Difference between revisions of "Hepatoblastoma"
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Warner-admin (talk | contribs) m (Text replacement - "'''dosing details in manuscript have been reviewed'''" to "'''dosing details in manuscript have been reviewed by our editors'''") |
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− | + | <span id="BackToTop"></span> | |
− | + | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | |
+ | [[#top|Back to Top]] | ||
+ | </div> | ||
+ | {{#lst:Editorial board transclusions|blastomas}} | ||
+ | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
− | |style="background-color:# | + | |<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div> |
− | + | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div> | |
+ | |} | ||
+ | {{TOC limit|limit=3}} | ||
+ | =High-risk, upfront therapy= | ||
+ | ==COG AHEP0731 protocol H - responders {{#subobject:3a8i39|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:a15cb47|Variant=1}}=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy, VIT portion (cycles 1 & 2)==== | ||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8 | ||
+ | |||
+ | *[[Irinotecan (Camptosar)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1.67 mg/kg (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5 | ||
+ | **10 kg or more: 50 mg/m<sup>2</sup> (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5 | ||
+ | ====Targeted therapy, VIT portion (cycles 1 & 2)==== | ||
+ | *[[Temsirolimus (Torisel)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1.2 mg/kg IV over 30 minutes once per day on days 1 & 8 | ||
+ | **10 kg or more: 35 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | ||
+ | |||
+ | ====Chemotherapy, C5VD portion (cycles 3 to 6)==== | ||
+ | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1 | ||
+ | **10 kg or more: 100 mg/m<sup>2</sup> IV once over 6 hours on day 1 | ||
+ | |||
+ | *[[Fluorouracil (5-FU)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2 | ||
+ | **10 kg or more: 600 mg/m<sup>2</sup> IV push over 2 to 4 minutes once on day 2 | ||
+ | |||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | |||
+ | *[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2 | ||
+ | **10 kg or more: 30 mg/m<sup>2</sup> IV over 15 minutes once per day on days 1 & 2 | ||
+ | |||
+ | ====Chemotherapy, VIT portion (cycle 7)==== | ||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8 | ||
+ | |||
+ | *[[Irinotecan (Camptosar)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1.67 mg/kg (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5 | ||
+ | **10 kg or more: 50 mg/m<sup>2</sup> (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5 | ||
+ | |||
+ | ====Targeted therapy, VIT portion (cycle 7)==== | ||
+ | *[[Temsirolimus (Torisel)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1.2 mg/kg IV over 30 minutes once per day on days 1 & 8 | ||
+ | **10 kg or more: 35 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | ||
+ | |||
+ | ====Chemotherapy, C5VD portion (cycles 8 & 9)==== | ||
+ | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1 | ||
+ | **10 kg or more: 100 mg/m<sup>2</sup> IV once over 6 hours on day 1 | ||
+ | |||
+ | *[[Fluorouracil (5-FU)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2 | ||
+ | **10 kg or more: 600 mg/m<sup>2</sup> IV push over 2 to 4 minutes once on day 2 | ||
+ | |||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | |||
+ | *[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2 | ||
+ | **10 kg or more: 30 mg/m<sup>2</sup> IV over 15 minutes once per day on days 1 & 2 | ||
+ | ====Supportive therapy, C5VD portion (cycles 8 & 9)==== | ||
+ | *[[Dexrazoxane (Zinecard)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 10 mg/kg IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2 | ||
+ | **10 kg or more: 300 mg/m<sup>2</sup> IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2 | ||
+ | |||
+ | ====Chemotherapy, VIT portion (cycle 10)==== | ||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8 | ||
