title: Phase I dose-escalation study of docetaxel, nedaplatin, and 5-fluorouracil combination chemotherapy in patients with advanced esophageal cancer.
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/m(2) (day 1), 70 mg/m(2) (day 1), and 700 mg/m(2) (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.
authors.affiliation: Department of General Surgical Science Surgery 1, Gunma University Graduate School, 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan. tatsuyamiyazaki@gunma-u.ac.jp
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Miyazaki
authors.forename: Makoto
authors.initials: M
authors.lastname: Sohda
authors.forename: Naritaka
authors.initials: N
authors.lastname: Tanaka
authors.forename: Shigemasa
authors.initials: S
authors.lastname: Suzuki
authors.forename: Keisuke
authors.initials: K
authors.lastname: Ieta
authors.forename: Makoto
authors.initials: M
authors.lastname: Sakai
authors.forename: Akihiko
authors.initials: A
authors.lastname: Sano
authors.forename: Takehiko
authors.initials: T
authors.lastname: Yokobori
authors.forename: Takanori
authors.initials: T
authors.lastname: Inose
authors.forename: Masanobu
authors.initials: M
authors.lastname: Nakajima
authors.forename: Minoru
authors.initials: M
authors.lastname: Fukuchi
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ojima
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kato
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kuwano
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D011379:Prognosis; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077143:Docetaxel; C053989:nedaplatin; D005472:Fluorouracil