The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity

N Engl J Med. 1986 Jun 19;314(25):1600-6. doi: 10.1056/NEJM198606193142502.


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 less than 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bone Neoplasms / drug therapy*
  • Bone Neoplasms / mortality
  • Bone Neoplasms / surgery
  • Child
  • Clinical Trials as Topic
  • Combined Modality Therapy
  • Extremities*
  • Female
  • Femoral Neoplasms / drug therapy
  • Femoral Neoplasms / mortality
  • Femoral Neoplasms / surgery
  • Fibula
  • Follow-Up Studies
  • Humans
  • Humerus
  • Male
  • Osteosarcoma / drug therapy*
  • Osteosarcoma / mortality
  • Osteosarcoma / surgery
  • Postoperative Care
  • Random Allocation
  • Tibia