Cancer Resources > Cancer News > 2010 > February

Extended interferon therapy not beneficial in primary melanoma

Scott Baltic

Last Updated: 2010-02-03 15:27:02 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Extending conventional low-dose interferon (IFN)-alpha 2a therapy from 18 months to 5 years yields no significant benefit for patients with intermediate- or high-risk primary melanoma, according to German researchers.

In their January 4 online report in the Journal of Clinical Oncology, they also note that more than a third of patients assigned to 60 months of therapy discontinued early.

The results "indicate that low-dose IFN for patients who are lymph node negative should not be extended beyond the routine duration of 18 months," the report concludes.

The randomized, multicenter phase III trial evaluated 840 patients with clinically node-negative melanoma, with or without positive sentinel nodes, whose tumor thickness was at least 1.5 mm.

Patients were randomly assigned to receive 3 MU of IFN 2a subcutaneously 3 times a week for either 18 or 60 months. In case of grade 3 adverse events, IFN could be interrupted for up to 2 weeks, but dose reductions were not allowed.

Median patient age at enrollment was 54 years; median follow-up was 4.3 years.

The estimated 5-year relapse-free survival rates were 75.6% in the 18-month group and 72.6% in the 60-month group. Estimated 5-year rates of distant metastasis-free survival (81.9% vs. 79.7%) and overall survival (85.9% vs. 84.9%) were likewise very similar between the two groups.

On multivariate analysis, the thickness of the primary tumor and sentinel lymph node status were significant predictors of relapse risk.

Both groups generally tolerated the treatment well, and there were no treatment-related deaths. The authors point out that whereas the discontinuation rate in the 18-month group (17.8%) was consistent with earlier reports, the rate in the 60-month group was 37.9%. Overall, the most common factors leading to withdrawal were fatigue, depression and a general unwillingness to accept IFN for a total of 5 years.

The study was supported by Roche, which markets IFN-alpha2a as Roferon A.

J Clin Oncol 2010.

Copyright © 2010 Reuters Limited. All rights reserved.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.