title: An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer.
abstract: The aim of the study was to evaluate the response rate and safety of weekly paclitaxel (Taxol((R))) combination chemotherapy with UFT (tegafur, an oral 5-fluorouracil prodrug, and uracil at a 1 : 4 molar ratio) and leucovorin (LV) in patients with advanced gastric cancer. Patients with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Paclitaxel 1-h infusion at a dose of 100 mg m(-2) on days 1 and 8 and oral UFT 300 mg m(-2) day(-1) plus LV 90 mg day(-1) were given starting from day 1 for 14 days, followed by a 7-day period without treatment. Treatment was repeated every 21 days. From February 2003 to October 2004, 55 patients were enrolled. The median age was 62 years (range: 32-82). Among the 48 patients evaluated for tumour response, two achieved a complete response and 22 a partial response, with an overall response rate of 50% (95% confidence interval: 35-65%). All 55 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 4.4 and 9.8 months, respectively. Major grade 3-4 toxicities were neutropenia in 25 patients (45%) and diarrhoea in eight patients (15%). Although treatment was discontinued owing to treatment-related toxicities in nine patients (16%), there was no treatment-related mortality. Weekly paclitaxel plus oral UFT/LV is effective, convenient, and well tolerated in treating patients with advanced gastric cancer.
authors.affiliation: Cancer Center, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Y
authors.initials: Y
authors.lastname: Chao
authors.forename: C P
authors.initials: CP
authors.lastname: Li
authors.forename: T Y
authors.initials: TY
authors.lastname: Chao
authors.forename: W C
authors.initials: WC
authors.lastname: Su
authors.forename: R K
authors.initials: RK
authors.lastname: Hsieh
authors.forename: M F
authors.initials: MF
authors.lastname: Wu
authors.forename: K H
authors.initials: KH
authors.lastname: Yeh
authors.forename: W Y
authors.initials: WY
authors.lastname: Kao
authors.forename: L T
authors.initials: LT
authors.lastname: Chen
authors.forename: A L
authors.initials: AL
authors.lastname: Cheng
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects* / Q000627:therapeutic use; D011446:Prospective Studies; D012449:Safety; D013274:Stomach Neoplasms / Q000188:drug therapy*; D015996:Survival Rate; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014498:Uracil / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D004338:Drug Combinations; D005641:Tegafur; D014498:Uracil; D017239:Paclitaxel; D002955:Leucovorin