Radiotherapy Dose Escalation in Unresectable Ewing's Sarcoma: Final Results of a Phase III Randomized Controlled Trial
Abstract
PURPOSE/OBJECTIVE
Assess the impact of Radiation Therapy (RT) dose escalation on outcomes in surgically unresectable Ewing's sarcoma (ES)/ Primitive Neuroectodermal Tumor (PNET).
MATERIALS/METHODS
Patients with non-metastatic unresectable ES/PNET (excluding intracranial/chest wall) receiving VAC/IE chemotherapy, planned for definitive RT were accrued in this single institute open label Phase III Randomized Controlled Trial. Randomization was between standard dose RT (SDRT: 55.8Gy/31 fractions/ 5 days a week) vs. escalated dose RT (EDRT: 70.2Gy/39 fractions/ 5 days a week) with a primary objective of improving Local Control (LC) by 17% (65% to 82%). Secondary outcomes included Disease Free Survival (DFS), Overall Survival (OS) and functional outcomes by Musculoskeletal Tumor Society (MSTS) score.
RESULTS
Between April 2005 to December 2015, 95 patients (SDRT: 47 and EDRT: 48) with a median age of 17 years (IQR 13-23 years) were accrued. Majority of patients were males (59%). Pelvis was the commonest site of primary disease {60 (63%)}. The median largest tumor dimension (9.7cm) and the median SUVmax (8.2) on the pre-treatment FDG PET-CT were similar. At a median follow-up of 67 months, the 5 year LC, DFS and OS for the entire cohort was 62.4%, 41.3% and 51.9% respectively. The 5 year LC was significantly better in EDRT as compared to SDRT (76.4% vs 49.4%, p=0.02). The differences in DFS and OS at 5 year (for EDRT vs SDRT) did not achieve statistical significance {(DFS- 46.7%…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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