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Duration of High-Dose Interferon Alfa-2b Regimen for Resected High-Risk Melanoma

2009; Lippincott Williams & Wilkins; Volume: 27; Issue: 25 Linguagem: Inglês

10.1200/jco.2009.23.0334

1527-7755

Sanjiv S. Agarwala, Robert J. Gray, Michael K.K. Wong,

Immunotherapy and Immune Responses

HDI actually utilized. The induction therapy dose was 15 10 6 U/m 2 /d intravenously (IV) for 5 of 7 days for 4 weeks, whereas the standard HDI dose on the ECOG trials is 20 10 6 U/m 2 /d. This was followed by a flat dose of 10 10 6 U subcutaneously (SC) 3 times per week for 48 weeks (as compared to the standard HDI dose of 10 10 6 U/m 2 3 times per week for 48 weeks). Even if one allowed for dose reductions during the induction phase of the ECOG studies to match the lower prescribed dose on the Hellenic trial, the maintenance-phase dose is problematic. The latter has already been shown to be ineffective compared with observation in a large randomized European Organisation for Research and Treatment of Cancer trial (18952) 6 where 10 10 6 U administered SC for 1 year was found to be no better than observation alone. In effect, this nullifies any effect of the SC maintenance phase of the Hellenic trial and reduces this study to a comparison of “induction versus induction,” with all the additional caveats previously discussed. Since adjuvant therapy is given with curative intent, any change in its administration can have significant impact on patients. It is our contention, therefore, that the results of the Hellenic trial cannot and should not be considered conclusive and that the 1-year HDI regimen remain the standard of care for patients with high-risk melanoma as defined in the ECOG trials. The ongoing, high-priority ECOG 1697 trial we are conducting is randomly assigning 1,420 patients with intermediate- and high-risk melanoma to 1 month of IV induction at full standard dosages or to observation, and will shed more light on the issue of whether the induction therapy alone is sufficient for patients in the adjuvant setting.