A randomised factorial trial of sequential doxorubicin and CMF vs CMF and chemotherapy alone vs chemotherapy followed by goserelin plus tamoxifen as adjuvant treatment of node-positive breast cancer
A randomised factorial trial of sequential doxorubicin and CMF vs CMF and chemotherapy alone vs chemotherapy followed by goserelin plus tamoxifen as adjuvant treatment of node-positive breast cancer
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DOI：
10.1038/sj.bjc.6602355
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发表时间：
2005-02-14
影响因子：
8.8
通讯作者：
Bianco, AR
中科院分区：
文献类型：
--
作者：
De Placido, S;De Laurentiis, M;Bianco, AR
序贯阿霉素--> CMF（CMF =环磷酰胺、甲氨蝶呤、氟尿嘧啶）方案从未在随机试验中与CMF进行过比较。化疗后加用戈舍瑞林和他莫昔芬的作用尚不清楚。共有466例绝经前淋巴结阳性患者被随机分配至：（a）CMF x 6个周期（CMF）;（B）多柔比星x 4个周期，随后CMF x 6个周期（A --> CMF）;（c）CMF x 6个周期，随后为戈舍瑞林+他莫昔芬x 2年（CMF --> GT）;和（d）多柔比星× 4个周期，随后CMF × 6个周期，随后戈舍瑞林加他莫昔芬× 2年（A --> CMF --> GT）。该研究采用2 × 2析因实验设计来评估：（1）化疗方案的效果（CMF vs A --> CMF或组a+c vs B+d）和（2）化疗后添加GT的效果（组a+B vs c+d）。在中位随访72个月时，A --> CMF与CMF相比显著改善了无病生存期（DFS），多变量风险比（HR）= 0.740（95%置信区间（CI）：0.556 - 0.986; P = 0.040），总生存期（OS）无显著改善（HR = 0.764; 95% CI：0.489 - 1.193）。化疗后加用GT可显著改善DFS（HR = 0.74; 95%CI：0.555 ~ 0.987; P = 0.040），OS改善不显著（HR = 0.84; 95%CI：0.54 ~ 1.32）。A --> CMF上级CMF。化疗后加用GT对绝经前淋巴结阳性患者有益。
The sequential doxorubicin --> CMF (CMF = cyclophosphamide, methotrexate, fluorouracil) regimen has never been compared to CMF in a randomised trial. The role of adding goserelin and tamoxifen after chemotherapy is unclear. In all, 466 premenopausal node-positive patients were randomised to: ( a) CMF x 6 cycles (CMF); ( b) doxorubicin x 4 cycles followed by CMF x 6 cycles ( A --> CMF); ( c) CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (CMF --> GT); and (d) doxorubicin x 4 cycles followed by CMF x 6 cycles followed by goserelin plus tamoxifen x 2 years (A --> CMF --> GT). The study used a 2 x 2 factorial experimental design to assess: ( 1) the effect of the chemotherapy regimens (CMF vs A --> CMF or arms a+c vs b+d) and (2) the effect of adding GT after chemotherapy ( arms a+b vs c+d). At a median follow-up of 72 months, A --> CMF as compared to CMF significantly improved disease-free survival (DFS) with a multivariate hazard ratio (HR) = 0.740 (95% confidence interval (CI): 0.556 - 0.986; P = 0.040) and produced a nonsignificant improvement of overall survival (OS) (HR = 0.764; 95% CI: 0.489 - 1.193). The addition of GT after chemotherapy significantly improved DFS (HR = 0.74; 95% CI: 0.555 - 0.987; P = 0.040), with a nonsignificant improvement of OS (HR = 0.84; 95% CI: 0.54 - 1.32). A --> CMF is superior to CMF. Adding GT after chemotherapy is beneficial for premenopausal node-positive patients.