Background Primary breast cancer (BC) patients with extensive axillary lymph-node involvement have a limited prognosis. The Arbeitsgemeinschaft fuer Gynaekologische Onkologie (AGO) trial compared intense dose-dense (idd) adjuvant chemotherapy with conventionally scheduled chemotherapy in high-risk BC patients. Here we report the final, 10-year follow-up analysis. Patients and methods Enrolment took place between December 1998 and April 2003. A total of 1284 patients with 4 or more involved axillary lymph nodes were randomly assigned to receive 3 courses each of idd sequential epirubicin, paclitaxel and cyclophosphamide (iddEPC) q2w or standard epirubicin/cyclophosphamide followed by paclitaxel (EC → P) q3w. Event-free survival (EFS) was the primary end point. Results A total of 658 patients were assigned to receive iddEPC and 626 patients were assigned to receive EC → P. The median duration of follow-up was 122 months. EFS was 47% (95% CI 43% to 52%) in the standard group and 56% (95% CI 52% to 60%) in the iddEPC group [hazard ratio (HR) 0.74, 95% CI 0.63-0.87; log-rank P = 0.00014, one-sided]. This benefit was independent of menopausal, hormone receptor or HER2 status. Ten-year overall survival (OS) was 59% (95% CI 55% to 63%) for patients in the standard group and 69% (95% CI 65% to 73%) for patients in the iddEPC group (HR = 0.72, 95% CI 0.60-0.87; log-rank P = 0.0007, two-sided). Nine versus two cases of secondary myeloid leukemia/myelodysplastic syndrome were observed in the iddEPC and the EC → P arm, respectively. Conclusion The previously reported OS benefit of iddEPC in comparison to conventionally dosed EC → P has been further increased and achieved an absolute difference of 10% after 10 years of follow-up.

中文翻译：

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在高风险原发性乳腺癌中，密集剂量密集化疗的十年结果显示，与常规方案相比，其生存期更长：AGO III期iddEPC试验的最终结果。

背景腋窝淋巴结广泛受累的原发性乳腺癌（BC）患者的预后有限。Arbeitsgemeinschaft fuer Gynaekologische Onkologie（AGO）试验在高危BC患者中比较了强剂量密集（idd）辅助化疗与常规计划化疗的比较。在这里，我们报告了为期10年的最终跟踪分析。患者和方法登记时间为1998年12月至2003年4月。随机分配1284例具有4个或更多腋窝淋巴结转移的患者，分别接受idd序贯表柔比星，紫杉醇和环磷酰胺（iddEPC）q2w或标准表柔比星/环磷酰胺，然后紫杉醇（EC→P）q3w。无事件生存（EFS）是主要终点。结果共有658例患者接受了iddEPC治疗，有626例患者接受了EC→P治疗。中位随访时间为122个月。标准组的EFS为47％（95％CI 43％至52％），iddEPC组的EFS为56％（95％CI 52％至60％）[危险比（HR）0.74，95％CI 0.63-0.87; 对数秩P = 0.00014，单边]。此益处与更年期，激素受体或HER2状态无关。标准组患者的十年总体生存率（OS）为59％（95％CI 55％至63％），iddEPC组患者为十年（OS = 0.72 CI 95％CI 65％至73％）（HR = 0.72） ，95％CI 0.60-0.87；对数秩P = 0.0007，两侧）。在iddEPC和EC→P组中分别观察到9例和2例继发性髓样白血病/骨髓增生异常综合征。