托瑞米芬联合NP方案治疗非小细胞肺癌的临床疗效分析

The Clinical Efficacy of Toremifene plus NP chemotherapy on Non-small Cell Lung Cancer

目的观察托瑞米芬(toremifene,TOR)联合NP方案(长春瑞滨加顺铂)治疗非小细胞肺癌(non-small cell lung cancer,NSCLC)的近期疗效和毒性反应。方法将43例确诊的Ⅲa～Ⅳ期NSCLC患者随机分为治疗组和对照组,治疗组采用TOR+NP方案治疗,对照组仅用NP方案治疗。在口服TOR后第2天和第8天,采用高效液相法对治疗组患者进行血药浓度监测。治疗结束后,观察和比较两组的总有效率和不良反应发生情况。结果治疗结束后,治疗组中PR7例,SD13例,PD2例,总有效率为31.8%;对照组中PR1例,SD17例,PD3例,总有效率为4.7%,两组间总有效率的差异有统计学意义(P<0.05);而两组之间不良反应的发生率差异无统计学意义(P>0.05)。TOR血药浓度监测结果显示:平均血药浓度为7.58μmol.L-1,最高浓度14.3μmol.L-1,最低浓度3.32μmol.L-1。结论托瑞米芬能增强长春瑞滨和顺铂的抗肿瘤作用,联合NP方案治疗NSCLC安全有效。

Objective To Observe the short term efficacy and toxiciW of toremifene （TOR） plus NP （vinorelbine and cisplatin） chemotherapy on non-small cell lung cancer （NSCLC）. Methods 43 patients with advanced NSCLC （stage Ⅲ a to IV） were randomized into treatment group and control group. The treatment group was treated by high-dose TOR plus NP regimen and the control group was treated by NP scheme. TOR Serum levels of treatment patients were meas- ured by using HPLC on the 2nd and the 8th day after taking ＇FOR. After treatment, the total efficacy and adverse effects were an：dyzed and compared. Results There were 7 cases of PR, 13 cases of SD and 2 cases of PD in the treatment group and the response rate was 31.8%; while there was only one case of PR, 17 cases of SD and 3 cases of PD in the control group, with response rate of 4.7%, which was significantly lower than that in the treannent group （P〈0.05）. There was no significant difference in incidence of adverse reaction between the two groups （P 〉 0.05）. The average plasma concentration of TOR was 7.58μmol·L^-1, the maximum plasma concentration was 14.3μmol·L^-1, and the lowest plasma concentration was 3.32μmol·L^- 1. Conclusion TOR could strengthen the antitumor effect ofvinorelbine and cisplatin. TOR plus NP regimen is effective and safe in the treatment of advanced NSCLC.