Article: Final results of the EORTC 18871/DKG 80-1 randomised phase III trial. rIFN-alpha2b versus rIFN-gamma versus ISCADOR M versus observation after surgery in melanoma patients with either high-risk primary (thickness >3 mm) or regional lymph node metastasis.
European journal of cancer (Oxford, England : 1990)
2003 Volume 40, Issue 3, Page(s) 390–402
Abstract: ... in comparison with an untreated control group. The German Cancer Society (DKG) added a fourth arm with Iscador M ... M versus control. In terms of OS, the corresponding estimates (95% CI) for the 3 treatment ... comparisons were: for IFN-alpha2b 0.96 (0.76, 1.21), for rIFN-gamma 0.87 (0.69, 1.10) and for Iscador M 1.21 ...
| Abstract | Between 1988 and 1996, the European Organisation for Research and Treatment of Cancer Melanoma Group (EORTC-MG) performed a prospective, randomised phase III adjuvant trial to evaluate the efficacy and toxicity of low dose recombinant interferon-alpha 2 b (rIFN-alpha2b) (1 MU) or recombinant interferon gamma (rIFN-gamma), (0.2 mg) both given subcutaneously (s.c.), every other day (qod), for 12 months in comparison with an untreated control group. The German Cancer Society (DKG) added a fourth arm with Iscador M, a popular mistletoe extract. High-risk stage II patients (thickness >3 mm) and stage III patients (positive lymph nodes) without distant metastasis were randomised and followed until their first progression or death. An intention-to-treat analysis was performed. From 1988 to 1996, a total of 830 patients were randomised: 423 in the three-arm EORTC 18871 trial and 407 patients in the four-arm DKG 80-1 trial. The median follow-up was 8.2 years and a total of 537 relapses and 475 deaths were reported. At 8 years, the disease-free interval (DFI) rate was 32.4% and the overall survival (OS) rate was 40.0%. In terms of the DFI, the hazard ratio estimates (95% Confidence Intervals (CI)) were: 1.04 (0.84, 1.30) for the comparison of rIFN-alpha2b versus control, 0.96 (0.77, 1.20) for rIFN-gamma versus control, and 1.32 (0.93, 1.87) for Iscador M versus control. In terms of OS, the corresponding estimates (95% CI) for the 3 treatment comparisons were: for IFN-alpha2b 0.96 (0.76, 1.21), for rIFN-gamma 0.87 (0.69, 1.10) and for Iscador M 1.21 (0.84, 1.75), respectively. The results show no clinical benefit for adjuvant treatment with low dose rIFN-alpha2b or rIFN-gamma or with Iscador M in high-risk melanoma patients. |
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| MeSH term(s) | Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/therapeutic use ; Disease-Free Survival ; Feasibility Studies ; Female ; Humans ; Interferon alpha-2 ; Interferon-alpha/therapeutic use ; Interferon-gamma/therapeutic use ; Lymphatic Metastasis ; Male ; Melanoma/drug therapy ; Middle Aged ; Plant Extracts/therapeutic use ; Plant Proteins/therapeutic use ; Recombinant Proteins ; Risk Factors ; Skin Neoplasms/drug therapy ; Treatment Outcome |
| Chemical Substances | Antineoplastic Agents ; Interferon alpha-2 ; Interferon-alpha ; Plant Extracts ; Plant Proteins ; Recombinant Proteins ; Interferon-gamma (82115-62-6) ; viscum album peptide (BK9092J5MP) |
| Language | English |
| Publishing date | 2003-12-04 |
| Publishing country | England |
| Document type | Clinical Trial ; Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S. |
| ZDB-ID | 82061-1 |
| ISSN | 1879-0852 ; 0959-8049 ; 0277-5379 ; 0964-1947 |
| ISSN (online) | 1879-0852 |
| ISSN | 0959-8049 ; 0277-5379 ; 0964-1947 |
| DOI | 10.1016/j.ejca.2003.07.004 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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