Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma Journal Article


Authors: Bernthal, N. M.; Federman, N.; Eilber, F. R.; Nelson, S. D.; Eckardt, J. J.; Eilber, F. C.; Tap, W. D.
Article Title: Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma
Abstract: BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. © 2012 American Cancer Society.
Keywords: osteosarcoma; adolescent; adult; cancer chemotherapy; cancer survival; child; controlled study; preschool child; school child; aged; bone neoplasms; child, preschool; disease-free survival; middle aged; cancer surgery; major clinical study; overall survival; histopathology; cisplatin; doxorubicin; cancer adjuvant therapy; cancer radiotherapy; disease free survival; chemotherapy, adjuvant; chemotherapy; methotrexate; outcome assessment; follow up; cancer grading; prospective studies; multiple cycle treatment; cyclophosphamide; necrosis; survival time; long term care; dactinomycin; bleomycin; randomized trial; long-term follow-up; randomized controlled trial (topic); tumor necrosis
Journal Title: Cancer
Volume: 118
Issue: 23
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2012-12-01
Start Page: 5888
End Page: 5893
Language: English
DOI: 10.1002/cncr.27651
PROVIDER: scopus
PUBMED: 22648705
DOI/URL:
Notes: --- - "Cited By (since 1996): 1" - "Export Date: 3 December 2012" - "CODEN: CANCA" - "Source: Scopus"
Altmetric
Citation Impact
MSK Authors
  1. William Douglas Tap
    315 Tap