Loading
SIOPEL-3 showed that children with standard-risk hepatoblastoma can be cured with cisplatin alone before and after surgery, leaving out doxorubicin and its heart damage, because the cure rate was the same as with the two-drug combination.
SIOPEL-3 was the international liver tumour trial of the SIOP group. Children with standard-risk hepatoblastoma were randomised to cisplatin alone or to cisplatin plus doxorubicin, given as pre-operative chemotherapy with delayed resection and continued after surgery; the primary endpoint was the complete resection rate, with survival and toxicity as secondary endpoints. A separate high-risk stratum received intensified therapy.
Complete resection was achieved in 95 percent of the cisplatin group and 93 percent of the combination group; three-year event-free survival was 83 against 85 percent and overall survival 95 against 93 percent, while grade 3 or 4 acute toxicity was far more frequent with the combination (74.4 against 20.6 percent). Cisplatin monotherapy with delayed resection is the standard for standard-risk hepatoblastoma on the corpus's hepatoblastoma page, with sodium thiosulfate added after each dose to protect hearing following SIOPEL-6.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
255 randomised.
95% CI 77 to 90; median follow-up 46 months · 95% CI 79 to 92
Source95% CI 91 to 99 · 95% CI 88 to 98
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete resection (intention to treat)primary | Cisplatin alone | 126 | 95% | - | - | link |
| Cisplatin + doxorubicin (PLADO) | 129 | 93% | ||||
| Event-free survival at 3 years | Cisplatin alone | 126 | 83% | - | - | link |
| Cisplatin + doxorubicin (PLADO) | 129 | 85% | ||||
| Overall survival at 3 years | Cisplatin alone | 126 | 95% | - | - | link |
| Cisplatin + doxorubicin (PLADO) | 129 | 93% | ||||
| Acute grade 3 or 4 adverse events | Cisplatin alone | 126 | 20.6% | - | - | link |
| Cisplatin + doxorubicin (PLADO) | 129 | 74.4% |
Shares Hepatoblastoma, Childhood cancers (all types), Doxorubicin, Cisplatin and the tag soc-trials.
Shares Childhood cancers (all types), Doxorubicin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Doxorubicin, Cisplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Cisplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Cisplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Doxorubicin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Doxorubicin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Childhood cancers (all types), Doxorubicin, Cytotoxic chemotherapy and the tag soc-trials.