title: Weekly gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase II study.
abstract: BACKGROUND
  The combination of gemcitabine and cisplatin has proven effective in the treatment of advanced non-small-cell lung cancer (NSCLC). However, the optimal schedule for administration of the two drugs has not yet been determined. In this study we evaluated the activity and toxicity of a weekly gemcitabine and cisplatin schedule.
  
  
  METHODS
  Thirty-six untreated patients with stage IIIB IV NSCLC entered the study. Treatment consisted of gemcitabine 1000 mg/m2 i.v. and cisplatin 35 mg/m2 i.v., both given weekly on day 1,8, and 15, followed by one week of rest.
  
  
  RESULTS
  Ninety-seven courses (273 weekly administrations) were delivered. The median dose-intensity was 612 mg/m2 per week for gemcitabine (82%) and 21 mg/m2 per week for cisplatin (80%). All 36 of the patients were evaluable for toxicity, and 30 for response. Partial remissions were observed in 12 patients, for an overall response rate of 40% (95% confidence interval (95% CI): 22.5%-57.5%). Most of the partial remissions were seen in IIIB patients (54% of the stage IIIB and 22% of the stage IV patients responded). According to the intent-to-treat principle, the response rate was 33.3% (12 of 36 patients). The median response duration was 9.9 months (range 4-23) and the median survival time 11.8 months (range 1-24). World Health Organization (WHO) grade 3-4 myelotoxicity was: thrombocytopenia in nine patients (25%), neutropenia in six (16.6%) and anemia in six (16.6%); there was very little additional major toxicity.
  
  
  CONCLUSIONS
  This regimen appears to be active and to have a favourable toxicity profile.
authors: Department of Medical Oncology, Ancona University, Italy.
authors: P
authors: P
authors: Lippe
authors: D
authors: D
authors: Tummarello
authors: M C
authors: MC
authors: Monterubbianesi
authors: R R
authors: RR
authors: Silva
authors: L
authors: L
authors: Giuliodori
authors: D
authors: D
authors: Mari
authors: A
authors: A
authors: Santo
authors: F
authors: F
authors: Pasini
authors: G L
authors: GL
authors: Cetto
authors: D
authors: D
authors: Rossi
authors: E
authors: E
authors: Porfiri
authors: S
authors: S
authors: Cascinu
authors: R
authors: R
authors: Cellerino
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine