双环铂联合紫杉醇与卡铂联合紫杉醇方案在初治晚期非小细胞肺癌的Ⅱ期临床研究

Chemotherapy-naive Patients with Advanced Non-small-cell Lung Cancer-Single Institution Experience

目的:评价双环铂联合紫杉醇与卡铂联合紫杉醇化疗方案在初治晚期非小细胞肺癌患者的疗效和毒性。方法:本研究为随机、对照、开放的Ⅱ期临床研究,符合条件的受试耆随机分入试验组和对照组,试验组给予双环铂450mg/m2+紫杉醇175mg/m2,每3周一次;对照组给予卡铂(AUC=5)+紫杉醇175mg/m2,每3周一次。按照RE-CIST标准进行疗效评价,观察记录不良反应,随访患者生存率。结果:中山大学肿瘤防治中心共入组合格受试者32例,中位随访时间:12.5月,随机分配入试验组和对照组各16例,两组受试者的分配在性别、年龄、PS评分、分期和组织学分类是均衡的。两组受试者在试验组和对照组缓解率分别为31.2%和37.5%(P=1.000),总中位生存时间在试验组未观察到,对照组:10.7个月(P=0.295),1年生存率分别为54.8%和20.1%(P=0.028),两组主要的毒性反应均为骨髓抑制和消化道反应,对照组有较多的淋巴细胞减少,其他的不良反应和Ⅲ～Ⅳ度的不良反应两组受试者来观察到有统计学意义的差异。结论:双环铂联合紫杉醇的化疗方案和卡铂联合紫杉醇方案在初治晚期非小细胞肺癌疗效类似且安全有效,值得开展更大规模Ⅲ期临床研究进一步评价双环铂的疗效和毒性。

Objective： To investigate the efficacy and toxicity of dicycloplatin plus paclitaxel regimen and carboplatin plus paclitaxel regimen in chemotherapy-naive patients with advanced non-small-cell lung cancer （NSCLC）. Methods： It was a randomized, controlied and open phase Ⅱ clinical trial Patients who met the criteria were randomly assigned to the experimental group of dicycloplatin plus paclitaxel or the control group of carboplatin plus paclitaxel. The experimental group was given dicycloplatin 450mg/m^2 plus paclitaxel 175mg/m^2 q3w, and the control arm was given carboplatin AUC=5 plus paclitaxel 175mg/m^2 q3w. Response rate and adverse reactions were evaluated according to RECIST criteria and survival follow-up was performed. Results： A total of 32 patients were enrolled in the study in the cancer center of Sun Yat-Sen University. The median follow-up time was 12.5 months. These patients were randomized into two arms, with 16 patients in each arm. These two arms were well balanced with regard to gender, age, performance status, stage and histology. The overall response rates of patients in the experimental group and control group were 31.2% and 37.5% （P=1.000）, respectively. The median survival rate was not obtained in the experimental group and was 10.7 months in the control group （P=-0.451）, and the corresponding 1-year survival rates was 54.8% and 20.1% （P=-0.028）, respectively. Adverse reactions in both groups included myelosuppression and gastrointestinal reactions. Lymphocytopenia was more frequent in the control group. No significant differences were found in other adverse reactions between the two groups. No chemotherapy related death was observed in both groups. Conclusion： The efficacy and safety of dicyclorplatin plus paclitaxel regimen are comparable to those of carboplatin plus paclitaxel regimen in the treatment of chemotherapy-naive patients with advanced NSCLC. Phase Ⅲ clinical study is needed to further evaluate the efficacy and toxicity of dicycloplatin.