title: Neoadjuvant gemcitabine, docetaxel, and capecitabine followed by gemcitabine and capecitabine/radiation therapy and surgery in locally advanced, unresectable pancreatic adenocarcinoma.
abstract: BACKGROUND
  This prospective study was undertaken to assess toxicity, resectability, and survival in pancreatic adenocarcinoma patients presenting with locally advanced, unresectable disease treated with neoadjuvant gemcitabine, docetaxel, and capecitabine (GTX) and gemcitabine and capecitabine (GX)/radiation therapy (RT).
  
  
  METHODS
  All patients presenting to the Pancreas Center were evaluated for eligibility. Forty-five patients (mean age, 64 years; range, 44-83 years)-34 patients deemed unresectable because of arterial involvement and 11 patients deemed unresectable because of extensive venous involvement-were treated with 6 cycles of GTX. Those with arterial involvement were treated with GX/RT after chemotherapy.
  
  
  RESULTS
  The GTX and GX/RT treatments were tolerated with the expected drug-related toxicities. There were no bowel perforations, cases of pancreatitis, or delayed strictures. Among those with arterial involvement, 29 underwent subsequent resection, with 20 (69%) achieving R0 resections. All 11 patients with venous-only involvement underwent resection, with 8 achieving R0 resections and 3 achieving complete pathologic responses. For the arterial arm, the 1-year survival rate was 71% (24 of 34 patients), and the median survival was 29 months (95% confidence interval, 21-38 months). Thirteen patients (38%) have not relapsed (range, 5-49+ months). For the venous arm, the median survival has not been reached at more than 42 months. Six patients (55%) in the venous arm did not experience recurrence (range, 6.2-42+ months).
  
  
  CONCLUSIONS
  GTX plus GX/RT is an effective neoadjuvant regimen that can be safely administered to patients up to at least the age of 83 years. It is associated with a high response rate, a high rate of R0 resections, and prolonged overall survival.
authors.affiliation: Pancreas Center, Columbia University, New York, New York.
authors.forename: William H
authors.initials: WH
authors.lastname: Sherman
authors.forename: Kyung
authors.initials: K
authors.lastname: Chu
authors.forename: John
authors.initials: J
authors.lastname: Chabot
authors.forename: John
authors.initials: J
authors.lastname: Allendorf
authors.forename: Beth Ann
authors.initials: BA
authors.lastname: Schrope
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hecht
authors.forename: Brian
authors.initials: B
authors.lastname: Jin
authors.forename: David
authors.initials: D
authors.lastname: Leung
authors.forename: Helen
authors.initials: H
authors.lastname: Remotti
authors.forename: Gisella
authors.initials: G
authors.lastname: Addeo
authors.forename: Inna
authors.initials: I
authors.lastname: Postolov
authors.forename: Wei
authors.initials: W
authors.lastname: Tsai
authors.forename: Robert L
authors.initials: RL
authors.lastname: Fine
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology*; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D011446:Prospective Studies; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine
keywords: capecitabine; docetaxel; gemcitabine; pancreatic cancer; radiation therapy