Institut Gustave Roussy, Département de Médecine, 39, rue Camille Desmoulins, 94908 Villejuif, France.
J Clin Oncol. 2009 Dec 20;27(36):6129-34. doi: 10.1200/JCO.2009.23.0946. Epub 2009 Nov 16.
To evaluate the efficacy of trastuzumab in patients with node-positive breast cancer treated with surgery, adjuvant chemotherapy, radiotherapy, and hormone therapy if applicable.
Three thousand ten patients with operable node-positive breast cancer were randomly assigned to receive adjuvant anthracycline-based chemotherapy with or without docetaxel. Patients who presented human epidermal growth factor receptor 2 (HER2) -overexpressing tumors were secondary randomly assigned to either a sequential regimen of trastuzumab (6 mg/kg every 3 weeks) for 1 year or observation. The primary end point was disease-free survival (DFS).
Overall 528 patients were randomly assigned between trastuzumab (n = 260) and observation (n = 268) arm. Of the 234 patients (90%) who received at least one administration of trastuzumab, 196 (84%) received at least 6 months of treatment, and 41 (18%) discontinued treatment due to cardiac events (any grade). At the date of analysis (October 2007), 129 DFS events were recorded. Random assignment to the trastuzumab arm was associated with a nonsignificant 14% reduction in the risk of relapse (hazard ratio, 0.86; 95% CI, 0.61 to 1.22; P = .41, log-rank stratified on pathologic node involvement). Three-year DFS rates were 78% (95% CI, 72.3 to 82.5) and 81% (95% CI, 75.3 to 85.4) in the observation and trastuzumab arms, respectively.
After a 47-month median follow-up, 1 year of trastuzumab given sequentially after adjuvant chemotherapy was not associated with a statistically significant decrease in the risk of relapse.
评估曲妥珠单抗在接受手术、辅助化疗、放疗和激素治疗（如适用）的淋巴结阳性乳腺癌患者中的疗效。
将 3110 例可手术的淋巴结阳性乳腺癌患者随机分配接受辅助蒽环类药物化疗联合或不联合多西紫杉醇。人表皮生长因子受体 2（HER2）过表达肿瘤患者进行二次随机分配，分别接受曲妥珠单抗（每 3 周 6mg/kg）序贯治疗 1 年或观察。主要终点是无病生存期（DFS）。
共有 528 例患者随机分配至曲妥珠单抗（n=260）和观察组（n=268）。在接受至少一次曲妥珠单抗治疗的 234 例患者中（90%），196 例（84%）接受了至少 6 个月的治疗，41 例（18%）因心脏事件（任何级别）停止治疗。在分析日期（2007 年 10 月），记录了 129 例 DFS 事件。随机分配至曲妥珠单抗组与复发风险降低 14%无关（风险比，0.86；95%CI，0.61 至 1.22；P=0.41，按病理淋巴结受累分层的对数秩检验）。观察组和曲妥珠单抗组的 3 年 DFS 率分别为 78%（95%CI，72.3%至 82.5%）和 81%（95%CI，75.3%至 85.4%）。
在中位随访 47 个月后，辅助化疗后序贯给予曲妥珠单抗 1 年与复发风险降低无统计学意义相关。
