title: [Clinical phase trial of concurrent chemoradiotherapy combined TS-1 and nedaplatin].
abstract: We have treated head and neck carcinoma by concurrent chemoradiotherapy combined with 5-fluorouracil (5-FU) and cisplatin (CDDP). However,this chemoradiotherapy could not show an enormous effect in the advanced carcinoma of Stage III and IV. Therefore,we changed the contents of the chemotherapy, i.e., we replaced 5-FU, one of the agents with time dependency, to continuous administration of TS-1 for 2 weeks,also replacing CDDP, one of the agents with dose dependency, to nedaplatin (CDGP) in order to reduce kidney dysfunction. In this concurrent chemoradiotherapy, oral TS-1 was continued for 2 weeks and CDGP was administered on the 4 th day from the start of TS-1. In addition, radiotherapy was performed concurrently. In this way,we performed a phase I clinical trial of concurrent chemoradiotherapy combining TS-1 and nedaplatin (CDGP). As for the incidence of adverse events,grade 3 mucositis due to radiation was observed in two patients. As a result of the phase I clinical trial,we decided the maximum-tolerated dose (MTD) of TS-1 to be 80 mg/m2 (maximum 120 mg/body) and 100 mg/m2 for CDGP, and then determined the recommended dose(RD) of TS-1 as 80 mg/m2 (maximum 120 mg/ body) TS-1 and of CDGP as 9 0 mg/m2 CDGP.
authors.affiliation: Dept. of Otolaryngology, Fujigaoka Hospital of Showa University.
authors.forename: Hideki
authors.initials: H
authors.lastname: Takemura
authors.forename: Sei
authors.initials: S
authors.lastname: Kobayashi
authors.forename: Masahiro
authors.initials: M
authors.lastname: Katsuno
authors.forename: Rie
authors.initials: R
authors.lastname: Asano
authors.forename: Masato
authors.initials: M
authors.lastname: Morimoto
authors.forename: Shinya
authors.initials: S
authors.lastname: Tachibana
authors.forename: Hayato
authors.initials: H
authors.lastname: Kubota
authors.forename: Masaki
authors.initials: M
authors.lastname: Iida
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Kadokura
authors.forename: Takeyuki
authors.initials: T
authors.lastname: Sanbe
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D010094:Oxonic Acid / Q000008:administration & dosage; D011725:Pyridines / Q000008:administration & dosage; D011879:Radiotherapy Dosage; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; D009944:Organoplatinum Compounds; D011725:Pyridines; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; C053989:nedaplatin