[Pilot study of interferon alpha-2b tolerance in patients with stage III melanoma]. / Etude pilote sur la tolérance à l'interféron alpha-2b chez des patients atteints d'un mélanome stade III.

ABSTRACT

GOAL Evaluation of interferon alpha-2b adjuvant treatment (INF alpha-2b) toxicity by monitoring biologic parameters in patients with stage III melanoma. METHOD: Between January 7th till October 29th 1998, we administered 674 injections of INF alpha-2b to eight patients who previously had undergone surgery for stage III melanoma. Patients received 20 MU/m2/d IV for a month and 10 MU/m2/d sub-cutaneously three time a week for 48 weeks. All these patients were followed with at least one complete blood count and hepatic profile every week. Interferon alpha-2b doses were changed accordingly. RESULTS: Patients received on average 51.5% of the total dose. Doses were decreased in patients with neutropenia or hepatic profiles anomalies. Only one patient could received 100% of the total regimen. In four patients treatment was discontinued. In three out of four patients this was due to disease progression, and in one out of four patients this was due to hepatic toxicity. CONCLUSION: INF alpha-2b is less well tolerated than initially thought. Dosage was frequently decreased due to hematologic and hepatic toxicities. This could compromise the treatments efficacity. The minimal dose required to obtain an optimal response will thus have to be defined.