title: A phase II study of capecitabine plus cisplatin in metastatic triple-negative breast cancer patients pretreated with anthracyclines and taxanes.
abstract: BACKGROUND
  Cisplatin is an effective agent for triple-negative breast cancer (TNBC) and synergistic activity between cisplatin and capecitabine has been demonstrated by in vitro and in vivo studies. This study was designed as a prospective clinical trial to evaluate the efficacy and safety of capecitabine plus cisplatin (XP) regimen in metastatic TNBC patients pretreated with anthracyclines and taxanes.
  
  
  METHODS
  Thirty-three patients with metastatic TNBC who had anthracyclines and taxanes as prior therapy were treated with capecitabine 2000 mg/m(2) orally on day 1 through 14 plus cisplatin 75 mg/m(2) intravenously on day 1 of a 21-day cycle, followed by capecitabine maintenance medications after a maximum of 6 cycles. The primary end point was objective response rate (ORR) and the secondary end points included progression-free survival (PFS), overall survival (OS) and toxicity profiles.
  
  
  RESULTS
  A total of 162 cycles was given. ORR was 63.6%. Median PFS was 8.2 (95%CI: 4.8-11.6) months in the entire population and 10.8 (95%CI: 6.5-15.1) months in responding patients. Median OS was 17.8 (95%CI: 14.4-21.2) months in all enrolled patients and 25.8 (95%CI: 14.6-37.0) months in responding patients. Most adverse events were mild and manageable, with neutropenia and nausea/vomiting as the most common toxicities. Grade 3/4 toxicities included leukopenia (10, 30.3%), neutropenia (10, 30.3%), anemia (2, 6.1%), thrombocytopenia (1, 3.0%), nausea/vomiting (3, 9.1%), hand-foot syndrome (HFS; 1, 3.0%), and sensory neuropathy (1, 3.0%).
  
  
  CONCLUSIONS
  Capecitabine plus cisplatin demonstrated an excellent activity and an acceptable safety profile in metastatic TNBC patients pretreated with anthracyclines and taxanes.
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Qiao
authors.initials: Q
authors.lastname: Li
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Li
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Pin
authors.initials: P
authors.lastname: Zhang
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Peng
authors.initials: P
authors.lastname: Yuan
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Jiayu
authors.initials: J
authors.lastname: Wang
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Fei
authors.initials: F
authors.lastname: Ma
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Luo
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Fan
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Ruigang
authors.initials: R
authors.lastname: Cai
authors.affiliation: a Department of Medical Oncology ; Cancer Hospital; Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College ; Beijing , China.
authors.forename: Binghe
authors.initials: B
authors.lastname: Xu
mesh_terms: D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D019233:Retreatment; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*
chemical_list: D018943:Anthracyclines; D043823:Taxoids; D000069287:Capecitabine; D002945:Cisplatin
keywords: Triple-negative; capecitabine; cisplatin; metastatic breast cancer