Horibe Keizo, Takimoto Tetsuya, Yokozawa Toshiya, Makimoto Atsushi, Kobayashi Yukio, Ogawa Chitose, Ohno Ryuzo, Koh Nobuyuki, Katsura Koichi, Tobinai Kensei
Nagoya Medical Center Clinical Research Center.
Rinsho Ketsueki. 2011 Jun;52(6):406-15.
The safety, tolerability, pharmacokinetics and efficacy of nelarabine were evaluated in adult and pediatric patients with relapsed or refractory T-ALL/T-LBL. Adult patients received nelarabine i.v. over 2 hours on days 1, 3 and 5 in every 21 days, and pediatric patients received this regimen over 1 hour for 5 consecutive days in every 21 days. Safety was evaluated in 7 adult and 6 pediatric patients. Adverse events (AEs) were reported in all patients. Most frequently reported AEs included somnolence and nausea in adult patients and leukopenia and lymphocytopenia in pediatric patients. Five grade 3/4 AEs were reported in both adult and pediatric patients, most of which were hematologic events. There were no dose-limiting toxicities. Efficacy was evaluated in 7 adult and 4 pediatric patients. Complete response was noted in 1 adult and 2 pediatric patients. Higher intracellular ara-GTP concentrations were suggested to be associated with efficacy. Japanese adult and pediatric patients with T-ALL/T-LBL well tolerated nelarabine treatment, warranting further investigation.
在复发或难治性T细胞急性淋巴细胞白血病（T-ALL）/T淋巴母细胞淋巴瘤（T-LBL）的成年和儿科患者中评估了奈拉滨的安全性、耐受性、药代动力学和疗效。成年患者在每21天的第1、3和5天静脉输注奈拉滨2小时，儿科患者在每21天连续5天静脉输注该方案1小时。对7名成年患者和6名儿科患者进行了安全性评估。所有患者均报告了不良事件（AE）。成年患者最常报告的AE包括嗜睡和恶心，儿科患者为白细胞减少和淋巴细胞减少。成年和儿科患者均报告了5例3/4级AE，其中大多数为血液学事件。未出现剂量限制性毒性。对7名成年患者和4名儿科患者进行了疗效评估。1名成年患者和2名儿科患者出现完全缓解。较高的细胞内阿糖鸟苷三磷酸（ara-GTP）浓度被认为与疗效相关。日本成年和儿科T-ALL/T-LBL患者对奈拉滨治疗耐受性良好，值得进一步研究。
