SIOPEL-3
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.
Overview
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.
- 95 vs 93 out of 100 had no sign of cancer on scans or tests with Cisplatin alone compared with Cisplatin + doxorubicin (PLADO); 2 more per 100.
- Roughly one extra person helped for every 50 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 83 vs 85 out of 100 free of a major event at 3 years with Cisplatin alone compared with Cisplatin + doxorubicin (PLADO); 2 fewer per 100.
- On this measure the first group did worse, not better.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 95 vs 93 out of 100 alive at 3 years with Cisplatin alone compared with Cisplatin + doxorubicin (PLADO); 2 more per 100.
- Roughly one extra person helped for every 50 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 20.6 vs 74.4 out of 100 reached this endpoint with Cisplatin alone compared with Cisplatin + doxorubicin (PLADO); 53.8 fewer per 100.
- Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Standard-risk hepatoblastoma in children (tumour confined to the liver, no more than three sectors involved, no metastases): pre-operative cisplatin alone against cisplatin plus doxorubicin (PLADO), with delayed resection and post-operative chemotherapy. People in a different situation may not see the same effect.
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% |
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