Long term follow up of the EORTC 18952 trial of adjuvant therapy in resected stage IIB-III cutaneous melanoma patients comparing intermediate doses of interferon-alpha-2b (IFN) with observation: Ulceration of primary is key determinant for IFN-sensitivity
Long term follow up of the EORTC 18952 trial of adjuvant therapy in resected stage IIB-III cutaneous melanoma patients comparing intermediate doses of interferon-alpha-2b (IFN) with observation: Ulceration of primary is key determinant for IFN-sensitivity
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DOI：
10.1016/j.ejca.2015.11.014
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发表时间：
2016-03-01
影响因子：
8.4
通讯作者：
Testori, Alessandro
中科院分区：
文献类型：
--
作者：
Eggermont, Alexander M. M.;Suciu, Stefan;Testori, Alessandro
背景资料：我们报告了EORTC 18952辅助干扰素（IFN）试验在1388例切除的IIB/III期黑色素瘤患者中的长期结局，并确定了结局的关键预测因素。我们分析了EORTC 18952试验的结果（IFN，10 MU，每周5次，持续4周，随后12个月IFN，10 MU，3次/周vs随后24个月IFN 5 MU 3次/周vs观察）的无复发生存期（RFS）、无远处转移间期/生存期结果：在中位随访11年时，IFN 13个月与IFN 25个月与观察结果的比较得出RFS的估计风险比（HR）为0.94与0.84（p = 0.06）; DMFI 0.95与0.82（p = 0.027）; DMFS 0.95与0.84（p = 0.07）; OS 0.95与0.84（p = 0.08）。溃疡组治疗的影响最大，而在原发灶未溃疡的患者中，影响为零（HR>= 1.0）。在溃疡性黑色素瘤患者中，IFN 13个月vs 25个月vs观察组的HR为：RFS 0.82（p = 0.16）vs 0.61（p = 0.0008）; DMFS 0.76（p = 0.06）vs 0.57（p = 0.0003）; OS 0.80（p = 0.13）vs 0.59（p = 0.0007）。IIB/III-N1期（仅显微镜下淋巴结受累）溃疡性黑色素瘤患者的HR估计值为：RFS 0.85 vs 0.62; DMFS 0.80 vs 0.56; OS 0.77 vs 0.54。结论：EORTC 18952试验的长期报告证明了25-一个月的IFN方案，并定义溃疡的主要作为压倒性的预测因子IFN敏感性。2015爱思唯尔有限公司版权所有。
Background: We report on the long term outcome of the EORTC 18952 adjuvant interferon (IFN) trial in 1388 resected stage IIB/III melanoma patients and identify key predictive factors for outcome.Methods: We analysed outcome of the EORTC 18952 trial (4 weeks of IFN, 10 MU, 5 times/week for 4 weeks followed by 12 months IFN at 10 MU, 3 times/week versus followed by 24 months IFN at 5 MU 3 times/week versus observation) regarding relapse-free survival (RFS), distant metastasis-free interval/survival (DMFI/DMFS), and overall survival (OS), and analysed potential predictive factors of outcome.Findings: At a median follow-up of 11 years, the comparison of IFN 13 months versus IFN 25 months versus observation yielded estimated hazard ratios (HR) for RFS of 0.94 versus 0.84 (p = 0.06); for DMFI 0.95 versus 0.82 (p = 0.027); for DMFS 0.95 versus 0.84 (p = 0.07); and for OS 0.95 versus 0.84 (p = 0.08), respectively. The impact of treatment was greatest in the ulceration group, whereas in patients with non-ulcerated primaries the impact was null (HR >= 1.0). In patients with ulcerated melanoma the HR for IFN 13 months versus 25 months versus observation were for: RFS 0.82 (p = 0.16) versus 0.61 (p = 0.0008); DMFS 0.76 (p = 0.06) versus 0.57 (p = 0.0003); OS 0.80 (p = 0.13) versus 0.59 (p = 0.0007). In stage IIB/III-N1 (microscopic nodal involvement only) patients with ulcerated melanoma the HR estimates were for: RFS 0.85 versus 0.62; DMFS 0.80 versus 0.56; OS 0.77 versus 0.54.Conclusions: This long term report of the EORTC 18952 trial demonstrates the superiority of the 25-month IFN schedule and defines ulceration of the primary as the overriding predictive factor for IFN-sensitivity. 2015 Elsevier Ltd. All rights reserved.