Cheng Ying, Wu Lin, Liu Xiaoqing, Zhao Yanqiu, Liu Chunling, Chen Qun, Sun Tao, Zheng Qingshan
Jilin Cancer Hospital, Changchun.
Hunan Cancer Hospital, Changsha.
Medicine (Baltimore). 2019 Jan;98(3):e14136. doi: 10.1097/MD.0000000000014136.
Lobaplatin (LBP) is a third-generation platinum compound.
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).
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.
With Ccr ≥ 60 ml/min, BSA based administration is necessary. Meanwhile, LBP-based regimens are reliable in treating elderly patients with SCLC.
洛铂（LBP）是一种第三代铂类化合物。
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）。
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。
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。
