Treatment patterns of adjuvant interferon-α2b for high-risk melanoma: a retrospective study of the Grupo Español Multidisciplinar de Melanoma – Prima study

Abstract

Adjuvant interferon-α2b (IFN-α2b) has been studied extensively in clinical trials, but there have been few studies of real-world use. The aim of this study is to describe the IFN-α2b real-world patterns in patients with high-risk melanoma in Spain. This was a retrospective and multicentre chart review study of an unselected cohort of patients with melanoma at high risk for relapse (stage IIB/IIC/III) treated with IFN-α2b. Patterns were assessed in terms of dose and compliance to planned treatment. A survival analysis was carried out for the full population and according to Kirkwood scheme compliance and the presence of ulceration. Of 327 patients treated with IFN-α2b, 318 received a high-dose regimen following the standard Kirkwood scheme; thus, patterns are described for this regimen. A total of 121 (38%) and 88 (28%) patients had at least one dose reduction during the induction and maintenance phases, respectively. Dose delay was required in fewer than 10% of patients. A total of 78, 40 and 38% of the patients completed the induction phase, maintenance phase and completed treatment, respectively. The median progression-free and overall survival for the full population were 3.2 and 10.5 years, respectively. There were no differences in progression-free survival and overall survival according to Kirkwood scheme compliance and the presence of ulceration. The most frequent adverse events were neutropenia (31%) and fatigue (30%). High-dose IFN-α2b is the most frequently used regimen in Spain as an adjuvant systemic treatment for high-risk melanoma. Despite poor compliance, in this retrospective study, IFN-α2b treatment provided a benefit consistent with that described previously.

Adjuvant Therapy Versus Watch-and-Wait Post Surgery for Stage III Melanoma: A Multicountry Retrospective Chart Review

“…This variation in treatment schedules aligns with prior studies, for example, a multicountry retrospective and prospective observational study found that 33% of patients with stage IIIB/C melanoma who were treated with high-dose IFN experienced a dose delay and/or reduction, and 29% discontinued therapy [44]. Similarly, results from another retrospective study reported modifications in both induction and maintenance schedules in 38 and 28% of patients, respectively [45]. The variability in treatment dose, schedule and duration, has resulted in a lack of clear insight regarding the risk benefit to patients [46,47].…”

Comprehensive Survey of Clinical Trials Registration for Melanoma Immunotherapy in the ClinicalTrials.gov

“…The anti-tumor effect of IFN-a is expected to be induced by CD8+ T cell-mediated autologous tumor cell lysis. High-dose IFN is currently the standard adjuvant therapy, despite the high incidence of adverse events (Espinosa et al, 2016). The significant clinical efficacy of oncolytic virus (Andtbacka et al, 2015) and toll-like receptor agonist (Mauldin et al, 2015) had opened up a new path for melanoma immunotherapy, and follow-up clinical research is underway.…”

Direct and indirect effects of IFN-α2b in malignancy treatment: not only an archer but also an arrow

“…One of the important factors limiting the large-scale application of IFN-α2b in treating malignancy is the prevailing adverse effects, although they are not life-threatening in most cases. In a retrospective study of melanoma, 71% of the patients were found to experience at least one kind of adverse effect, but no drug-related death was observed [ 251 ]. Another study on Sézary syndrome reported a similar percentage of patients who experienced a toxic response (60%) [ 196 ].…”