title: A randomized phase II trial of two schedules of docetaxel in elderly or poor performance status patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  We conducted a multicenter randomized phase II trial to evaluate two schedules of single-agent docetaxel in the first-line treatment of elderly and performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Patients 70 years of age and older with a PS 0-1 or patients of any age and PS 2 were randomly assigned to docetaxel 75 mg/m2 on day 1 every 3 weeks or 30 mg/m2 on days 1, 8, and 15 every 28 days. The primary end point was frequency of grade 3/4 toxicities. Health-related quality of life, response, and survival were secondary end points.
  
  
  RESULTS
  Fifty-five patients were randomized to received docetaxel every 3 weeks and 56 to receive docetaxel weekly. Hematologic toxicity, primarily grade 3/4 neutropenia, was significantly lower in the weekly schedule (0% versus 44%; p < 0.001). Health-related quality of life was similar between the two arms. Efficacy parameters were not significantly different, with a trend toward better survival in the weekly schedule group (6.7 versus 3.5 months). Patients with PS 0-1 had a significantly longer survival compared with PS 2 patients (7.8 versus 2.9 months; p < 0.001). A subset analysis of 30 octogenarian patients revealed similar outcomes as in 70- to 79-year-old patients.
  
  
  CONCLUSIONS
  Weekly docetaxel is associated with less neutropenia and a trend toward improved survival in elderly or PS 2 patients. PS rather than age is the primary determinant of outcome in this population. Octogenarians benefited from weekly docetaxel. Future studies should separate elderly patients from PS 2 patients.
authors.affiliation: Mount Sinai Cancer Center, Miami Beach, FL 33140, USA. rlilenbaum@aptiumoncology.com
authors.forename: Rogerio
authors.initials: R
authors.lastname: Lilenbaum
authors.forename: Mark
authors.initials: M
authors.lastname: Rubin
authors.forename: Joyce
authors.initials: J
authors.lastname: Samuel
authors.forename: Laszlo
authors.initials: L
authors.lastname: Boros
authors.forename: Tarek
authors.initials: T
authors.lastname: Chidiac
authors.forename: Leonard
authors.initials: L
authors.lastname: Seigel
authors.forename: Afshin
authors.initials: A
authors.lastname: Dowlati
authors.forename: Patricia
authors.initials: P
authors.lastname: Graham
authors.forename: Jennifer
authors.initials: J
authors.lastname: Beaumont
authors.forename: Hongyan
authors.initials: H
authors.lastname: Du
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D016014:Linear Models; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced / Q000453:epidemiology; D011336:Probability; D016016:Proportional Hazards Models; D012307:Risk Factors; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel