title: Elderly subgroup analysis of a randomized phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for first-line treatment of advanced nonsmall cell lung carcinoma (TAX 326).
abstract: BACKGROUND
  Controversy continues over whether elderly patients with advanced nonsmall cell lung carcinoma (NSCLC) should receive platinum-based chemotherapy. TAX 326 reported improved survival with docetaxel-cisplatin (DC) versus vinorelbine-cisplatin (VC) for advanced NSCLC. DC and docetaxel-carboplatin (DCb) were better tolerated than VC. We analyzed the efficacy and toxicity in patients ages < 65 and > or = 65 years.
  
  
  METHODS
  Chemotherapy-naive, TNM Stage IIIB-IV NSCLC patients were randomized to DC (docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2), d1 q3w), DCb (docetaxel 75 mg/m(2) and carboplatin area under the concentration-time curve 6 mg/mL.min, d1 q3w), or VC (vinorelbine 25 mg/m(2), d1, 8, 15, and 22 and cisplatin 100 mg/m(2), d1 q4w).
  
  
  RESULTS
  Of 1218 patients, 401 were age > or = 65 years (149/118/134 DC/DCb/VC arms). In the elderly, median survival was 12.6 versus 9.9 months, 1-year survival was 52% versus 41%, 2-year survival was 24% versus 17% for DC versus VC, respectively. DCb survival results were similar to those for VC: median, 9.0 months; 1-year, 38%; 2-year, 19%. Survival outcomes were similar between elderly and younger patients across treatment arms. Compared with younger patients, elderly patients reported moderately higher incidences of NCI CTC (version 1.0) Grade 3-4 asthenia, infection, and pulmonary toxicities across treatment arms, and diarrhea and sensory neurotoxicity for cisplatin-containing arms. Most hematologic toxicities occurred with similar incidences between elderly and younger patients, although neutropenia was slightly increased in elderly patients.
  
  
  CONCLUSIONS
  First-line docetaxel-cisplatin chemotherapy showed similar activity in elderly and younger patients with advanced/metastatic NSCLC; elderly patients tolerated docetaxel-platinum well despite experiencing slightly more toxicity than younger patients.
authors.affiliation: Lung and Thoracic Malignancies Program, University of Pittsburgh Cancer Institute, PA 15232, USA. belanicp@upmc.edu
authors.forename: Chandra P
authors.initials: CP
authors.lastname: Belani
authors.forename: Frank
authors.initials: F
authors.lastname: Fossella
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; 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; D009367:Neoplasm Staging; D018570:Risk Assessment; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine