title: Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial.
abstract: OBJECTIVE
  The purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer.
  
  
  METHODS
  Patients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m(2)/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m(2)/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m(2) for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed.
  
  
  RESULTS
  Of 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test).
  
  
  CONCLUSIONS
  This trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity.
authors.affiliation: Indiana University Melvin and Bren Simon Cancer Center, 980 West Walnut St, Suite C528, Indianapolis, IN 46202, USA. ploehrer@iupui.edu
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Loehrer
authors.forename: Yang
authors.initials: Y
authors.lastname: Feng
authors.forename: Higinia
authors.initials: H
authors.lastname: Cardenes
authors.forename: Lynne
authors.initials: L
authors.lastname: Wagner
authors.forename: Joanna M
authors.initials: JM
authors.lastname: Brell
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Patrick
authors.initials: P
authors.lastname: Flynn
authors.forename: Ramesh K
authors.initials: RK
authors.lastname: Ramanathan
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Crane
authors.forename: Steven R
authors.initials: SR
authors.lastname: Alberts
authors.forename: Al B
authors.initials: AB
authors.lastname: Benson
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine