197P - Comparative safety of Epirubicin and cyclophosphamide versus Docetaxel and cyclophosphamide in lymph node negative, HR-positive, HER2-negative breast cancer (ELEGANT): A randomized trial

Background

In adjuvant setting, epirubicin and cyclophosphamide (EC), 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 safety profile directly comparing EC and TC are lacking.

Methods

ELEGANT (NCT02549677) is an observational, prospective, randomized, open-label, non-inferior hematological safety trial. Eligible patients with lymph node-negative HR+/HER2- tumours (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. After randomization, no blinding was performed. The primary endpoint is the incidence of grade 3 or 4 neutropenia refined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 on an intention-to-treat basis. Non-inferiority was defined as an upper 95% CI less than a non-inferiority margin of 15%. The secondary endpoints are other hematological and non-hematological toxicities, 3-year disease-free survival (DFS) and 3-year overall survival (OS).

Results

In the intention-to-treat population, 140 and 136 patients were randomized into EC and TC arm, respectively. For the primary endpoint, the rate of grade 3 or 4 neutropenia is 50.71% (95% CI 42% - 59%) in EC arm and 49.26% (95% CI 41% - 58%) in TC arm (risk difference: 95% CI -11% – 14%), showing non-inferiority of EC arm. The mean first time of grade 3 or 4 in EC arm (1.55 cycle) is earlier than that in TC arm (1.88 cycle) (p=0.006). For secondary endpoints, the rate of all grade anemia is higher in EC arm (EC 42.86% versus TC 22.79%, p=0.006), and more patients suffer from nausea/vomiting (p<0.01), hair loss (p<0.01) and nail changes (p<0.01) in EC arm.

Conclusions

EC is noninferior to TC in the rate of grade 3 or 4 neutropenia. Longer follow-up is awaited to derive efficacy endpoints.

Clinical trial identification

NCT02549677.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.