The first 2 authors contributed equally to this article.
Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma†
Article first published online: 30 MAY 2012
Copyright © 2012 American Cancer Society
Volume 118, Issue 23, pages 5888–5893, 1 December 2012
How to Cite
Bernthal, N. M., Federman, N., Eilber, F. R., Nelson, S. D., Eckardt, J. J., Eilber, F. C. and Tap, W. D. (2012), Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma. Cancer, 118: 5888–5893. doi: 10.1002/cncr.27651
- Issue published online: 19 NOV 2012
- Article first published online: 30 MAY 2012
- Manuscript Accepted: 26 MAR 2012
- Manuscript Revised: 19 MAR 2012
- Manuscript Received: 4 DEC 2011
- randomized trial;
- long-term follow-up
The authors present the long-term follow-up (>25 years) data from 1 of the original prospective, randomized trials that compared adjuvant chemotherapy with expectant management in patients with high-grade, localized osteosarcoma. In addition, the value of pathologic necrosis induced by a single cycle of neoadjuvant chemotherapy was analyzed as a predictive marker of disease-free and overall survival.
Fifty-nine patients with high-grade, localized osteosarcoma were enrolled in a prospective trial that was performed between 1981 and 1984 at the University of California-Los Angeles (UCLA). Patients were randomized to receive either adjuvant chemotherapy or observation after surgical resection. Long-term outcomes, follow-up, and pathologic review of all available histologic sections were performed.
The 25-year disease-free survival rate was 28% for patients who received adjuvant chemotherapy compared with 15% for the untreated patients (P = .02). The overall survival rate at 25 years was also significantly higher for treated patients versus untreated patients (38% vs 15%; P = .02). Tumor necrosis >90% after a single round of chemotherapy was a statistically significant predictor of overall survival and disease-free survival for patients who received adjuvant therapy (164 months vs 65 months [P = .04] and 141 months vs 14 months [P < .01], respectively).
Patients with high-grade, localized osteosarcoma who received adjuvant chemotherapy after undergoing definitive surgical resection had a statistically significant benefit in disease-free and overall survival that was maintained through 25 years. Tumor necrosis after just 1 cycle of neoadjuvant chemotherapy and radiation was predictive of overall survival and disease-free survival in patients who received adjuvant chemotherapy. Cancer 2012. © 2012 American Cancer Society.