title: Phase II study of vinorelbine and docetaxel in the treatment of advanced non-small-cell lung cancer as frontline and second-line therapy.
abstract: OBJECTIVE
  Combination chemotherapy with third-generation, nonplatinum agents (ie, gemcitabine, vinorelbine, taxanes, or camptothecins) represents a well-tolerated frontline treatment option for metastatic non-small-cell lung cancer and might play a role as salvage therapy as well. The aim of this phase 2 study was to investigate the use of docetaxel and vinorelbine in the frontline and second-line setting in patients with incurable non-small-cell lung cancer.
  
  
  METHODS
  Seventy-eight patients (42 untreated, 36 previously treated) were administered vinorelbine (20 mg/m) on days 1 and 8 and docetaxel (75 mg/m for untreated patients; 60 mg/m for previously treated patients for cycle 1, increased to 75 mg/m for the subsequent cycles in the absence of grade 3 fever/neutropenia) on day 8, repeated every 21 days, with routine filgrastim support.
  
  
  RESULTS
  The most common grade 3 to 4 nonhematologic toxicities were diarrhea, dyspnea, fatigue, and nausea/vomiting (5% each). Grade 3 to 4 granulocytopenia occurred in 55% of the patients, however only 5% experienced febrile neutropenia. Response rates were 13% in the chemotherapy-naive cohort and 9% in previously treated patients. Median time to progression was 2.9 and 3.0 months and median overall survival was 15.0 and 6.2 months, for the frontline and second-line patients, respectively.
  
  
  CONCLUSIONS
  Compared with historical controls, in the first-line setting, the combination of docetaxel and vinorelbine did not demonstrate increased efficacy advantages over platinum- or other nonplatinum-based doublets. In the second-line setting, single agent chemotherapy is as effective as, and less toxic than the docetaxel-vinorelbine combination, and the former remains the cytotoxic treatment of choice.
authors.affiliation: Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: William N
authors.initials: WN
authors.lastname: William
authors.forename: Fadlo R
authors.initials: FR
authors.lastname: Khuri
authors.forename: Frank V
authors.initials: FV
authors.lastname: Fossella
authors.forename: Bonnie S
authors.initials: BS
authors.lastname: Glisson
authors.forename: Ralph G
authors.initials: RG
authors.lastname: Zinner
authors.forename: J Jack
authors.initials: JJ
authors.lastname: Lee
authors.forename: Roy S
authors.initials: RS
authors.lastname: Herbst
authors.forename: Scott M
authors.initials: SM
authors.lastname: Lippman
authors.forename: Edward S
authors.initials: ES
authors.lastname: Kim
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016879:Salvage Therapy; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D000077235:Vinorelbine
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