title: Capecitabine combined with docetaxel versus vinorelbine followed by capecitabine maintenance medication for first-line treatment of patients with advanced breast cancer: Phase 3 randomized trial.
abstract: BACKGROUND
  In this prospective study, progression-free survival (PFS) and the safety profiles of docetaxel/capecitabine (TX) and vinorelbine/capecitabine (NX) followed by capecitabine maintenance therapy were compared in patients with metastatic breast cancer.
  
  
  METHODS
  Patients with advanced metastatic breast cancer were randomly assigned to a TX group (n = 104) and an NX group (n = 102), both of which included capecitabine maintenance medication. The primary endpoint was progression-free survival (PFS).
  
  
  RESULTS
  The trial met its primary endpoint and was closed to accrual subsequent to interim analysis. Forty-eight patients in the TX group (46.2%) and 42 patients in the NX group (41.2%) received maintenance medication. The median PFS (8.4 vs 7.1 months; P = .0026; 95% confidence interval, 1.18-2.3; hazard ratio, 1.65), the response duration (7.8 vs 6.6 months; P = .0451), and the median overall survival (OS) (35.3 vs 19.8 months; P = .1349; 95% confidence interval, 0.88-2.47; hazard ratio, 1.48) in the TX group appeared to be longer compared with those in the NX group, although the difference did reach not statistical significance. Patients aged ≥40 years who were postmenopausal and presented with visceral metastases were more likely to benefit from the TX regimen in terms of PFS and OS, whereas positive hormone receptor and human epidermal growth factor receptor 2 status or a history of taxane treatments did not affect differences in PFS and OS between the TX and NX groups. Hand-foot syndrome occurred more frequently in the TX group than in the NX group (47% vs 16.7%; P < .0001), but the frequencies of other minor adverse effects were similar in both groups.
  
  
  CONCLUSIONS
  A TX regimen for advanced breast cancer followed by capecitabine maintenance medication led to longer PFS and response duration than an NX regimen, even for patients who had previously received taxane in (neo)adjuvant settings. Cancer 2015. © 2015 American Cancer Society. Cancer 2015;121:3435-43. © 2015 American Cancer Society.
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Jiayu
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Binghe
authors.initials: B
authors.lastname: Xu
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Peng
authors.initials: P
authors.lastname: Yuan
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Ma
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Pin
authors.initials: P
authors.lastname: Zhang
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Ruigang
authors.initials: R
authors.lastname: Cai
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Fan
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Luo
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Qiao
authors.initials: Q
authors.lastname: Li
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine / Q000008:administration & dosage / Q000627:therapeutic use*; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use*; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000964:Antimetabolites, Antineoplastic; D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D000069287:Capecitabine; D000077235:Vinorelbine
keywords: advanced breast cancer; capecitabine; docetaxel; maintenance therapy; vinorelbine