High-dose methotrexate used alone and in combination for measurable primary or metastatic osteosarcoma

High-dose methotrexate with leucovorin rescue was used alone or in combination with Adriamycin and cyclophosphamide for the treatment of 27 osteosarcoma patients with measurable indicators of disease. Three patients developed complete responses of measurable lesions, two had partial responses, two had static disease, one had symptomatic improvement, and one had return to normal of physical findings following treatment of a flat bone primary osteosarcoma. While the doses and frequency of administration of high-dose methotrexate differed from those used by previous investigators, these results suggest that aggressive treatment with high-dose methotrexate must be attempted to further evaluate its efficacy as single-agent therapy for osteosarcoma patients not eligible for adjuvant chemotherapy trials.