SIOPEL-4: dose-dense cisplatin-based chemotherapy and surgery for high-risk hepatoblastoma
Weekly cisplatin with doxorubicin before surgery got almost every child with high-risk hepatoblastoma to respond and three quarters to complete removal of the tumour, with three-year survival of 83 percent in a group that previously did poorly.
Overview
Prospective single-arm feasibility study of the SIOPEL group in 62 children with high-risk hepatoblastoma (39 with lung metastases): dose-dense cisplatin with doxorubicin before surgery (including transplantation and metastasectomy where needed), then carboplatin and doxorubicin.
60 of 61 evaluable patients had a partial response to pre-operative chemotherapy, 46 (74 percent) had complete resection and 49 (79 percent) were in complete remission at the end of therapy. Three-year event-free survival was 76 percent and overall survival 83 percent at a median follow-up of 52 months; 97 percent had grade 3 or 4 haematological toxicity and 71 percent febrile neutropenia.
- Complete remission at the end of therapy 79 percent (95% CI 67 to 88).
- Partial response to pre-operative chemotherapy in 98 percent; complete resection in 74 percent.
- Three-year event-free survival 76 percent (65 to 87) and overall survival 83 percent (73 to 93).
Dose-dense cisplatin became the SIOPEL standard for high-risk hepatoblastoma and one arm of the international PHITT trial.
- Single-arm feasibility design with heavy haematological toxicity; hearing loss from cumulative cisplatin is a long-term concern.
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