伊立替康联合卡铂合并放疗治疗晚期非小细胞肺癌临床研究

目的：观察伊立替康联合卡铂合并放疗治疗晚期非小细胞肺癌（non-small-celllung carcinoma，NSCLC）的疗效以及不良反应。方法：经病理学或细胞学确诊的初治晚期NSCLC患者100例，随机分为Ⅰ组和Ⅱ组。Ⅰ组采用伊立替康80 mg·（m^2）^-1第1、8、15天，静脉滴注，顺铂80 mg·（m^2）^-1，在第1～3天共分3天使用，静脉滴注，每4周为1个周期。Ⅱ组采用伊立替康30mg·（m^2）^-1联合卡铂（浓度/时间曲线下面积AUC=2）给药7周、胸腔放疗3～4周（共63 Gy：1.8 Gy×25 d＋2 Gy×9 d），然后每21天予以多西他赛75 mg·（m^2）^-1强化3个周期。治疗2周期以上开始评价治疗效果及毒性反应。结果：Ⅰ组CR 9例，PR 17例，SD 6例和PD 8例，总有效率为65.0%。1年生存率45%，2年生存率7.5%，中位生存9个月。Ⅱ组CR 10例，PR30例，SD15例和PD 5例，总有效率为66.7%。1年生存率50%，2年生存率10%，中位生存13个月。主要毒副反应表现为血液系统毒性和消化道反应。结论：伊立替康联合卡铂合并放疗治疗晚期NSCLC疗效确切，不良反应发生率低，耐受性较好。

Curative Research on Irinotecan in Combination with Carboplatin plus Radiotherapy for Advanced Nonsmall-cell Lung Cancer

OBJECTIVE： To observe the clinical efficacy and adverse effects of Irinotecan in combination with Carboplatin plus Radiotherapy for advanced nonsmall-cell lung cancer （NSCLC）. METHODS： A total of 100 patients who had been confirmed as having NSCLC by pathology or cytology were randomly divided into Group Ⅰ and Group Ⅱ ： Group I received Irinoteean [80 mg·（m^2）^-1 ] iv gtt on day 1, 8 and 15 plus Carboplatin [80 mg·（m^2）^-1 ] iv gtt for the first 3 day, and 4-week treatment was regarded as one cycle in Group Ⅰ ; Group Ⅱ received Irinotecan [ 30 mg·（m^2）^-1 ] plus Carboplatin （AUC = 2） for 7 weeks in addition to thoracic radiotherapy for 3 to 4 weeks （63 Gy in total： 1.8 Gy × 25 d ＋ 2 Gy × 9 d）, followed by intensification therapy with docetaxel [75mg·（m^2）^-1 ] for 3 weeks in every 21 days. After treatment for at least 2 cycles, the clinical efficacy and toxicity in the two groups were evaluated. RESULTS： In Group Ⅰ, the total effective rate was 65.0% （9 CR, 17 PR, 6 SD, and 8 PD cases）, and the 1-year and 2-year survival rates and the median survival time were 45%, 7.5% and 9 months, respectively; in Group Ⅱ , the total effective rate was 66.7% （10 CR, 30 PR, 15 SD, and 5 PD cases）, and the 1-year and 2-year survival rates and the median survival time were 50%, 10% and 13 months, respectively. The main side reactions manifested as toxicity of hematological system and digestive system. CONCLUSION： Irinotecan in combination with Carboplatin plus radiotherapy had confirmed efficacy, satisfactory safety and good tolerance in patients with advanced NSCLC.