title: A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer.
abstract: OBJECTIVE
  To assess the effect of gemcitabine in patients with metastatic pancreas cancer that had progressed despite prior treatment with 5-FU.
  
  
  METHODS
  Seventy-four patients were enrolled in this multicenter trial. Alleviation of cancer-related symptoms was the primary endpoint. Sixty-three patients completed a pain stabilization period and were treated with gemcitabine. Clinical Benefit Response was defined as a > or = 50% reduction in pain intensity, > or = 50% reduction in daily analgesic consumption, or > or = 20 point improvement in KPS that was sustained for > or = 4 consecutive weeks.
  
  
  RESULTS
  Seventeen of 63 pts (27.0%) attained a Clinical Benefit Response (95% CI: 16.0%-38.0%). The median duration of Clinical Benefit Response was 14 weeks (range: 4-69 weeks). Median survival for patients treated with gemcitabine was 3.85 months (range: 0.3-18.0+ months). Therapy was generally well-tolerated with a low incidence of grade 3 or 4 toxicities.
  
  
  CONCLUSIONS
  Systematic assessment of subjective outcomes can be used to evaluate the clinical impact of new therapies for pancreas cancer, a highly symptomatic disease. Our findings suggest that gemcitabine is a useful palliative agent in patients with 5-FU-refractory pancreas cancer.
authors.affiliation: University of Texas Health Science Center at San Antonio, USA.
authors.forename: M L
authors.initials: ML
authors.lastname: Rothenberg
authors.forename: M J
authors.initials: MJ
authors.lastname: Moore
authors.forename: M C
authors.initials: MC
authors.lastname: Cripps
authors.forename: J S
authors.initials: JS
authors.lastname: Andersen
authors.forename: R K
authors.initials: RK
authors.lastname: Portenoy
authors.forename: H A
authors.initials: HA
authors.lastname: Burris
authors.forename: M R
authors.initials: MR
authors.lastname: Green
authors.forename: P G
authors.initials: PG
authors.lastname: Tarassoff
authors.forename: T D
authors.initials: TD
authors.lastname: Brown
authors.forename: E S
authors.initials: ES
authors.lastname: Casper
authors.forename: A M
authors.initials: AM
authors.lastname: Storniolo
authors.forename: D D
authors.initials: DD
authors.lastname: Von Hoff
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001835:Body Weight / Q000187:drug effects; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D019233:Retreatment; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine