title: Gemcitabine, ifosfamide and vinorelbine in advanced non-small cell lung cancer: a phase II study.
abstract: BACKGROUND
  The objective of this phase II study was to determine the activity and toxicity of gemcitabine, ifosfamide and vinorelbine, in the treatment of patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Chemotherapy-naïve patients with unresectable, stage IIIB and stage IV NSCLC, measurable lesions and an Eastern Cooperative Oncology Group (ECOG) performance status < or = 3, were entered into the trial. The treatment consisted of ifosfamide 1500 mg/m2 on days 1 to 3 with vinorelbine 25 mg/m2 and gemcitabine 1000 mg/m2 on days 3 and 8, every 3 weeks.
  
  
  RESULTS
  Fifty-four patients with stage IIIB (24%) and stage IV (76%) were enrolled into the trial. The median age of the patients was 65 years. The performance status was 0-1, 2 and 3 in 48%, 43% and 9% of patients, respectively. The histology was mainly squamous cell carcinoma (52%), which was poorly-differentiated in 30% of patients. All patients, receiving a total of 249 chemotherapy courses, were assessable for response and toxicity on an intent-to-treat basis. Objective responses included complete response in 3 (5.6%) patients (95% CI: 1.1% to 15.3%), partial response in 26 (48.1%) patients (95% CI: 34.3% to 62.2%), giving an overall response rate of 53.7% (95% CI: 39.6% to 674%). Stable disease was observed in 20 (37%) patients (95% CI: 24.3% to 51.2%) and progressive disease in 5 (9.3%) patients (95% CI: 3% to 20.3%). The median time to progression was 8.8 months (range: 2-55+ months). The median overall survival was 13.2 months (range: 2-55+). The 1-year survival rate was 56% for all patients, comprising 78% and 47% for stage IIIB and stage IV patients, respectively (p=0.088). Myelosuppression was the main side-effect with (WHO) grade 3/4 neutropenia and thrombocytopenia in 56% and 13% of the patients, respectively.
  
  
  CONCLUSIONS
  Our results showed that even patients with a poor performance status may benefit from gemcitabine, ifosfamide and vinorelbine treatment, with acceptable toxicity.
authors.affiliation: Unità operativa di Oncologia, Ospedale Civile di Avezzano, Università degli studi di L'Aquila, Italy. franre@ermes.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Recchia
authors.forename: Marco
authors.initials: M
authors.lastname: Lombardo
authors.forename: Sandro
authors.initials: S
authors.lastname: De Filippis
authors.forename: Michele
authors.initials: M
authors.lastname: Rosselli
authors.forename: Silvio
authors.initials: S
authors.lastname: Rea
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D007069:Ifosfamide; D000093542:Gemcitabine