title: Single-fraction stereotactic body radiation therapy and sequential gemcitabine for the treatment of locally advanced pancreatic cancer.
abstract: OBJECTIVE
  This Phase II trial evaluated the toxicity, local control, and overall survival in patients treated with sequential gemcitabine and linear accelerator-based single-fraction stereotactic body radiotherapy (SBRT).
  
  
  METHODS
  Twenty patients with locally advanced, nonmetastatic pancreatic adenocarcinoma were enrolled on this prospective single-institution, institutional review board-approved study. Gemcitabine was administered on Days 1, 8, and 15, and SBRT on Day 29. Gemcitabine was restarted on Day 43 and continued for 3-5 cycles. SBRT of 25 Gy in a single fraction was delivered to the internal target volume with a 2- 3-mm margin using a nine-field intensity-modulated radiotherapy technique. Respiratory gating was used to account for breathing motion. Follow-up evaluations occurred at 4-6 weeks, 10-12 weeks, and every 3 months after SBRT.
  
  
  RESULTS
  All patients completed SBRT and a median of five cycles of chemotherapy. Follow-up for the 2 remaining alive patients was 25.1 and 36.4 months. No acute Grade 3 or greater nonhematologic toxicity was observed. Late Grade 3 or greater toxicities occurred in 1 patient (5%) and consisted of a duodenal perforation (G4). Three patients (15%) developed ulcers (G2) that were medically managed. Overall, median survival was 11.8 months, with 1-year survival of 50% and 2-year survival of 20%. Using serial computed tomography, the freedom from local progression was 94% at 1 year.
  
  
  CONCLUSIONS
  Linear accelerator-delivered SBRT with sequential gemcitabine resulted in excellent local control of locally advanced pancreatic cancer. Future studies will address strategies for reducing long-term duodenal toxicity associated with SBRT.
authors.affiliation: Department of Radiation Oncology, BC Cancer Agency, Surrey, British Columbia, Canada.
authors.forename: Devin
authors.initials: D
authors.lastname: Schellenberg
authors.forename: Jeff
authors.initials: J
authors.lastname: Kim
authors.forename: Claudia
authors.initials: C
authors.lastname: Christman-Skieller
authors.forename: Carlene L
authors.initials: CL
authors.lastname: Chun
authors.forename: Laurie Ann
authors.initials: LA
authors.lastname: Columbo
authors.forename: James M
authors.initials: JM
authors.lastname: Ford
authors.forename: George A
authors.initials: GA
authors.lastname: Fisher
authors.forename: Pamela L
authors.initials: PL
authors.lastname: Kunz
authors.forename: Jacques
authors.initials: J
authors.lastname: Van Dam
authors.forename: Andrew
authors.initials: A
authors.lastname: Quon
authors.forename: Terry S
authors.initials: TS
authors.lastname: Desser
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Norton
authors.forename: Annie
authors.initials: A
authors.lastname: Hsu
authors.forename: Peter G
authors.initials: PG
authors.lastname: Maxim
authors.forename: Lei
authors.initials: L
authors.lastname: Xing
authors.forename: Karyn A
authors.initials: KA
authors.lastname: Goodman
authors.forename: Daniel T
authors.initials: DT
authors.lastname: Chang
authors.forename: Albert C
authors.initials: AC
authors.lastname: Koong
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy / Q000379:methods / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D011446:Prospective Studies; D016634:Radiosurgery / Q000379:methods*; D011879:Radiotherapy Dosage; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000093542:Gemcitabine