title: A phase II study of the docetaxel-ifosfamide-carboplatin combination in advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  In the present phase II study we evaluated the docetaxel-ifosfamide-carboplatin (DICb) combination in the outpatient setting in patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with advanced NSCLC (stages IIIB/IV), WHO performance status (PS) <2, and no prior chemotherapy were eligible. Chemotherapy drug doses were: docetaxel: 80 mg/m2, ifosfamide: 3.5 g/m2, and carboplatin at a target area under the curve of 5 (based on Calvert's formula), all on day 1, followed by prophylactic G-CSF.
  
  
  RESULTS
  Fourty patients were entered and all are evaluable for response and toxicity: median age: 64 (48-72); PS: 1 (0-1); gender: 29 males/11 females; stages: IIIB: 13 (33%), IV: 27 (67%). Metastatic sites at diagnosis included: lymph nodes: 25; bone: 7; liver: 4; brain: 5; lung nodules: 13; adrenals: 6. Responses were as follows: 22/40 [55%; 95% confidence interval (CI), 54-81%] evaluable patients responded: 4 complete responses, 18 partial responses, 11 had stable disease, and 7 had progressive disease. The median response duration was 7 months (range 2-14 months), median time to progression 9 months (range 2-18 months) and median overall survival 11 months (range 3-46+ months). 1-year survival was 47.5%. Grade 3/4 toxicities included: neutropenia 28/40, with 12 developing grade 4 and 12% febrile neutropenia, thrombocytopenia grade 3: 3/40 and grade 4: 1/40, no grade 3 neuropathy, grade 1 CNS toxicity in 3, no renal toxicity, 8 grade 2 diarrhea and 4 grade 3 vomiting.
  
  
  CONCLUSIONS
  In the present phase II study the DICb combination yielded important activity and good tolerability in advanced NSCLC.
authors.affiliation: Department of Medicine, Second Division of Medical Oncology, Metaxa Memorial Hospital, Piraeus, and Athens University School of Medicine, Greece. ckosm@ath.forthnet.gr
authors.forename: Christos
authors.initials: C
authors.lastname: Kosmas
authors.forename: Nicolas
authors.initials: N
authors.lastname: Tsavaris
authors.forename: Aggelos
authors.initials: A
authors.lastname: Koutras
authors.forename: Thomas
authors.initials: T
authors.lastname: Makatsoris
authors.forename: Nicolas
authors.initials: N
authors.lastname: Mylonakis
authors.forename: George
authors.initials: G
authors.lastname: Tzelepis
authors.forename: Antonis
authors.initials: A
authors.lastname: Dimitrakopoulos
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Spyropoulos
authors.forename: Aristidis
authors.initials: A
authors.lastname: Polyzos
authors.forename: Athanasios
authors.initials: A
authors.lastname: Karabelis
authors.forename: Haralambos P
authors.initials: HP
authors.lastname: Kalofonos
mesh_terms: D000206:Actuarial Analysis; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011788:Quality of Life; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin; D007069:Ifosfamide