Hamilton Regional Cancer Centre, Hamilton, ON, USA.
Curr Oncol. 2008 Jan;15(1):36-41. doi: 10.3747/co.2008.200.
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.
本报告所描述的为期 1 年的观察性、多中心、开放性研究的目的是确定影响高剂量干扰素 α-2b 辅助治疗高危复发性恶性黑色素瘤患者的因素。该研究在加拿大 23 个三级护理中心进行。该研究共纳入 225 例手术切除后需要干扰素 α-2b 辅助治疗的恶性黑色素瘤患者。其中 64%为男性，平均年龄为 51.7 岁。所有患者均接受了为期 4 周的诱导期（每周 5 天，静脉内 20 MU/m2）和 48 周的维持期（每周 3 天，皮下 10 MU/m2）干扰素 α-2b 治疗。肿瘤护士在诱导期和维持期前与患者一起审查了副作用管理情况。为患者提供了每日日记、综合教育材料和持续的护理支持。通过患者访谈和日记获得了副作用和停药数据。主要的疗效测量指标与治疗停药有关：停药率、时间、原因和预防。在 225 例患者中，75 例（33.3%）在诱导期停止干扰素治疗，58 例（25.8%）在维持期停止治疗。停药的主要原因是不良事件（58%）和疾病进展（26%）。每日液体摄入量大于 1.5 L 的患者比摄入量小于 1.5 L 的患者更有可能完成治疗（64%比 36%，p<0.0001）。在纳入干扰素 α-2b 健康管理计划的 225 例患者中，41%完成了 1 年的治疗过程。较高的液体摄入量（>1.5 L/天）与增加对治疗的依从性相关。
