Hancock B W, Wheatley K, Harris S, Ives N, Harrison G, Horsman J M, Middleton M R, Thatcher N, Lorigan P C, Marsden J R, Burrows L, Gore M
Academic Unit of Clinical Oncology, The University of Sheffield, Weston Park Hospital, Whitham Rd, Sheffield S10 2SJ, UK.
J Clin Oncol. 2004 Jan 1;22(1):53-61. doi: 10.1200/JCO.2004.03.185. Epub 2003 Dec 9.
To evaluate low-dose extended duration interferon alfa-2a as adjuvant therapy in patients with thick (> or = 4 mm) primary cutaneous melanoma and/or locoregional metastases.
In this randomized controlled trial involving 674 patients, the effect of interferon alfa-2a (3 megaunits three times per week for 2 years or until recurrence) on overall survival (OS) and recurrence-free survival (RFS) was compared with that of no further treatment in radically resected stage IIB and stage III cutaneous malignant melanoma.
The OS and RFS rates at 5 years were 44% (SE, 2.6) and 32% (SE, 2.1), respectively. There was no significant difference in OS or RFS between the interferon-treated and control arms (odds ratio [OR], 0.94; 95% CI, 0.75 to 1.18; P =.6; and OR, 0.91; 95% CI, 0.75 to 1.10; P =.3; respectively). Male sex (P =.003) and regional lymph node involvement (P =.0009), but not age (P =.7), were statistically significant adverse features for OS. Subgroup analysis by disease stage, age, and sex did not show any clear differences between interferon-treated and control groups in either OS or RFS. Interferon-related toxicities were modest: grade 3 (and in only one case, grade 4) fatigue or mood disturbance was seen in 7% and 4% respectively, of patients. However, there were 50 withdrawals (15%) from interferon treatment due to toxicity.
The results from this study, taken in isolation, do not indicate that extended-duration low-dose interferon is significantly better than observation alone in the initial treatment of completely resected high-risk malignant melanoma.
评估低剂量延长疗程的干扰素α-2a作为厚（≥4mm）原发性皮肤黑色素瘤和/或局部区域转移患者辅助治疗的效果。
在这项纳入674例患者的随机对照试验中，比较了干扰素α-2a（300万单位，每周3次，共2年或直至复发）与根治性切除的IIB期和III期皮肤恶性黑色素瘤患者不再接受进一步治疗相比，对总生存期（OS）和无复发生存期（RFS）的影响。
5年时的OS率和RFS率分别为44%（标准误，2.6）和32%（标准误，2.1）。干扰素治疗组和对照组在OS或RFS方面无显著差异（优势比[OR]，0.94；95%置信区间，0.75至1.18；P = 0.6；以及OR，0.91；95%置信区间，0.75至1.10；P = 0.3）。男性（P = 0.003）和区域淋巴结受累（P = 0.0009），而非年龄（P = 0.7），是OS的统计学显著不良特征。按疾病分期、年龄和性别进行的亚组分析在OS或RFS方面未显示干扰素治疗组和对照组之间有任何明显差异。干扰素相关毒性较轻：分别有7%和4%的患者出现3级（仅1例为4级）疲劳或情绪障碍。然而，有50例（15%）患者因毒性而停止干扰素治疗。
单独来看，本研究结果并未表明延长疗程的低剂量干扰素在完全切除的高危恶性黑色素瘤初始治疗中明显优于单纯观察。
