title: Fixed dose-rate infusion of gemcitabine in combination with cisplatin and UFT in advanced carcinoma of the pancreas.
abstract: BACKGROUND
  Gemcitabine is currently considered the standard treatment for advanced pancreatic cancer (APC). Cisplatin and a fluoropyrimidine have some activity in the treatment of this cancer. The aim of this trial is to evaluate the efficacy and toxicity of a fixed dose-rate infusion of gemcitabine associated with cisplatin and UFT in patients with APC.
  
  
  METHODS
  Forty-six chemotherapy-naïve patients with APC that was either unresectable or metastatic were included in this phase II study. All of them had Karnofsky performance status > or =50 and unidimensionally measurable disease. Treatment consisted of gemcitabine 1,200 mg/m2 given as a 120-min infusion weekly for three consecutive weeks, cisplatin 50 mg/m2 on day 1 and oral UFT 400 mg/m2/day (in two to three daily doses) on days 1 to 21; cycles of treatment were given every 28 days.
  
  
  RESULTS
  A total of 208 cycles of chemotherapy were given with a median of 4 per patient. Fourteen patients (30%) achieved partial responses (95% CI 19-48%) and 17 (37%) had stable disease. The median time to progression was 5 months, and the median overall survival 9 months. Nineteen patients (49%; 95% CI 32-64%) had a clinical benefit response. Grade 3-4 WHO toxicities were as follows: neutropaenia in 26 patients (57%), with 5 cases of febrile neutropaenia (11%), thrombocytopaenia in 15 (33%), anaemia in six (13%), diarrhoea in 5 (11%), asthenia in 2 (4%) and mucositis in 1 (2%). Seven patients required hospitalisation for treatment-related complications.
  
  
  CONCLUSIONS
  A fixed dose-rate infusion of gemcitabine associated with cisplatin and UFT is active in patients with APC, though at the cost of considerable toxicity.
authors.affiliation: Servicio de Oncología Médica, Hospital La Paz, Paseo de la Castellana, 261, 28046, Madrid, Spain. jfeliu.hulp@salud.madrid.org
authors.forename: J
authors.initials: J
authors.lastname: Feliu
authors.forename: J García
authors.initials: JG
authors.lastname: Sáenz
authors.forename: A Rodríguez
authors.initials: AR
authors.lastname: Jaráiz
authors.forename: C
authors.initials: C
authors.lastname: Castañón
authors.forename: M
authors.initials: M
authors.lastname: Cruz
authors.forename: E
authors.initials: E
authors.lastname: Fonseca
authors.forename: M
authors.initials: M
authors.lastname: Lomas
authors.forename: J
authors.initials: J
authors.lastname: Castro
authors.forename: C
authors.initials: C
authors.lastname: Jara
authors.forename: E
authors.initials: E
authors.lastname: Casado
authors.forename: A
authors.initials: A
authors.lastname: León
authors.forename: M González
authors.initials: MG
authors.lastname: Barón
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D005641:Tegafur; D014498:Uracil; D002945:Cisplatin; D000093542:Gemcitabine