title: Randomized, multicenter, phase II study of gemcitabine plus cisplatin versus gemcitabine plus carboplatin in patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  We conducted a phase II randomized study to assess the efficacy, with response as the primary endpoint, and the toxicity of gemcitabine/cisplatin (GP) and gemcitabine/carboplatin (GC) in patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Patients were randomized to GP (gemcitabine 1200 mg/m(2), days 1 and 8 plus cisplatin 80 mg/m(2) day 2) or GC (gemcitabine 1200 mg/m(2), days 1 and 8 plus carboplatin AUC=5 day 2). Cycles were repeated every 3 weeks.
  
  
  RESULTS
  Sixty-two patients were randomized to GP and 58 to GC. A total of 533 cycles were delivered (264 GP, 269 GC), with a median of four cycles/patient. The objective response rate was 41.9% (95% C.I., 29.6-54.2%) for GP and 31.0% (95% C.I., 18.2-42.8%) for GC (P=0.29). No significant differences between arms were observed in median survival (10.4 months GP, 10.8 months GC) and median time to progression (5.4 months GP, 5.1 months GC). Both regimens were very well tolerated with no statistical differences between arms in grade 3/4 toxicities. When all toxicity grades were combined, emesis, neuropathy and renal toxicity occurred more frequently on the GP arm (P<0.005).
  
  
  CONCLUSIONS
  GC arm did not provide a significant difference in response rate compared with GP arm, with better overall tolerability. Carboplatin could be a valid alternative to cisplatin in the palliative setting.
authors.affiliation: Department of Medical Oncology, Azienda Ospedaliera Umberto I, via Conca, 60122 Torrette di Ancona, Italy. p.mazzanti@ao-umbertoprimo.marche.it
authors.forename: Paola
authors.initials: P
authors.lastname: Mazzanti
authors.forename: Cristian
authors.initials: C
authors.lastname: Massacesi
authors.forename: Marco B L
authors.initials: MB
authors.lastname: Rocchi
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Mattioli
authors.forename: Paolo
authors.initials: P
authors.lastname: Lippe
authors.forename: Raffaele
authors.initials: R
authors.lastname: Trivisonne
authors.forename: Franco
authors.initials: F
authors.lastname: Buzzi
authors.forename: Giorgio
authors.initials: G
authors.lastname: De Signoribus
authors.forename: Guido
authors.initials: G
authors.lastname: Tuveri
authors.forename: Giorgio
authors.initials: G
authors.lastname: Rossi
authors.forename: Liberato
authors.initials: L
authors.lastname: Di Lullo
authors.forename: Fabio
authors.initials: F
authors.lastname: Sturba
authors.forename: Donatella
authors.initials: D
authors.lastname: Morale
authors.forename: Sergio
authors.initials: S
authors.lastname: Catanzani
authors.forename: Alberta
authors.initials: A
authors.lastname: Pilone
authors.forename: Maurizio
authors.initials: M
authors.lastname: Bonsignori
authors.forename: Tullio
authors.initials: T
authors.lastname: Battelli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D003841:Deoxycytidine; D016190:Carboplatin; D002945:Cisplatin; D000093542:Gemcitabine