title: Gemcitabine and cisplatin in the treatment of advanced or metastatic pancreatic cancer.
abstract: BACKGROUND
  This phase II study was initiated to determine the efficacy and safety of gemcitabine plus cisplatin in patients with pancreatic cancer.
  
  
  METHODS
  Gemcitabine 1000 mg/m2 was given on days 1, 8, and 15 of a 28-day schedule, and cisplatin 50 mg/m2 on days 1 and 15 to chemonaive patients with locally advanced or metastatic pancreatic cancer.
  
  
  RESULTS
  Of the 41 patients enrolled (median age 57, and 61% male), median Karnofsky performance status was 80%. Patients received a median of 4.2 cycles (range 1-11). In 35 evaluable patients, one complete response (CR) and three partial responses (PR) were observed, for an overall response rate of 11% (95% confidence interval (95% CI): 3.2% -26.7%). Stable disease (SD) > 3 months occurred in 20 (57%) patients; 6 survived > or = 1 year. Median time to progressive disease was 4.3 months (95% CI: 3.0-5.7 months). For all patients, median survival was 8.2 months (95% CI: 6.1-10.6 months) with a one-year survival rate of 27%. Therapy was well tolerated. Grade 3-4 neutropenia (no grade 3-4 infection), thrombocytopenia (no bleeding), nausea/vomiting, and alopecia were reported in 29%, 13%, and 2.6% of patients, respectively.
  
  
  CONCLUSIONS
  The combination of gemcitabine and cisplatin is a moderately active treatment for patients with locally advanced and metastatic pancreatic cancer without compromising tolerability.
authors.affiliation: Klinikum Grosshadern, Medizinisches Klinik III, München, Germany. Volker.Heinemann@med3.med.uni-muenchen.de
authors.forename: V
authors.initials: V
authors.lastname: Heinemann
authors.forename: H
authors.initials: H
authors.lastname: Wilke
authors.forename: H G
authors.initials: HG
authors.lastname: Mergenthaler
authors.forename: M
authors.initials: M
authors.lastname: Clemens
authors.forename: H
authors.initials: H
authors.lastname: König
authors.forename: H J
authors.initials: HJ
authors.lastname: Illiger
authors.forename: M
authors.initials: M
authors.lastname: Arning
authors.forename: A
authors.initials: A
authors.lastname: Schalhorn
authors.forename: K
authors.initials: K
authors.lastname: Possinger
authors.forename: U
authors.initials: U
authors.lastname: Fink
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010180:Pancreatectomy; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D010342:Patient Acceptance of Health Care; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine