A trial of chemotherapy in patients with osteosarcoma (a report to the Medical Research Council by their Working Party on Bone Sarcoma.

Two hundred and thirty five patients with osteosarcoma, aged less than 40 years, and treated by amputation or radiotherapy, were entered in a randomised trial of two forms of adjuvant chemotherapy. A two drug regimen, namely vincristine 2 mg m-2 (maximum 2mg) followed by methotrexate 200 mgm-2, given every three weeks, was compared with a three drug regimen, comprising the same vincristine-methotrexate treatment, alternating every three weeks with doxorubicin 60 mg m-2. Both regimens were continued for 54 weeks. Forty-one patients were excluded, most because of inadequate histology, leaving 194 patients for analysis. One hundred and seventy of these had immediate amputation, 14 were treated by a policy of radiotherapy, with surgery delayed for 9 months, provided no distant metastases had appeared, and 10 by a policy of radiotherapy only. Patients have been followed-up for between 26 and 94 months after entry to the trial. The 2- and 5-year survival rates were 48% and 27%. No significant difference in survival was observed between the two regimens, but toxicity was less with the two drug regimen.

RCT Entities:   Population Interventions Outcomes