Adjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma.

Conference item

PURPOSE: To evaluate low-dose extended duration interferon alfa-2a as adjuvant therapy in patients with thick (> or = 4 mm) primary cutaneous melanoma and/or locoregional metastases. PATIENTS AND METHODS: In this randomized controlled trial involving 674 patients, the effect of interferon alfa-2a (3 megaunits three times per week for 2 years or until recurrence) on overall survival (OS) and recurrence-free survival (RFS) was compared with that of no further treatment in radically resected stage IIB and stage III cutaneous malignant melanoma. RESULTS: The OS and RFS rates at 5 years were 44% (SE, 2.6) and 32% (SE, 2.1), respectively. There was no significant difference in OS or RFS between the interferon-treated and control arms (odds ratio [OR], 0.94; 95% CI, 0.75 to 1.18; P =.6; and OR, 0.91; 95% CI, 0.75 to 1.10; P =.3; respectively). Male sex (P =.003) and regional lymph node involvement (P =.0009), but not age (P =.7), were statistically significant adverse features for OS. Subgroup analysis by disease stage, age, and sex did not show any clear differences between interferon-treated and control groups in either OS or RFS. Interferon-related toxicities were modest: grade 3 (and in only one case, grade 4) fatigue or mood disturbance was seen in 7% and 4% respectively, of patients. However, there were 50 withdrawals (15%) from interferon treatment due to toxicity. CONCLUSION: The results from this study, taken in isolation, do not indicate that extended-duration low-dose interferon is significantly better than observation alone in the initial treatment of completely resected high-risk malignant melanoma.

Authors: Hancock, B; Wheatley, K; Harris, S; Ives, N; Harrison, G

• Publication status: Published
• Host title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
• Volume: 22
• Issue: 1
• Pages: 53-61
• Publication date: 2004-01-01
• Event location: United States
• DOI: 10.1200/jco.2004.03.185
• EISSN: 1527-7755
• ISSN: 0732-183X
• Keywords: Aged; Affect; Interferon-alpha; Male; Antineoplastic Agents; Fatigue; Drug Administration Schedule; Skin Neoplasms; Humans; Middle Aged; Aged, 80 and over; Risk Factors; Age Factors; Female; Melanoma; Adolescent; Dose-Response Relationship, Drug; Adult; Treatment Outcome; Disease-Free Survival