Maintenance therapy boosts high-risk pediatric rhabdomyosarcoma survival
medwireNews: A significant overall survival (OS) benefit with the use of maintenance chemotherapy has been demonstrated by the RMS2005 trial of children who have completed standard treatment for high-risk, nonmetastatic rhabdomyosarcoma.
High-risk patients, who make up to 65% of diagnoses, have tumours at an unfavorable site such as the pelvis or head and neck, alveolar histology, and/or nodal involvement, explained Gianni Bisogno, from the University Hospital of Padova in Italy, to delegates attending the ASCO Annual Meeting 2018 in Chicago, Illinois, USA.
All 371 patients, recruited from 14 countries in Europe and South America, had no radiological evidence of tumour after completing surgery, radiotherapy, and nine cycles of standard chemotherapy with ifosfamide, vincristine, and actinomycin D, with or without doxorubicin.
The 5-year disease-free survival (DFS) rate was 77.6% for the 185 patients randomly assigned to receive a 24-week maintenance regimen of vinorelbine 25 mg/m2 on days 1, 8, and 15 of a 28-day cycle, alongside daily cyclophosphamide 25 mg/m2 per day.
This compared with a DFS rate of 69.8% for the 186 patients who did not receive any further treatment, resulting in a hazard ratio (HR) of 0.68, although it did not reach significance. However, the corresponding overall survival rates were 86.5% versus 73.7%, with a significant HR of 0.52.
Noting that maintenance therapy was associated with less myelotoxicity, infection, and organ dysfunction than standard chemotherapy, Bisogno concluded that the study established “the new standard of care” for patients with high-risk rhabdomyosarcoma, at least for those treated under the European Paediatric Soft Tissue Sarcoma Study Group.
The study has now been published in The Lancet Oncology.
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