We conducted a randomized controlled trial to determine whether intensive multi-agent adjuvant chemotherapy improves the chances of relapse-free survival in patients with nonmetastatic high-grade osteosarcoma of the extremity, as compared with concurrent controls. After undergoing definitive surgery, 36 patients were randomly assigned to adjuvant chemotherapy or to observation without adjuvant treatment. At two years the actuarial relapse-free survival was 17 percent in the control group, similar to that found In studies before 1970, and 66 percent in the adjuvant-chemotherapy group (P<0.001). Similar results were observed among 77 additional patients who declined to undergo randomization but who elected observation or chemotherapy. We conclude that the natural history of osteosarcoma of the extremity has remained stable over the past two decades, that adjuvant chemotherapy increases the chances of relapse-free survival of patients with high-grade osteosarcoma, and that it should be given to all such patients. (N Engl J Med 1986; 314:1600–6.), ALTHOUGH the prognosis for children with osteosarcoma has improved dramatically over the past 15 years, the contribution of adjuvant chemotherapy to this improvement in prognosis has been less certain.1,2 Before the 1970s, the prognosis for children with osteosarcoma of the extremity was dismal.3 Although control of the primary tumor could be achieved in most cases by amputation of the involved extremity, distant metastases developed in the majority of patients, and they died. This discouraging clinical course was documented at a number of centers,4 5 6 where metastases developed within six months of amputation in more than half the patients presenting with tumor.
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