title: Pegylated liposomal doxorubicin, 5-fluorouracil and cisplatin versus mitomycin-C, 5-fluorouracil and cisplatin for advanced gastric cancer: a randomized phase II trial.
abstract: OBJECTIVE
  Clinical data suggested that a regimen incorporating doxorubicin to 5-fluorouracil (5-FU) and cisplatin may be more effective but probably quite toxic for advanced gastric cancer patients. With the aim to maintain efficacy while reducing toxicity, we compared the activity and safety of a combination of 5-FU, cisplatin and pegylated liposomal doxorubicin with a combination of 5-FU, cisplatin and mitomycin-C.
  
  
  METHODS
  Seventy-eight patients were randomised to receive 5-FU (400 mg/m(2) bolus, 600 mg/m(2) 22 h continuous infusion day 1 and 2) and cisplatin (50 mg/m(2) day 1) every 2 weeks, combined either with pegylated liposomal doxorubicin (20 mg/m(2) day 1 every two weeks) (arm A) or mitomycin-C (7 mg/m(2) every 6 weeks) (arm B).
  
  
  RESULTS
  The overall response rate was 64.1% in arm A and 38.5% in arm B (P = 0.041). The median time to tumour progression and overall survival were 7.93 and 5.14 months (P = 0.04) and 12.1 and 8.3 months (P = 0.02) in arm A and B, respectively. Fourteen patients in arm A and 18 patients in arm B experienced a grade 3/4 toxic effect.
  
  
  CONCLUSIONS
  A combination of pegylated liposomal doxorubicin, cisplatin and 5-FU can be safely administered in gastric cancer patients with a promising efficacy profile.
authors.affiliation: Clinica di Oncologia Medica, AO Ospedali Riuniti, Università Politecnica delle Marche, Via Conca, 60020 Ancona, Italy. cascinu@yahoo.com
authors.forename: Stefano
authors.initials: S
authors.lastname: Cascinu
authors.forename: Eva
authors.initials: E
authors.lastname: Galizia
authors.forename: Roberto
authors.initials: R
authors.lastname: Labianca
authors.forename: Francesco
authors.initials: F
authors.lastname: Ferraù
authors.forename: Francesca
authors.initials: F
authors.lastname: Pucci
authors.forename: Rosa Rita
authors.initials: RR
authors.lastname: Silva
authors.forename: Gabriele
authors.initials: G
authors.lastname: Luppi
authors.forename: Giordano Domenico
authors.initials: GD
authors.lastname: Beretta
authors.forename: Rossana
authors.initials: R
authors.lastname: Berardi
authors.forename: Mario
authors.initials: M
authors.lastname: Scartozzi
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000009:adverse effects / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D013270:Stomach; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D016685:Mitomycin; D004317:Doxorubicin; D002945:Cisplatin; D005472:Fluorouracil