+ | |||
+ | *[[Irinotecan (Camptosar)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1.67 mg/kg (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5 | ||
+ | **10 kg or more: 50 mg/m<sup>2</sup> (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5 | ||
+ | ====Targeted therapy, VIT portion (cycle 10)==== | ||
+ | *[[Temsirolimus (Torisel)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1.2 mg/kg IV over 30 minutes once per day on days 1 & 8 | ||
+ | **10 kg or more: 35 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | ||
+ | |||
+ | '''21-day cycle for 10 cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #None yet identified | ||
+ | |||
+ | ==COG AHEP0731 protocol H - non-responders {{#subobject:3a882f|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:a15cb47|Variant=2}}=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy, VIT portion (cycles 1 & 2)==== | ||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8 | ||
+ | |||
+ | *[[Irinotecan (Camptosar)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1.67 mg/kg (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5 | ||
+ | **10 kg or more: 50 mg/m<sup>2</sup> (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5 | ||
+ | |||
+ | ====Targeted therapy, VIT portion (cycles 1 & 2)==== | ||
+ | |||
+ | *[[Temsirolimus (Torisel)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1.2 mg/kg IV over 30 minutes once per day on days 1 & 8 | ||
+ | **10 kg or more: 35 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | ||
+ | |||
+ | ====Chemotherapy, C5VD portion (cycles 3 to 6)==== | ||
+ | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1 | ||
+ | **10 kg or more: 100 mg/m<sup>2</sup> IV once over 6 hours on day 1 | ||
+ | |||
+ | *[[Fluorouracil (5-FU)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2 | ||
+ | **10 kg or more: 600 mg/m<sup>2</sup> IV push over 2 to 4 minutes once on day 2 | ||
+ | |||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | |||
+ | *[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2 | ||
+ | **10 kg or more: 30 mg/m<sup>2</sup> IV over 15 minutes once per day on days 1 & 2 | ||
+ | |||
+ | ====Chemotherapy, C5VD portion (cycles 7 to 8)==== | ||
+ | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1 | ||
+ | **10 kg or more: 100 mg/m<sup>2</sup> IV once over 6 hours on day 1 | ||
+ | |||
+ | *[[Fluorouracil (5-FU)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2 | ||
+ | **10 kg or more: 600 mg/m<sup>2</sup> IV push over 2 to 4 minutes once on day 2 | ||
+ | |||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | |||
+ | *[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2 | ||
+ | **10 kg or more: 30 mg/m<sup>2</sup> IV over 15 minutes once per day on days 1 & 2 | ||
+ | |||
+ | ====Supportive therapy, C5VD portion (cycles 7 to 8)==== | ||
+ | *[[Dexrazoxane (Zinecard)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 10 mg/kg IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2 | ||
+ | **10 kg or more: 300 mg/m<sup>2</sup> IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2 | ||
+ | |||
+ | '''21-day cycle for 8 cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #None yet identified | ||
+ | |||
+ | ==COG AHEP0731 protocol W {{#subobject:3a8i39|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:a15cb47|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5665173/ Katzenstein et al. 2017 (COG AHEP0731 HR)] | ||
+ | |2009-09 to 2012-02 | ||
+ | | style="background-color:#91cf61" |Non-randomized | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Irinotecan (Camptosar)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1.67 mg/kg IV over 90 minutes once per day on days 1 to 5 | ||
+ | **10 kg or more: 50 mg/m<sup>2</sup> IV over 90 minutes once per day on days 1 to 5 | ||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg IV once per day on days 1 & 8 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
