A randomized study comparing high-dose methotrexate with moderate-dose methotrexate as components of adjuvant chemotherapy in childhood nonmetastatic osteosarcoma: A report from the childrens cancer study group
Article first published online: 20 JUL 2006
Copyright © 1987 Wiley-Liss, Inc., A Wiley Company
Medical and Pediatric Oncology
Volume 15, Issue 2, pages 69–77, 1987
How to Cite
Krailo, M., Ertel, I., Makley, J., Fryer, C. J. H., Baum, E., Weetman, R., Yunis, E., Barnes, L., Bleyer, W. A. and Hammond, G. D. (1987), A randomized study comparing high-dose methotrexate with moderate-dose methotrexate as components of adjuvant chemotherapy in childhood nonmetastatic osteosarcoma: A report from the childrens cancer study group. Med. Pediatr. Oncol., 15: 69–77. doi: 10.1002/mpo.2950150205
- Issue published online: 20 JUL 2006
- Article first published online: 20 JUL 2006
- Division of Cancer Treatment, National Cancer Institute
- National Institutes of Health, Department of Health and Human Resources
- adjuvant therapy
Methotrexate (MTX) has demonstrated significant activity against relapsed and metastatic osteosarcoma. However, there is little published data to indicate the appropriate dose for MTX when given as a component of a multidrug regimen for the treatment of osteosarcoma. Therefore, the investigators at the Childrens Cancer Study Group undertook a randomized clinical trial that compared Adriamycin and vincristine given with either highdose methotrexate or moderate-dose methotrexate as postoperation chemotherapy in the treatment of childhood osteosarcoma. We report here the results for 166 patients with completely resected nonmetastatic disease of an extremity.
The two therapies demonstrated equivalent disease-free survival (DFS). Further, no therapy prejudices survival after relapse. Approximately 38% of patients remain disease free 4 years after diganosis. Two relapses occurred in patients free of disease at least 36 months after initiation of treatment. Some factors found by other investigators to be prognostic of poorer DFS, namely, male sex, primary tumor in the humerus or femur, and larger primary tumors, demonstrated similar though not statistically significant trends. The presence of spontaneous necrosis in the tumor sample from the definitive surgery was associated with poor prognosis for DFS. We postulate that this feature represents rapidly growing tumors with increased potential for metastases.