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Long‐term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high‐grade, operable osteosarcoma
Author(s) -
Bernthal Nicholas M.,
Federman Noah,
Eilber Frederick R.,
Nelson Scott D.,
Eckardt Jeffrey J.,
Eilber Fritz C.,
Tap William D.
Publication year - 2012
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.27651
Subject(s) - medicine , chemotherapy , osteosarcoma , surgery , prospective cohort study , randomized controlled trial , adjuvant therapy , neoadjuvant therapy , adjuvant , cancer , pathology , breast cancer
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. Cancer 2012. © 2012 American Cancer Society.