinical Medicine, and eInstitute of Toxicology, National Taiwan University College of Medicine, fDivision of Cancer Research, National Health Research Institutes, Taipei, and gDepartment of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan, ROC

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Oncology 2003;65:242–249

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Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Published online: December 05, 2003
Issue release date: December 2003

Number of Print Pages: 8
Number of Figures: 2
Number of Tables: 4

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL

Abstract

Objective: To analyze the efficacy of oral thalidomide in the treatment of advanced hepatocellular carcinoma (HCC). Methods: Sixty-eight patients with unresectable and nonembolizable HCC were consecutively enrolled in a compassionate treatment program of oral thalidomide. Tumor response and treatment-related toxicity were prospectively followed. Thalidomide was given at a starting dose of 200 mg per day. The dose was gradually escalated in 100-mg steps up to 600 mg per day if no limiting toxicities developed. Results: Sixty-three patients were evaluable for response. One complete and 3 partial responses, defined by World Health Organization criteria, were seen, with a response rate of 6.3% (95% CI 0–12.5). The duration of response was 50+, 24.6, 11.6+ and 8.7+ weeks, respectively. All 4 responders had a dramatic decrease in α-fetoprotein (α-FP) levels. Another 6 of the 42 patients with elevated α-FP levels before treatment had a more than 50% decrease in their α-FP levels after thalidomide treatment. Totally 10 patients had an objective response to thalidomide. The median overall survival for all of the 68 patients was 18.7 weeks (95% CI 11.8– 25.6) with a 1-year survival rate of 27.6%. The median overall survival of the 10 patients with an objective response to thalidomide was 62.4 weeks (95% CI 31.2–93.6 weeks). All responders responded at a dose equal to or less than 300 mg per day. Toxicities of thalidomide were generally manageable, and only 16, 6, and 0 patients developed grade 2, 3, and 4 toxicities, respectively. Conclusion: Low-dose thalidomide is safe and induces unequivocal tumor response in a minority of patients with advanced HCC.

© 2003 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Published online: December 05, 2003
Issue release date: December 2003

Number of Print Pages: 8
Number of Figures: 2
Number of Tables: 4

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL


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