A randomized study comparing docetaxel/cyclophosphamide (TC), 5-fluorouracil/epirubicin/cyclophosphamide (FEC) 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; pp. 715 - 724
• Main Authors: Ishiguro, Hiroshi, Masuda, Norikazu, Sato, Nobuaki, Higaki, Kenji, Morimoto, Takashi, Yanagita, Yasuhiro, Mizutani, Makiko, Ohtani, Shoichiro, Kaneko, Koji, Fujisawa, Tomomi, Takahashi, Masato, Kadoya, Takayuki, Matsunami, Nobuki, Yamamoto, Yutaka, Ohno, Shinji, Takano, Toshimi, Morita, Satoshi, Tanaka-Mizuno, Sachiko, Toi, Masakazu
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.04.2020; Springer Nature B.V
• Subjects: 5-Fluorouracil; Adult; Aged; Anthracycline; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Cancer therapies; Carcinoma, Ductal, Breast - drug therapy; Carcinoma, Ductal, Breast - pathology; Carcinoma, Lobular - drug therapy; Carcinoma, Lobular - pathology; Chemotherapy; Clinical Trial; Clinical trials; Creatinine; Cyclophosphamide; Cyclophosphamide - administration & dosage; Docetaxel - administration & dosage; Drug dosages; Edema; Epirubicin; Epirubicin - administration & dosage; ErbB-2 protein; Estrogens; Female; Fluorouracil - administration & dosage; Follow-Up Studies; Granulocytes; Hemoglobin; Humans; Medical research; Medicine; Medicine & Public Health; Middle Aged; Neutropenia; Oncology; Patients; Peripheral neuropathy; Prognosis; Receptor, ErbB-2 - metabolism; Receptors, Estrogen - metabolism; Receptors, Progesterone - metabolism; Registration; Statistical analysis; Survival Rate; UMIN; UMIN000003283; Young Adult; Neoadjuvant chemotherapy; Cyclophosphamide; Breast cancer; Randomized clinical trial; Doxorubicin; Docetaxel
• ISSN: 0167-6806; 1573-7217
• 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 https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003873 .