Health management program: factors influencing completion of therapy with high-dose interferon alfa-2b for high-risk melanoma
N Levesque, K Mitchinson, D Lawrie, L Fedorak, D Macdonald, C Normand, J F Pouliot, N Levesque, K Mitchinson, D Lawrie, L Fedorak, D Macdonald, C Normand, J F Pouliot
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 tertiary-care 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.
Keywords: Melanoma; adherence; clinical trial; interferon alfa-2b.
Figures
FIGURE 3
Discontinuations occurring during the induction…
FIGURE 3
Discontinuations occurring during the induction and maintenance phases of a 1-year course of…
References
- Canadian Cancer Society and the National Cancer Institute of Canada. Canadian Cancer Statistics 2006. Toronto: Canadian Cancer Society; 2006.
- Rataj D, Jankowiak B, Krajewska–Kulak E, et al. Quality-of-life evaluation in an interferon therapy after radical surgery in cutaneous melanoma patients. Cancer Nurs. 2005;28:172–8.
- United States, National Institutes of Health, National Cancer Institute, Surveillance, Epidemiology, and End Results (seer) database, 1975–2003. Trends (annual percent change) of seer incidence rates [Web resource] Bethesda, MD: National Cancer Institute;
- Kirkwood JM, Ernstoff MS. Role of interferons in the therapy of melanoma. J Invest Dermatol. 1990;95(suppl):180S–4S.
- Kirkwood JM, Ibrahim JG, Sosman JA, et al. High-dose interferon alfa-2b significantly prolongs relapse-free and overall survival compared with the GM2-KLH/QS-21 vaccine in patients with resected stage IIB-III melanoma: results of Intergroup trial E1694/S9512/C509801. J Clin Oncol. 2001;19:2370–80.
- Moschos SJ, Edington HD, Land SR, Rao UN, Shipe–Spotloe J, Kirkwood JM. Neoadjuvant treatment of regional stage IIIB melanoma with high-dose interferon alfa-2b induces objective tumor regression in association with modulation of tumor infiltrating host cellular immune responses. J Clin Oncol. 2006;24:3164–71.
- Kirkwood JM, Strawderman MH, Ernstoff MS, Smith TJ, Borden EC, Blum RH. Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group Trial est 1684. J Clin Oncol. 1996;14:7–17.
- Kirkwood JM, Ibrahim JG, Sondak VK, et al. High- and low-dose interferon alfa-2b in high-risk melanoma: first analysis of Intergroup trial E1690/S9111/C9190. J Clin Oncol. 2000;18:2444–58.
- Kirkwood JM, Bender C, Agarwala S, et al. Mechanisms and management of toxicities associated with high-dose interferon alfa-2b therapy. J Clin Oncol. 2002;20:3703–18.
- Trask PC, Paterson AG, Esper P, Pau J, Redman B. Longitudinal course of depression, fatigue, and quality of life in patients with high risk melanoma receiving adjuvant interferon. Psychooncology. 2004;13:526–36.
- Greenberg DB, Jonasch E, Gadd MA, et al. Adjuvant therapy of melanoma with interferon-alpha-2b is associated with mania and bipolar syndromes. Cancer. 2000;89:356–62.
- Fluck M, Kamanabrou D, Lippold A, Reitz M, Atzpodien J. Dose-dependent treatment benefit in high-risk melanoma patients receiving adjuvant high-dose interferon alfa-2b. Cancer Biother Radiopharm. 2005;20:280–9.
- Kirkwood JM, Ernstoff MS. Potential applications of the interferons in oncology: lessons drawn from studies of human melanoma. Semin Oncol. 1986;13:48–56.
- Kilbridge KL, Weeks JC, Sober AJ, et al. Patient preferences for adjuvant interferon alfa-2b treatment. J Clin Oncol. 2001;19:812–23.
- Kiley KE, Gale DM. Nursing management of patients with malignant melanoma receiving adjuvant alpha interferon-2b. Clin J Oncol Nurs. 1998;2:11–16.
- Donnelly S. Patient management strategies for interferon alfa-2b as adjuvant therapy of high-risk melanoma. Oncol Nurs Forum. 1998;25:921–7.
- Romanini A, Sarti S, Murr R, et al. Toxicity of adjuvant treatment with high-dose interferon alpha 2b (hd-ifn) in high-risk stage III melanoma patients (pts): the Italian experience [abstract] Proc Am Soc Clin Oncol. 2005;23:7568.
Source: PubMed