Phase II trial of gemcitabine in patients with previously untreated metastatic cancer of the esophagus or gastroesophageal junction |
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Authors: | A B Sandler H L Kindler L H Einhorn E Mitchell G Masters M Kraut S Nicol and D Raghavan |
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Institution: | (1) Department of Medicine, Indiana University, Indianapolis, Indiana, USA;(2) Roswell Park Cancer Institute, Buffalo, New York, USA;(3) Jefferson Medical College, Philadelphia, Pennsylvania, USA;(4) University of Chicago, Chicago, Illinois, USA;(5) Wayne State University, Detroit, Michigan, USA;(6) Eli Lilly and Company, Indianapolis, Indiana, USA |
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Abstract: | Background:There were approximately 12,500 cases of esophageal carcinoma diagnosed in the US in 1992 and 12,200 deaths. The impact of chemotherapy on patients with metastatic disease is marginal with a median survival of only five months. Gemcitabine (LY188011,2,2,–difluorodeoxycytidine: dFdC), an analog of cytosine arabinoside (ara-C), is a pyrimidine antimetabolite. Gemcitabine has shown interesting clinical activity in initial phase II clinical trials in a variety of malignancies, including the aerodigestive malignancies, squamous-cell carcinoma of the head/neck and both non-small-cell and small-cell lung cancer.
Patients and methods:A total of 21 patients with chemotherapy-naïve metastatic esophageal carcinoma were entered. Nineteen patients were evaluable for toxicity and seventeen patients were evaluable for response. Gemcitabine was administered intravenously at 1250 mg/m2 over 30–60 minutes on days 1, 8, and 15 followed by 1 week of rest. This four-week schedule defined a cycle of treatment. Patients may have received a maximum of six cycles.
Results:Gemcitabine was well tolerated with minimal non-hematologic toxicity and grade 3–4 anemia, granulocytopenia, and thrombocytopenia occurring in 10.5%, 21%, and 0% of patients, respectively. No responses were seen in the seventeen evaluable patients.
Conclusions:At the dose and schedule studied it would appear that gemcitabine has no activity in patients with chemotherapy-naïve esophageal carcinoma. |
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Keywords: | chemotherapy esophageal cancer gemcitabine |
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