التفاصيل البيبلوغرافية
| العنوان: |
Randomised trial of interferon alpha-2a as adjuvant therapy in resected primary melanoma thicker than 1.5 mm without clinically detectable node metastases. French Cooperative Group on Melanoma. |
| المؤلفون: |
Grob, Jean Jauques, Dreno, Bridgitte, De la Salmoniere, Pauline, Delaunay, Michele, Cupissol, Didier, Guillot, Bernard, Souteyrand, Pierre, Sassolas, Bruno, Cesarini, Jean-Pierre, Lionnet, Sylvie, Lok, Catherine, Chastang, Claude, Bonerandi, Jean Jacques, Grob, J J1 (AUTHOR), Dreno, B (AUTHOR), de la Salmonière, P (AUTHOR), Delaunay, M (AUTHOR), Cupissol, D (AUTHOR), Guillot, B (AUTHOR), Souteyrand, P (AUTHOR) |
| المصدر: |
Lancet. 6/27/1998, Vol. 351 Issue 9120, p1905-1910. 6p. 4 Charts, 5 Graphs. |
| مصطلحات موضوعية: |
MELANOMA treatment |
| مستخلص: |
Background: Owing to the limited efficacy of therapy on melanoma at the stage of distant metastases, a well-tolerated adjuvant therapy is needed for patients with high-risk primary melanoma. Our hypothesis was that an adjuvant treatment with low doses of interferon alpha could be effective in patients with localised melanoma.Methods: After resection of a primary cutaneous melanoma thicker than 1.5 mm, patients without clinically detectable node metastases were randomly assigned to receive either 3x10(6) IU interferon alpha-2a, three-times weekly for 18 months, or no treatment. The primary endpoint was the relapse-free interval.Findings: 499 patients were enrolled, of whom 489 were eligible. When used as part of a sequential procedure, interferon alpha-2a was of significant benefit for relapse-free interval (p=0.038). A long-term analysis, after a median follow-up of 5 years, showed a significant extension of relapse-free interval (p=0.035) and a clear trend towards an increase in overall survival (p=0.059) in interferon alpha-2a-treated patients compared with controls. There were 100 relapses and 59 deaths among the 244 interferon alpha-2a-treated patients compared with 119 relapses and 76 deaths among the 245 controls. The estimated 3-year-relapse rates were 32% in the interferon alpha-2a group and 44% in controls; the 3-year death rates were 15% and 21%, respectively. Only 10% of patients experienced WHO grade 3 or 4 adverse events. Treatment was compatible with normal daily life.Interpretation: Adjuvant therapy of high-risk melanoma with low doses of interferon alpha-2a for 18 months is safe and is beneficial when started before clinically detectable node metastases develop. [ABSTRACT FROM AUTHOR] |
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