title: Gemcitabine and carboplatin in patients with locally advanced or metastatic non-small cell lung cancer: a prospective phase II study.
abstract: OBJECTIVE
  The primary objective of this phase II study was to determine the tumor remission rates in previously untreated patients with advanced or metastatic non-small cell lung cancer (stage IIIB and IV), after treatment with gemcitabine plus carboplatin. Secondary objectives of this study were to determine toxicity, median survival and progression free survival in the same patient population treated with gemcitabine plus carboplatin.
  
  
  METHODS
  Chemonaive patients with histological or cytological diagnosis of stage IIIB or IV NSCLC and Karnofsky performance status >/=60 received gemcitabine 1000 mg/m(2) over 30 min on days 1 and 8 and carboplatin AUC 5.0 over 30 min on day 1 after the gemcitabine infusion. Treatment cycles were repeated every 21 days for a maximum of six cycles, or until disease progression or unacceptable toxicity occurred.
  
  
  RESULTS
  Of the 60 patients qualified for efficacy analysis, five achieved complete remissions, 15 partial remissions and 33 had stable disease, for an overall objective response rate (CR+PR) of 33.3% (95% CI, 21.7-46.7%). Four patients had progressive disease. The predominant toxicity was hematologic, with grade 3/4 leucopoenia being most common (35% patients). The median duration of response was 5 months, median time to progression was 6 months and median survival was 9 months with 80% of patients censored.
  
  
  CONCLUSIONS
  Gemcitabine plus carboplatin is an effective and well tolerated treatment for advanced NSCLC.
authors.affiliation: Department of Pulmonary Medicine, St. Hildegardis-Hospital, Hildegardstr. 2, 55131, Mainz, Germany. pneumo@kortsik.de
authors.forename: C
authors.initials: C
authors.lastname: Kortsik
authors.forename: P
authors.initials: P
authors.lastname: Albrecht
authors.forename: A
authors.initials: A
authors.lastname: Elmer
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D015996:Survival Rate; D013997:Time Factors; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine