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黑色素瘤切除后高危患者中对接受1个月或1年高剂量α-2b干扰素辅助治疗进行比较的随机III期研究

Randomized Phase III Study of 1 Month Versus 1 Year of Adjuvant High-Dose Interferon Alfa-2b in Patients With Resected High-Risk Melanoma

Pectasides D, Dafni U, Bafaloukos D 2009/7/24 12:13:21

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J Clin Oncol, 2009,

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Purpose:

A high-dose interferon alfa (IFN-α) regimen as reported in E1684 was unique for the incorporation of an induction phase of maximally tolerated dosages of intravenous (IV) therapy for the initial 4 weeks. This is the only trial that has shown prolongation of overall survival and relapse-free survival (RFS) in comparison with observation. Analysis of the hazard curves for RFS and overall survival (OS) in E1684 revealed separation of the high-dose and observation arms, suggesting that the induction phase may represent a critical component of this regimen, although this has not been tested prospectively.

Patients and Methods:

We conducted a prospective randomized study of IV induction therapy versus a full year of high-dose IFN, with primary end points of RFS and OS for patients with stage IIB, IIC, and III melanoma, within 56 days of curative surgery. Patients were randomly assigned to receive IFN-α-2b 15×106U/m2 IV×5/7 days weekly×4 weeks (arm A) versus the same regimen followed by IFN-α-2b 10×106U (flat dose) administered subcutaneously three times a week for 48 weeks (arm B).

Results:

Between 1998 and 2004, 364 patients were enrolled (353 eligible: arm A, n=177; arm B, n=176). At a median follow-up of 63 months (95% CI, 58.1 to 67.7), the median RFS was 24.1 months versus 27.9 months (P=.9) and the median OS was 64.4 months versus 65.3 months (P=.49). Patients in arm B had more grade 1 to 2 hepatotoxicity, nausea/vomiting, alopecia, and neurologic toxicity.

Conclusion:

There were no significant differences in OS and RFS between the regimens of 1 month and 1 year of treatment.

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病例分析 [栏目介绍]

呼吸急促伴精神状态改变——《西氏内科学》病例

摘自：《西氏内科学》，第23版

患者男性，36岁，幼年有吸入性肺损伤史，因呼吸急促和精神状态改变来我院就诊。患者睡眠和运动时，吸氧流量基值为2 L/min，每天均进行肺功能康复训练。患者居住在美国中西部，入院5天前曾离家乘船来这里看望其兄弟。入院前一天，患者呼吸急促加剧，自觉发热并注意到其慢性咳嗽稍加重，但痰液无变化。当天晚上，家人注意到患者更加急躁并有点偏执。由于症状加重，患者于次日送我院就诊。

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