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Full-Dose Gemcitabine With Concurrent Radiation Therapy in Patients With Nonmetastatic Pancreatic Cancer: A Multicenter Phase II Trial

William Small, Jr, Jordan Berlin, Gary M. Freedman, Theodore Lawrence, Mark S. Talamonti, Mary F. Mulcahy, A. Bapsi Chakravarthy, Andre A. Konski, Mark M. Zalupski, Philip A. Philip, Timothy J. Kinsella, Nipun B. Merchant, John P. Hoffman, Al B. Benson, Steven Nicol, Rong M. Xu, John F. Gill, Cornelius J. McGinn

From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN

Address reprint requests to William Small Jr, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, 251 East Huron St, LC-178, Chicago, IL 60611; e-mail: wsmall{at}nmff.org

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/m² 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.

Supported by a grant from Eli Lilly & Co, Indianapolis, IN.

Presented in part at the 48th Annual Scientific Meeting of the American Society for Therapeutic Radiology and Oncology, November 5-9, 2006, Philadelphia, PA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Related Correspondence

• Nonmetastatic Pancreatic Cancer: Many Trials, Little Progress
  Jörg Kleeff and Helmut Friess
  JCO 2008 26: 3100 [Full Text]

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				J. Kleeff and H. Friess Nonmetastatic Pancreatic Cancer: Many Trials, Little Progress J. Clin. Oncol., June 20, 2008; 26(18): 3100 - 3100. [Full Text] [PDF]

				W. Small Jr, J. Berlin, G. M. Freedman, A. A. Konski, T. S. Lawrence, M. S. Talamonti, M. F. Mulcahy, A. B. Chakravarthy, M. M. Zalupski, P. A. Philip, et al. In Reply J. Clin. Oncol., June 20, 2008; 26(18): 3100 - 3101. [Full Text] [PDF]