title: Intravenous or oral vinorelbine plus capecitabine as first-line treatment in HER2- metastatic breast cancer: joint analysis of 2 consecutive prospective phase II trials.
abstract: BACKGROUND
  The purpose of this study was to assess the activity and safety of the combination of vinorelbine (VNR) and capecitabine (CAP) as first-line treatment in HER2-negative (HER(-)) metastatic breast cancer (MBC).
  
  
  METHODS
  Patients (42) enrolled in trial A received intravenous (i.v.) VNR 25 mg/m2 on days 1 and 8 of a 21-day cycle combined with CAP 1000 mg/m2 twice daily for 14 consecutive days followed by 1 week of rest. Trial B (46 patients) followed trial A when the oral formulation of VNR became available at our institution. Patients received oral VNR (60 mg/m(2) on days 1-8) combined with the same CAP schedule as in trial A.
  
  
  RESULTS
  The response rate (RR) in trial A was 73.2% (95% confidence interval [CI], 56.4-82.8), including 12.2% complete responses (CRs). Clinical benefit was achieved in 78% of patients (95% CI, 63.2-87.9). In trial B, overall RR was 76% (95% CI, 62.0-86.0), with 13% CRs and clinical benefit of 80.4% (95% CI, 66.8-89.3). In trial A, median progression-free survival (PFS) was 8.2 months (range, 6-14+ months) and median overall survival (OS) was 32.4 months (range, 17-36+ months). In trial B, median PFS and OS were 8.8 months (range, 8-21+ months) and 34.3 months (14-39+ months), respectively. Treatment-related toxicity was manageable. Quality of life assessment showed a statistically significant difference regarding body image (p = .001), sexual functioning (p = .02), and future perspectives (p = .03) in women receiving chemotherapy fully by the oral route.
  
  
  CONCLUSIONS
  This joint analysis shows that both tested schedules can produce high objective RRs with encouraging PFS, manageable toxicity profile, and suggested benefit on some aspects of quality of life for the fully oral combination.
authors.affiliation: Unit of Rehabilitative Oncology, Fondazione Maugeri, Pavia, Italy. mariarosa.strada@fsm.it
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: Strada
authors.forename: Raffaella
authors.initials: R
authors.lastname: Palumbo
authors.forename: Antonio
authors.initials: A
authors.lastname: Bernardo
authors.forename: Alberto
authors.initials: A
authors.lastname: Riccardi
authors.forename: Cristina
authors.initials: C
authors.lastname: Teragni
authors.forename: Guido
authors.initials: G
authors.lastname: Poggi
authors.forename: Mara
authors.initials: M
authors.lastname: Frascaroli
authors.forename: Alessio
authors.initials: A
authors.lastname: Amatu
authors.forename: Benedetta
authors.initials: B
authors.lastname: Montagna
authors.forename: Federico
authors.initials: F
authors.lastname: Sottotetti
authors.forename: Barbara
authors.initials: B
authors.lastname: Tagliaferri
authors.forename: Giovanni
authors.initials: G
authors.lastname: Bernardo
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000069287:Capecitabine; D003841:Deoxycytidine; D005472:Fluorouracil; D018719:Erb-b2 Receptor Tyrosine Kinases; D014747:Vinblastine; D000077235:Vinorelbine