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Vol. 69, No. 2, 2005
Issue release date: September 2005
Oncology 2005;69:130–134

A Phase II Trial of Gemcitabine, 5-Fluorouracil and Leucovorin in Advanced Esophageal Carcinoma

Morgan-Meadows S. · Mulkerin D. · Berlin J.D. · Kim K. · Bailey H. · Saphner T. · Jumonville A. · Hansen R. · Ahuja H. · McFarland T. · Thomas J.P.
aUniversity of Wisconsin Comprehensive Cancer Center, Madison, Wisc., bVanderbilt University, Nashville, Tenn., cGreen Bay Oncology, Green Bay, Wisc., dGunderson Clinic, Ltd., La Crosse, Wisc., eOconomowoc Memorial Hospital, Oconomowoc, Wisc., fWausau Hospital, Wausau, Wisc., and gUW Health Oncology and Hematology, Madison, Wisc., USA

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Background: The aim of this study was to evaluate the overall response rate, toxicity and overall survival in patients with locally advanced or metastatic esophageal cancer treated with gemcitabine, 5-fluorouracil (5-FU) and leucovorin. Patients and Methods: Patients with either adenocarcinoma or squamous cell carcinoma of the esophagus could enroll; however, patients could not have received prior chemotherapy for metastatic disease. Treatment cycles consisted of infusions of all three agents at days 1, 8 and 15, repeated every 28 days. Patients received gemcitabine 1,000, leucovorin 25 and 5-FU 600 mg/m2. Tumor assessment was performed every 2 cycles. Responses were assessed using the Eastern Cooperative Oncology Group solid tumor response criteria. Results: Thirty-five patients with metastatic or locally advanced esophageal cancer enrolled. One complete response and ten partial responses were observed for an overall response rate of 31.4%. An additional 11 patients had stable disease as their best response. The median survival was 9.8 months with a 1-year survival rate of 37.1%. Toxicity was predominately hematologic, with 58% of patients experiencing grade 3 or 4 neutropenia. Conclusion: The combination of gemcitabine, 5-FU and leucovorin had activity in advanced esophageal cancer. Patients tolerated the regimen well, with myelosuppression occurring most commonly. The combination merits further investigation as a treatment for esophageal cancer.

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