+ | '''21-day cycle for 2 cycles''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Subsequent treatment==== | ||
+ | *Depends on response; see paper for details | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''COG AHEP0731 HR:''' Katzenstein HM, Furman WL, Malogolowkin MH, Krailo MD, McCarville MB, Towbin AJ, Tiao GM, Finegold MJ, Ranganathan S, Dunn SP, Langham MR, McGahren ED, Rodriguez-Galindo C, Meyers RL. Upfront window vincristine/irinotecan treatment of high-risk hepatoblastoma: A report from the Children's Oncology Group AHEP0731 study committee. Cancer. 2017 Jun 15;123(12):2360-2367. Epub 2017 Feb 17. [https://doi.org/10.1002/cncr.30591 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5665173/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/28211941/ PubMed] [https://clinicaltrials.gov/study/NCT00980460 NCT00980460] | ||
+ | |||
+ | ==SIOPEL-4 protocol, resectable after A3 {{#subobject:3a6ad9|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#c8a2c8"> | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3730732/ Zsiros et al. 2013 (SIOPEL-4)] | ||
+ | |2005-01-01 to 2009-08-31 | ||
+ | | style="background-color:#91cf61" |Non-randomized | ||
|- | |- | ||
|} | |} | ||
− | {| class="wikitable" style=" | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Neoadjuvant, "Cycles A1, A2, A3" {{#subobject:59db47|Variant=1}}=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cisplatin (Platinol)]] as follows: | ||
+ | **Cycle 1: 80 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1, then 70 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on days 8 & 15 (total dose: 220 mg/m<sup>2</sup>) | ||
+ | **Cycle 2: 70 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on days 1, 8, 15 (total dose: 210 mg/m<sup>2</sup>) | ||
+ | **Cycle 3: 70 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on days 1 & 8 (total dose: 140 mg/m<sup>2</sup>) | ||
+ | *[[Doxorubicin (Adriamycin)]] as follows: | ||
+ | **Cycles 1 & 2: 30 mg/m<sup>2</sup>/day IV continuous infusion over 48 hours, started on day 8 (total dose per cycle: 60 mg/m<sup>2</sup>) | ||
+ | **Cycle 3: 30 mg/m<sup>2</sup>/day IV continuous infusion over 48 hours, started on day 1 (total dose: 60 mg/m<sup>2</sup>) | ||
+ | '''28-day cycle for 3 cycles, followed by determination of resectability, then:''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Definitive=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Local therapy==== | ||
+ | *[[Surgery#Surgical_resection|Surgical resection]], including liver transplantation and [[Surgery#Metastasectomy|metastasectomy]], if needed | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Adjuvant, "Cycle C"=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Carboplatin (Paraplatin)]] AUC 6.6 IV over 60 minutes once on day 1 | ||
+ | *[[Doxorubicin (Adriamycin)]] 20 mg/m<sup>2</sup>/day IV continuous infusion over 48 hours, started on day 1 (total dose per cycle: 40 mg/m<sup>2</sup>) | ||
+ | '''21-day cycle for 3 cycles''' | ||
+ | </div></div></div> | ||
+ | ===References=== | ||
+ | #'''SIOPEL-4:''' Zsiros J, Brugieres L, Brock P, Roebuck D, Maibach R, Zimmermann A, Childs M, Pariente D, Laithier V, Otte JB, Branchereau S, Aronson D, Rangaswami A, Ronghe M, Casanova M, Sullivan M, Morland B, Czauderna P, Perilongo G; International Childhood Liver Tumours Strategy Group (SIOPEL). Dose-dense cisplatin-based chemotherapy and surgery for children with high-risk hepatoblastoma (SIOPEL-4): a prospective, single-arm, feasibility study. Lancet Oncol. 2013 Aug;14(9):834-42. Epub 2013 Jul 4. [https://doi.org/10.1016/s1470-2045(13)70272-9 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3730732/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/23831416/ PubMed] [https://clinicaltrials.gov/study/NCT00077389 NCT00077389] | ||
+ | |||
+ | ==SIOPEL-4 protocol, unresectable after A3 {{#subobject:3aund9|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#c8a2c8"> | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3730732/ Zsiros et al. 2013 (SIOPEL-4)] | ||
