A Phase II Study of Docetaxel in Chemotherapy-Naïve Patients With Recurrent or Metastatic Adult Soft Tissue Sarcoma.

PURPOSE: To determine the efficacy and toxicity of docetaxel as first-line chemotherapy in adult patients with locally advanced and/or metastatic soft tissue sarcoma (STS).Patients/methods. Thirty eligible patients, with histologically proven STS, Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and bidimensionally measurable disease, entered this study. None had received previous chemotherapy. Docetaxel 100 mg m(-2) was given as a 1-h intravenous infusion every 3 weeks. Patients were evaluable for response, evaluated by WHO criteria, after one cycle of chemotherapy and toxicity was graded by NCIC-CTG common toxicity criteria.Results. One hundred and thirty two cycles were aldministered, with a range per patient of 1-9. The median delivered dose intensity was 32.2 mg m(-2) weekm(-1) (planned 33.3 mg m(-2) weekm(-1) ) and 67% of patients received >/=90% planned dose intensity. There were three partial responses (10.7%; 95% confidence interval 2.3-28.2) with a median duration of 7 months (range 6.4-8.3 months). Thirty patients were evaluable for non-haematological toxicity and 28 for haematological toxicity (repeat counts were not available in two patients). Haematological toxicity was moderately severe, with 18 (64%) patients experiencing at least one episode of grade 4 neutropenia, and 7 (25%) patients experiencing febrile neutropenia.Conclusions. In this study, activity of docetaxel in adult chemotherapy-naïve patients with advanced STS was modest.