Medical Oncology

, 32:240 | Cite as

Efficacy and safety of pirarubicin plus capecitabine versus pirarubicin plus cyclophosphamide in Chinese node-negative breast cancer patients: a 4-year open-label, randomized, controlled study

  • Xiaohui Zhang
  • Yidong Zhou
  • Feng Mao
  • Yan Lin
  • Jinghong Guan
  • Qiang SunEmail author
Original Paper


This study aimed to evaluate the efficacy and safety of adjuvant chemotherapy with pirarubicin plus capecitabine (AX regimen) in Chinese node-negative breast cancer (BCa) patients. Two hundred eighty Chinese pT1-2N0M0 BCa patients under 70 years of age were equally and randomly assigned to receive four cycles of adjuvant therapy with the AX regimen or pirarubicin and cyclophosphamide (AC regimen) between January 2010 and May 2011. End points included overall survival (OS), disease-free survival (DFS), chemotherapy-induced toxicities, and quality of life (QoL). The 4-year DFS (AX vs. AC, 93.6 vs. 92.9 %, P = 0.761) and OS (97.1 vs. 96.4 %, P = 0.965) were similar between the two treatment arms. The AX group, compared to the AC group, experienced significantly less frequent grade III/IV vomiting (11.4 vs. 26.4 %, P < 0.001), whereas the incidence of other grade III/IV chemotherapy-associated toxicities was comparable between the two groups (all P values >0.05). Use of the AX regimen was associated with significantly higher QoL scores in the domains of physical, role, and social functions than the AC regimen (P values <0.05), although the two regimens were similar in the domains of emotional and cognitive functions (all P values >0.05). In comparison with the AC regimen, AX adjuvant chemotherapy is equally beneficial for node-negative BCa patients younger than 70 years with respect to OS and DFS. The AX regimen is primarily advantageous over the AC regimen based on less frequent severe toxicities and better health-related QoL.


Node-negative breast cancer Adjuvant chemotherapy Survival Toxicity Quality of life Randomized, controlled study 


Compliance with ethical standards

Conflict of interest



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Copyright information

© Springer Science+Business Media New York 2015

Authors and Affiliations

  • Xiaohui Zhang
    • 1
  • Yidong Zhou
    • 1
  • Feng Mao
    • 1
  • Yan Lin
    • 1
  • Jinghong Guan
    • 1
  • Qiang Sun
    • 1
    Email author
  1. 1.Department of Breast Surgery, Peking Union Medical College HospitalChinese Academy of Medical Science and Peking Union Medical CollegeBeijingChina

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