+ | |2005-01-01 to 2009-08-31 | ||
+ | | style="background-color:#91cf61" |Non-randomized | ||
|- | |- | ||
− | |||
− | |||
|} | |} | ||
− | {{ | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Neoadjuvant, "Cycles A1, A2, A3" {{#subobject:5c4c47|Variant=1}}=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cisplatin (Platinol)]] as follows: | ||
+ | **Cycle 1: 80 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1, then 70 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on days 8 & 15 (total dose: 220 mg/m<sup>2</sup>) | ||
+ | **Cycle 2: 70 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on days 1, 8, 15 (total dose: 210 mg/m<sup>2</sup>) | ||
+ | **Cycle 3: 70 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on days 1 & 8 (total dose: 140 mg/m<sup>2</sup>) | ||
+ | *[[Doxorubicin (Adriamycin)]] as follows: | ||
+ | **Cycles 1 & 2: 30 mg/m<sup>2</sup>/day IV continuous infusion over 48 hours, started on day 8 (total dose per cycle: 60 mg/m<sup>2</sup>) | ||
+ | **Cycle 3: 30 mg/m<sup>2</sup>/day IV continuous infusion over 48 hours, started on day 1 (total dose: 60 mg/m<sup>2</sup>) | ||
+ | '''28-day cycle for 3 cycles, followed by determination of unresectability, then:''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Neoadjuvant, "Cycle B"=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Carboplatin (Paraplatin)]] AUC 10.6 IV over 60 minutes once on day 1 | ||
+ | *[[Doxorubicin (Adriamycin)]] 25 mg/m<sup>2</sup>/day IV continuous infusion over 72 hours, started on day 1 (total dose per cycle: 75 mg/m<sup>2</sup>) | ||
+ | '''21-day cycle for 2 cycles, followed by:''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Definitive=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Local therapy==== | ||
+ | *[[Surgery#Surgical_resection|Surgical resection]], including liver transplantation and [[Surgery#Metastasectomy|metastasectomy]], if needed | ||
+ | </div></div></div> | ||
+ | ===References=== | ||
+ | #'''SIOPEL-4:''' Zsiros J, Brugieres L, Brock P, Roebuck D, Maibach R, Zimmermann A, Childs M, Pariente D, Laithier V, Otte JB, Branchereau S, Aronson D, Rangaswami A, Ronghe M, Casanova M, Sullivan M, Morland B, Czauderna P, Perilongo G; International Childhood Liver Tumours Strategy Group (SIOPEL). Dose-dense cisplatin-based chemotherapy and surgery for children with high-risk hepatoblastoma (SIOPEL-4): a prospective, single-arm, feasibility study. Lancet Oncol. 2013 Aug;14(9):834-42. Epub 2013 Jul 4. [https://doi.org/10.1016/s1470-2045(13)70272-9 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3730732/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/23831416/ PubMed] [https://clinicaltrials.gov/study/NCT00077389 NCT00077389] | ||
+ | |||
+ | =Intermediate-risk, upfront therapy= | ||
+ | ==COG AHEP0731 protocol F {{#subobject:3a8i39|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:a15cb47|Variant=1}}=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy, C5VD portion (cycles 1 to 4)==== | ||
+ | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1 | ||
+ | **10 kg or more: 100 mg/m<sup>2</sup> IV once over 6 hours on day 1 | ||
+ | |||
+ | *[[Fluorouracil (5-FU)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2 | ||
+ | **10 kg or more: 600 mg/m<sup>2</sup> IV push over 2 to 4 minutes once on day 2 | ||
+ | |||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | |||
+ | *[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2 | ||
+ | **10 kg or more: 30 mg/m<sup>2</sup> IV over 15 minutes once per day on days 1 & 2 | ||
+ | |||
+ | ====Chemotherapy, C5VD portion (cycles 5 & 6)==== | ||
+ | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1 | ||
+ | **10 kg or more: 100 mg/m<sup>2</sup> IV once over 6 hours on day 1 | ||
+ | |||
+ | *[[Fluorouracil (5-FU)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2 | ||
+ | **10 kg or more: 600 mg/m<sup>2</sup> IV push over 2 to 4 minutes once on day 2 | ||
+ | |||
+ | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | |||
