Schilling Bastian, Vaubel Julia, Schadendorf Dirk
Universitätsklinikum Essen, 45122 Essen, Germany.
Oncol Lett. 2010 Mar;1(2):237-241. doi: 10.3892/ol_00000042. Epub 2010 Mar 1.
Although adjuvant high-dose interferon α-2b therapy significantly improves recurrence-free survival vs. observation in high-risk resected melanoma, the overall survival benefit is presently unclear. Pegylation of interferon α-2b (peginterferon α-2b) allows for a reduction in the dosing frequency with increased drug exposure. Adjuvant peginterferon α-2b therapy has also been shown to provide a significant, sustained improvement in recurrence-free survival compared with observation in patients with stage III melanoma. We report on the use of adjuvant peginterferon α-2b (3 μg/kg/week) in clinical practice in a series of 8 patients treated at the Universitätsklinikum Essen in Germany following complete resection of primary melanoma at intermediate- and high-risk of recurrence (stage II-III). Treatment duration ranged from 2 to 29 months, with 4 patients receiving long-term therapy (≥24 months). Following treatment, 5 patients (stage II) remained disease-free at 33, 33, 37, 39 and 43 months from the time of diagnosis. In 2 patients, peginterferon α-2b was terminated 4 and 9 months after treatment initiation due to disease progression. Once-weekly subcutaneous administration of peginterferon α-2b was convenient in all patients. In 3 patients experiencing adverse events, dose reductions led to a resolution of symptoms and enabled treatment to continue long-term. Three further patients discontinued therapy due to adverse events at 2, 8 and 27 months of therapy (persistent elevation of γ-glutamyl transpeptidase, liver transaminase elevation and urosepsis); dose modifications were not applicable in these patients. Thus, long-term adjuvant peginterferon α-2b therapy was feasible in the clinical practice setting and was generally well tolerated in these intermediate- and high-risk melanoma patients.
尽管与观察等待相比,辅助性大剂量干扰素α-2b治疗可显著提高高危切除黑色素瘤患者的无复发生存率,但目前总体生存获益尚不清楚。干扰素α-2b聚乙二醇化(聚乙二醇干扰素α-2b)可减少给药频率并增加药物暴露量。与观察等待相比,辅助性聚乙二醇干扰素α-2b治疗也已显示可显著、持续地提高III期黑色素瘤患者的无复发生存率。我们报告了德国埃森大学医院对8例患者在临床实践中使用辅助性聚乙二醇干扰素α-2b(3μg/kg/周)的情况,这些患者在原发性黑色素瘤完全切除后处于复发的中高危状态(II-III期)。治疗持续时间为2至29个月,4例患者接受了长期治疗(≥24个月)。治疗后,5例II期患者自诊断起33、33、37、39和43个月时仍无疾病。2例患者在治疗开始后4个月和9个月因疾病进展终止了聚乙二醇干扰素α-2b治疗。所有患者每周一次皮下注射聚乙二醇干扰素α-2b均很方便。3例出现不良事件的患者,剂量减少后症状得到缓解,治疗得以继续长期进行。另外3例患者在治疗2、8和27个月时因不良事件(γ-谷氨酰转肽酶持续升高、肝转氨酶升高和泌尿道感染)停止治疗;这些患者无法进行剂量调整。因此,长期辅助性聚乙二醇干扰素α-2b治疗在临床实践中是可行的,并且这些中高危黑色素瘤患者通常耐受性良好。