title: Docetaxel and carboplatin is an active regimen in advanced non-small-cell lung cancer: a phase II study in Caucasian and Asian patients.
abstract: BACKGROUND
  The purpose of this study was to report response rates, survival and toxicity in advanced non-small-cell lung cancer (NSCLC) following docetaxel and carboplatin, and to explore potential differences in these end points between Caucasian and Asian patients.
  
  
  METHODS
  Sixty-eight patients of good performance status with Stage IIIB or IV NSCLC were entered on a phase II study at three sites in Australia and Singapore. Docetaxel 75 mg/m2 and carboplatin AUC 6 were given every 3 weeks. Response to treatment and toxicity were graded by standard criteria. The Kaplan-Meier method was used to estimate survival rates, and subgroups compared by the log-rank test. Cox's proportional hazards regression was used to determine which potentially explanatory variables independently affected the outcome.
  
  
  RESULTS
  The response rate was 39% (95% confidence interval 27% to 52%), and 42% in evaluable patients. Response occurred in 65% of Asian and 31% of Caucasian patients (P = 0.01). Ethnicity was the only significant predictor of response in multivariate analysis. The 1-year survival rate was 53%. Performance status (P = 0.021), ethnicity (P = 0.035) and presence of bone or liver metastases (P = 0.011) were independent predictors of overall survival. Neutropenia (grade IV in 73% of patients), febrile neutropenia (26% patients) and diarrhea (grade III/IV in 11% of patients) were the major treatment related toxicities. A high rate (three of six) of febrile neutropenia in Singapore, including one treatment-related death in the initial patients treated, resulted in a reduction in the carboplatin dose to AUC 4.5 at that site.
  
  
  CONCLUSIONS
  This regimen is active in advanced NSCLC. The potential impact of ethnicity on efficacy and toxicity of treatment requires further investigation.
authors.affiliation: Cancer Therapeutics Research Group, Sydney Cancer Centre, Sydney, Australia. michaelm@canc.rpa.cs.nsw.gov.au
authors.forename: M J
authors.initials: MJ
authors.lastname: Millward
authors.forename: M J
authors.initials: MJ
authors.lastname: Boyer
authors.forename: M
authors.initials: M
authors.lastname: Lehnert
authors.forename: S
authors.initials: S
authors.lastname: Clarke
authors.forename: D
authors.initials: D
authors.lastname: Rischin
authors.forename: B-C
authors.initials: BC
authors.lastname: Goh
authors.forename: J
authors.initials: J
authors.lastname: Wong
authors.forename: E
authors.initials: E
authors.lastname: McNeil
authors.forename: J F
authors.initials: JF
authors.lastname: Bishop
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000208:ethnology* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000208:ethnology* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D044465:White People
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin