title: Stereotactic body radiation therapy with concurrent full-dose gemcitabine for locally advanced pancreatic cancer: a pilot trial demonstrating safety.
abstract: BACKGROUND
  Concurrent chemoradiation is a standard option for locally advanced pancreatic cancer (LAPC). Concurrent conventional radiation with full-dose gemcitabine has significant toxicity. Stereotactic body radiation therapy (SBRT) may provide the opportunity to administer radiation in a shorter time frame with similar efficacy and reduced toxicity. This Pilot study assessed the safety of concurrent full-dose gemcitabine with SBRT for LAPC.
  
  
  METHODS
  Patients received gemcitabine, 1000 mg/m2 for 6 cycles. During week 4 of cycle 1, patients received SBRT (25 Gy delivered in five consecutive daily fractions of 5 Gy prescribed to the 75-83% isodose line). Acute and late toxicities were assessed using NIH CTCAE v3. Tumor response was assessed by RECIST. Patients underwent an esophagogastroduodenoscopy at baseline, 2, and 6 months to assess the duodenal mucosa. Quality of life (QoL) data was collected before and after treatment using the QLQ-C30 and QLQ-PAN26 questionnaires.
  
  
  RESULTS
  Between September 2009 and February 2011, 11 patients enrolled with one withdrawal during radiation therapy. Patients had grade 1 to 2 gastrointestinal toxicity from the start of SBRT to 2 weeks after treatment. There were no grade 3 or greater radiation-related toxicities or delays for cycle 2 of gemcitabine. On endoscopy, there were no grade 2 or higher mucosal toxicities. Two patients had a partial response. The median progression free and overall survival were 6.8 and 12.2 months, respectively. Global QoL did not change between baseline and immediately after radiation treatment.
  
  
  CONCLUSIONS
  SBRT with concurrent full dose gemcitabine is safe when administered to patients with LAPC. There is no delay in administration of radiation or chemotherapy, and radiation is completed with minimal toxicity.
authors: Department of Radiation Oncology, Georgetown University Hospital, Washington, DC 20007, USA.
authors: Marie K
authors: MK
authors: Gurka
authors: Sean P
authors: SP
authors: Collins
authors: Rebecca
authors: R
authors: Slack
authors: Gary
authors: G
authors: Tse
authors: Aline
authors: A
authors: Charabaty
authors: Lisa
authors: L
authors: Ley
authors: Liam
authors: L
authors: Berzcel
authors: Siyuan
authors: S
authors: Lei
authors: Simeng
authors: S
authors: Suy
authors: Nadim
authors: N
authors: Haddad
authors: Reena
authors: R
authors: Jha
authors: Colin D
authors: CD
authors: Johnson
authors: Patrick
authors: P
authors: Jackson
authors: John L
authors: JL
authors: Marshall
authors: Michael J
authors: MJ
authors: Pishvaian
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D059248:Chemoradiotherapy / Q000009:adverse effects* / Q000379:methods*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D010865:Pilot Projects; D011788:Quality of Life; D016634:Radiosurgery / Q000009:adverse effects / Q000379:methods; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine