title: Gemcitabine as single agent chemotherapy in elderly patients with stages III-IV non-small cell lung cancer (NSCLC): a phase II study.
abstract: BACKGROUND
  In the past the unfavourable profile of toxicity of antineoplastic drugs employed (i.e. cisplatinum) weakened the role of chemotherapy in aged patients with non-small cell lung cancer (NSCLC). Recently, new active drugs with lesser toxicity have became widely used in this setting. In this prospective study we evaluated the efficacy and tolerability of gemcitabine in elderly patients with stages III-IV NSCLC.
  
  
  METHODS
  From December 1996 to April 1999, we enrolled 52 previously untreated elderly patients with advanced/metastatic NSCLC. Gemcitabine was administered at 1000 mg/mq i.v. over 30 minutes weekly for three consecutive weeks every 28 days. The planned number of cycles was three while responding or stable patients received chemotherapy until disease progression or the ninth cycle. A total of 291 cycles were delivered with a median number of 6 cycles (range: 3-9). An evaluation of the quality of life was performed every three courses of gemcitabine.
  
  
  RESULTS
  After three cycles of treatment, a complete response was seen in four patients (7.7%), partial response in 16 patients (30.8%) with an overall response rate of 38.5%. Nineteen patients (36.5%) showed stable disease, while thirteen patients (25%) progressed. Median progression-free survival was 22 weeks, median duration of response 26 weeks, median overall survival 34 weeks and 1-year overall survival 46.1%. A statistically significant improvement in the quality of life was registered only after the first three cycles of gemcitabine (p = 0.045). Toxicity was extremely mild.
  
  
  CONCLUSIONS
  In elderly patients with stages III-IV NSCLC gemcitabine showed good activity with a mild toxicity and could be considered a valid therapeutic option in this setting.
authors.affiliation: U.O. Clinical Oncology, Policlinico Umberto I, Department of Experimental Medicine, University of Rome La Sapienza, Rome, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Bianco
authors.forename: Antonio
authors.initials: A
authors.lastname: Rozzi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tonini
authors.forename: Daniele
authors.initials: D
authors.lastname: Santini
authors.forename: Emanuela
authors.initials: E
authors.lastname: Magnolfi
authors.forename: Bruno
authors.initials: B
authors.lastname: Vincenzi
authors.forename: Rolando
authors.initials: R
authors.lastname: D'Angelillo
authors.forename: Paolo
authors.initials: P
authors.lastname: Marchei
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D011788:Quality of Life; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine