title: A retrospective analysis of outcomes by age in a three-arm phase III trial of gemcitabine in combination with carboplatin or paclitaxel vs. paclitaxel plus carboplatin for advanced non-small cell lung cancer.
abstract: OBJECTIVE
  Sufficient data are currently unavailable to assist in defining suitable regimens for patients ≥ 70 years with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Chemonaïve patients with a performance status (PS) of 0 or 1 and stage IIIB or IV NSCLC were randomized to gemcitabine 1000mg/m(2) on days 1 and 8 plus carboplatin area under the curve (AUC) 5.5 on day 1; the same schedule of gemcitabine plus paclitaxel 200mg/m(2) on day 1; or paclitaxel 225mg/m(2) on day 1 plus carboplatin AUC 6.0 on day 1. Cycles were every 21 days up to 6. Efficacy and toxicity results were compared by age groups.
  
  
  RESULTS
  Overall survival (OS) between patients <70 years (8.6 months, 95% CI: 7.9, 9.5) and ≥ 70 years (7.9 months, 95% CI: 7.1, 9.5) was similar. OS was 8.8 months (95% CI: 7.5, 10.3) among patients 70-74 years, 6.5 months (95% CI: 5.6, 9.3) among patients 75-79 years, and 7.9 months (95% CI: 6.3, 10.3) among patients ≥ 80 years. OS was lower among patients 75-79 years compared with patients 70-74 years (P=0.04). Compared with patients <70 years, patients ≥ 70 years experienced similar rates of myelosuppresion, but younger patients experienced more vomiting and nausea. There was no clear pattern with respect to differences in efficacy by treatments across age groups.
  
  
  CONCLUSIONS
  Based on the similarity of patient outcomes across age groups, doublet chemotherapy is feasible among carefully selected elderly patients with good PS.
authors.affiliation: Northern Indiana Cancer Research Consortium, South Bend, IN 46601-1169, United States. lwassner@mhopc.com
authors.forename: Rafat H
authors.initials: RH
authors.lastname: Ansari
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Edelman
authors.forename: Chandra P
authors.initials: CP
authors.lastname: Belani
authors.forename: René
authors.initials: R
authors.lastname: Gonin
authors.forename: Robert B
authors.initials: RB
authors.lastname: Catalano
authors.forename: Donna M
authors.initials: DM
authors.lastname: Marinucci
authors.forename: Robert L
authors.initials: RL
authors.lastname: Comis
authors.forename: Coleman K
authors.initials: CK
authors.lastname: Obasaju
authors.forename: Ruqin
authors.initials: R
authors.lastname: Chen
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Monberg
authors.forename: Joseph
authors.initials: J
authors.lastname: Treat
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; 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* / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D016190:Carboplatin; D017239:Paclitaxel; D000093542:Gemcitabine