Phase I study of the combination of nedaplatin, adriamycin and 5-fluorouracil for treatment of advanced esophageal cancer |
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Authors: | M Hirao K Fujitani T Tsujinaka |
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Institution: | Department of Surgery, Osaka National Hospital, Osaka, Japan. hiraom@onh.go.jp |
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Abstract: | This trial was conducted to determine the maximum-tolerated dose, principal toxicity, and recommended dose (RD) for the phase II study of the combination of nedaplatin (NED), adriamycin (ADM), and 5-fluorouracil (5-FU) in patients with advanced esophageal cancer. Patients with previously untreated esophageal cancer were eligible if they had performance status 0-1, were 75 years or younger and had adequate organ function. The dose of NED, the key anticancer platinum complex drug, was increased from 60 to 70, and 80 mg/m(2) on day 1. ADM and 5-FU were administered at fixed doses (30 mg/m(2) on day 1, and 700 mg/m(2) on days 1-5). The dose-limiting toxicities of NED were neutropenia and severe diarrhea, and its maximum-tolerated dose and RD were 70 mg/m(2) and 60 mg/m(2), respectively. There were four responders among the six patients administered the RD. The present study thus revealed combination chemotherapy with NED, ADM, and 5-FU to be active and well-tolerated and to warrant phase II study. |
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Keywords: | cancer chemotherapy esophagus nedaplatin phase I |
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