title: Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer.
abstract: BACKGROUND
  The Lung Cancer Cetuximab Study is an open-label, randomized phase II pilot study of cisplatin and vinorelbine combined with the epidermal growth factor receptor (EGFR)-targeted monoclonal antibody cetuximab versus cisplatin and vinorelbine alone, in patients with advanced EGFR-expressing, non-small-cell lung cancer (NSCLC). End points of the study are activity, safety and pharmacokinetics.
  
  
  METHODS
  Following randomization, for a maximum of eight cycles, patients received three-weekly cycles of cisplatin (80 mg/m(2), day 1) and vinorelbine (25 mg/m(2) on days 1 and 8) alone or following cetuximab treatment (initial dose 400 mg/m(2), followed by 250 mg/m(2) weekly thereafter).
  
  
  RESULTS
  Eighty-six patients were randomly allocated to the study (43 per arm). Confirmed response rates were 28% in the cisplatin/vinorelbine arm (A) and 35% in the cetuximab plus cisplatin/vinorelbine arm (B). Median progression-free survival (PFS) was 4.6 months in arm A and 5.0 months in arm B, with PFS rates at 12 months of 0% and 15%, respectively. Median survival was 7.3 months in arm A and 8.3 months in arm B. The 24-month survival rates were 0% and 16%, respectively. The cetuximab combination was well tolerated.
  
  
  CONCLUSIONS
  In the first-line treatment of advanced NSCLC, the combination of cetuximab plus cisplatin/vinorelbine demonstrated an acceptable safety profile and the potential to improve activity over cisplatin/vinorelbine alone.
authors.affiliation: Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain. rrosell@ico.scs.es
authors.forename: R
authors.initials: R
authors.lastname: Rosell
authors.forename: G
authors.initials: G
authors.lastname: Robinet
authors.forename: A
authors.initials: A
authors.lastname: Szczesna
authors.forename: R
authors.initials: R
authors.lastname: Ramlau
authors.forename: M
authors.initials: M
authors.lastname: Constenla
authors.forename: B C
authors.initials: BC
authors.lastname: Mennecier
authors.forename: W
authors.initials: W
authors.lastname: Pfeifer
authors.forename: K J
authors.initials: KJ
authors.lastname: O'Byrne
authors.forename: T
authors.initials: T
authors.lastname: Welte
authors.forename: R
authors.initials: R
authors.lastname: Kolb
authors.forename: R
authors.initials: R
authors.lastname: Pirker
authors.forename: A
authors.initials: A
authors.lastname: Chemaissani
authors.forename: M
authors.initials: M
authors.lastname: Perol
authors.forename: M R
authors.initials: MR
authors.lastname: Ranson
authors.forename: P A
authors.initials: PA
authors.lastname: Ellis
authors.forename: K
authors.initials: K
authors.lastname: Pilz
authors.forename: M
authors.initials: M
authors.lastname: Reck
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D000068818:Cetuximab; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology*; D009367:Neoplasm Staging; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014747:Vinblastine; D000068818:Cetuximab; D002945:Cisplatin; D000077235:Vinorelbine