title: Temozolomide in adult patients with advanced soft tissue sarcoma: a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group.
abstract: Temozolomide, an oral imidazotetrazine derivative, was given to 31 patients with advanced soft tissue sarcoma. The dose of 750 mg/m2 was divided over 5 consecutive days, and escalated to 1000 mg/m2 over 5 days at cycle 2 if myelosuppression no worse than common toxicity criteria grade 2 was noted in the first 28-day cycle. A total of 99 treatment cycles were given to 31 patients. The drug was well tolerated, with nausea and vomiting as the most common side-effects. Only one partial tumour response was documented, giving a response rate of 3.33%, 95% confidence interval, (CI) 0.1-17.2%. The median time to progression was 8 weeks and the median survival was 27 weeks. These results indicate that temozolomide in this schedule is not active as second-line treatment in advanced soft tissue sarcoma.
authors.affiliation: City Hospital, Nottingham, U.K. penella.woll@nott.ac.uk
authors.forename: P J
authors.initials: PJ
authors.lastname: Woll
authors.forename: I
authors.initials: I
authors.lastname: Judson
authors.forename: S M
authors.initials: SM
authors.lastname: Lee
authors.forename: S
authors.initials: S
authors.lastname: Rodenhuis
authors.forename: O S
authors.initials: OS
authors.lastname: Nielsen
authors.forename: J M
authors.initials: JM
authors.lastname: Buesa
authors.forename: P C
authors.initials: PC
authors.lastname: Lorigan
authors.forename: S
authors.initials: S
authors.lastname: Leyvraz
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
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012509:Sarcoma / Q000188:drug therapy*; D016019:Survival Analysis; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide