期刊
JOURNAL OF SURGICAL ONCOLOGY
卷 101, 期 7, 页码 587-592出版社
WILEY-LISS
DOI: 10.1002/jso.21527
关键词
radiotherapy; gemcitabine; pancreatic cancer
资金
- Public Health Service [CA23318, CA66636, CA21115, CA27525, CA07190, CA21076, CA49957, CA17145]
- National Cancer Institute, National Institutes of Health
- Department of Health and Human Services
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 arm B 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. J. Surg. Oncol. 2010;101:587-592. (C) 2010 Wiley-Liss, Inc.
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