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Medline ® Abstract for Reference 113

of 'Initial chemotherapy and radiation for nonmetastatic, locally advanced, unresectable and borderline resectable, exocrine pancreatic cancer'

113
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Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma.
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Landry J, Catalano PJ, Staley C, Harris W, Hoffman J, Talamonti M, Xu N, Cooper H, Benson AB 3rd
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J Surg Oncol. 2010 Jun;101(7):587-92.
 
PURPOSE: A randomized phase II trial (E1200) was designed to assess toxicities and surgical resection rates in two neoadjuvant gemcitabine-based chemoradiation regimens in patients with borderline resectable pancreatic cancer. The trial was terminated early due to poor accrual.
PATIENTS AND METHODS: Patients with borderline resectable adenocarcinomas of the pancreas were enrolled. Arm A patients (n = 10) received gemcitabine 500 mg/m(2) IV weekly for 6 weeks, with radiation to 50.4 Gy followed by surgical resection. Arm B patients (n = 11) received preoperative gemcitabine 175 mg/m(2) on days 1, 5, 29, and 33, cisplatin 20 mg/m(2) on days 1-5 and 29-32, 5-FU 600 mg/m(2) on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m(2) for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m(2) weekly x 3 for five cycles.
RESULTS: Three patients in arm A, and two patients in armB were resected. Hematologic toxicity was comparable between the two arms except more patients in arm B developed grade 3 or 4 thrombocytopenia than those in arm A. Arm B had fewer grade 1-2 GI toxicities although more patients (45%) experienced grade 3-4 GI toxicity.
CONCLUSIONS: This phase II trial showed that both regimens were tolerable, and resectability and survival were comparable to previous studies.
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Department of Radiation Oncology, Emory University School of Medicine, Atlanta, Georgia 30322, USA. jerome@radonc.emory.org
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