+ | *[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2 | ||
+ | **10 kg or more: 30 mg/m<sup>2</sup> IV over 15 minutes once per day on days 1 & 2 | ||
+ | ====Supportive therapy, C5VD portion (cycles 5 & 6)==== | ||
+ | *[[Dexrazoxane (Zinecard)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 10 mg/kg IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2 | ||
+ | **10 kg or more: 300 mg/m<sup>2</sup> IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2 | ||
+ | |||
+ | '''21-day cycle for 6 cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #Not yet identified | ||
+ | |||
+ | =Low-risk, upfront therapy= | ||
+ | ==COG AHEP0731 protocol T {{#subobject:3a8i39|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:a15cb47|Variant=1}}=== | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *[[Surgery#Surgical_resection|Surgical resection]] | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1 | ||
+ | **10 kg or more: 100 mg/m<sup>2</sup> IV once over 6 hours on day 1 | ||
+ | |||
+ | *[[Fluorouracil (5-FU)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2 | ||
+ | **10 kg or more: 600 mg/m<sup>2</sup> IV push over 2 to 4 minutes once on day 2 | ||
− | + | *[[Vincristine (Oncovin)]] by the following weight-based criteria: | |
+ | **Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16 | ||
− | [[ | + | '''21-day cycle for 2 cycles''' |
− | + | </div></div> | |
− | [ | + | ===References=== |
+ | #'''COG AHEP0731:''' Katzenstein HM, Langham MR, Malogolowkin MH, Krailo MD, Towbin AJ, McCarville MB, Finegold MJ, Ranganathan S, Dunn S, McGahren ED, Tiao GM, O'Neill AF, Qayed M, Furman WL, Xia C, Rodriguez-Galindo C, Meyers RL; Children's Oncology Group. Minimal adjuvant chemotherapy for children with hepatoblastoma resected at diagnosis (AHEP0731): a Children's Oncology Group, multicentre, phase 3 trial. Lancet Oncology. 2019 May 1. 20(5) 719-727. Epub 2019 Apr 8. [https://doi.org/10.1016/S1470-2045(18)30895-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6499702/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30975630/ PubMed] [https://clinicaltrials.gov/study/NCT00980460 NCT00980460] | ||
+ | =Neoadjuvant therapy= | ||
==Cisplatin monotherapy {{#subobject:ea894c|Regimen=1}}== | ==Cisplatin monotherapy {{#subobject:ea894c|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen {{#subobject:9134b2|Variant=1}}=== | ===Regimen {{#subobject:9134b2|Variant=1}}=== | ||
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
− | !style="width: | + | !style="width: 17%"|Study |
− | !style="width: | + | !style="width: 15%"|Dates of enrollment |
− | !style="width: | + | !style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 17%"|Comparator |
+ | !style="width: 17%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | !style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1056/NEJMoa0810613 Perilongo et al. 2009 (SIOPEL 3)] |
− | | style="background-color:#1a9851" |Phase | + | |1998-2006 |
+ | | style="background-color:#1a9851" |Phase 3 (E-de-esc) | ||
|[[#Cisplatin_.26_Doxorubicin|Cisplatin & Doxorubicin]] | |[[#Cisplatin_.26_Doxorubicin|Cisplatin & Doxorubicin]] | ||
− | | style="background-color:#eeee01" |Non-inferior complete resection rate | + | | style="background-color:#eeee01" |Non-inferior complete resection rate (primary endpoint) |
+ | | | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6117111/ Brock et al. 2018 (SIOPEL 6)] | ||
+ | |2007-2014 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Cisplatin_.26_Sodium_thiosulfate_999|Cisplatin & Sodium thiosulfate]] | ||
+ | | | ||
+ | | style="background-color:#d73027" |More hearing loss | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Cisplatin (Platinol)]] | + | *[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1 |
