Randomized Phase III Study of 1 Month Versus 1 Year of Adjuvant High-Dose Interferon Alfa-2b in Patients With Resected High-Risk Melanoma

Abstract

There were no significant differences in OS and RFS between the regimens of 1 month and 1 year of treatment.

Phase II Randomized Trial Comparing High-Dose IFN-α2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma

“…Patients in group B were treated with i.v. 15 Â 10 6 U/m 2 /d IFN-a2b (Intron; Merck & Co.) on days 1 to 5 each week for 4 weeks, and then followed by s.c. 9 Â 10 6 U IFN-a2b three times per week for 48 weeks, which has been confirmed by previous trial to be tolerable and may be the optimal dose intensity for Chinese patients and Europeans (25,26). Patients in group C were treated with per os 200 mg/m 2 /d temozolomide (Temodal or Temodar; Merck & Co.) on days 1 to 5 plus i.v.…”

Update on Current Phase III Clinical Trials in Melanoma

“…Patients in arm B had more grade 1 to grade 2 hepatotoxicity, nausea, vomiting, alopecia, and neurologic toxicity. Thus the study concluded that there is no difference between a one month and a one year treatment in terms of relapsed-free or overall survival (Pectasides et al, 2009). High dose interferon alpha-2b is however associated with toxic effects.…”

Mental Health Services Use by Melanoma Patients Receiving Adjuvant Interferon: Association of Pre-treatment Mental Health Care with Early Discontinuation

“…In multivariable analysis, long-course hd-ifn was associated with improved survival (hazard ratio: 0.59; 95% cl: 0.38, 0.92). In another trial evaluating the effect of ifn duration on outcome, Pectasides et al 21 reported negative results, but their target dose was much less than the dose used in standard hd-ifn regimens. Although the supportive evidence is not robust, our observed association between pre-existing mental health care and early discontinuation of hd-ifn emphasizes, at minimum, the importance of optimizing the mental health care of patients who are to receive hd-ifn so as to ensure delivery of treatment per protocol.…”