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

Publication ,  Journal Article
Evans, DB; Varadhachary, GR; Crane, CH; Sun, CC; Lee, JE; Pisters, PWT; Vauthey, J-N; Wang, H; Cleary, KR; Staerkel, GA; Charnsangavej, C ...
Published in: J Clin Oncol
July 20, 2008

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.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

July 20, 2008

Volume

26

Issue

21

Start / End Page

3496 / 3502

Location

United States

Related Subject Headings

  • Radiotherapy, Adjuvant
  • Preoperative Care
  • Pancreaticoduodenectomy
  • Pancreatic Neoplasms
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoadjuvant Therapy
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
 

Citation

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Evans, D. B., Varadhachary, G. R., Crane, C. H., Sun, C. C., Lee, J. E., Pisters, P. W. T., … Wolff, R. A. (2008). Preoperative gemcitabine-based chemoradiation for patients with resectable adenocarcinoma of the pancreatic head. J Clin Oncol, 26(21), 3496–3502. https://doi.org/10.1200/JCO.2007.15.8634
Evans, Douglas B., Gauri R. Varadhachary, Christopher H. Crane, Charlotte C. Sun, Jeffrey E. Lee, Peter W. T. Pisters, Jean-Nicolas Vauthey, et al. “Preoperative gemcitabine-based chemoradiation for patients with resectable adenocarcinoma of the pancreatic head.J Clin Oncol 26, no. 21 (July 20, 2008): 3496–3502. https://doi.org/10.1200/JCO.2007.15.8634.
Evans DB, Varadhachary GR, Crane CH, Sun CC, Lee JE, Pisters PWT, et al. Preoperative gemcitabine-based chemoradiation for patients with resectable adenocarcinoma of the pancreatic head. J Clin Oncol. 2008 Jul 20;26(21):3496–502.
Evans, Douglas B., et al. “Preoperative gemcitabine-based chemoradiation for patients with resectable adenocarcinoma of the pancreatic head.J Clin Oncol, vol. 26, no. 21, July 2008, pp. 3496–502. Pubmed, doi:10.1200/JCO.2007.15.8634.
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. Preoperative gemcitabine-based chemoradiation for patients with resectable adenocarcinoma of the pancreatic head. J Clin Oncol. 2008 Jul 20;26(21):3496–3502.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

July 20, 2008

Volume

26

Issue

21

Start / End Page

3496 / 3502

Location

United States

Related Subject Headings

  • Radiotherapy, Adjuvant
  • Preoperative Care
  • Pancreaticoduodenectomy
  • Pancreatic Neoplasms
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoadjuvant Therapy
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate