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Small W Jr , Berlin J , Freedman GM , Lawrence T , Talamonti MS , Mulcahy MF , Chakravarthy AB , Konski AA , Zalupski MM , Philip PA , Kinsella TJ , Merchant NB , Hoffman JP , Benson AB , Nicol S , Xu RM , Gill JF , McGinn CJ
Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer: a multicenter phase II trial
J Clin Oncol. 2008 Feb 20;26(6) :942-7
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PURPOSE: Gemcitabine is effective in the treatment of pancreatic cancer and is a potent radiosensitizer. This study assessed safety and efficacy of full-dose gemcitabine administered before and during concurrent three-dimensional conformal radiation (3D-CRT) in patients with nonmetastatic pancreatic cancer. PATIENTS AND METHODS: During cycles 1 and 3, patients received gemcitabine at 1,000 mg/m(2) on days 1 and 8 of each 21-day cycle. Cycle 2 included the same dose of gemcitabine on days 1, 8, and 15 of a 28-day cycle with concurrent 3D-CRT at 36 Gy, administered in 15 fractions of 2.4 Gy, over 3 weeks. Resectable patients underwent surgery 4 to 6 weeks after treatment. The primary objective was evaluation of toxicity. Tumor response, CA 19-9, and 1-year survival were also assessed. RESULTS: Forty-one patients enrolled at six institutions between April 2002 and October 2003. Among the 39 treated patients, the most common toxicities were grade 3 neutropenia (12.8%), grade 3 nausea (10.3%), and grade 3 vomiting (10.3%). The response rate was 5.1% and disease control rate was 84.6%. Mean post-treatment CA 19-9 levels (228 +/- 347 U/mL) were significantly (P = .006) reduced compared with pretreatment levels (1,241 +/- 2,124 U/mL). Thirteen (81%) of 16 patients initially judged resectable, three (33%) of nine borderline-resectable patients, and one (7%) of 14 unresectable patients underwent resection after therapy. One-year survival rates were 73% for all patients, 94% for resectable patients, 76% for borderline-resectable patients, and 47% for unresectable patients. CONCLUSION: Full-dose gemcitabine with concurrent radiotherapy was well tolerated and active. Evaluation of this regimen in a larger, randomized trial for patients with resectable or borderline-resectable disease may be warranted.
Small, William Jr Berlin, Jordan Freedman, Gary M Lawrence, Theodore Talamonti, Mark S Mulcahy, Mary F Chakravarthy, A Bapsi Konski, Andre A Zalupski, Mark M Philip, Philip A Kinsella, Timothy J Merchant, Nipun B Hoffman, John P Benson, Al B Nicol, Steven Xu, Rong M Gill, John F McGinn, Cornelius J Clinical Trial, Phase II Multicenter Study United States Journal of clinical oncology : official journal of the American Society of Clinical Oncology J Clin Oncol. 2008 Feb 20;26(6):942-7.