Weekly taxane-anthracycline combination regimen versus tri-weekly anthracycline-based regimen for the treatment of locally advanced breast cancer：a randomized controlled trial

• Published in: Ai zheng 2017-03, Vol.36 (6), p.274-281, Article 27
• Main Authors: Tan, Qiu‐Wen, Luo, Ting, Zheng, Hong, Tian, Ting‐Lun, He, Ping, Chen, Jie, Zeng, He‐Lin, Lv, Qing
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anthracycline; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Biopsy; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Breast Neoplasms - surgery; Cancer therapies; Chemotherapy; Clinical trials; Cyclophosphamide - administration & dosage; Cyclophosphamide - adverse effects; Cyclophosphamide - therapeutic use; Disease; Drug Administration Schedule; Epirubicin - administration & dosage; Epirubicin - adverse effects; Epirubicin - therapeutic use; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - therapeutic use; Granulocytes; Humans; Locally advanced breast cancer; Mastectomy; Medical imaging; Medical prognosis; Middle Aged; Neoadjuvant; Neutropenia; Original; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Paclitaxel - therapeutic use; Patients; Radiation therapy; Randomized clinical trial; Skin cancer; Surgery; Taxanes; Treatment Outcome; Womens health; Young Adult; 乳腺癌; 晚期; 治疗方案; 环类; 紫杉烷; 药物; 蒽; 随机对照试验
• ISSN: 1000-467X; 2523-3548; 1944-446X; 1944-446X; 2523-3548
• DOI: 10.1186/s40880-017-0196-5

Background：Extensive studies have confirmed the efficacy of taxanes in combination with anthracycline-based chemotherapy on breast cancer.However,few studies have assessed the efficacy of weekly taxane-anthracycline regimens on locally advanced breast cancer.This study was to compare the efficacy and safety of a weekly taxaneanthracycline regimen with those of tri-weekly anthracycline-based regimen in patients with locally advanced breast cancer.Methods：Patients with locally advanced breast cancer were randomized to receive 4-6 cycles of neoadjuvant chemotherapy with tri-weekly 5-fluorouracil-epirubicin-cyclophosphamide（FEC） regimen or weekly paclitaxel-epirubicin（PE） regimen.The primary endpoint was the pathologic complete response（pCR） rate.Other endpoints included the clinical tumor response,breast-conserving surgery rate,and adverse events.Results：Between March 2010 and September 2013,293 patients were randomized to the FEC（n=151） and PE（n=142） arms.The overall clinical response rate was significantly higher in the PE arm than in the FEC arm（76.06%vs.59.95%,P=0.001）.Consistently,the post-chemotherapy pathologic T and N stages were significantly lower in the PE arm than in the FEC arm（P〈0.001）.However,the pCR rate was similar in the two arms（10.61%vs.12.31%,P=0.665）.Overall,36（27.27%） patients in the FEC arm and 6（35.28%） in the PE arm were qualified for breast-conserving surgery.Most adverse events were comparable in both arms,with more severe neutropenia in the PE arm than in the FEC arm（11.97%vs.5.96%,P=0.031）.Conclusions：In patients with locally advanced breast cancer,weekly PE was not superior to FEC in terms of pCR.However,weekly PE has a higher response rate and superior down-staging effects.On this account,the PE regimen may be considered an alternative option for locally advanced breast cancer.Long-term follow-up data are needed to confirm the efficacy of this regimen on locally advanced breast cancer.Trial registration Chinese clinical trial registry,ChiCTR-TRC-10001043,September 21,2014