Department of Breast Surgery, Key Laboratory of Breast Cancer in Shanghai, Fudan University Shanghai Cancer Center, Shanghai, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Cancer. 2019 Jul 1;125(13):2185-2193. doi: 10.1002/cncr.32057. Epub 2019 Mar 20.
The current randomized, controlled, multicenter clinical trial was conducted to investigate the efficacy of concurrent neoadjuvant chemotherapy (NCT) and estrogen deprivation in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Eligible patients with AJCC stage IIB to stage IIIC, ER-positive, HER2-negative breast cancer were enrolled and randomly assigned to receive NCT with or without estrogen deprivation. The primary endpoint was the objective response rate (ORR).
A total of 249 patients were assigned to either neoadjuvant chemoendocrine therapy (NCET) (125 patients) or the NCT group (124 patients). In the intention-to-treat analysis, the ORR was found to be significantly higher in the NCET group compared with the NCT group (84.8% vs 72.6%; odds ratio, 2.11 [95% CI, 1.13-3.95; P = .02). The efficacy of NCET was more prominent in tumors with a higher Ki-67 index (>20%), with an ORR of 91.2% reported in the NCET group versus 68.7% in the NCT group (P = .001). The pathologic complete response and pathological response rates did not differ significantly between the 2 groups. Although there was no significant difference with regard to progression-free survival (PFS) between the 2 groups (P = .188), patients with a higher baseline Ki-67 index appeared to derive a greater PFS benefit from NCET (2-year PFS rate of 91.5% in the NCET group vs 76.5% in the NCT group; P = .058). Adding endocrine agents to NCT did not result in significant differences in adverse events (grade 3 or 4; graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]) between the 2 groups.
The addition of estrogen deprivation to NCT appears to improve the clinical response in patients with ER-positive, HER2-negative breast cancer, especially for those individuals with a higher Ki-67 index. Patients with a higher Ki-67 index might derive more PFS benefit from concurrent neoadjuvant treatment.
本随机、对照、多中心临床试验旨在研究新辅助化疗（NCT）联合雌激素剥夺治疗雌激素受体（ER）阳性、人表皮生长因子受体 2（HER2）阴性乳腺癌患者的疗效。
纳入 AJCC 分期为 IIB 期至 IIIIC 期、ER 阳性、HER2 阴性的乳腺癌患者，按 1:1 随机分为接受 NCT 联合或不联合雌激素剥夺的治疗组。主要终点为客观缓解率（ORR）。
共有 249 例患者按意向治疗原则被分配至新辅助化疗内分泌治疗（NCET）组（125 例）或 NCT 组（124 例）。在意向治疗分析中，NCET 组的 ORR 显著高于 NCT 组（84.8%比 72.6%；优势比，2.11[95%CI，1.13-3.95；P=0.02]）。在 Ki-67 指数较高（>20%）的肿瘤中，NCET 的疗效更为显著，NCET 组的 ORR 为 91.2%，而 NCT 组为 68.7%（P=0.001）。两组的病理完全缓解和病理反应率无显著差异。虽然两组患者的无进展生存期（PFS）无显著差异（P=0.188），但 Ki-67 指数较高的患者从 NCET 中获益更多（NCET 组 2 年 PFS 率为 91.5%，NCT 组为 76.5%；P=0.058）。在 NCT 中加入内分泌药物并未导致两组间不良事件（根据美国国立癌症研究所不良事件通用术语标准[版本 3.0]分级，3 或 4 级）有显著差异。
在 ER 阳性、HER2 阴性乳腺癌患者中，NCT 联合雌激素剥夺治疗似乎能提高临床疗效，尤其对 Ki-67 指数较高的患者更为有效。Ki-67 指数较高的患者可能从同步新辅助治疗中获得更长的 PFS 获益。
Zotero 插件