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Analysis of Fluorouracil-Based Adjuvant Chemotherapy and Radiation After Pancreaticoduodenectomy for Ductal Adenocarcinoma of the Pancreas: Results of a Large, Prospectively Collected Database at the Johns Hopkins Hospital

Joseph M. Herman, Michael J. Swartz, Charles C. Hsu, Jordan Winter, Timothy M. Pawlik, Elizabeth Sugar, Ray Robinson, Daniel A. Laheru, Elizabeth Jaffee, Ralph H. Hruban, Kurtis A. Campbell, Christopher L. Wolfgang, Fariba Asrari, Ross Donehower, Manuel Hidalgo, Luis A. Diaz, Jr, Charles Yeo, John L. Cameron, Richard D. Schulick, Ross Abrams

From the Departments of Radiation Oncology & Molecular Radiation Sciences, Surgery, Pathology, and Medical Oncology, the Sol Goldman Pancreatic Cancer Research Center, Johns Hopkins Hospital; and the Departments of Epidemiology and Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD

Corresponding author: Joseph M. Herman, MD, Department of Radiation Oncology & Molecular Radiation Sciences, 401 North Broadway, Suite 1440, Baltimore, MD 21231-2410; e-mail: jherma15{at}jhmi.edu

Purpose To examine the efficacy of adjuvant chemoradiotherapy after pancreaticoduodenectomy (PD) for pancreatic adenocarcinoma (PC) in patients undergoing resection at Johns Hopkins Hospital (JHH; Baltimore, MD).

Patients and Methods Between August 30, 1993, and February 28, 2005, a total of 908 patients underwent PD for PC at JHH. A prospective database was reviewed to determine which patients received fluorouracil (FU) -based CRT. Excluded patients had metastatic disease, died 60 or fewer days after PD, received preoperative therapy, an experimental vaccine, adjuvant chemotherapy or radiation alone. The final cohort includes 616 patients.

Results The median follow-up was 17.8 months (interquartile range, 9.7 to 33.5 months). Overall median survival was 17.9 months (95% CI, 16.3 to 19.5 months). Groups were similar with respect to tumor size, nodal status, and margin status, but the CRT group was younger (P < .001), and less likely to present with a severe comorbid disease (P = .001). Patients with carcinomas larger than 3 cm (P = .001), grade 3 and 4 (P < .001), margin-positive resection (P = .001), and complications after surgery (P = .017) had poor long-term survival. Patients receiving CRT experienced an improved median (21.2 v 14.4 months; P < .001), 2-year (43.9% v 31.9%), and 5-year (20.1% v 15.4%) survival compared with no CRT. After controlling for high-risk features, CRT was still associated with improved survival (relative risk = 0.74; 95% CI, 0.62 to 0.89).

Conclusion These data suggest that adjuvant concurrent FU-based CRT significantly improves survival after PD for PC when compared with patients not receiving CRT. These data support the use of combined adjuvant CRT for PC.

Presented at the 48th Annual 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.

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