title: Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer: a multicenter phase II trial.
abstract: OBJECTIVE
  Gemcitabine is effective in the treatment of pancreatic cancer and is a potent radiosensitizer. This study assessed safety and efficacy of full-dose gemcitabine administered before and during concurrent three-dimensional conformal radiation (3D-CRT) in patients with nonmetastatic pancreatic cancer.
  
  
  METHODS
  During cycles 1 and 3, patients received gemcitabine at 1,000 mg/m(2) on days 1 and 8 of each 21-day cycle. Cycle 2 included the same dose of gemcitabine on days 1, 8, and 15 of a 28-day cycle with concurrent 3D-CRT at 36 Gy, administered in 15 fractions of 2.4 Gy, over 3 weeks. Resectable patients underwent surgery 4 to 6 weeks after treatment. The primary objective was evaluation of toxicity. Tumor response, CA 19-9, and 1-year survival were also assessed.
  
  
  RESULTS
  Forty-one patients enrolled at six institutions between April 2002 and October 2003. Among the 39 treated patients, the most common toxicities were grade 3 neutropenia (12.8%), grade 3 nausea (10.3%), and grade 3 vomiting (10.3%). The response rate was 5.1% and disease control rate was 84.6%. Mean post-treatment CA 19-9 levels (228 +/- 347 U/mL) were significantly (P = .006) reduced compared with pretreatment levels (1,241 +/- 2,124 U/mL). Thirteen (81%) of 16 patients initially judged resectable, three (33%) of nine borderline-resectable patients, and one (7%) of 14 unresectable patients underwent resection after therapy. One-year survival rates were 73% for all patients, 94% for resectable patients, 76% for borderline-resectable patients, and 47% for unresectable patients.
  
  
  CONCLUSIONS
  Full-dose gemcitabine with concurrent radiotherapy was well tolerated and active. Evaluation of this regimen in a larger, randomized trial for patients with resectable or borderline-resectable disease may be warranted.
authors.affiliation: Robert H. Lurie Comprehensive Cancer Center of Northwestern University, 251 East Huron St, LC-178, Chicago, IL 60611, USA. wsmall@nmff.org
authors.forename: William
authors.initials: W
authors.lastname: Small
authors.forename: Jordan
authors.initials: J
authors.lastname: Berlin
authors.forename: Gary M
authors.initials: GM
authors.lastname: Freedman
authors.forename: Theodore
authors.initials: T
authors.lastname: Lawrence
authors.forename: Mark S
authors.initials: MS
authors.lastname: Talamonti
authors.forename: Mary F
authors.initials: MF
authors.lastname: Mulcahy
authors.forename: A Bapsi
authors.initials: AB
authors.lastname: Chakravarthy
authors.forename: Andre A
authors.initials: AA
authors.lastname: Konski
authors.forename: Mark M
authors.initials: MM
authors.lastname: Zalupski
authors.forename: Philip A
authors.initials: PA
authors.lastname: Philip
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Kinsella
authors.forename: Nipun B
authors.initials: NB
authors.lastname: Merchant
authors.forename: John P
authors.initials: JP
authors.lastname: Hoffman
authors.forename: Al B
authors.initials: AB
authors.lastname: Benson
authors.forename: Steven
authors.initials: S
authors.lastname: Nicol
authors.forename: Rong M
authors.initials: RM
authors.lastname: Xu
authors.forename: John F
authors.initials: JF
authors.lastname: Gill
authors.forename: Cornelius J
authors.initials: CJ
authors.lastname: McGinn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D018395:CA-19-9 Antigen / Q000097:blood; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D018714:Radiotherapy, Adjuvant; D020266:Radiotherapy, Conformal; D016019:Survival Analysis; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D014408:Biomarkers, Tumor; D018395:CA-19-9 Antigen; D003841:Deoxycytidine; D000093542:Gemcitabine