DOXORUBICIN AND CISPLATIN WITH GRANULOCYTE-COLONY-STIMULATING FACTOR AS ADJUVANT CHEMOTHERAPY FOR OSTEOSARCOMA - PHASE-II TRIAL OF THE EUROPEAN-OSTEOSARCOMA-INTERGROUP

Purpose: This report describes the toxicity and feasibility of adminis tering doxorubicin (DOX) and cisplatin (CDDP) at 2-week intervals with granulocyte colony-stimulating factor (G-CSF) to patients with asteos arcoma and the compatibility of this regimen with endoprosthetic surge ry performed after three cycles.Patients and Methods: Twenty-four pati ents with biopsy-proven-osteosarcoma were treated with three preoperat ive cycles of DOX 25 mg/m(2)/d on days 1 to 3 and CDDP 100 mg/m(2) on day 1 with G-CSF 5 mu g/kg/d on days 4 to 14. Surgery was scheduled at week 6 to be followed by three further cycles of chemotherapy at 2-we ek intervals. Results: Two-week chemotherapy was feasible, but delays and dose reductions only allowed 74% and 78% of the intended dose-inte nsity of DOX and CDDP to be administered. Thrombocytopenia accounted f or 50% of delays. Significant toxicity included neutropenic sepsis, se vere mucositis, prolonged nausea and vomiting, and electrolyte disturb ances. Twenty-one limb salvage procedures and one amputation were perf ormed. there were eight episodes of excessive perioperative bleeding. Conclusion: Intensive 2-week chemotherapy with intercurrent surgery is feasible and allows a greater dose-intensity of chemotherapy to be ad ministered compared with the same regimen administered at 3-week inter vals without G-CSF. The toxicity is considerable, but manageable. (C) 1994 by American Society of Clinical Oncology.