Okuyama Sonia, Gonzalez Rene, Lewis Karl D
Division of Medical Oncology, Department of Cutaneous Oncology, University of Colorado, Denver, CO, USA.
Core Evid. 2010 Oct 21;5:39-48. doi: 10.2147/ce.s8588.
Stage III melanoma, also referred to as regional metastatic melanoma, has five-year survival rates ranging between 40% and 78%. In order to reduce the likelihood of recurrence in this high-risk population, patients undergo resection of primary tumors and all involved nodal basins. Systemic therapy is being pursued in an effort to improve outcome data, but the best strategy has yet to be defined. Interferon alpha-2b remains to date the most promising approach available. Toxicities and intensive intravenous administration, unfortunately, are major concerns. An alternative is the use of interferon in its pegylated subcutaneous form. The aim of this research was to review the evidence for the use of pegylated interferon alpha-2b in Stage III malignant melanoma.
ECOG 1684 was the pivotal trial that first demonstrated a statistically significant benefit in relapse-free and overall survival for adjuvant interferon alpha-2b in high-risk melanoma. Other larger studies, such as ECOG 1690, confirmed a relapse-free survival benefit but did not achieve statistical significance for overall survival. The first study of the pegylated form of interferon alpha-2b in Stage III melanoma, EORTC 18991, is reviewed here. This trial showed a statistically significant improvement in relapse-free survival but not overall survival. Encouraging data of potential equivalent efficacy, easier administration, and fewer Grade 3 and 4 adverse reactions compared with high-dose intravenous interferon raises the question of its potential role in Stage III melanoma in the adjuvant setting.
III期黑色素瘤，也称为区域转移性黑色素瘤，其五年生存率在40%至78%之间。为了降低这一高危人群复发的可能性，患者需切除原发性肿瘤及所有受累的淋巴结区域。目前正在探索全身治疗以改善治疗结果数据，但最佳策略尚未确定。迄今为止，α-2b干扰素仍然是最有前景的可用方法。然而，毒性和密集的静脉给药是主要问题。一种替代方法是使用聚乙二醇化皮下注射形式的干扰素。本研究的目的是回顾聚乙二醇化α-2b干扰素用于III期恶性黑色素瘤治疗的证据。
ECOG 1684是一项关键试验，首次证明辅助性α-2b干扰素在高危黑色素瘤的无复发生存率和总生存率方面具有统计学显著益处。其他更大规模的研究，如ECOG 1690，证实了无复发生存率的益处，但总生存率未达到统计学显著性。本文回顾了第一项关于聚乙二醇化α-2b干扰素用于III期黑色素瘤治疗的研究EORTC 18991。该试验显示无复发生存率有统计学显著改善，但总生存率未改善。与高剂量静脉注射干扰素相比，聚乙二醇化干扰素具有潜在等效疗效、给药更简便且3级和4级不良反应更少的鼓舞人心的数据，这引发了其在III期黑色素瘤辅助治疗中潜在作用的问题。
