A Phase II Study of Docetaxel for the Treatment of Recurrent Osteosarcoma.

Purpose: To determine the response and toxicity of docetaxel in recurrent osteosarcoma and related spindle cell tumours of bone.

Patients And Methods: Fourteen patients, 10 males and four females, were enrolled, median age 30.5 years (range, 17-46). Diagnosis was: conventional osteosarcoma, 12 patients; periosteal osteosarcoma, one patient; and malignant fibrous histiocytoma of bone, one patient. Initial chemotherapy had been with doxorubicin and cisplatin in 10 patients, and multiagent regimens in four. Nine had been treated with second line chemotherapy before receiving docetaxel. Thirteen patients had lung metastases and one intra-abdominal disease. Docetaxel 100 mg/malpha(2) was given as a 1-h infusion every 3 weeks. Response was assessed every two cycles to a maximum of six.

Results: A total of 43 cycles were given, median of two per patient (range 1-6). Thirteen patients were evaluable for response. A single partial remission was seen, for a response rate of 8%. Two patients had stable disease, and one patient a mixed response. Forty cycles were evaluable for toxicity. The principle toxicity was haematological, with a median neutrophil count of 0.9 (range 0-9.6). There were four episodes of neutropenic sepsis (10%). The only non-haematological toxicity >/=grade 3 was stomatitis, occurring in just one patient. There were no toxic deaths.

Conclusion: Docetaxel at this dose and schedule is well tolerated, but is not associated with significant activity in patients with relapsed osteosarcoma.