Phase I dose-escalation study of docetaxel, nedaplatin, and 5-fluorouracil combination chemotherapy in patients with advanced esophageal cancer |
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| Authors: | Tatsuya Miyazaki Makoto Sohda Naritaka Tanaka Shigemasa Suzuki Keisuke Ieta Makoto Sakai Akihiko Sano Takehiko Yokobori Takanori Inose Masanobu Nakajima Minoru Fukuchi Hitoshi Ojima Hiroyuki Kato Hiroyuki Kuwano |
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| Institution: | 1. Department of General Surgical Science (Surgery 1), Gunma University Graduate School, 3-39-22, Showa-machi, Maebashi, Gunma, 371-8511, Japan
2. First Department of Surgery, Dokkyo Medical University, Tochigi, Japan
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| Abstract: | More effective protocols are needed for unresectable and recurrent esophageal cancer. Therefore, we conducted a phase I trial to establish the recommended dose of docetaxel, nedaplatin, and 5-fluorouracil (DNF) as combination chemotherapy. Fourteen patients with esophageal cancer were enrolled and received DNF combination therapy at different dose levels according to the treatment and examination plan. Dose-limiting toxicities (DLTs) included febrile neutropenia. DLTs occurred in 3/5 patients at level 4. The recommended doses (level 3) of DNF were 60 mg/m2 (day 1), 70 mg/m2 (day 1), and 700 mg/m2 (days 1–5), respectively, given at 3-week intervals. In conclusion, DNF combined chemotherapy for advanced esophageal cancer was associated with relatively minor adverse events and was safely administered at the recommended dose. A phase II study is now underway. |
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