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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Phase I study of oral lenalidomide in patients with refractory metastatic cancer.
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Phase I study of oral lenalidomide in patients with refractory metastatic cancer.

机译：难治性转移性癌症患者口服来那度胺的I期研究。

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摘要

Objectives of this study were to determine the maximum tolerated dose and to characterize the side effect profile and pharmacokinetics of lenalidomide in patients with advanced refractory solid tumors. Patients were treated on a modified Fibronacci dose escalation scheme with an oral daily dose of lenalidomide. A total of 45 patients with 8 different tumor types were accrued. Doses administered included 5, 10, and 20 mg continuous daily doses, every 28 days (n = 15), later modified to intermittent doses of 15, 20, 25, 30, 35, and 40 mg, with a 21 days-on and 7 days-off schedule, due to observed side effects. Lenalidomide exhibited a linear pharmacokinetics over a wide range of doses with the mean half-life of 3.9 hours. The renal function affected lenalidomide clearance, resulting in 50% reduction in patients with mild renal impairment compared with patients with normal function (CL/F = 243 mL/min). Stable disease was documented in 12 of 44 evaluable patients, of whom 9 patients had prostate cancer. Most frequent grade 1 and 2 toxicities included fatigue, nausea, pruritus/rash, neutropenia, and neuropathy. Grade 3/4 events were predominantly hematologic. Lenalidomide was well tolerated up to a 35-mg/d intermittent dosing schedule at doses higher than previously indicated for hematologic malignancies.
机译：这项研究的目的是确定最大耐受剂量，并表征来那度胺对晚期难治性实体瘤患者的副作用和药代动力学。患者采用改良的Fibronacci剂量递增方案治疗，每日口服来那度胺。共有45位患者患有8种不同的肿瘤类型。给药剂量为每28天连续服用5、10和20 mg的每日剂量（n = 15），后来改为15、20、25、30、35和40 mg的间歇剂量，持续21天和由于观察到的副作用，计划7天休息。来那度胺在大剂量范围内均表现出线性药代动力学，平均半衰期为3.9小时。肾功能影响来那度胺清除率，与功能正常的患者（CL / F = 243 mL / min）相比，轻度肾功能不全的患者减少50％。在44例可评估患者中，有12例记录了稳定的疾病，其中9例患有前列腺癌。最常见的1级和2级毒性包括疲劳，恶心，瘙痒/皮疹，中性粒细胞减少和神经病。 3/4级事件主要是血液学的。来那度胺可耐受高达35 mg / d的间歇给药方案，其剂量要高于先前对血液系统恶性肿瘤的指示剂量。

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