title: Phase II study of cisplatin preceding gemcitabine in patients with advanced oesophageal cancer.
abstract: BACKGROUND
  For oesophageal cancer there is no effective standard therapy. We studied the feasibility and efficacy of the cisplatin-gemcitabine combination chemotherapy in patients with unresectable oesophageal cancer.
  
  
  METHODS
  Thirty-six chemonaïve patients with unresectable or metastatic oesophageal adenocarcinoma (24) or squamous-cell-carcinoma (12) were treated with cisplatin (50 mg/m2, days 1 and 8), followed by gemcitabine (800 mg/m2, days 2, 9 and 16), every 28 days. Feasibility and efficacy were studied.
  
  
  RESULTS
  Toxicity was substantial but manageable. A median number of four therapy cycles was given. The most frequent grade > or = 3 toxicities were leukopenia (75%) and neutropenia (83%). Three patients developed neutropenic fever. Grade 3/4 thrombocytopenia occurred in 24 out of 36 patients (67%), but did not result in serious bleeding disorders. Myelotoxicity was cumulative and required omission of gemcitabine on day 16 in 63% of cycles. Anaemia required treatment with erythropoietin, red blood cells or both in 81% of patients. Non-haematological toxicity consisted mainly of grade 1/2 nausea/vomiting or fatigue. Fourteen out of 34 evaluable patients had a major objective response (41%; two complete and 12 partial responses). The median actuarial survival was 9.8 months.
  
  
  CONCLUSIONS
  This cisplatin-gemcitabine regimen was feasible, with myelosupression being the main toxicity, and had significant activity in patients with advanced oesophageal cancer.
authors.affiliation: Department of Medical Oncology, VU Medical Centre, Amsterdam, The Netherlands. jr_kroep@hotmail.com
authors.forename: J R
authors.initials: JR
authors.lastname: Kroep
authors.forename: H M
authors.initials: HM
authors.lastname: Pinedo
authors.forename: G
authors.initials: G
authors.lastname: Giaccone
authors.forename: A
authors.initials: A
authors.lastname: Van Bochove
authors.forename: G J
authors.initials: GJ
authors.lastname: Peters
authors.forename: C J
authors.initials: CJ
authors.lastname: Van Groeningen
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine