title: Randomized phase II trial of first-line treatment with tailored irinotecan and S-1 therapy versus S-1 monotherapy for advanced or recurrent gastric carcinoma (JFMC31-0301).
abstract: The pharmacokinetics of irinotecan vary markedly between individuals. This study sought to compare tailored irinotecan and S-1 therapy with S-1 monotherapy for the treatment of patients with advanced/recurrent gastric cancer. Patients with advanced/recurrent gastric cancer were randomized to receive tailored irinotecan and S-1 (arm A) therapy or S-1 therapy alone (arm B). Arm A received S-1 (80-120 mg/m(2)/day) for 14 days, with irinotecan on days 1 and 15. The initial irinotecan dose of 75 mg/m(2) (level 0) was adjusted for toxicity during an earlier course. In arm B, S-1 (80-120 mg/day) was administered alone for 28 days, followed by 14 days without therapy. Ninety-five patients were randomized (48 patients to arm A and 47 patients to arm B). The response rate of the primary tumor (Japanese criteria) was 25.0% in arm A (12 of 48 patients) and 14.9% in arm B (seven of 47 patients), whereas the response rates according to Response Evaluation Criteria In Solid Tumors were 27.8% (10 of 36) versus 21.9% (seven of 32). Hematological toxicity, anorexia, and diarrhea were significantly more common in arm A, but both arms had similar grades 3-4 toxicities. These findings suggest the usefulness of tailored irinotecan and S-1 therapy for gastric cancer.
authors.affiliation: Division of Cancer Chemotherapy, Hokkaido University Hospital Cancer Centre, Sapporo, Japan. ykomatsu@med.hokudai.ac.jp
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kimura
authors.forename: Hisashi
authors.initials: H
authors.lastname: Oda
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Tajima
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Tamura
authors.forename: Jo
authors.initials: J
authors.lastname: Sakurai
authors.forename: Takehiro
authors.initials: T
authors.lastname: Wakasugi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Tatebe
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takahashi
authors.forename: Yuh
authors.initials: Y
authors.lastname: Sakata
authors.forename: Masaki
authors.initials: M
authors.lastname: Kitajima
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Shigetoyo
authors.initials: S
authors.lastname: Saji
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001772:Blood Cell Count; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin