title: A randomised multicentre phase II study with cisplatin/docetaxel vs oxaliplatin/docetaxel as first-line therapy in patients with advanced or metastatic non-small cell lung cancer.
abstract: BACKGROUND
  This study was designed to compare cisplatin/docetaxel with oxaliplatin/docetaxel in patients with advanced and metastatic non-small lung cancer as a first-line treatment.
  
  
  METHODS
  Patients were randomly assigned to receive either cisplatin 75 mg m(-2) and docetaxel 75 mg m(-2) every 3 weeks or oxaliplatin 85 mg m(-2) and docetaxel 50 mg m(-2) every 2 weeks. The primary end point was response rate, and secondary end points were toxicity, time to progression and overall survival.
  
  
  RESULTS
  A total of 88 patients (median age: 65 (39-86) years; stage IV: 93%) were randomly assigned. Response rate (complete and partial response) was 47% (95% CI: 33-61%) in the cisplatin/docetaxel arm and 28% (95% CI: 17-43%) in the oxaliplatin/docetaxel arm (P=0.118). There was no significant difference in time to progression (6.3 vs 4.9 months, P=0.111) and median overall survival (11.6 vs 7.0 months, P=0.102) with cisplatin/docetaxel vs oxaliplatin/docetaxel, although slight trends favouring cisplatin were seen. Oxaliplatin/docetaxel was associated with significantly less (any grade) renal toxicity (56% vs 11%), any grade fatigue (81% vs 59%), complete alopecia (76% vs 27%), any grade leukopenia (84% vs 61%) and grade 3/4 leukopenia (44% vs 14%) and neutropenia (56% vs 27%).
  
  
  CONCLUSIONS
  Oxaliplatin/docetaxel has activity in metastatic non-small cell lung cancer, but it seems to be inferior to cisplatin/docetaxel.
authors: Department of Hematology and Oncology, Institute of Clinical Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, 60488 Frankfurt am Main, Germany. atmaca.akin@khnw.de
authors: A
authors: A
authors: Atmaca
authors: S-E
authors: SE
authors: Al-Batran
authors: D
authors: D
authors: Werner
authors: C
authors: C
authors: Pauligk
authors: T
authors: T
authors: Güner
authors: A
authors: A
authors: Koepke
authors: H
authors: H
authors: Bernhard
authors: T
authors: T
authors: Wenzel
authors: A-G
authors: AG
authors: Banat
authors: P
authors: P
authors: Brueck
authors: K
authors: K
authors: Caca
authors: N
authors: N
authors: Prasnikar
authors: F
authors: F
authors: Kullmann
authors: H
authors: H
authors: Günther Derigs
authors: M
authors: M
authors: Koenigsmann
authors: G
authors: G
authors: Dingeldein
authors: T
authors: T
authors: Neuhaus
authors: E
authors: E
authors: Jäger
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077150:Oxaliplatin; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel; D000068258:Bevacizumab; D002945:Cisplatin