Héry Michel, Bonneterre Jacques, Roché Henri, Luporsi Elisabeth, Kerbrat Pierre, Namer Moïse, Fumoleau Pierre, Monnier Alain, Fargeot Pierre
Centre hospitalier Princesse Grace, avenue Pasteur, 98000 Monaco.
Bull Cancer. 2006 Oct;93(10):E109-14.
We evaluated the contribution of an epirubicin-based adjuvant chemotherapy on disease-free survival (DFS) in poor prognosis, node-negative breast cancer (BC) patients. Poor prognostic factors were defined as: pathologic tumor size >or= 4 cm, estrogen-receptor negative, and progesterone-receptor negative. Scarff-Bloom Richardson grade 2 tumors must have two of these factors, and only one in case of grade 3. Between 1988 and 1994, 328 patients were randomized to receive either no systemic treatment (control, n = 161), or fluorouracil 500 mg/m(2), epirubicin 50 mg/m(2), cyclophosphamide 500 mg/m(2), 6 cycles every 21 days (FEC50, n = 167), without any hormonal treatment. The median follow up was 114 months. The 10-year DFS rates were 64 and 71%, respectively (p = 0.23). In the Cox regression model, independent prognostic factors of relapse were the number of nodes examined < 10 (p = 0.002), BCS (p = 0.01), and premenopausal status (p = 0.04). In this model, the relative risk of relapse was 1.46 (CI95 %: 1.05-1.87) in favor of FEC50. In patients who underwent BCS, 21 % developed a local relapse (24 versus 18 %, respectively). The 10-year local DFS was 70.5 and 79.3 %, respectively (p = 0.27). The 10-year overall survival was not different (74.1 versus 70.7 %, p = 0.82). After 10 years of follow-up, the FEC50 regimen reduced the risk of relapse in poor-prognosis node-negative BC patients. The incidence of local relapse was high, and probably related to inclusion criteria. Epirubicin was probably underdosed in such patients, and ongoing studies using 100 mg/m(2) of epirubicin will give us the answer in a near future.
我们评估了基于表柔比星的辅助化疗对预后较差的淋巴结阴性乳腺癌（BC）患者无病生存期（DFS）的影响。预后不良因素定义为：病理肿瘤大小≥4 cm、雌激素受体阴性和孕激素受体阴性。斯卡夫-布卢姆-理查森2级肿瘤必须具备其中两个因素，3级肿瘤则只需具备一个因素。1988年至1994年期间，328例患者被随机分为两组，一组不接受全身治疗（对照组，n = 161），另一组接受氟尿嘧啶500 mg/m²、表柔比星50 mg/m²、环磷酰胺500 mg/m²，每21天进行6个周期的治疗（FEC50，n = 167），且不接受任何激素治疗。中位随访时间为114个月。10年DFS率分别为64%和71%（p = 0.23）。在Cox回归模型中，复发的独立预后因素为检查的淋巴结数量<10个（p = 0.002）、保乳手术（p = 0.01）和绝经前状态（p = 0.04）。在该模型中，FEC50组复发的相对风险为1.46（95%CI：1.05 - 1.87）。接受保乳手术的患者中，21%出现局部复发（分别为24%和18%）。10年局部DFS率分别为70.5%和79.3%（p = 0.27）。10年总生存率无差异（74.1%对70.7%，p = 0.82）。经过10年的随访，FEC50方案降低了预后较差的淋巴结阴性BC患者的复发风险。局部复发率较高，可能与纳入标准有关。在此类患者中表柔比星可能剂量不足，正在进行的使用100 mg/m²表柔比星的研究将在不久的将来给出答案。
