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A Multi-Institutional Phase II Trial of Preoperative Full-Dose Gemcitabine and Concurrent Radiation for Patients With Potentially Resectable Pancreatic Carcinoma

¹ Division of Surgical Oncology, Feinberg School of Medicine, Northwestern University, 201 E. Huron, Galter 10-105, Chicago, Illinois 60611
² Division of Radiation Oncology, Feinberg School of Medicine, Northwestern University, 251 E. Huron, LC-178, Chicago, Illinois 60611
³ Division of Hematology/Oncology, Feinberg School of Medicine, Northwestern University, 675 N. St. Clair, Galter 21-100, Chicago, Illinois 60611
⁴ Division of Gastrointestinal Surgery, University of Michigan Health System, 2922 G Taubman-0331, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109
⁵ Hematology Oncology, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109
⁶ Department of Radiation Oncology, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111
⁷ Department of Radiation Oncology, University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, Ohio 44106-6068
⁸ Division of Hematology Oncology, Wayne State University, 3990 John R. Street, Detroit, Michigan 48201-2018
⁹ Department of Radiation Oncology, University of South Maine, 22 Bramhall Street, Portland, Maine 04102

Correspondence: Address correspondence and reprint requests to: Mark S. Talamonti, MD; E-mail: mtalamonti{at}nmff.org.

Background: We report the results of a multi-institutional phase II trial that used preoperative full-dose gemcitabine and radiotherapy for patients with potentially resectable pancreatic carcinoma.

Methods: Patients were treated before surgery with three cycles of full-dose gemcitabine (1000 mg/m² intravenously), with radiation during the second cycle (36 Gy in daily 2.4-Gy fractions). Patients underwent surgery 4 to 6 weeks after the last gemcitabine infusion.

Results: There were 10 men and 10 women, with a median age of 58 years (range, 50–80 years). Nineteen patients (95%) completed therapy without interruption, and one experienced grade 3 gastrointestinal toxicity. The mean weight loss after therapy was 4.0%. Of 20 patients taken to surgery, 17 (85%) underwent resections (16 pancreaticoduodenectomies and 1 distal pancreatectomy). The complication rate was 24%, with an average length of stay of 13.5 days. There were no operative deaths. Pathologic analysis revealed clear margins in 16 (94%) of 17 and uninvolved lymph nodes in 11 (65%) of 17 specimens. One specimen contained no residual tumor, and three specimens revealed only microscopic foci of residual disease. With a median follow-up of 18 months, 7 (41%) of the 17 patients with resected disease are alive with no recurrence, 3 (18%) are alive with distant metastases, and 7 (41%) have died.

Conclusions: Preoperative gemcitabine/radiotherapy is well tolerated and safe when delivered in a multi-institutional setting. This protocol had a high rate of subsequent resection, with acceptable morbidity. The high rate of negative margins and uninvolved nodes suggests a significant tumor response. Preliminary survival data are encouraging. This regimen should be considered in future neoadjuvant trials for pancreatic cancer.

Key Words: Neoadjuvant therapy • Pancreas surgery • Gemcitabine and radiotherapy • Pancreas cancer

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