Fluorouracil, Epirubicin, and Cyclophosphamide With Either Docetaxel or Vinorelbine, With or Without Trastuzumab, As Adjuvant Treatments of Breast Cancer: Final Results of the FinHer Trial
Fluorouracil, Epirubicin, and Cyclophosphamide With Either Docetaxel or Vinorelbine, With or Without Trastuzumab, As Adjuvant Treatments of Breast Cancer: Final Results of the FinHer Trial
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DOI：
10.1200/jco.2008.21.4577
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发表时间：
2009-12-01
影响因子：
45.3
通讯作者：
Kellokumpu-Lehtinen, Pirkko-Liisa
中科院分区：
文献类型：
--
作者：
Joensuu, Heikki;Bono, Petri;Kellokumpu-Lehtinen, Pirkko-Liisa
目的：多西紫杉醇与长春瑞滨在早期乳腺癌辅助治疗中的应用尚未进行比较。短期辅助曲妥珠单抗联合化疗治疗人表皮生长因子受体2 （HER2）阳性癌症的疗效和长期安全性尚不清楚。患者和方法1100例腋下淋巴结阳性或高危淋巴结阴性乳腺癌患者随机分配接受3个周期的多西他赛或长春瑞滨治疗，随后两组分别接受3个周期的氟尿嘧啶、表柔比星和环磷酰胺（FEC）治疗。her2阳性癌症妇女（n = 232）进一步被分配接受或不接受曲妥珠单抗和多西他赛或长春瑞滨9周。随机分配后的中位随访时间为62个月。结果：多西他赛组的女性远端无病生存期（DDFS）优于长春瑞滨组（风险比[HR] = 0.66; 95% CI, 0.49 ~ 0.91; P = 0.010）。在her2阳性疾病亚组中，曲妥珠单抗治疗的患者往往比仅化疗治疗的患者有更好的DDFS （HR = 0.65; 95% CI， 0.38至1.12;P = 0.12；调整腋窝淋巴结转移的存在，HR = 0.57; P = 0.047）。在探索性分析中，与多西他赛+ FEC （HR = 0.32; P = 0.029）和维诺瑞滨、曲妥珠单抗+ FEC （HR = 0.31; P = 0.020）相比，多西他赛、曲妥珠单抗和FEC改善了DDFS。曲妥珠单抗治疗患者的左室射血分数中位数在5年随访期间保持不变；只有一名接受曲妥珠单抗治疗的女性被诊断为心力衰竭。结论与长春瑞滨相比，多西紫杉醇辅助治疗可改善DDFS。曲妥珠单抗与多西他赛联合使用的短期疗程是安全有效的，值得进一步评估。
PurposeDocetaxel has not been compared with vinorelbine as adjuvant treatment of early breast cancer. Efficacy and long-term safety of a short course of adjuvant trastuzumab administered concomitantly with chemotherapy for human epidermal growth factor receptor 2 (HER2)-positive cancer are unknown.Patients and MethodsOne thousand ten women with axillary node-positive or high-risk node-negative breast cancer were randomly assigned to receive three cycles of docetaxel or vinorelbine, followed in both groups by three cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC). Women with HER2-positive cancer (n = 232) were further assigned to either receive or not receive trastuzumab for 9 weeks with docetaxel or vinorelbine. The median follow-up time was 62 months after random assignment.ResultsWomen assigned to docetaxel had better distant disease-free survival (DDFS) than those assigned to vinorelbine ( hazard ratio [HR] = 0.66; 95% CI, 0.49 to 0.91; P = .010). In the subgroup of HER2-positive disease, patients treated with trastuzumab tended to have better DDFS than those treated with chemotherapy only (HR = 0.65; 95% CI, 0.38 to 1.12; P = .12; with adjustment for presence of axillary nodal metastases, HR = 0.57; P = .047). In exploratory analyses, docetaxel, trastuzumab, and FEC improved DDFS compared with docetaxel plus FEC ( HR = 0.32; P = .029) and vinorelbine, trastuzumab, and FEC (HR = 0.31; P = .020). The median left ventricular ejection fraction of trastuzumab-treated patients remained unaltered during the 5-year follow-up; only one woman treated with trastuzumab was diagnosed with a heart failure.ConclusionAdjuvant treatment with docetaxel improves DDFS compared with vinorelbine. A brief course of trastuzumab administered concomitantly with docetaxel is safe and effective and warrants further evaluation.