title: Acceptable but limited efficacy of capecitabine-based doublets in the first-line treatment of metastatic triple-negative breast cancer: a pilot study.
abstract: BACKGROUND
  This open-label, nonrandomized phase II clinical trial investigated the efficacy of capecitabine-based doublets in the first-line treatment of metastatic triple-negative breast cancer (mTNBC).
  
  
  METHODS
  Eligible mTNBC women with measurable diseases were recruited to receive either TX regimen (docetaxel 75 mg/m(2) i.v. on day 1 plus capecitabine 1,000 mg/m(2) b.i.d. on days 1-14 every 3 weeks) or NX regimen (vinorelbine 25 mg/m(2) i.v. on days 1 and 8 plus capecitabine 1,000 mg/m(2) b.i.d. on days 1-14 every 3 weeks) for up to 6 cycles until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) and secondary end points included progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR).
  
  
  RESULTS
  Forty-five mTNBC patients, 27 in TX and 18 in NX were recruited. The total ORR was 20.0% and CBR was 40%. After a median follow-up of 28 months, PFS was 5.2 months (95% CI, 4.1-6.3 months) and OS was 18.2 months (95% CI, 8.7-27.7 months). The response rate was numerically but not statistically lower in the TX group than in the NX group (27.8 vs. 14.8%, p = 0.449). No difference was found in either PFS (4.9 vs. 5.2 months, p = 0.483) or OS (21.5 vs. 18.3 months, p = 0.964) between the two regimens.
  
  
  CONCLUSIONS
  Although the OS seems to be reasonable, the efficacy of capecitabine-containing TX or NX regimen was limited in terms of response and PFS in mTNBC patients, suggesting capecitabine-based doublet may be acceptable but has limited potency in this subtype.
authors: Department of Medical Oncology, Jiangxi Cancer Hospital, Nanchang, China.
authors: Yuqian
authors: Y
authors: Liao
authors: Ying
authors: Y
authors: Fan
authors: Yiye
authors: Y
authors: Wan
authors: Jun
authors: J
authors: Li
authors: Lixiang
authors: L
authors: Peng
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077143:Docetaxel; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016017:Odds Ratio; D010865:Pilot Projects; D016019:Survival Analysis; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil