• J. Clin. Oncol. · Jul 2008

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

    • Douglas B Evans, Gauri R Varadhachary, Christopher H Crane, Charlotte C Sun, Jeffrey E Lee, Peter W T Pisters, Jean-Nicolas Vauthey, Huamin Wang, Karen R Cleary, Gregg A Staerkel, Chusilp Charnsangavej, Elizabeth A Lano, Linus Ho, Renato Lenzi, James L Abbruzzese, and Robert A Wolff.
    • Department of Surgical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA. devans@mdanderson.org
    • J. Clin. Oncol. 2008 Jul 20; 26 (21): 3496-502.

    PurposeWe 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 MethodsEligible 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.ResultsThe 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.ConclusionPreoperative 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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