Concurrent neoadjuvant chemotherapy and estrogen deprivation in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (CBCSG-036): A randomized, controlled, multicenter trial
Concurrent neoadjuvant chemotherapy and estrogen deprivation in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (CBCSG-036): A randomized, controlled, multicenter trial
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雌激素受体阳性、人表皮生长因子受体 2 阴性乳腺癌患者同步新辅助化疗和雌激素剥夺 (CBCSG-036)：一项随机、对照、多中心试验
作者：
Yu Ke Da;Wu Si Yu;Liu Guang Yu;Wu Jiong;Di Gen Hong;Hu Zhen;Hou Yi Feng;Chen Can Ming;Fan Lei;Tang Li Chen;Shen Zhen Zhou;Wu Ke Jin;Zhuang Zhi Gang;Zhang Hong Wei;Shao Zhi Ming
本研究采用随机、对照、多中心临床试验方法，观察雌激素受体(ER)阳性、人表皮生长因子受体2(HER2)阴性乳腺癌患者同时接受新辅助化疗(NCT)和去雌激素治疗的疗效。结果249例患者分为新辅助化疗内分泌治疗组(125例)和新辅助化疗内分泌治疗组(124例)。在意向处理分析中，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=2.02])。NCET的疗效在Ki-67指数较高的肿瘤中更为突出(>；20%)，NCET组报告的ORR为91.2%，而NCT组为68.7%(P=0.001)。两组的病理完全缓解率和病理缓解率均无显著差异。虽然两组之间的无进展生存率(PFS)没有显著差异(P=9.188)，但基线Ki-67指数较高的患者似乎从NCET中获得了更大的PFS益处(NCET组的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之间的不良事件(3级或4级；根据美国国家癌症研究所不良事件通用术语标准[3.0版]进行分级)的显著差异。结论在NCT中加入雌激素剥夺似乎可以改善ER阳性、HER2阴性乳腺癌患者的临床疗效，尤其是对Ki-67指数较高的患者。Ki-67指数较高的患者可能从同时接受新辅助治疗中获得更多的PFS。
BackgroundThe 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.MethodsEligible 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).ResultsA 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.ConclusionsThe 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.