A randomized study comparing docetaxel/cyclophosphamide followed by TC, and TC followed by FEC for patients with hormone receptor-positive HER2-negative primary breast cancer

• Published in: Breast cancer research and treatment Vol. 180; no. 3; p. 715
• Main Authors: Ishiguro, Hiroshi, Masuda, Norikazu, Sato, Nobuaki, Higaki, Kenji, Morimoto, Takashi, Yanagita, Yasuhiro, Mizutani, Makiko
• Format: Journal Article
• Language: English
• Published: Springer 01.04.2020
• Subjects: Anthracyclines; Breast cancer; Cancer; Care and treatment; Chemotherapy; Cyclophosphamide; Evidence-based medicine; Hormones
• ISSN: 0167-6806
• DOI: 10.1007/s10549-020-05590-w

Purpose Our primary objective was to determine the benefit/risk of anthracycline-free regimens by comparing docetaxel + cyclophosphamide (TC) alone, fluorouracil + epirubicin + cyclophosphamide (FEC) followed by TC, or TC followed by FEC as a primary treatment for patients with HR-positive, HER2-negative BC. Methods We randomized patients with stage I-III HR-positive HER2-negative, operable BC to receive either six cycles of TC (TC6), three cycles of FEC followed by three cycles of TC (FEC-TC), or three cycles of TC followed by three cycles of FEC (TC-FEC). The primary endpoint was the pathological response. Secondary endpoints included clinical response, type of surgical procedure, recurrence, death, and adverse events (by NCI-Common Terminology Criteria for Adverse Events v.3.0). We conducted all statistical analyses using SAS Version 9.2. Results We enrolled 195 patients and analyzed data from 193 as the intention-to-treat population. Pathological complete response rates were numerically higher in the TC6 group than in the other groups (p = 0.321). The breast conservation rate was significantly higher in the TC6 group (73%) than in the other groups (FEC-TC 51%, TC-FEC 45%, p = 0.007). Adverse events with grade > 3 were not common in the treatment groups (p = 0.569). The overall and distant disease-free survivals were similar among the groups with median follow-up of 5.80 years. Conclusions Despite similar long-term efficacy and safety profile, the higher breast conservation rate in the TC6 group suggests that preoperative chemotherapy without an anthracycline may benefit patients with HR-positive HER2-negative BC. Trial registration UMIN000003283