title: Phase II study of docetaxel and irinotecan combination chemotherapy in metastatic gastric carcinoma.
abstract: The current treatment for metastatic gastric cancer (MGC) consists of cisplatin and/or fluorouracil (5-FU) based combination chemotherapy, but cisplatin-based regimens are associated with considerable toxicity. We evaluated the efficacy and safety of a noncisplatin-, non-5-FU-containing regimen, docetaxel/irinotecan in MGC. Chemo-naive patients with MGC received docetaxel (30 mg m(-2)) and irinotecan (70 mg m(-2)) on days 1 and 8 every 3 weeks. The 48 eligible patients (median age 56 years) received a median of four cycles of docetaxel/irinotecan (range 1-18). Of the 46 patients in whom efficacy could be evaluated, 21 showed a partial response (response rate=45.7%; 95% confidence interval (CI) 31.3-60.1%). At a median follow-up of 15.0 months, the median time to progression was 4.5 months (95% CI 3.8-5.2 months) and overall survival was 8.2 months (95% CI, 5.8-10.6 months). Grade 3/4 neutropenia developed in 57.4% of patients, and febrile neutropenia/neutropenic infection in 19.1%. Nonhaematological toxicities were moderate; grade 3/4 diarrhoea occurred in 19.1% of patients, however, was manageable by a dose reduction. There was one possible treatment-related death. In conclusion, weekly docetaxel/irinotecan is a promising outpatient regimen in MGC, with appropriate dose modification.
authors.affiliation: Research Institute and Hospital, National Cancer Center, 809 Madu1, Ilsan, Goyang, Gyeonggi 410-769, Republic of Korea.
authors.forename: S R
authors.initials: SR
authors.lastname: Park
authors.forename: J H
authors.initials: JH
authors.lastname: Chun
authors.forename: M S
authors.initials: MS
authors.lastname: Yu
authors.forename: J H
authors.initials: JH
authors.lastname: Lee
authors.forename: K W
authors.initials: KW
authors.lastname: Ryu
authors.forename: I J
authors.initials: IJ
authors.lastname: Choi
authors.forename: C G
authors.initials: CG
authors.lastname: Kim
authors.forename: J S
authors.initials: JS
authors.lastname: Lee
authors.forename: Y W
authors.initials: YW
authors.lastname: Kim
authors.forename: J-M
authors.initials: JM
authors.lastname: Bae
authors.forename: H K
authors.initials: HK
authors.lastname: Kim
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000556:secondary; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000556:secondary; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin