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
PURPOSE: Ipilimumab is an effective treatment for melanoma; however, toxicity rates remain high. The objective of this study was to describe the rates of adverse events (AEs), emergency room (ER) visits, hospitalizations, and nursing resource utilization for patients enrolled in a nurse-led telephone toxicity monitoring program. METHODS: Patients received weekly telephone calls from nursing to review a toxicity checklist during ipilimumab treatment and for 8 weeks after completion. To evaluate this program, a single-center retrospective review was performed for patients treated between July 2012 and September 2017 with single agent ipilimumab for advanced melanoma. Data were collected up to 3 months post-ipilimumab. RESULTS: A total of 67 patients were included, with a mean (standard deviation) age of 61 (14.6) years. Thirty-three (49%) patients received four doses of ipilimumab, and 17 (25%) had one dose delay. The median (IQR) of any AEs reported per patient was 11 (8-17). There were 44 (66%) patients with AEs deemed to be definitely or probably related to ipilimumab, and of those, 3 (4%) experienced a grade 3 AE, whereas 4 (6%) experienced grade 4 AEs. Twenty patients (30%) had ER visits, and 31 (46%) were hospitalized during follow-up (9% ER visits and 6% hospitalizations were related to drug toxicity). CONCLUSION: Ipilimumab is associated with high rates of toxicity; however, a proactive nurse-led monitoring program was feasible and patients had low rates of grade 3-4 toxicity. Hospitalization rates and ER visits remained high; however, the minority of those were related to drug toxicity.
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