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Preoperative Gemcitabine and Cisplatin Followed by Gemcitabine-Based Chemoradiation for Resectable Adenocarcinoma of the Pancreatic Head

Gauri R. Varadhachary, Robert A. Wolff, Christopher H. Crane, Charlotte C. Sun, Jeffrey E. Lee, Peter W.T. Pisters, Jean-Nicolas Vauthey, Eddie Abdalla, Huamin Wang, Gregg A. Staerkel, Jeffrey H. Lee, William A. Ross, Eric P. Tamm, Priya R. Bhosale, Sunil Krishnan, Prajnan Das, Linus Ho, Henry Xiong, James L. Abbruzzese, Douglas B. Evans

From the Departments of Gastrointestinal Medical Oncology, Radiation Oncology, Gynecologic Oncology, Surgical Oncology, Pathology, Gastroenterology, Hepatology, Nutrition, and Diagnostic Imaging; The University of Texas M.D. Anderson Cancer Center, Houston; and the Center for Cancer and Blood Disorders, Fort Worth, TX

Corresponding author: Gauri R. Varadhachary, MD, Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 426, Houston, TX 77030; e-mail: gvaradha{at}mdanderson.org

Purpose We conducted a phase II trial of preoperative gemcitabine and cisplatin chemotherapy in addition to chemoradiation (Gem-Cis-XRT) and pancreaticoduodenectomy (PD) for patients with stage I/II pancreatic adenocarcinoma.

Patients and Methods Chemotherapy consisted of gemcitabine (750 mg/m²) and cisplatin (30 mg/m²) given every 2 weeks for four doses. Chemoradiation consisted of four weekly infusions of gemcitabine (400 mg/m²) combined with radiation therapy (30 Gy in 10 fractions administered over 2 weeks) delivered 5 days per week. Patients underwent restaging 4 to 6 weeks after completion of chemoradiation and, in the absence of disease progression, were taken to surgery.

Results The study enrolled 90 patients; 79 patients (88%) completed chemo-chemoradiation. Sixty-two (78%) of 79 patients were taken to surgery and 52 (66%) of 79 underwent PD. The median overall survival of all 90 patients was 17.4 months. Median survival for the 79 patients who completed chemo-chemoradiation was 18.7 months, with a median survival of 31 months for the 52 patients who underwent PD and 10.5 months for the 27 patients who did not undergo surgical resection of their primary tumor (P < .001).

Conclusion Preoperative Gem-Cis-XRT did not improve survival beyond that achieved with preoperative gemcitabine-based chemoradiation (Gem-XRT) alone. The longer preoperative interval required more durable biliary decompression (metal stents) but was not associated with local tumor progression. The gemcitabine-based chemoradiation platform is a reasonable foundation on which to build future phase II multimodality trials for stage I/II pancreatic cancer incorporating emerging systemic therapies.

Supported by the Various Donor Fund for Pancreatic Cancer Research and National Institutes of Health Grant No. CA101936-01 (Specialized Programs of Research Excellence in Pancreatic Cancer) at The University of Texas M.D. Anderson Cancer Center (data management support). Research support provided by Eli Lilly Corporation.

Presented in part at the Gastrointestinal Cancer Symposium, 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006 Atlanta, GA (abstr 95).

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

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