title: Meta-analysis of published efficacy and safety data for docetaxel in second-line treatment of patients with advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  To gain a better understanding of the impact of dose and other prognostic factors on safety and efficacy of docetaxel in second-line non-small-cell lung cancer patients.
  
  
  METHODS
  A model-based meta-analysis (MBMA) of a published docetaxel monotherapy data in 6085 second-line non-small-cell lung cancer patients from 46 trials was conducted.
  
  
  RESULTS
  The logit of grade 3/4 neutropenia incidence was a linear function of dose, with a 5% increase in the odds of neutropenia per mg/m(2) increase in dose [odds ratio (OR) 1.05, 95% confidence interval (CI) 1.04-1.06], and a Japanese study effect (OR 17.1, 95% CI 6.05-48.4). The logit of overall response rate (ORR) was a linear function of cumulative dose (0.4% increase in the odds of response per mg/m(2) increase; OR 1.004, 95% CI 1.001-1.008) and median population age (OR 1.08 per year, 95% CI 1.02-1.15). A Japanese study effect was identified for overall survival (OS) in addition to prognostic factors identified by a previous meta-analysis.
  
  
  CONCLUSIONS
  This current MBMA identified docetaxel dose-response relationships for both neutropenia and ORR, an effect of age on ORR, and Japanese study effects on both neutropenia and OS.
authors.affiliation: Department of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA. strohm@gene.com.
authors.forename: Mark
authors.initials: M
authors.lastname: Stroh
authors.affiliation: Drug Development Consulting Services, Quantitative Solutions, Menlo Park, CA, USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Green
authors.affiliation: Clinical Science, Genentech, Inc., South San Francisco, CA, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Cha
authors.affiliation: Drug Development Consulting Services, Quantitative Solutions, Menlo Park, CA, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Zhang
authors.affiliation: Drug Development Consulting Services, Quantitative Solutions, Menlo Park, CA, USA.
authors.forename: Russ
authors.initials: R
authors.lastname: Wada
authors.affiliation: Department of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
authors.forename: Jin
authors.initials: J
authors.lastname: Jin
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D011379:Prognosis; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel
keywords: Docetaxel; Dose–response; Model-based meta-analysis; Non‐small‐cell lung cancer