title: Gemcitabine in advanced adult soft-tissue sarcomas. A phase II study of the EORTC Soft Tissue and Bone Sarcoma Group.
abstract: Gemcitabine (2'-deoxy-2'-difluorocytidine monohydrochloride) at a dose of 1250 mg/m(2) was given as a 30-min intravenous (i.v.) infusion on days 1 and 8 in a 3-weekly schedule to 32 patients with advanced soft-tissue sarcoma (STS) failing first-line chemotherapy. One patient was ineligible due to a delay between the previous chemotherapy and the start of treatment. Of the eligible patients, median age was 53 years (range 23-73 years). The predominant histological subtype was leiomyosarcoma in 12 patients (38%). The median number of cycles was three (range 1-8 cycles) with a median total dose of gemcitabine of 6.25 g/m(2) (range 1.25-19.97 g/m(2)). The relative dose intensity of gemcitabine was 96% (range 50-103%). Treatment was tolerated very well with non-complicated haematological toxicity as the most frequently observed side-effect. Only one partial tumour response was documented, giving a response rate of 3.23% (95% Confidence Interval (CI): 0.08-16.2%). The median overall survival was 268 days (95% CI: 129-377) and the median time to progression was 45 days (95% CI: 41-79). These results indicate that gemcitabine given at this dose and schedule is not active as second-line therapy in advanced STS.
authors.affiliation: National Cancer Institute, Bratislava, Slovakia.
authors.forename: L
authors.initials: L
authors.lastname: Svancárová
authors.forename: J Y
authors.initials: JY
authors.lastname: Blay
authors.forename: I R
authors.initials: IR
authors.lastname: Judson
authors.forename: Q G C M
authors.initials: QG
authors.lastname: van Hoesel
authors.forename: A T
authors.initials: AT
authors.lastname: van Oosterom
authors.forename: A
authors.initials: A
authors.lastname: le Cesne
authors.forename: H J
authors.initials: HJ
authors.lastname: Keizer
authors.forename: C
authors.initials: C
authors.lastname: Hermans
authors.forename: M
authors.initials: M
authors.lastname: van Glabbeke
authors.forename: J
authors.initials: J
authors.lastname: Verweij
authors.forename: P C W
authors.initials: PC
authors.lastname: Hogendoorn
authors.forename: O S
authors.initials: OS
authors.lastname: Nielsen
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine