title: Reversibility of liver failure secondary to metastatic breast cancer by vinorelbine and cisplatin chemotherapy.
abstract: OBJECTIVE
  The development of liver metastases from breast cancer is associated with a very poor prognosis, estimated at 4 months median survival. Since treatment with many chemotherapeutic agents is relatively contraindicated, we assessed the safety, tolerability and potential efficacy of combination chemotherapy with vinorelbine and cisplatin (ViP).
  
  
  METHODS
  Pilot study in 11 patients with histologically confirmed breast carcinoma, radiological evidence of liver metastases and serum bilirubin greater than 1.5 times the upper limit of normal. Patients received up to six cycles of cisplatin (75 mg/m2) every 21 days and vinorelbine (20 mg/m2) on days 1 and 8 of every 21-day cycle. Measurement of liver lesions was performed on CT scan every 8 weeks into treatment.
  
  
  RESULTS
  The most frequently reported adverse event was myelosuppression. Other adverse effects included nausea, vomiting and mild neurotoxicity. Two patients died after one treatment with ViP, one of whom suffered an intracerebral haemorrhage that was possibly treatment-related. Improvement in liver function tests was observed in 10 patients, and mean time to normalization of bilirubin levels was 36 days. Partial responses were documented radiologically in 7 out of 11 patients treated. Median overall survival from trial entry was 6.5 months (range 11-364 days), with one patient alive 13 months from trial entry.
  
  
  CONCLUSIONS
  Normalization of liver function is possible with ViP treatment of metastatic breast cancer, offering the potential to prolong survival. Phase II clinical trials of this regimen in this patient group should include measurement of quality of life in order to assess risk versus benefit.
authors.affiliation: Department of Oncology, Leicester Royal Infirmary, University Hospitals of Leicester, Leicester, LE1 5WW, UK. ras20@le.ac.uk
authors.forename: Ricky A
authors.initials: RA
authors.lastname: Sharma
authors.forename: Marios P
authors.initials: MP
authors.lastname: Decatris
authors.forename: Sundar
authors.initials: S
authors.lastname: Santhanam
authors.forename: Rajarshi
authors.initials: R
authors.lastname: Roy
authors.forename: Ahmed E
authors.initials: AE
authors.lastname: Osman
authors.forename: Christine B
authors.initials: CB
authors.lastname: Clarke
authors.forename: Subhash
authors.initials: S
authors.lastname: Khanna
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: O'Byrne
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001855:Bone Marrow Diseases / Q000139:chemically induced; D001943:Breast Neoplasms / Q000473:pathology*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D017093:Liver Failure / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology*; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000556:secondary*; D008875:Middle Aged; D010865:Pilot Projects; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine