摘要
目的探讨洛铂联合紫杉醇一线治疗晚期非小细胞肺癌(NSCLC)方案中洛铂的最大耐受剂量(MTD)。方法固定紫杉醇剂量为175 mg/m^2,进行洛铂剂量递增。洛铂初始剂量为20 mg/m^2,组间递增剂量为10 mg/m^2,每个剂量组至少3位受试者。如无剂量限制性毒性反应(DLT)则进入下一剂量组,直至得到MTD,定期评价疗效及不良反应。结果共入组15例患者,其中20 mg/m^2组3例、30 mg/m^2组6例和40 mg/m^2组6例,40 mg/m^2组出现2例DLT,因此MTD确定为30mg/m^2。14例患者可进行疗效评估,疾病控制率为71.4%(10/14)。主要毒性反应为骨髓抑制。结论洛铂联合紫杉醇治疗一线晚期NSCLC方案中洛铂的推荐剂量为30 mg/m^2,该方案疗效可靠,安全性较好,值得开展进一步临床研究。
Objective To define the maximum-tolerated dose （MTD） of lobaplatin in combination with fixed-dose paclitaxel for Chinese patients with advanced non-small cell lung cancer （NSCLC） as the first-line therapy. Methods Escalating doses of loba- platin with fixed paclitaxel dose of 175 mg/m2 were administered. The initial dose of lobaplatin was 20 mg/m2 ; escalating dose was 10 mg/m2. Each group had 3 patients at least. Patients proceeded to the next group until dose-limiting toxicity （DLT） appeared. The MTD was declared to be 1 dose level below the level at which DLT appeared. Efficacy and toxicity were evaluated regularly. Results Fifteen patients were enrolled, including 3 patients in 20 mg/m2, 6 patients in 30 mg/m2 and 6 patients in 40 mg/m2. Two patients occurred DLT in group of 40 mg/m2, so the MTD was 30 mg/m2. Fourteen of them were assessable. Disease control rate was 71.4% （10/14）. The most common toxicity was reversible bone marrow suppression. Conclusion The recommended dose of lobaplatin in combination with paclitaxel for patients with advanced NSCLC as the first-line therapy was 30 mg/m2. Thus the regimen is reliable, tolerable and worthy of further clinical study.
作者
秦叔逵
程颖
陈振东
石建华
孙旭
QIN Shukui, CHENG Ying, CHEN Zhendong, SHI Jianhua, SUN Xu.(Cancer Center of PLA, the 81st Hospital of PLA, Nanjing University of Chinese Medicine, Nanjing 210002, Chin)
出处
《临床肿瘤学杂志》
CAS
北大核心
2018年第2期97-100,共4页
Chinese Clinical Oncology
基金
国家"863计划"资助重点课题(2006AA020608)
关键词
非小细胞肺癌
洛铂
紫杉醇
剂量探索
耐受性
Non-small cell lung cancer
Lobaplatin
Paclitaxel
Dose escalation
Tolerability
