title: Efficacy and toxicity of capecitabine-based chemotherapy in patients with metastatic or advanced breast cancer: results from ten randomized trials.
abstract: OBJECTIVE
  The efficacy and adverse effects of capecitabine-based chemotherapy versus other regimens reported in previous trials were discordant. The aim of the present study was to determine the efficacy and toxicity profiles of capecitabine-based chemotherapy versus capecitabine-free regimens in patients with metastatic and/or advanced breast cancer.
  
  
  METHODS
  Randomized trials in which capecitabine-based chemotherapy was compared with capecitabine-free chemotherapy were included by searching the PubMed database. Differences in efficacy and grade 3-4 toxicities between capecitabine-based chemotherapy and other chemotherapy were compared.
  
  
  RESULTS
  Ten randomized controlled trials were included in our meta-analysis. Compared to patients treated with capecitabine-free chemotherapy, patients treated with capecitabine-based chemotherapy did not have a significantly different complete response (odds ratio (OR): 1.25, 95% confidence interval (CI): 0.87-1.79, p = 0.231), partial response (OR: 1.16, 95% CI: 0.95-1.41, p = 0.147), and overall response (OR: 1.21, 95% CI: 1.00-1.47, p = 0.053). Compared to the capecitabine-free group, less hematological toxicity and more gastrointestinal toxicity occurred in patients treated with capecitabine-based chemotherapy, including neutropenia (OR: 0.34, 95% CI: 0.19-0.59, p <0.001), anemia (OR: 0.41, 95% CI: 0.20-0.85, p = 0.016), leukocytopenia (OR: 0.50, 95% CI: 0.32-0.78, p = 0.002), and diarrhea (OR: 2.35, 95% CI: 1.62-3.42, p < 0.001). Furthermore, patients in the capecitabine group exhibited a significantly higher rate of grade 3 hand-foot syndrome than the capecitabine-free group (OR: 25.16, 95% CI: 12.27-51.58, p < 0.001).
  
  
  CONCLUSIONS
  The present study suggests that capecitabine-based chemotherapy is as effective as capecitabine-free chemotherapy in patients with metastatic and/or advanced breast cancer with different toxicity profiles. Capecitabine-based chemotherapy may be better tolerated than capecitabine-free chemotherapy. Due to several limitations in our study, future large randomized trials are needed.
authors.affiliation: Research Division of Clinical Pharmacology, the First Affiliated Hospital, Nanjing Medical University, Nanjing, China.
authors.forename: Yongqing
authors.initials: Y
authors.lastname: Wang
authors.forename: Haiwei
authors.initials: H
authors.lastname: Yang
authors.forename: Ji-Fu
authors.initials: JF
authors.lastname: Wei
authors.forename: Ling
authors.initials: L
authors.lastname: Meng
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D009362:Neoplasm Metastasis; D016032:Randomized Controlled Trials as Topic
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil