title: Low-dose docetaxel and cisplatin combination chemotherapy for stage II/III gastric cancer showing resistance to S-1 adjuvant chemotherapy: a phase I study.
abstract: To establish a safe, long-term regimen of docetaxel (DOC) and cisplatin (CDDP) in an outpatient setting for gastric cancer refractory to S-1 adjuvant chemotherapy, a dose-escalating phase I study was conducted. Cohorts of patients were treated with escalating doses of DOC (starting at 20 mg/m² per week with 5 mg/m² increments) and a fixed dose of CDDP (25 mg/m²). Drugs were administered on days 1, 8, and 15. A cycle of this treatment was 28 days. In total, 52 courses were performed, and the mean number of courses was 5.3. Two of the four patients at dose level 3 showed dose-limiting toxicities (grade 4 neutropenia, and grade 3 anorexia and dehydration). The recommended dose (RD) of DOC was therefore defined as 25 mg/m². There is a need for a phase II clinical trial using this regimen in patients with S-1-refractory stage II/III gastric cancer.
authors.affiliation: Department of Surgery, Gastroenterological Center, Yokohama City University, Yokohama, Japan. s0714@med.yokohama-cu.ac.jp
authors.forename: Chikara
authors.initials: C
authors.lastname: Kunisaki
authors.forename: Hidetaka A
authors.initials: HA
authors.lastname: Ono
authors.forename: Shinichi
authors.initials: S
authors.lastname: Hasegawa
authors.forename: Takashi
authors.initials: T
authors.lastname: Oshima
authors.forename: Shoichi
authors.initials: S
authors.lastname: Fujii
authors.forename: Motohiko
authors.initials: M
authors.lastname: Tokuhisa
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Izumisawa
authors.forename: Ryo
authors.initials: R
authors.lastname: Takagawa
authors.forename: Jun
authors.initials: J
authors.lastname: Kimura
authors.forename: Takashi
authors.initials: T
authors.lastname: Kosaka
authors.forename: Hirochika
authors.initials: H
authors.lastname: Makino
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Akiyama
authors.forename: Itaru
authors.initials: I
authors.lastname: Endo
mesh_terms: D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D003681:Dehydration / Q000139:chemically induced; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D019008:Drug Resistance, Neoplasm; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000627:therapeutic use; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005641:Tegafur / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D002945:Cisplatin