老年中国小细胞肺癌患者洛铂治疗的群体药代动力学及个体化给药方案
Population pharmacokinetics and individualized lobaplatin regimen for the treatment of Chinese small cell lung cancer in the elderly.
作者信息
Cheng Ying, Wu Lin, Liu Xiaoqing, Zhao Yanqiu, Liu Chunling, Chen Qun, Sun Tao, Zheng Qingshan
机构信息
Jilin Cancer Hospital, Changchun.
Hunan Cancer Hospital, Changsha.
出版信息
Medicine (Baltimore). 2019 Jan;98(3):e14136. doi: 10.1097/MD.0000000000014136.
BACKGROUND
Lobaplatin (LBP) is a third-generation platinum compound.
MATERIAL AND METHODS
This prospective study was performed in 7 institutions in 2014-2016. Elderly small cell lung cancer (SCLC) patients (≥65 years old) were divided into 2 groups to receive LBP regimens according to endogenous creatinine clearance rate (Ccr). LBP was administered at 30 and 20 mg/m in groups A (Ccr ≥ 80 ml/min) and B (60 ml/min ≤ Ccr < 80 ml/min), respectively. The primary endpoint was plasma LBP concentrations. Secondary endpoints were safety and efficacy parameters, including progression-free survival (PFS) and overall survival (OS).
RESULTS
One-hundred patients were enrolled. Median PFS and OS in groups A and B were 155 vs170 days and 306 vs 272 days, respectively. The rates of grade III/IV AEs in groups A and B were 60.8% (n = 31) and 51.0% (n = 25), respectively. In population pharmacokinetics, the area under the curve (AUC) value for group B was 39% lower than that of group A. With LBP administration based on body surface area (BSA), AUC differences between individuals were small.
CONCLUSION
With Ccr ≥ 60 ml/min, BSA based administration is necessary. Meanwhile, LBP-based regimens are reliable in treating elderly patients with SCLC.
背景
洛铂（LBP）是一种第三代铂类化合物。
材料与方法
这项前瞻性研究于2014年至2016年在7家机构进行。老年小细胞肺癌（SCLC）患者（≥65岁）根据内生肌酐清除率（Ccr）分为两组接受LBP方案治疗。A组（Ccr≥80 ml/min）和B组（60 ml/min≤Ccr＜80 ml/min）的LBP给药剂量分别为30和20 mg/m²。主要终点是血浆LBP浓度。次要终点是安全性和有效性参数，包括无进展生存期（PFS）和总生存期（OS）。
结果
共纳入100例患者。A组和B组的中位PFS分别为155天和170天，中位OS分别为306天和272天。A组和B组的III/IV级不良事件发生率分别为60.8%（n = 31）和51.0%（n = 25）。在群体药代动力学中，B组的曲线下面积（AUC）值比A组低39%。基于体表面积（BSA）给药时，个体间的AUC差异较小。
结论
当Ccr≥60 ml/min时，有必要基于BSA给药。同时，基于LBP的方案在治疗老年SCLC患者方面是可靠的。
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