title: Efficacy and safety of oxaliplatin and docetaxel in patients with locally advanced and metastatic non-small-cell lung cancer (NSCLC).
abstract: OBJECTIVE
  Platinum-based doublets are recommended as treatment for advanced or metastatic non-small-cell lung cancer (NSCLC); however, chemotherapy must be tailored to limit side effects. A phase II study was conducted to evaluate the efficacy and safety of oxaliplatin combined with docetaxel for NSCLC.
  
  
  METHODS
  Patients with stage IIIB or IV, chemotherapy-naive NSCLC received docetaxel 70 mg/m(2), oxaliplatin 130 mg/m(2), and pegfilgrastim 6 mg every 21 days for up to six cycles. Primary endpoint was overall response rate (ORR), secondary endpoints were progression-free (PFS) and overall survival (OS), and safety.
  
  
  RESULTS
  Twenty-nine patients were treated; 93% had stage IV disease and 28% had brain metastases. In 27 evaluable patients with follow-up, there were 10 partial responses for an ORR of 37% (90% confidence interval [CI], 22-55%). Median PFS was 4.6 months (95% CI, 2.6-6.5 months); 12-month PFS was 14.8% (95% CI, 3.4-34.0%). Median OS was 10.9 months (95% CI, 8.9-16.8 months); 12-month OS was 40% (95% CI, 19-61%) and 18-month OS was 16% (95% CI, 1-46%). In 29 treated patients, there were no unusual or unexpected adverse events. The most common grade 3 and 4 toxicities were anemia (14% of patients) and hyperglycemia (10%); there were only two reports of neutropenia; both were grade 1 or 2.
  
  
  CONCLUSIONS
  These phase II findings suggest that the combination of oxaliplatin and docetaxel is active and well tolerated, and should be further investigated as a feasible treatment alternative for patients with advanced or metastatic NSCLC.
authors.affiliation: Division of Hematology/Oncology, University of Miami Miller School of Medicine, 1475 NW 12 Avenue, Suite 3510, Miami, FL 33136, USA. lraez@med.miami.edu
authors.forename: Luis E
authors.initials: LE
authors.lastname: Raez
authors.forename: Edgardo S
authors.initials: ES
authors.lastname: Santos
authors.forename: Gilberto
authors.initials: G
authors.lastname: Lopes
authors.forename: Manuel F
authors.initials: MF
authors.lastname: Rosado
authors.forename: Lawrence M
authors.initials: LM
authors.lastname: Negret
authors.forename: Caio
authors.initials: C
authors.lastname: Rocha-Lima
authors.forename: Kalhed
authors.initials: K
authors.lastname: Tolba
authors.forename: Nancy
authors.initials: N
authors.lastname: Farfan
authors.forename: Kara
authors.initials: K
authors.lastname: Hamilton-Nelson
authors.forename: Orlando
authors.initials: O
authors.lastname: Silva
authors.forename: Eloy
authors.initials: E
authors.lastname: Roman
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage*; D000077150:Oxaliplatin; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel