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Titolo:
RANDOMIZED, SURGICAL ADJUVANT CLINICAL-TRIAL OF RECOMBINANT INTERFERON ALFA-2A IN SELECTED PATIENTS WITH MALIGNANT-MELANOMA
Autore:
CREAGAN ET; DALTON RJ; AHMANN DL; JUNG SH; MORTON RF; LANGDON RM; KUGLER J; RODRIGUE LJ;
Indirizzi:
MAYO CLIN,200 1ST ST SW ROCHESTER MN 55905 MAYO CLIN & MAYO FDN,DIV MED ONCOL ROCHESTER MN 55905 MAYO CLIN & MAYO FDN,CANC STAT UNIT ROCHESTER MN 55905 DULUTH COMMUNITY CLIN ONCOL PROGRAM DULUTH MN 00000 IOWA ONCOL RES ASSOC,COMMUNITY CLIN ONCOL PROGRAM DES MOINES IA 00000 CREIGHTON UNIV,NEBRASKA ONCOL GRP OMAHA NE 00000 UNIV NEBRASKA,MED CTR & ASSOCIATES LINCOLN NE 68583 UNIV NEBRASKA,MED CTR OMAHA NE 00000 ILLINOIS ONCOL RES ASSOC,COMMUNITY CLIN ONCOL PROGRAM PEORIA IL 00000 SASKATCHEWAN CANC FDN,ALLAN BLAIR MEM CLIN REGINA SK CANADA
Titolo Testata:
Journal of clinical oncology
fascicolo: 11, volume: 13, anno: 1995,
pagine: 2776 - 2783
SICI:
0732-183X(1995)13:11<2776:RSACOR>2.0.ZU;2-N
Fonte:
ISI
Lingua:
ENG
Soggetto:
LYMPH-NODE METASTASES; STAGE-I MELANOMA; PROGNOSTIC FACTORS; MULTIFACTORIAL ANALYSIS; TUMOR THICKNESS; THERAPY; DISSECTION; IMMUNOTHERAPY; MANAGEMENT;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
34
Recensione:
Indirizzi per estratti:
Citazione:
E.T. Creagan et al., "RANDOMIZED, SURGICAL ADJUVANT CLINICAL-TRIAL OF RECOMBINANT INTERFERON ALFA-2A IN SELECTED PATIENTS WITH MALIGNANT-MELANOMA", Journal of clinical oncology, 13(11), 1995, pp. 2776-2783

Abstract

Purpose: We conducted a randomized prospective trial in selected patients with fully resected high-risk stage I and II malignant melanoma. Patients and methods: Interferon alfa-2a (IFN-alpha 2a) 20 x 10(6) U/m(2) was administered three times each week for 12 weeks by the intramuscular route, Both the treatment group (n = 131) and the control group(n = 131) were evenly balanced with regard to relevant prognostic discriminants. Results: The median disease-free survival (DFS) time was 2.4 years for the IFN-alpha 2a group and 2.0 years for the observation group (log-rank P = 0.19), The median survival times were 6.6 years for IFN-alpha 2a and 5.0 years for observation (log-rank P = .40). For stage I patients (n = 102), there was no apparent therapeutic advantagefrom IFN-alpha 2a therapy. The DFS for stage II patients was a medianof 10.8 months in the control group versus 17 months in the treatmentgroup. The overall survival time was 4.1 years for the treatment group versus 2.7 years for the control group, The differences in DFS for stage II patient were significant in a Cox model. These results must beinterpreted cautiously because of subset analysis. A severe fly-like toxicity occurred in 44% of patients, 13% lost at least 10% of their baseline weight, and 45% experienced a worsening of Eastern CooperativeOncology Group (ECOG) performance score. Conclusion: Our findings indicate trends that suggest a possible benefit for selected patients with high-risk malignant melanoma, The results will require further studyin a larger patient population for confirmation. (C) 1995 by AmericanSociety of Clinical Oncology.

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Documento generato il 28/11/20 alle ore 04:16:13