title: A randomised phase II study of docetaxel/oxaliplatin and docetaxel in patients with previously treated non-small cell lung cancer: an Alpe-Adria Thoracic Oncology Multidisciplinary group trial (ATOM 019).
abstract: BACKGROUND
  To date, no combination regimen has proven superior to single agent chemotherapy as a second-line treatment for non-small cell lung cancer (NSCLC).
  
  
  METHODS
  This multicenter, non-comparative randomised phase II trial evaluated the activity of docetaxel (75 mg/m(2) on day 1) with oxaliplatin (70 mg/m(2) on day 2) every 3 weeks in previously treated NSCLC patients; the reference arm was single-agent docetaxel (75 mg/m(2) on day 1 every 3 weeks). It was designed as a one-stage, three-outcome phase II trial; 21 evaluable patients were required in each arm. The primary end-point was response rate; secondary end-points were toxicity, progression free survival (PFS) and overall survival.
  
  
  RESULTS
  Fifty patients were enrolled. Patient characteristics included male/female, 76/24%; median age 62 years; ECOG PS 0/1, 36/64%; previous platinum-based chemotherapy, 98%. Partial response was seen in 20% and 8%, stable disease in 52% and 32%, of patients treated with docetaxel/oxaliplatin and docetaxel, respectively. Main grade 3-4 toxicities were neutropenia 56% and 64%; febrile neutropenia 4% and 8%; diarrhoea 12% and 4% for docetaxel/oxaliplatin and docetaxel, respectively. Median PFS was 5.0 and 1.7 months, median survival 11.0 and 7.1 months, and 1-year survival 44% and 32% for docetaxel/oxaliplatin and docetaxel, respectively.
  
  
  CONCLUSIONS
  The study met its pre-defined study end-point; docetaxel/oxaliplatin and more generally platinum-containing doublets warrant further evaluation as second-line therapy for patients with NSCLC.
authors.affiliation: Department of Medical Oncology, Santa Maria della Misericordia University Hospital, Udine, Italy. ornella.belvedere@gmail.com
authors.forename: Ornella
authors.initials: O
authors.lastname: Belvedere
authors.forename: Alessandro
authors.initials: A
authors.lastname: Follador
authors.forename: Ciro
authors.initials: C
authors.lastname: Rossetto
authors.forename: Valentina
authors.initials: V
authors.lastname: Merlo
authors.forename: Carlotta
authors.initials: C
authors.lastname: Defferrari
authors.forename: Angela M
authors.initials: AM
authors.lastname: Sibau
authors.forename: Marianna
authors.initials: M
authors.lastname: Aita
authors.forename: Maria G
authors.initials: MG
authors.lastname: Dal Bello
authors.forename: Stefano
authors.initials: S
authors.lastname: Meduri
authors.forename: Marica
authors.initials: M
authors.lastname: Gaiardo
authors.forename: Gianpiero
authors.initials: G
authors.lastname: Fasola
authors.forename: Francesco
authors.initials: F
authors.lastname: Grossi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage*; D000077150:Oxaliplatin; D012107:Research Design; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel