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. Issue 13 (20th March 2019)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Cancer. Volume 125:Issue 13(2019)
• Page Start: 2185
• Page End: 2193
• Publication Date: 2019-03-20
• Subjects: breast cancer -- clinical trial -- concurrent -- estrogen deprivation -- neoadjuvant chemotherapy; Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.32057
• Languages: English
• ISSNs: 0008-543X

Abstract

Abstract : Background: 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. Methods: 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). Results: 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. Conclusions: 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. Abstract : The findings of the current study indicate that concurrent neoadjuvant chemotherapy and estrogen deprivation could be the preferred neoadjuvant treatment option for patients with estrogen receptor–positive, human epidermal growth factor receptor 2–negative breast cancer, especially for those with higher Ki‐67 levels. These results support concurrent treatment as part of a promising therapeutic strategy for this patient population.