title: Carboplatin and gemcitabine in the palliative treatment of stage IV non-small cell lung cancer: definitive results of a phase II trial.
abstract: BACKGROUND
  Cisplatin-containing regimens represent the gold standard in the treatment of advanced non-small cell lung cancer, but carboplatin is often preferred for its better toxic profile when palliation is the aim of the treatment. The synergistic effect and tolerability of carboplatin-gemcitabine combination are well known. In this phase II trial, we evaluated the activity and safety of a schedule with carboplatin and gemcitabine, defined in our previous phase I trial.
  
  
  METHODS
  Thirty-seven patients with measurable stage IV non-small cell lung cancer were treated with carboplatin, AUC 4.5 mg/ml/min on day 1, and gemcitabine, 800 mg/m2 on days 1 and 8, every 21 days. All patients were treated until disease progression or intractable toxicity and were evaluated before each course of chemotherapy for toxicity and after every 3 courses for response.
  
  
  RESULTS
  After a median follow-up of over 10 months, complete response, partial response, and stabilization of the disease were observed in 3 (8.1%), 9 (24.3%), and 15 patients (40.5%), respectively. Median time to progression was 7 months. At this writing, 27 patients have died, with a median survival of 10 months, and 29 (78.3%), 16 (43.2%), and 11 (29.7%) patients are alive after 6, 12, and 15 months of follow-up, respectively. Toxicity was mild, and mainly hematological, with a significant correlation with the number of courses of chemotherapy (P = 0.0003).
  
  
  CONCLUSIONS
  Our results are comparable with those reported in the literature and confirm the good activity and tolerability of the carboplatin-gemcitabine combination. Up to 4 courses of chemotherapy with carboplatin and gemcitabine may represent an interesting option in the palliative treatment of non-small cell lung cancer.
authors.affiliation: Department of Oncology, City Hospital, Rimini, Italy. dtassinari@rimini.com
authors.forename: Davide
authors.initials: D
authors.lastname: Tassinari
authors.forename: Francesca
authors.initials: F
authors.lastname: Fochessati
authors.forename: Valentina
authors.initials: V
authors.lastname: Arcangeli
authors.forename: Sergio
authors.initials: S
authors.lastname: Sartori
authors.forename: Vanessa
authors.initials: V
authors.lastname: Agostini
authors.forename: Manuela
authors.initials: M
authors.lastname: Fantini
authors.forename: Giovenzio
authors.initials: G
authors.lastname: Genestreti
authors.forename: Sergio
authors.initials: S
authors.lastname: Grassia
authors.forename: Giorgio
authors.initials: G
authors.lastname: Ioli
authors.forename: Manuela
authors.initials: M
authors.lastname: Imola
authors.forename: Domenico
authors.initials: D
authors.lastname: Iorio
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Mianulli
authors.forename: Giancarla
authors.initials: G
authors.lastname: Monticelli
authors.forename: Giovanni
authors.initials: G
authors.lastname: Oliverio
authors.forename: Ilaria
authors.initials: I
authors.lastname: Panzini
authors.forename: Maximilian
authors.initials: M
authors.lastname: Papi
authors.forename: Barbara
authors.initials: B
authors.lastname: Poggi
authors.forename: Antonio
authors.initials: A
authors.lastname: Polselli
authors.forename: Stefano
authors.initials: S
authors.lastname: Pulini
authors.forename: Emiliano
authors.initials: E
authors.lastname: Tamburini
authors.forename: Pier Paolo
authors.initials: PP
authors.lastname: Fattori
authors.forename: Alberto
authors.initials: A
authors.lastname: Ravaioli
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010166:Palliative Care / Q000379:methods*; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine