PMID- 35804991 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230308 IS - 2072-6694 (Print) IS - 2072-6694 (Electronic) IS - 2072-6694 (Linking) VI - 14 IP - 13 DP - 2022 Jun 30 TI - The Comparative Safety of Epirubicin and Cyclophosphamide versus Docetaxel and Cyclophosphamide in Lymph Node-Negative, HR-Positive, HER2-Negative Breast Cancer (ELEGANT): A Randomized Trial. LID - 10.3390/cancers14133221 [doi] LID - 3221 AB - Background: In adjuvant settings, epirubicin and cyclophosphamide (EC) and docetaxel and cyclophosphamide (TC) are both optional chemotherapy regimens for lymph node-negative, hormone receptor (HR)-positive, human epidermal receptor 2 (HER2)-negative breast cancer patients. Neutropenia is one of the most common adverse events (AEs) of these regimens. The rate of grade 3-4 neutropenia varies in different studies, and direct comparisons of safety profiles between EC and TC are lacking. Method: ELEGANT (NCT02549677) is a prospective, randomized, open-label, noninferior hematological safety trial. Eligible patients with lymph node-negative HR+/HER2-tumors (1:1) were randomly assigned to received four cycles of EC (90/600 mg/m2) or TC (75/600 mg/m2) every three weeks as adjuvant chemotherapy. The primary endpoint was the incidence of grade 3 or 4 neutropenia defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 on an intention-to-treat basis. Noninferiority was defined as an upper 95% CI less than a noninferiority margin of 15%. Results: In the intention-to-treat population, 140 and 135 patients were randomized into the EC and TC arms, respectively. For the primary endpoint, the rate of grade 3 or 4 neutropenia is 50.71% (95% CI: 42.18%, 59.21%) in the EC arm and 48.15% (95% CI: 39.53%, 56.87%) in the TC arm (95%CI risk difference: -0.100, 0.151), showing the noninferiority of the EC arm. For secondary endpoints, the rate of all-grade anemia is higher in the EC arm (EC 42.86% versus TC 22.96%, p = 0.0007), and more patients suffer from nausea/vomiting, hair loss, and nail changes (p < 0.01) in the EC arm. No statistically different disease-free survival was observed between the two arms (p = 0.13). Conclusion: EC is not inferior to TC in the rate of grade 3 or 4 neutropenia, but more other AEs were observed in the EC group. FAU - Liu, Deyue AU - Liu D AUID- ORCID: 0000-0001-5131-5668 AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. AD - Department of Breast and Thyroid Surgery, Shanghai General Hospital, School of Medicine, Shanghai JiaoTong University, No. 100 Haining Road, Hongkou District, Shanghai 200080, China. FAU - Wu, Jiayi AU - Wu J AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Lin, Caijin AU - Lin C AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Ding, Shuning AU - Ding S AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Lu, Shuangshuang AU - Lu S AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Fang, Yan AU - Fang Y AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Huang, Jiahui AU - Huang J AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Hong, Jin AU - Hong J AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Gao, Weiqi AU - Gao W AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Zhu, Siji AU - Zhu S AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Chen, Xiaosong AU - Chen X AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Huang, Ou AU - Huang O AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - He, Jianrong AU - He J AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Chen, Weiguo AU - Chen W AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Li, Yafen AU - Li Y AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Shen, Kunwei AU - Shen K AD - Department of General Surgery, Comprehensive Breast Health Center, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200025, China. FAU - Zhu, Li AU - Zhu L AUID- ORCID: 0000-0002-9294-5727 AD - Department of Breast and Thyroid Surgery, Shanghai General Hospital, School of Medicine, Shanghai JiaoTong University, No. 100 Haining Road, Hongkou District, Shanghai 200080, China. LA - eng GR - 201840323/Shanghai Municipal Commission of Health and Family Planning/ PT - Journal Article DEP - 20220630 PL - Switzerland TA - Cancers (Basel) JT - Cancers JID - 101526829 PMC - PMC9264845 OTO - NOTNLM OT - adverse events OT - breast cancer OT - docetaxel OT - epirubicin OT - neutropenia COIS- The authors declare no conflict of interest. EDAT- 2022/07/10 06:00 MHDA- 2022/07/10 06:01 PMCR- 2022/06/30 CRDT- 2022/07/09 01:04 PHST- 2022/06/01 00:00 [received] PHST- 2022/06/25 00:00 [revised] PHST- 2022/06/27 00:00 [accepted] PHST- 2022/07/09 01:04 [entrez] PHST- 2022/07/10 06:00 [pubmed] PHST- 2022/07/10 06:01 [medline] PHST- 2022/06/30 00:00 [pmc-release] AID - cancers14133221 [pii] AID - cancers-14-03221 [pii] AID - 10.3390/cancers14133221 [doi] PST - epublish SO - Cancers (Basel). 2022 Jun 30;14(13):3221. doi: 10.3390/cancers14133221.