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 lobaplatin 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.%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/m2,进行洛铂剂量递增.洛铂初始剂量为20 mg/m2,组间递增剂量为10mg/m2,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/m2组3例、30 mg/m2组6例和40 mg/m2组6例,40 mg/m2组出现2例DLT,因此MTD确定为30 mg/m2.14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/m2,该方案疗效可靠,安全性较好,值得开展进一步临床研究.
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