A phase II trial of temozolomide and IFN-α in patients with advanced renal cell carcinoma
A phase II trial of temozolomide and IFN-α in patients with advanced renal cell carcinoma
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DOI：
10.1089/107999004772719891
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发表时间：
2004-01-01
影响因子：
2.3
通讯作者：
Carducci, MA
中科院分区：
文献类型：
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作者：
Sunkara, U;Walczak, JR;Carducci, MA
替莫唑胺（TEM）和干扰素-α（IFN-α）的组合先前证明转移性黑色素瘤的反应率为30%。一个单一的机构，II期临床试验评价TEM/干扰素在晚期肾细胞癌（RCC）患者的疗效进行。安全性和肿瘤缓解是主要结局。符合条件的患者接受200 mg/m2/天TEM口服，第1-5天，每28天一次，IFN 250万U/m2/天皮下注射（s.c.）第一周期第1-15天，每周三天，然后5百万U/m2/天s.c.在每个28天的周期中，每周间隔3天。每8周评估一次疗效，并通过减少罪魁祸首药物的剂量来治疗剂量限制性毒性（DLT）。最初招募了16名患者（年龄37-67岁）。在14例可评价患者中，有1例轻微缓解。最佳缓解为疾病稳定，7例患者继续参加研究≥ 6个月。5例存活超过2年，2例在入组后45个月和50个月仍存活。DLT包括TEM诱导的骨髓抑制和IFN诱导的发热/寒战。其他毒性为轻度至中度（1-3级）。TEM/IFN的组合证明是相当耐受的。该方案在预后差的人群中的反应似乎不活跃，但病情稳定≥ 6个月的患者仍然值得关注。
The combination of temozolomide (TEM) and interferon-alpha (IFN-alpha) previously demonstrated a 30% response rate in metastatic melanoma. A single institution, phase II trial evaluating the efficacy of TEM/IFN in patients with advanced renal cell carcinoma (RCC) was conducted. Safety and tumor response were the main outcomes. Eligible patients received 200 mg/m(2)/day TEM orally on days 1-5 every 28 days, with IFN 2.5 million U/m(2)/day subcutaneously (s.c.) three alternate days/week for days 1-15 first cycle, then 5 million U/m2/day s.c. 3 alternate days/week throughout each 28-day cycle. Efficacy was evaluated every 8 weeks, and dose-limiting toxicities (DLTs) were treated with dose reductions of the culprit drug. Sixteen patients (ages 37-67) were initially enrolled. Of the 14 evaluable patients, there was one minor response. Best response was stable disease, with 7 patients remaining on study for greater than or equal to6 months. Five were alive for more than 2 years, and 2 remain alive at 45 and 50 months after enrollment. DLTs included TEM-induced myelosuppression and IFN-induced fever/chills. Other toxicities were mild to moderate (grades 1-3). The combination of TEM/IFN proved quite tolerable. This regimen appears inactive in terms of response in this population with poor prognosis, but the patients with stable disease greater than or equal to6 months remain of interest.