Health Management Program: Factors Influencing Completion of Therapy with High-Dose Interferon Alfa-2b for High-Risk Melanoma

Abstract

The goal of the 1-year observational, multicentre, open-label study reported here was to identify factors influencing adherence to high-dose interferon alfa-2b adjuvant therapy in patients at high risk of recurrence following surgical excision of malignant melanoma. The study was carried out in 23 tertiarycare centres across Canada.The 225 patients enrolled in the study all had malignant melanoma that was surgically excised and that required adjuvant treatment with interferon alfa-2b. Of these patients, 64% were men. Mean age was 51.7 years. All patients received interferon alfa-2b treatment during a 4-week induction phase (20 MU/m 2 intravenously 5 days per week) followed by a 48-week maintenance phase (10 MU/m 2 subcutaneously 3 days per week).Oncology nurses reviewed side-effect management with the patients before the induction and maintenance phases. Patients were provided with daily diaries, comprehensive educational materials, and ongoing nursing support. Data on side effects and discontinuations were obtained from patient interviews and diaries.The main outcome measurements were related to treatment discontinuation: rate, timing, reason, and prevention. Of the 225 patients, 75 (33.3%) discontinued interferon during the induction phase, and 58 (25.8%) discontinued during the maintenance phase. The main reasons for discontinuation were adverse events (58%) and disease progression (26%). Patients with a daily fluid intake greater than 1.5 L were more likely to complete therapy than were those with an intake less than 1.5 L (64% vs. 36%, p < 0.0001).Of 225 patients enrolled in the interferon alfa-2b health management program, 41% completed the 1-year treatment course. Higher fluid intake (>1.5 L daily) was associated with increased adherence to therapy. KEY WORDSMelanoma, interferon alfa-2b, clinical trial, adherence

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

“…This observation suggests that dose adjustment is particularly relevant for treatment tolerance and should be considered as soon as side effects appear. This has also been observed elsewhere 1 .…”

“…In this series, 83% of the patients completed the full 52-week expected treatment 15 ; other larger studies reported figures similar to those reported here. A Canadian study with 225 patients showed that 41% completed the full therapy 1 . In the present study, a Cox regression analysis showed that age was a strong predictive factor.…”

“…The sample size was calculated with a 95% confidence interval (CI) and a 0.05 α error assuming that 67% of patients will complete induction and 41% will complete the entire treatment 1 . Thus, 325 patients should be included.…”

“…Melanoma causes almost 80% of all skin cancer deaths and its incidence is increasing worldwide 1 , 2 . In Spain, both melanoma incidence (5.2 cases per 100 000 inhabitants/year) and lethality are increasing 3 , 4 .…”

“…However, adverse IFN-α2b tolerability, mainly flu-like symptoms, mood changes and mental alterations, may lead to patient refusal, discontinuation or poor compliance 1 , 7 . Impairments in compliance may theoretically impact outcomes.…”