title: A clinical phase II study of a non-anthracycline sequential combination of cisplatin-vinorelbine followed by docetaxel as first-line treatment in metastatic breast cancer.
abstract: BACKGROUND
  We tested a sequential combination regimen using cisplatin and vinorelbine (PVn) followed by docetaxel as first-line chemotherapy in a phase II clinical trial in metastatic breast cancer (MBC).
  
  
  METHODS
  Thirty-five patients were enrolled. Cisplatin 80 mg/m(2) was given on day 1 and vinorelbine 30 mg/m(2) on days 1 and 8 every 3 weeks for 4 cycles. Responding patients received docetaxel 75 mg/m(2) every 21 days for a maximum of 4 cycles. Three patients were excluded from analysis because of death unrelated to treatment.
  
  
  RESULTS
  After a median follow-up of 14 months, 32 patients completed the study. The overall response rate was 53.1%. Complete remission was seen in 5 patients (15.6%), partial response in 12 (37.5%), stable disease in 6 (18.75%), and progressive disease in 9 patients (28.1%). Median time to disease progression was 8 months (range 1-24). At 24 months, 12 (37.5%) patients were alive. A total of 183 cycles were administered. Febrile neutropenia was observed in 4 patients (2.2%). Grade II nephrotoxicity occurred in 12 cycles (6.5%) and grade III vomiting in 31/183 cycles (16.9%).
  
  
  CONCLUSIONS
  PVn is a feasible non-anthracycline option as first-line chemotherapy in patients with metastatic breast cancer and has acceptable toxicity. The sequential addition of 4 cycles of docetaxel following 4 cycles of PVn did not improve the overall response rate and results.
authors.affiliation: American University of Beirut Medical Center, Beirut, Lebanon. as04@aub.edu.lb
authors.forename: Ali I
authors.initials: AI
authors.lastname: Shamseddine
authors.forename: Zaher K
authors.initials: ZK
authors.lastname: Otrock
authors.forename: Mohamad J
authors.initials: MJ
authors.lastname: Khalifeh
authors.forename: Hanan R
authors.initials: HR
authors.lastname: Yassine
authors.forename: Maya
authors.initials: M
authors.lastname: Charafeddine
authors.forename: Zeina
authors.initials: Z
authors.lastname: Abdel-Khalek
authors.forename: Aref
authors.initials: A
authors.lastname: Chehal
authors.forename: Nizar
authors.initials: N
authors.lastname: Bitar
authors.forename: Rahif
authors.initials: R
authors.lastname: Jalloul
authors.forename: Moussa
authors.initials: M
authors.lastname: Dheiny
authors.forename: Azzam
authors.initials: A
authors.lastname: Dandashi
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Wehbeh
authors.forename: Nagi S
authors.initials: NS
authors.lastname: El-Saghir
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000139:chemically induced; D005500:Follow-Up Studies; D006801:Humans; D007668:Kidney / Q000187:drug effects; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D014839:Vomiting / Q000139:chemically induced
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine