Temozolomide in adult patients with advanced soft tissue sarcoma: a phase II study of the EORTC soft tissue and bone sarcoma group

Temozolomide, an oral imidazotetrazine derivative, was given to 31 patients with advanced soft tissue sarcoma. The dose of 750 mg/m(2) was divided ove r 5 consecutive days, and escalated to 1000 mg/m(2) over 5 days at cycle 2 if myelosuppression no worse than common toxicity criteria grade 2 was note d in the first 28-day cycle. A total of 99 treatment cycles were given to 3 1 patients. The drug was well tolerated, with nausea and vomiting as the mo st common side-effects. Only one partial tumour response was documented, gi ving a response rate of 3.33%, 95% confidence interval, (CT) 0.1-17.2%. The median time to progression was 8 weeks and the median survival was 27 week s. These results indicate that temozolomide in this schedule is not active as second-line treatment in advanced soft tissue sarcoma. (C) 1999 Elsevier Science Ltd. All rights reserved.