toremifene增敏含铂方案治疗ⅢB、Ⅳ期NSCLC的临床Ⅱ期随机对照研究的初步结果

The preliminary results of a phase Ⅱ randomized clinical trial of high-dose toremifene chemosensitization in stage ⅢB/Ⅳ non-small cell lung cancer

目的 在ⅢB、Ⅳ期非小细胞肺癌 (NSCLC)患者中 ,观察大剂量toremifene是否能够增加含铂联合化疗方案的疗效。方法 ⅢB、Ⅳ期初治NSCLC患者随机分成A、B两组 ,A组接受大剂量toremifene加铂类为基础的联合化疗方案 ,B组仅行以铂类为基础的联合化疗。结果 第 1次中期分析有 3 0例符合入选标准的患者入组 ,两组之间的血液毒性和非血液毒性均没有统计学差异。A组中位生存期为 8个月 ,95 %置信区间 (CI)为 6.63～ 9.3 7,B组中位生存期为 7.5个月 ,95 %CI为 4.75～ 10 .2 5 ,差异无统计学意义 (P =0 .9)。A组 1年生存率为 3 1% ,对照组 2 8% ,差异无统计学意义 (P =0 .87)。A组化疗有效率为 2 5 % ( 4 /16) ,对照组 2 1% ( 3 /14 ) ,差异无统计学意义 (P =0 .99)。结论 大剂量toremifene加含铂联合化疗方案治疗ⅢB、Ⅳ期NSCLC ,与单用含铂联合化疗方案比较 ,未能显示增加化疗疗效作用 。

Objective To investigate whether high dose toremifene can enhance the efficacy of chemotherapy in non small cell lung cancer. Methods Untreated stage ⅢB/Ⅳ non small cell lung cancer patients were randomly devided into group A (high dose toremifene combined with the platinum based chemotherapy) or group B (the same platinum based chemotherapy alone). Results A total of 30 eligible patients had been recruited. Hemotologic and nonhemotologic toxicities were similar with no statistic difference. The median survival for group A was 8 months, 95% CI (6.63 9.37) versus 7.5 months, 95% CI (4.75 10.25) for group B ( P =0.9). One year survival rate was 31% for group A versus 28% for group B ( P =0.87). The response rate was 25% for group A versus 21% for group B ( P =0.99).Conclusion The results suggest that high dose toremifene does not enhance the efficacy of platinum based chemotherapy for ⅢB/Ⅳ non small cell lung cancer but toxicities are well tolerated.