Adjuvant therapy with pegylated interferon alfa-2b (36 months) versus low-dose interferon alfa-2b (18 months) in melanoma patients without macrometastatic nodes: An open-label, randomised, phase 3 European Association for Dermato-Oncology (EADO) study

作者：Grob Jean Jacques^*; Jouary Thomas; Dreno Brigitte; Asselineau Julien; Gutzmer Ralf; Hauschild Axel; Leccia Marie Therese; Landthaler Michael; Garbe Claus; Sassolas Bruno; Herbst Rudolf A; Guillot Bernard; Chene Genevieve; Pehamberger Hubert

来源：European Journal of Cancer, 2013, 49(1): 166-174.

DOI：10.1016/j.ejca.2012.07.018

• Adjuvant drug therapy
• Interferon alpha-2b
• Melanoma
• Peg-interferon alpha-2b
• Randomised control trial

Aim: Both low-dose interferon (IFN) alfa-2b and pegylated interferon (Peg-IFN) alfa-2b have been shown to be superior to observation in the adjuvant treatment of melanoma without macrometastatic nodes, but have never been directly compared. Peg-IFN facilitates prolongation of treatment, which could provide additional benefit. This multicentre, open-label, randomised, phase 3 trial compared standard low-dose interferon IFN and prolonged treatment with Peg-IFN. %26lt;br%26gt;Patients and methods: Patients with resected melanoma %26gt;= 1.5 mm thick and without clinically detectable node metastases were randomised 1: 1 to treatment with IFN 3 MU subcutaneously (SC) three times weekly for 18 months or Peg-IFN 100 mu g SC once weekly for 36 months. Sentinel lymph node dissection (SLND) was optional. The primary endpoint was disease-free survival (DFS). Secondary endpoints included distant metastasis-free survival (DMFS), overall survival (OS) and adverse events (AEs) grade 3-4. %26lt;br%26gt;Results: Of 898 patients enrolled, 896 (443 Peg-IFN, 453 IFN) were eligible for evaluation (median follow-up 4.7 years). SLND was performed in 68.2% of patients. There were no statistical differences between the two arms for the primary outcome of DFS (hazard ratio [HR] 0.91, 95% confidence interval [CI] 0.73-1.15) or the secondary outcomes of DMFS (HR 1.02, 95% CI 0.80-1.32) and OS (HR 1.09, 95% CI 0.82-1.45). Peg-IFN was associated with higher rates of grade 3-4 AEs (47.3% versus 25.2%; p %26lt; 0.0001) and discontinuations (54.3% versus 30.4%) compared with IFN. %26lt;br%26gt;Conclusion: This trial did not show superiority for adjuvant Peg-IFN over conventional low-dose IFN in melanoma patients without clinically detectable nodes. ClinicalTrials.gov identifier: NCT00221702.

• 出版日期2013-1