Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Richtig, E; Soyer, HP; Posch, M; Mossbacher, U; Bauer, P; Teban, L; Svolba, G; Wolf, IH; Fritsch, P; Zelger, B; Volc-Platzer, B; Gebhart, W; Mischer, P; Steiner, A; Pachinger, W; Hintner, H; Gschnait, F; Rappersberger, K; Pilarski, P; Pehamberger, H; European Cooperative Adjuvant Melanoma Treatment Study Group.
Prospective, randomized, multicenter, double-blind placebo-controlled trial comparing adjuvant interferon alfa and isotretinoin with interferon alfa alone in stage IIA and IIB melanoma: European Cooperative Adjuvant Melanoma Treatment Study Group.
J Clin Oncol. 2005; 23(34):8655-8663
Doi: 10.1200/JCO.2004.00.8128
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- Führende Autor*innen der Med Uni Graz
- Richtig Erika
- Co-Autor*innen der Med Uni Graz
- Soyer Hans Peter
- Wolf Ingrid
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- Abstract:
- The combination of interferon alfa (IFNalpha) and isotretinoin has shown a direct antiproliferative effect on human melanoma cell lines, but it remained unclear whether this combination is more effective than IFNalpha alone in patients with metastatic melanoma. We evaluated safety and efficacy of IFNalpha and isotretinoin compared with IFNalpha alone as adjuvant treatment in patients with primary malignant melanoma stage IIA and IIB. In a prospective, randomized, double-blind, placebo-controlled trial, 407 melanoma patients in stage IIA (301 patients) and IIB (106 patients) were randomly assigned to either IFNalpha and isotretinoin (isotretinoin group; 206 patients) or IFNalpha and placebo (placebo group; 201 patients) after excision of the primary tumor. IFNalpha was administered three times a week at a dose of 3 million units subcutaneously for 24 months. Isotretinoin at a dose of 20 mg for patients < or = 73 kg, 30 mg for patients greater than 73 kg, or placebo daily for 24 months. A scheduled interim analysis revealed no significant differences in survival rates, with the isotretinoin group and the placebo group showing 5-year disease-free survival rates of 55% (95% CI, 46% to 65%) and 67% (95% CI, 59% to 75%), respectively, and overall 5-year survival rates of 76% (95% CI, 67% to 84%) and 81% (95% CI, 74% to 88%), respectively. The trial was stopped for futility. The addition of isotretinoin to an adjuvant treatment of low-dose IFNalpha in patients with stage IIA and IIB melanoma had no significant effect on disease-free or overall survival and is therefore not recommended.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use
- Carcinoma, Basal Cell - drug therapy Carcinoma, Basal Cell - secondary
- Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - secondary
- Chemotherapy, Adjuvant -
- Disease-Free Survival -
- Double-Blind Method -
- Double-Blind Method -
- Female -
- Head and Neck Neoplasms - drug therapy Head and Neck Neoplasms - pathology
- Humans -
- Hyperlipidemias - chemically induced
- Interferon-alpha - adverse effects Interferon-alpha - therapeutic use
- Isotretinoin - adverse effects Isotretinoin - therapeutic use
- Male -
- Melanoma - drug therapy Melanoma - pathology
- Middle Aged -
- Multivariate Analysis -
- Neoplasm Staging -
- Prognosis -
- Prospective Studies -
- Quality of Life -
- Skin Diseases - chemically induced
- Treatment Outcome -