Long-term survival outcomes with maintenance chemotherapy for high-risk rhabdomyosarcoma in the RMS 2005 trial

The phase 3 RMS 2005 trial, at 102 centers in 14 European countries, evaluated maintenance chemotherapy with vinorelbine and low-dose cyclophosphamide among patients with high-risk rhabomyosarcoma. Patients who were in remission after standard treatment were randomized to stop treatment (standard group; n=186) or maintenance chemotherapy (experimental group; n=185) Ten-year outcomes of the trial have now been published. After a median follow-up of 122.1 months from diagnosis and 114 months from random assignment, recurrence, progression, or death occurred in 61 patients in the standard group and 42 patients in the experimental group. The 10-year disease-free survival rates were 66.5% in the standard group versus 77.1 % in the experimental group (p=0.025). Corresponding 10-year overall survival rates were 70.8% versus 82.9% (p=0.0099). The authors conclude that these results confirm the survival benefit with maintenance vinorelbine and low-dose cyclophosphamide for patients with high-risk rhabdomyosarcoma.