As reported in the Journal of Clinical Oncology by Gianni Bisogno, MD, PhD, and colleagues, long-term follow-up of the European Paediatric Soft Tissue Sarcoma Study Group RMS2005 trial showed significant survival advantages with the use of maintenance chemotherapy in pediatric patients with high-risk rhabdomyosarcoma (RMS).
Gianni Bisogno, MD, PhD
Study Details
In the international trial, patients were randomly assigned to discontinue treatment (standard group, n = 186) or receive maintenance chemotherapy with six 28-day cycles of vinorelbine at 25 mg/m2 once daily on days 1, 8, and 15, plus once-daily low-dose cyclophosphamide at 25 mg/m2 (maintenance group, n = 185). The initial report from the trial showed no significant difference in disease-free survival—the primary endpoint—between groups and an overall survival advantage for the maintenance group. The current report shows findings at a median follow-up of 114 months from randomization.
Key Findings
The 10-year disease-free survival was 66.5% (95% confidence interval [CI] = 59%–74%) in the standard group vs 77.1% (95% CI = 70.3%–82.5%) in the maintenance group (P = .025).
The 10-year overall survival was 70.8% (95% CI = 63.3%–77.0%) in the standard group vs 82.9% (95% CI = 76.6%–87.7%) in the maintenance group (P = .0099). The 10-year event-free survival was 64.1% (95% CI = 56.4%–70.7%) in the standard group vs 76.6% (95% CI = 69.7%–82.0%) in the maintenance group (P =.01).
The investigators concluded: “Long-term results of the RMS2005 trial confirm the survival benefit of maintenance chemotherapy with vinorelbine and low-dose cyclophosphamide for patients with high-risk RMS.”
Dr. Bisogno, of the Department of Women’s and Children’s Health, University of Padua, Italy, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was funded by Fondazione Cittá della Speranza, Alice’s Arc, and others. For full disclosures of the study authors, visit ascopubs.org.
