title: Open, randomized, multi-center phase II study comparing efficacy and tolerability of Erlotinib vs. Carboplatin/Vinorelbin in elderly patients (>70 years of age) with untreated non-small cell lung cancer.
abstract: BACKGROUND
  Targeting the epidermal-growth-factor-receptor (EGFR) in non-small cell lung cancer (NSCLC) is an established treatment option with less toxicity compared to conventional chemotherapy. This study was undertaken to determine whether Erlotinib is non-inferior compared to chemotherapy as a first-line therapy in unselected elderly patients.
  
  
  METHODS
  Patients ≥ 70 years with untreated, metastatic NSCLC were randomized to Erlotinib (E), 150 mg/day or Carboplatin (AUC5) plus Vinorelbine (25mg/m(2) on days 1 and 8) every three weeks (CV). Primary endpoint was progression-free survival (PFS). After progression, crossover was strongly recommended. Secondary endpoints were duration of response, 1-year survival, overall survival (OS), response rate (RR), quality of life (FACT-L), assessment of comorbidities by simplified comorbidity score (SCS) and Charlsons' comorbidity score, safety and assessment of molecular markers.
  
  
  RESULTS
  Between June 2006 and August 2008 284 pts were randomized to E (144) and CV (140). PFS was significantly inferior with E (median PFS 2.4 versus 4.6 months [HR 1.6, 75% CI 1.22-2.09, p: 0.0005]) as well as RR (7.8% v 28.3%, p: 0.0001). No significant difference in OS appeared (median E: 7.3 months versus CV: 8.4 months, HR: 1.24 [75% CI 0.9-1.71]). In never smokers PFS (median PFS: 3.7 v 4.3 m, E v CV, HR 0.72, 75% CI 0.35-1.48) and OS (median: 16.5 versus 17 months, HR 0.99 [75% CI 0.38-2.57]) were comparable. More skin toxicity and diarrhea was seen with E compared to more myelotoxicity, neurotoxicity and constipation with CV. Less severe adverse events were observed with E (81 v 102, E v CV).
  
  
  CONCLUSIONS
  CV had an increased efficacy compared with E in an unselected population of elderly patients with advanced NSCLC.
authors.affiliation: Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany. Electronic address: d.heigener@lungenclinic.de.
authors.forename: D F
authors.initials: DF
authors.lastname: Heigener
authors.affiliation: Department of Pulmonology, HELIOS Klinikum Erfurt, Erfurt, Germany.
authors.forename: K M
authors.initials: KM
authors.lastname: Deppermann
authors.affiliation: Department of Pulmonology, Asklepios Klinikum Gauting, Munich, Germany.
authors.forename: J V
authors.initials: JV
authors.lastname: Pawel
authors.affiliation: Department of Oncology, Klinik Löwenstein, Löwenstein, Germany.
authors.forename: J R
authors.initials: JR
authors.lastname: Fischer
authors.affiliation: Department of Pulmonology, Hildegardis Krankenhaus, Mainz, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Kortsik
authors.affiliation: Department of Pulmonology, Universitätsklinikum Schleswig Holstein Campus Lübeck, Member of the German Center for Lung Research (DZL), Lübeck, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Bohnet
authors.affiliation: Department of Internal Medicine, Malteser Hildegardis Krankenhaus Köln, Köln, Germany.
authors.forename: M V
authors.initials: MV
authors.lastname: Eiff
authors.affiliation: Department of Oncology, Kliniken Essen-Mitte Essen, Essen, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Koester
authors.affiliation: Thoracic Oncology, Thoraxklinik of Heidelberg University, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Department of Pathology, Thoraxklinik of Heidelberg University, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
authors.forename: P A
authors.initials: PA
authors.lastname: Schnabel
authors.affiliation: Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Reck
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; 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* / Q000401:mortality / Q000473:pathology; D066246:ErbB Receptors / Q000235:genetics; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D009154:Mutation; D009367:Neoplasm Staging; D011799:Quinazolines / Q000008:administration & dosage / Q000627:therapeutic use*; D012307:Risk Factors; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D011799:Quinazolines; D014747:Vinblastine; D016190:Carboplatin; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors; D000077235:Vinorelbine
keywords: Chemotherapy; Elderly; Erlotinib; NSCLC