title: A multi-institutional phase II trial of preoperative full-dose gemcitabine and concurrent radiation for patients with potentially resectable pancreatic carcinoma.
abstract: BACKGROUND
  We report the results of a multi-institutional phase II trial that used preoperative full-dose gemcitabine and radiotherapy for patients with potentially resectable pancreatic carcinoma.
  
  
  METHODS
  Patients were treated before surgery with three cycles of full-dose gemcitabine (1000 mg/m2 intravenously), with radiation during the second cycle (36 Gy in daily 2.4-Gy fractions). Patients underwent surgery 4 to 6 weeks after the last gemcitabine infusion.
  
  
  RESULTS
  There were 10 men and 10 women, with a median age of 58 years (range, 50-80 years). Nineteen patients (95%) completed therapy without interruption, and one experienced grade 3 gastrointestinal toxicity. The mean weight loss after therapy was 4.0%. Of 20 patients taken to surgery, 17 (85%) underwent resections (16 pancreaticoduodenectomies and 1 distal pancreatectomy). The complication rate was 24%, with an average length of stay of 13.5 days. There were no operative deaths. Pathologic analysis revealed clear margins in 16 (94%) of 17 and uninvolved lymph nodes in 11 (65%) of 17 specimens. One specimen contained no residual tumor, and three specimens revealed only microscopic foci of residual disease. With a median follow-up of 18 months, 7 (41%) of the 17 patients with resected disease are alive with no recurrence, 3 (18%) are alive with distant metastases, and 7 (41%) have died.
  
  
  CONCLUSIONS
  Preoperative gemcitabine/radiotherapy is well tolerated and safe when delivered in a multi-institutional setting. This protocol had a high rate of subsequent resection, with acceptable morbidity. The high rate of negative margins and uninvolved nodes suggests a significant tumor response. Preliminary survival data are encouraging. This regimen should be considered in future neoadjuvant trials for pancreatic cancer.
authors.affiliation: Division of Surgical Oncology, Feinberg School of Medicine, Northwestern University, 201 E. Huron, Galter 10-105, Chicago, Illinois 60611, USA. mtalamonti@nmff.org
authors.forename: Mark S
authors.initials: MS
authors.lastname: Talamonti
authors.forename: William
authors.initials: W
authors.lastname: Small
authors.forename: Mary F
authors.initials: MF
authors.lastname: Mulcahy
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Wayne
authors.forename: Vikram
authors.initials: V
authors.lastname: Attaluri
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Colletti
authors.forename: Mark M
authors.initials: MM
authors.lastname: Zalupski
authors.forename: John P
authors.initials: JP
authors.lastname: Hoffman
authors.forename: Gary M
authors.initials: GM
authors.lastname: Freedman
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Kinsella
authors.forename: Philip A
authors.initials: PA
authors.lastname: Philip
authors.forename: Cornelius J
authors.initials: CJ
authors.lastname: McGinn
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D011879:Radiotherapy Dosage; D012449:Safety; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine