title: A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer.
abstract: This randomised multicentre phase II study was conducted to investigate the activity and safety of two oral fluoropyrimidines, capecitabine or S-1, in elderly patients with advanced gastric cancer (AGC). Elderly (>or=65 years) chemo-naive patients with AGC were randomly assigned to receive capecitabine 1250 mg m(-2) two times daily on days 1-14 every 3 weeks or S-1 40-60 mg two times daily according to body surface area on days 1-28 every 6 weeks. Ninety-six patients were enrolled and 91 patients were randomised to capecitabine (N=46) or S-1 (N=45). Overall response rate, the primary end point, was 27.2% (95% CI, 14.1-40.4, 12 of 44 assessable patients) with capecitabine and 28.9% (95% CI, 15.6-42.1, 13 of 45) with S-1. Median times to progression and overall survival in the capecitabine arm (4.7 and 9.5 months, respectively) were similar to those in the S-1 arm (4.2 and 8.2 months, respectively). The incidence of grade 3-4 granulocytopenia was 6.8% with capecitabine and 4.8% with S-1. Grade 3-4 nonhaematologic toxicities were: asthenia (9.1% with capecitabine vs 7.1% with S-1), anorexia (6.8 vs 9.5%), diarrhoea (2.3 vs 0%), and hand-foot syndrome (6.8 vs 0%). Both capecitabine and S-1 monotherapies were active and tolerable as first-line treatment for elderly patients with AGC.
authors.affiliation: Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 138-736, Korea.
authors.forename: J-L
authors.initials: JL
authors.lastname: Lee
authors.forename: Y-K
authors.initials: YK
authors.lastname: Kang
authors.forename: H J
authors.initials: HJ
authors.lastname: Kang
authors.forename: K-H
authors.initials: KH
authors.lastname: Lee
authors.forename: D Y
authors.initials: DY
authors.lastname: Zang
authors.forename: B-Y
authors.initials: BY
authors.lastname: Ryoo
authors.forename: J G
authors.initials: JG
authors.lastname: Kim
authors.forename: S R
authors.initials: SR
authors.lastname: Park
authors.forename: W K
authors.initials: WK
authors.lastname: Kang
authors.forename: D B
authors.initials: DB
authors.lastname: Shin
authors.forename: M-H
authors.initials: MH
authors.lastname: Ryu
authors.forename: H M
authors.initials: HM
authors.lastname: Chang
authors.forename: T-W
authors.initials: TW
authors.lastname: Kim
authors.forename: J H
authors.initials: JH
authors.lastname: Baek
authors.forename: Y J
authors.initials: YJ
authors.lastname: Min
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary / Q000601:surgery; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary / Q000601:surgery; D000069287:Capecitabine; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary / Q000601:surgery; D008207:Lymphatic Metastasis; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D010094:Oxonic Acid / Q000627:therapeutic use*; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000556:secondary / Q000601:surgery; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D015996:Survival Rate; D005641:Tegafur / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000069287:Capecitabine; D005472:Fluorouracil