National Cancer Research Institute and the University of Genoa Largo Rosanna Benzi 10, IT-16132 Genoa, Italy.
Oncology. 2010;78(3-4):274-81. doi: 10.1159/000315735. Epub 2010 Jun 8.
Breast cancer patients with >3 involved nodes (N+) have a poor outcome. Chemotherapy (CT), alone or combined with endocrine therapy (ET) in hormone receptor (HOR)-positive patients, is the standard for these women. However, there are still questions surrounding the optimal adjuvant CT regimen.
244 patients with >3 N+ were randomized to receive either four 3-weekly courses of epirubicin (E: 100 mg/m(2), day 1) followed by four 4-weekly cycles of cyclophosphamide, methotrexate and 5-fluorouracil (CMF: 600, 40, 600 mg/m(2), days 1, 8: n = 122) or four 3-weekly courses of paclitaxel (T: 175 mg/m(2), day 1) followed by four 3-weekly cycles of epirubicin and vinorelbine (E: 75 mg/m(2), day 1; V: 25 mg/m(2), days 1, 8: n = 122). After CT, tamoxifen (plus an LH-RH analog in menstruating women) was given to all HOR-positive patients over a period of 5 years. Overall survival (OS) was the primary end point. Relapse-free survival (RFS) and toxicity were secondary end points.
At a median follow-up time of 102 months (range 3-146), OS and RFS did not differ significantly between groups (E-CMF vs. T-EV: OS, HR 0.94, 95% CI 0.59-1.48, p = 0.8; RFS, HR 0.86, 95% CI 0.57-1.29, p = 0.45). The lack of any difference between assigned treatments was confirmed by multivariate analysis (E-CMF vs. T-EV: RFS, HR 0.98, 95% CI 0.64-1.48, p = 0.9). The 2 regimens showed different toxicity profiles. In fact, significantly more women assigned to E-CMF were affected by stomatitis (p = 0.001) while significantly more women in the T-EV group developed peripheral neuropathy (p < 0.0001) and musculoskeletal disorders (p < 0.0001). However, side effects were moderate and manageable and no toxic death occurred in either arm of the study.
T-EV was safe and moderately toxic but was not superior to E-CMF.
三枚以上淋巴结转移（N+）的乳腺癌患者预后不良。化疗（CT），单独或联合激素受体（HOR）阳性患者的内分泌治疗（ET），是这些女性的标准治疗方法。然而，关于最佳辅助 CT 方案仍存在一些问题。
244 例 N+>3 的患者被随机分为两组，分别接受四周期每 3 周一次的表柔比星（E：100mg/m²，第 1 天）序贯四周期每 4 周一次的环磷酰胺、甲氨蝶呤和 5-氟尿嘧啶（CMF：600、40、600mg/m²，第 1、8 天：n=122）或四周期每 3 周一次的紫杉醇（T：175mg/m²，第 1 天）序贯四周期每 3 周一次的表柔比星和长春瑞滨（E：75mg/m²，第 1 天；V：25mg/m²，第 1、8 天：n=122）。CT 后，所有 HOR 阳性患者均接受为期 5 年的他莫昔芬（加用月经女性的 LH-RH 类似物）治疗。总生存（OS）是主要终点。无复发生存（RFS）和毒性是次要终点。
中位随访时间为 102 个月（范围 3-146），两组之间 OS 和 RFS 无显著差异（E-CMF 与 T-EV：OS，HR 0.94，95%CI 0.59-1.48，p=0.8；RFS，HR 0.86，95%CI 0.57-1.29，p=0.45）。多变量分析证实，两种治疗方法之间没有差异（E-CMF 与 T-EV：RFS，HR 0.98，95%CI 0.64-1.48，p=0.9）。两种方案显示出不同的毒性特征。事实上，接受 E-CMF 治疗的女性中，口腔炎的发生率明显更高（p=0.001），而接受 T-EV 治疗的女性中，周围神经病变（p<0.0001）和肌肉骨骼疾病（p<0.0001）的发生率明显更高。然而，副作用为中度且可管理，研究中任何一组均未发生毒性死亡。
T-EV 安全且毒性适中，但并不优于 E-CMF。
