Preoperative gemcitabine-based chemoradiation for patients with resectable adenocarcinoma of the pancreatic head.

Journal Article (Journal Article)

PURPOSE: We conducted a phase II trial to assess the outcomes of patients who received preoperative gemcitabine-based chemoradiation and pancreaticoduodenectomy (PD) for stage I/II pancreatic adenocarcinoma. PATIENTS AND METHODS: Eligible patients with pancreatic head/uncinate process adenocarcinoma and radiographically defined potentially resectable disease received chemoradiation with 7 weekly intravenous (IV) infusions of gemcitabine (400 mg/m(2) IV over 30 minutes) plus radiation therapy (30 Gy in 10 fractions over 2 weeks). Patients underwent restaging 4 to 6 weeks after completion of chemoradiation and, in the absence of disease progression, were taken to surgery. RESULTS: The study enrolled 86 patients. At the time of restaging, disease progression or a decline in performance status precluded 13 patients from surgery. Seventy-three (85%) of 86 patients were taken to surgery, extrapancreatic disease was found in nine, and 64 (74%) of 86 underwent a successful PD. Median overall survival (86 patients) was 22.7 months with a 27% 5-year survival. Median survival was 34 months for the 64 patients who underwent PD and 7 months for the 22 unresected patients (P < .001). The 5-year survival for those who did and did not undergo PD was 36% and 0%, respectively. CONCLUSION: Preoperative gemcitabine-based chemoradiation followed by restaging and evaluation for surgery separated the study population into two different subsets: patients likely to benefit from PD (n = 64) and those in whom surgery would be unlikely to provide clinical benefit (n = 22). Furthermore, the encouraging overall survival observed in this large trial supports the continued investigation of gemcitabine-based preoperative therapy in resectable pancreatic cancer.

Full Text

Duke Authors

Cited Authors

  • Evans, DB; Varadhachary, GR; Crane, CH; Sun, CC; Lee, JE; Pisters, PWT; Vauthey, J-N; Wang, H; Cleary, KR; Staerkel, GA; Charnsangavej, C; Lano, EA; Ho, L; Lenzi, R; Abbruzzese, JL; Wolff, RA

Published Date

  • July 20, 2008

Published In

Volume / Issue

  • 26 / 21

Start / End Page

  • 3496 - 3502

PubMed ID

  • 18640930

Electronic International Standard Serial Number (EISSN)

  • 1527-7755

Digital Object Identifier (DOI)

  • 10.1200/JCO.2007.15.8634


  • eng

Conference Location

  • United States