Why the study?
Does surgery and chemotherapy with high-dose methotrexate and vincristine improve disease-free survival compared to surgical ablation alone in patients with osteosarcoma?
Does surgery and chemotherapy with high-dose methotrexate and vincristine improve disease-free survival compared to surgical ablation alone in patients with osteosarcoma?
A historical randomized trial demonstrated that adjuvant chemotherapy with high-dose methotrexate and vincristine did not improve 5-year disease-free survival compared to surgery alone in osteosarcoma.
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Adjuvant high-dose methotrexate and vincristine failed to improve outcomes; leaves open the role of modern regimens in osteosarcoma.
In 1978 the relative tranquility of the therapeutic approach to osteosarcoma was shattered when data from the Mayo Clinic questioned the validity of the historical control results of approximately 20% survival in patients with osteosarcoma treated with surgery alone (1,2). They demonstrated an increase in disease-free survival from 20 % to 40 % at the Mayo Clinic in patients treated with various methods of surgical ablation of the primary osteosarcoma during a 15-year period; and this compared favorably with their results with adjuvant chemotherapy. This finding led them to mount a randomized study of surgical ablation alone (18 patients) versus surgery and chemotherapy with high-dose methotrexate and vincristine (20 patients) (3). The results of this small randomized trial substantiated their nonrandomized observations; 42% of patients in both arms remained continuously disease free at 5 years. An additional 20% of patients with recurrent disease were salvaged after aggressive resection of pulmonary metastases, yielding a survival of 52 %.
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Michael B. Harris (1989) studied this question.
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