PURPOSE Operable triple-negative breast cancers (TNBCs) have a higher risk of relapse than non-TNBCs with standard therapy. The GEICAM/2003-11_CIBOMA/2004-01 trial explored extended adjuvant capecitabine after completion of standard chemotherapy in patients with early TNBC. PATIENTS AND METHODS Eligible patients were those with operable, node-positive—or node negative with tumor 1 cm or greater—TNBC, with prior anthracycline- and/or taxane-containing chemotherapy. After central confirmation of TNBC status by immunohistochemistry, patients were randomly assigned to either capecitabine or observation. Stratification factors included institution, prior taxane-based therapy, involved axillary lymph nodes, and centrally determined phenotype (basal v nonbasal, according to cytokeratins 5/6 and/or epidermal growth factor receptor positivity by immunohistochemistry). The primary objective was to compare disease-free survival (DFS) between both arms. RESULTS Eight hundred seventy-six patients were randomly assigned to capecitabine (n = 448) or observation (n = 428). Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous anthracyclines plus taxanes. Median length of follow-up was 7.3 years. DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06; P = .136]. In a preplanned subgroup analysis, nonbasal patients seemed to derive benefit from the addition of capecitabine with a DFS HR of 0.53 versus 0.94 in those with basal phenotype (interaction test P = .0694) and an HR for overall survival of 0.42 versus 1.23 in basal phenotype (interaction test P = .0052). Tolerance of capecitabine was as expected, with 75.2% of patients completing the planned 8 cycles. CONCLUSION This study failed to show a statistically significant increase in DFS by adding extended capecitabine to standard chemotherapy in patients with early TNBC. In a preplanned subset analysis, patients with nonbasal phenotype seemed to obtain benefit with capecitabine, although this will require additional validation.

中文翻译：

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早期三阴性乳腺癌患者标准新/辅助化疗后卡培他滨辅助治疗的 III 期试验 (GEICAM/2003-11_CIBOMA/2004-01)

目的 可手术的三阴性乳腺癌 (TNBC) 比标准治疗的非 TNBC 具有更高的复发风险。GEICAM/2003-11_CIBOMA/2004-01 试验在早期 TNBC 患者完成标准化疗后探索了延长辅助卡培他滨。患者和方法 符合条件的患者是那些可手术的、淋巴结阳性或淋巴结阴性且肿瘤 1 cm 或更大的 TNBC，既往接受含蒽环类和/或紫杉烷的化疗。在通过免疫组织化学集中确认 TNBC 状态后，患者被随机分配到卡培他滨组或观察组。分层因素包括机构、既往基于紫杉烷的治疗、受累的腋窝淋巴结和集中确定的表型（基础与非基础、根据免疫组织化学的细胞角蛋白 5/6 和/或表皮生长因子受体阳性）。主要目的是比较两组之间的无病生存期 (DFS)。结果 876 名患者被随机分配到卡培他滨组（n = 448）或观察组（n = 428）。中位年龄为 49 岁，55.9% 淋巴结阴性，73.9% 有基础表型，67.5% 接受过蒽环类药物加紫杉类药物治疗。中位随访时间为 7.3 年。与观察相比，卡培他滨的 DFS 没有显着延长 [风险比 (HR)，0.82；95% CI，0.63 至 1.06；P = .136]。在预先计划的亚组分析中，非基础患者似乎从加用卡培他滨中获益，DFS HR 为 0.53，而基础表型患者的 DFS HR 为 0.94（交互检验 P = . 0694）和总生存率在基础表型中为 0.42 与 1.23（相互作用测试 P = .0052）。卡培他滨的耐受性符合预期，75.2% 的患者完成了计划的 8 个周期。结论 本研究未能显示早期 TNBC 患者在标准化疗中加入延长卡培他滨后 DFS 的统计学显着增加。在预先计划的亚组分析中，具有非基础表型的患者似乎从卡培他滨获益，尽管这需要额外的验证。结论 本研究未能显示早期 TNBC 患者在标准化疗中加入延长卡培他滨后 DFS 的统计学显着增加。在预先计划的亚组分析中，具有非基础表型的患者似乎从卡培他滨获益，尽管这需要额外的验证。结论 本研究未能显示早期 TNBC 患者在标准化疗中加入延长卡培他滨后 DFS 的统计学显着增加。在预先计划的亚组分析中，具有非基础表型的患者似乎从卡培他滨获益，尽管这需要额外的验证。