Ravaud A, Bedane C, Geoffrois L, Lesimple T, Delaunay M
Department of Medicine, Institut Bergonié, Comprehensive Cancer Center, Bordeaux, France.
Br J Cancer. 1999 Aug;80(11):1767-9. doi: 10.1038/sj.bjc.6690595.
To assess the feasibility and toxicity profile of high-dose interferon alpha-2b (IFN-alpha-2b) in the adjuvant treatment of patients with cutaneous malignant melanoma outside the reference ECOG 1684 clinical trial, we conducted a prospective follow-up in an identical population of patients (cutaneous melanoma, T4 and/or N1) treated by intravenous IFN-alpha-2b:20 MIU m(-2), 5 days a week for 4 weeks; and subcutaneous:10 MIU m(-2), 3 times a week for 11 months. Thirty-six consecutive patients were considered in four different institutions. The frequency and severity of side-effects related to IFN-alpha, as well as the percentage of the planned dose given to patients, were identical to those reported in the initial report by ECOG. Fifty per cent and 47% of patients had a grade 3/4 WHO toxicity in the induction and consolidation phase respectively. A dose modification was necessary for 47.2% and 55.8% of the patients in the induction and consolidation phase respectively. The schedule and dose of high-dose IFN-alpha-2b in the adjuvant treatment of cutaneous malignant melanoma, as reported by ECOG 1684, is feasible. The significant toxicity reported in ECOG 1684 was also seen in our patients. Nevertheless, this protocol will not be a 'standard' treatment until the publication of the ECOG 1690 trial.
为评估高剂量干扰素α-2b（IFN-α-2b）在参考ECOG 1684临床试验之外的皮肤恶性黑色素瘤患者辅助治疗中的可行性和毒性特征，我们对相同人群（皮肤黑色素瘤，T4和/或N1）进行了前瞻性随访，这些患者接受静脉注射IFN-α-2b治疗：20 MIU m(-2)，每周5天，共4周；以及皮下注射：10 MIU m(-2)，每周3次，共11个月。在四个不同机构中纳入了36例连续患者。与IFN-α相关的副作用的频率和严重程度，以及给予患者的计划剂量百分比，与ECOG初始报告中所报道的相同。分别有50%和47%的患者在诱导期和巩固期出现3/4级WHO毒性。分别有47.2%和55.8%的患者在诱导期和巩固期需要调整剂量。如ECOG 1684所报道，高剂量IFN-α-2b在皮肤恶性黑色素瘤辅助治疗中的方案和剂量是可行的。我们的患者中也出现了ECOG 1684所报道的显著毒性。然而，在ECOG 1690试验发表之前，该方案不会成为“标准”治疗。
