title: [A phase I/II study of docetaxel/TS-1 with radiation for esophageal cancer patients--step 1].
abstract: The therapy 5-FU and CDDP with radiation is thought to be the standard therapy for esophageal cancer patients by now. However, the therapy is associated with a comparatively high incidence of gastrointestinal disorders and requires hospitalization. We have proposed a new regimen of Docetaxel and TS-1 with radiation for maintaining of QOL and improving outcome. Step 1 of the clinical phase I/ II study was conducted for 10 cases from May 2004 to March 2006. Treatment could be accomplished in all cases, and no treatment-related deaths or adverse events of grade 4 were observed in any case. As for hematotoxicity, one case had leucopenia of grade 3 and neutropenia of grade 2. As for non-hematotoxic adverse events, anorexia of grade 3 was recognized in one case of level 3. The response rate evaluated by RECIST was 66% (CR in 2 cases, PR in 4 cases), and the rate based on the Guide Lines for the Clinical and Pathologic Studies on Carcinoma of Esophagus by the Japanese Society for Esophageal Cancer was 70% (CR in 3 cases, PR in 4 cases). We assumed that the recommended dosage of TXT was 30 mg/m(2) and that of TS-1 was 60 mg/m(2) with radiotherapy of 60 Gy. This combination therapy may be recommended because of fewer adverse events and a higher responsive rate than the standard therapies. We intend to continue this study to step 2 and 3, and to reveal the response rate and adverse events for more esophageal cancer patients.
authors.affiliation: Dept. of Gastroenterological Surgery, Kawasaki Medical School.
authors.forename: Hideo
authors.initials: H
authors.lastname: Matsumoto
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Hirai
authors.forename: Youko
authors.initials: Y
authors.lastname: Hirabayashi
authors.forename: Haruaki
authors.initials: H
authors.lastname: Murakami
authors.forename: Masaharu
authors.initials: M
authors.lastname: Higashida
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Kawabe
authors.forename: Atsushi
authors.initials: A
authors.lastname: Urakami
authors.forename: Kazuki
authors.initials: K
authors.lastname: Yamashita
authors.forename: Jyunichi
authors.initials: J
authors.lastname: Hiratsuka
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Imajyo
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Tsunoda
mesh_terms: D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid