Adjuvant Capecitabine, Docetaxel, Cyclophosphamide, and Epirubicin for Early Breast Cancer: Final Analysis of the Randomized FinXX Trial
Adjuvant Capecitabine, Docetaxel, Cyclophosphamide, and Epirubicin for Early Breast Cancer: Final Analysis of the Randomized FinXX Trial
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DOI：
10.1200/jco.2011.35.4639
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发表时间：
2012-01-01
影响因子：
45.3
通讯作者：
Lindman, Henrik
中科院分区：
文献类型：
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作者：
Joensuu, Heikki;Kellokumpu-Lehtinen, Pirkko-Liisa;Lindman, Henrik
目的卡培他滨是治疗乳腺癌的有效药物。目前尚不清楚是否卡培他滨整合到一个辅助方案，包含紫杉烷，蒽环类药物，环磷酰胺改善结果在早期breastcancer.Patients和MethodsWomen腋窝淋巴结阳性或高风险淋巴结阴性乳腺癌随机分配到接受三个周期的多西他赛和卡培他滨（TX），其次是三个周期的环磷酰胺，表阿霉素，卡培他滨（CEX; n = 753）或3个周期的多西他赛（T），随后3个周期的环磷酰胺、表阿霉素和氟尿嘧啶（CEF; n = 747）。主要终点是无复发生存期（RFSholds.ResultsDuring中位数随访时间为59个月，214 RFS事件发生（局部或远处复发或死亡; TX/CEX，n = 96; T/CEF，n = 118）。两组的RFS无显著差异（风险比[HR]，0.79; 95% CI，0.60 - 1.04; P = 0.087; TX/CEX组的5年RFS为86.6%，T/CEF组为84.1%）。随访期间，TX/CEX组有五十六例患者死亡，而T/CEF组有75例患者死亡（HR，0.73; 95% CI，0.52 - 1.04; P = 0.080）。在探索性分析中，TX/CEX改善了乳腺癌特异性生存率（HR，0.64; 95%CI，0.44 - 0.95; P = 0.027）和RFS，在诊断时患有三阴性疾病的女性和有三个以上转移性腋窝淋巴结的女性中。我们检测到很少严重的晚期toxics.ConclusionIntegration卡培他滨到一个方案，包含多西他赛，epiraldehyde，环磷酰胺没有改善RFS显着相比，一个类似的方案，没有卡培他滨。J Clin Oncol 30：11 - 18. (c)2011年美国临床肿瘤学会
PurposeCapecitabine is an active agent in the treatment of breast cancer. It is not known whether integration of capecitabine into an adjuvant regimen that contains a taxane, an anthracycline, and cyclophosphamide improves outcome in early breast cancer.Patients and MethodsWomen with axillary node-positive or high-risk node-negative breast cancer were randomly assigned to receive either three cycles of docetaxel and capecitabine (TX) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (CEX; n = 753) or three cycles of docetaxel (T) followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (CEF; n = 747). The primary end point was recurrence-free survival (RFS).ResultsDuring a median follow-up time of 59 months, 214 RFS events occurred (local or distant recurrences or deaths; TX/CEX, n = 96; T/CEF, n = 118). RFS was not significantly different between the groups (hazard ratio [HR], 0.79; 95% CI, 0.60 to 1.04; P = .087; 5-year RFS, 86.6% for TX/CEX v 84.1% for T/CEF). Fifty-six patients assigned to TX/CEX died during the follow-up compared with 75 of patients assigned to T/CEF (HR, 0.73; 95% CI, 0.52 to 1.04; P = .080). In exploratory analyses, TX/CEX improved breast cancer-specific survival (HR, 0.64; 95% CI, 0.44 to 0.95; P = .027) and RFS in women with triple-negative disease and in women who had more than three metastatic axillary lymph nodes at the time of diagnosis. We detected little severe late toxicity.ConclusionIntegration of capecitabine into a regimen that contains docetaxel, epirubicin, and cyclophosphamide did not improve RFS significantly compared with a similar regimen without capecitabine. J Clin Oncol 30:11-18. (c) 2011 by American Society of Clinical Oncology