The GIM2 phase III trial demonstrated the benefit of dose-dense chemotherapy in node-positive early breast cancer (eBC). To better define the dose-dense effect in the hormone receptor-positive subgroup, we evaluated its benefit through a composite measure of recurrence risk. We conducted an ancillary analysis of the GIM2 trial evaluating the absolute treatment effect through a composite measure of recurrence risk (CPRS) in patients with hormone receptor-positive HER2-negative eBC. CPRS was estimated through Cox proportional hazards models applied to the different clinicopathological features. The treatment effect was compared to the values of CPRS by using the Sub-population Treatment Effect Pattern Plot (STEPP) process. The Disease-Free Survival (DFS)-oriented STEPP analysis showed distinct patterns of relative treatment effect with respect to CPRS. Overall, 5-year DFS differed across CPRS quartiles ranging from 95.2 to 66.4%. Each CPRS quartile was characterized by a different patients’ composition, especially for age, lymph node involvement, tumor size, estrogen and progesterone receptor expression, and Ki-67. A number needed to treat of 154 and 6 was associated with the lowest and the highest CPRS quartile, respectively. Dose-dense adjuvant chemotherapy showed a consistent benefit in node-positive eBC patients with hormone receptor-positive HER2-negative disease, but its effect varied according to CPRS.

GIM2 III 期试验证明了剂量密集型化疗对淋巴结阳性早期乳腺癌 (eBC) 的益处。为了更好地定义激素受体阳性亚组中的剂量密集效应，我们通过综合衡量复发风险评估了其益处。我们对 GIM2 试验进行了一项辅助分析，该试验通过激素受体阳性 HER2 阴性 eBC 患者的复发风险综合测量 (CPRS) 评估绝对治疗效果。通过应用于不同临床病理特征的 Cox 比例风险模型估计 CPRS。通过使用亚群治疗效果模式图 (STEPP) 过程，将治疗效果与 CPRS 的值进行比较。以无病生存 (DFS) 为导向的 STEPP 分析显示了相对于 CPRS 的不同治疗效果模式。总体而言，CPRS 四分位数的 5 年 DFS 差异从 95.2% 到 66.4%。每个 CPRS 四分位数的特征在于不同的患者组成，尤其是年龄、淋巴结受累、肿瘤大小、雌激素和孕激素受体表达以及 Ki-67。需要治疗的人数 154 和 6 分别与最低和最高的 CPRS 四分位数相关。剂量密集的辅助化疗在具有激素受体阳性 HER2 阴性疾病的淋巴结阳性 eBC 患者中显示出一致的益处，但其效果因 CPRS 而异。尤其是年龄、淋巴结受累、肿瘤大小、雌激素和孕激素受体表达以及 Ki-67。需要治疗的人数 154 和 6 分别与最低和最高的 CPRS 四分位数相关。剂量密集的辅助化疗在具有激素受体阳性 HER2 阴性疾病的淋巴结阳性 eBC 患者中显示出一致的益处，但其效果因 CPRS 而异。尤其是年龄、淋巴结受累、肿瘤大小、雌激素和孕激素受体表达以及 Ki-67。需要治疗的人数 154 和 6 分别与最低和最高的 CPRS 四分位数相关。剂量密集的辅助化疗在具有激素受体阳性 HER2 阴性疾病的淋巴结阳性 eBC 患者中显示出一致的益处，但其效果因 CPRS 而异。