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Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival
Date:7/11/2008

ng better evidence-based treatment options for patients."

Peginterferon alfa-2b is not approved for treatment of melanoma in either the US or EU.

About The Study

The study was designed to assess the efficacy and safety of long-term pegylated interferon alfa-2b vs. observation. Researchers randomised patients to either peginterferon alfa-2b adjuvant treatment (n=627) or observation only (n=629) within 70 days of regional lymph node dissection (intent-to-treat population). The endpoint was RFS. Participants randomized to pegylated interferon alfa-2b were to receive a dose of 6 micrograms/kg/week for an eight week induction phase followed by 3 micrograms/kg/wk (maintenance phase), for an intended total treatment duration of 5 years. Patients randomized to observation received no study treatment. The study results presented were analyzed by the EORTC.

Median RFS was 34.8 months and 25.6 months in the peginterferon alfa-2b and observation alfa-2b arms, respectively (difference of 9.2 months). The improvement in RFS was more pronounced in patients with a lower tumor burden in the lymph nodes based on predefined subgroups. For the subgroup of patients with clinically non-palpable (microscopic) lymph node disease, the HR for RFS was 0.73 (99 percent CI, 0.53-1.02, P=0.016, log-rank test) in favor of peginterferon alfa-2b treatment, as compared to 0.86 (99 percent CI, 0.68-1.10) in patients with clinically palpable nodes. Similarly, the HR in patients with one positive lymph node was 0.71 (99 percent CI, 0.53-0.97, P=0.004) as compared to 0.94 (99 percent CI, 0.73-1.21) in patients with more than one positive lymph node.

Peginterferon alfa-2b adjuvant treatment was not associated with a benefit on overall survival, a secondary endpoint, with a HR of 0.98 (95 percent CI, 0.82-1.16).

Grade 3 events occurred in 40 percent (246 patients) in the pegylated interferon alfa-2b arm versus 10 percent (60 patients) in the observational arm. Gra
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SOURCE Schering-Plough
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