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Phase II Trial of Infusional Fluorouracil, Leucovorin, Mitomycin, and Dipyridamole in Locally Advanced Unresectable Pancreatic Adenocarcinoma: SWOG S9700

William H. Isacoff, Jacqueline K. Bendetti, John J. Barstis, Abdul-Rahman Jazieh, John S. Macdonald, Philip A. Philip

From the University of California, Los Angeles Medical Center, Los Angeles, CA; Southwest Oncology Group Statistical Center, Seattle, WA; University of Cincinnati Medical Center, Cincinnati, OH; St Vincent's Cancer Care Center, New York, NY; and Karmanos Cancer Institute, Wayne Sate University, Detroit, MI

Address reprint requests to Philip A. Philip, MD, PhD, FRCP, Karmanos Cancer Center, 4-HWCRC, 4100 John R St, Detroit, MI 48201; e-mail: philipp{at}karmanos.org

Purpose To test the hypothesis that dual biochemical modulation of fluorouracil (FU) in combination with mitomycin improves the survival of patients with pancreas cancer.

Patients and Methods Eligibility included stage II or III unresectable adenocarcinoma of the pancreas, performance status of 0 to 2, and adequate organ function. Treatment included FU 200 mg/m²/d via continuous intravenous infusion for 4 weeks followed by 1 week of rest; leucovorin 30 mg/m² administered via intravenous bolus infusion on days 1, 8, 15, and 22, followed by 1 week rest; mitomycin 10 mg/m² intravenous bolus infusion every 6 weeks for a total of four doses. Dipyridamole 75 mg was administered orally three times daily during the FU administration.

Results Fifty patients (median age, 61 years; 23 males, 27 females) with localized unresectable pancreatic cancer were eligible for this trial. Twenty-seven patients survived past 1 year for a 1-year survival probability of 54% (95% CI, 40% to 68%). Overall, the objective response rate was 26% (confirmed and unconfirmed) in the 47 patients with measurable disease, with two complete responders. Six of the responding patients underwent curative successful resection of the tumor. The most common toxicity to treatment was stomatitis. Three patients had reversible hemolytic uremic syndrome. Five patients experienced grade 4 toxicity. There were no treatment-related deaths.

Conclusion Potential improvement in survival and resectability of localized unresectable pancreatic cancer may be attained without radiation. The strategy of dual biochemical modulation of FU warrants additional investigation in a randomized fashion.

Supported in part by the following Public Health Service cooperative agreement grants by the National Cancer Institute, Department of Health and Human Services: Grants No. CA38926, CA32102, CA58348, CA76429, CA45450, CA58723, CA67575, CA46441, CA63844, CA37981, CA12644, CA46113, CA20319, CA35431, CA04919, CA16385, CA45560, CA35996, CA22433, CA35119, and CA58861.

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

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This article has been cited by other articles:

				W. H. Isacoff and P. A. Philip In Reply: J. Clin. Oncol., January 1, 2008; 26(1): 162 - 164. [Full Text] [PDF]

				E. Ben-Josef, T. S. Lawrence, and M. M. Zalupski Radiotherapy for Locally Advanced Pancreatic Cancer J. Clin. Oncol., October 20, 2007; 25(30): 4861 - 4861. [Full Text] [PDF]