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