+ | '''14-day cycle for 4 cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | # '''SIOPEL 3:''' Perilongo G, Maibach R, Shafford E, Brugieres L, Brock P, Morland B, de Camargo B, Zsiros J, Roebuck D, Zimmermann A, Aronson D, Childs M, Widing E, Laithier V, Plaschkes J, Pritchard J, Scopinaro M, MacKinlay G, Czauderna P. Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma. N Engl J Med. 2009 Oct 22;361(17):1662-70. [https://doi.org/10.1056/NEJMoa0810613 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/19846851/ PubMed] [https://clinicaltrials.gov/study/NCT00003912 NCT00003912] | ||
+ | # '''SIOPEL 6:''' Brock PR, Maibach R, Childs M, Rajput K, Roebuck D, Sullivan MJ, Laithier V, Ronghe M, Dall'Igna P, Hiyama E, Brichard B, Skeen J, Mateos ME, Capra M, Rangaswami AA, Ansari M, Rechnitzer C, Veal GJ, Covezzoli A, Brugières L, Perilongo G, Czauderna P, Morland B, Neuwelt EA. Sodium Thiosulfate for Protection from Cisplatin-Induced Hearing Loss. N Engl J Med. 2018 Jun 21;378(25):2376-2385. [https://doi.org/10.1056/nejmoa1801109 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6117111/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29924955/ PubMed] [https://clinicaltrials.gov/study/NCT00652132 NCT00652132] | ||
+ | =Adjuvant therapy= | ||
+ | ==Cisplatin & Fluorouracil (CF) & Vincristine {{#subobject:50f9da|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6499702/ Katzenstein et al. 2019 (COG AHEP0731)] | ||
+ | |2010-2014 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-esc) | ||
+ | |[[#Observation|Observation]] | ||
+ | | style="background-color:#91cf60" |Seems to have superior EFS (primary endpoint) | ||
+ | |- | ||
+ | |} | ||
+ | ''For stage 1 or 2 '''hepatoblastoma''' without 100% pure fetal stage I or small-cell undifferentiated histology with complete resection at diagnosis and no history of prior chemotherapy or liver directed therapy. Eligible patients include: patients< 21 years old, elevated serum α-fetoprotein level (>100 ng/mL), at least 50% Karnofsky (patients >16 years) or Lansky (patients ≤16 years) performance status.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *Curative [[Surgery#Hepatobiliary_cancer_surgery|surgical resection]] | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1 | ||
+ | **10 kg or more: 100 mg/m<sup>2</sup> over 6 hours once on day 1 | ||
+ | *[[Fluorouracil (5-FU)|Fluorouracil]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 20 mg/kg IV once on day 2 | ||
+ | **10 kg or more: 600 mg/m<sup>2</sup> IV once on day 2 | ||
+ | *[[Vincristine (Oncovin)|Vincristine]] by the following weight-based criteria: | ||
+ | **Less than 10 kg: 0.05 mg/kg IV once per day on days 2, 9, 16 | ||
+ | **10 kg or more: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once per day on days 2, 9, 16 | ||
+ | '''21-day course; to be given within 42 days of resection''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # ''' | + | #'''COG AHEP0731:''' Katzenstein HM, Langham MR, Malogolowkin MH, Krailo MD, Towbin AJ, McCarville MB, Finegold MJ, Ranganathan S, Dunn S, McGahren ED, Tiao GM, O'Neill AF, Qayed M, Furman WL, Xia C, Rodriguez-Galindo C, Meyers RL; Children's Oncology Group. Minimal adjuvant chemotherapy for children with hepatoblastoma resected at diagnosis (AHEP0731): a Children's Oncology Group, multicentre, phase 3 trial. Lancet Oncology. 2019 May 1. 20(5) 719-727. Epub 2019 Apr 8. [https://doi.org/10.1016/S1470-2045(18)30895-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6499702/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30975630/ PubMed] [https://clinicaltrials.gov/study/NCT00980460 NCT00980460] |
+ | =All lines of therapy= | ||
==Cisplatin & Doxorubicin {{#subobject:7bb59c|Regimen=1}}== | ==Cisplatin & Doxorubicin {{#subobject:7bb59c|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
PLADO: '''<u>PLA</u>'''tinol (Cisplatin) & '''<u>DO</u>'''xorubicin | PLADO: '''<u>PLA</u>'''tinol (Cisplatin) & '''<u>DO</u>'''xorubicin | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:c48515|Variant=1}}=== | ===Regimen {{#subobject:c48515|Variant=1}}=== | ||
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
− | !style="width: | + | !style="width: 17%"|Study |
− | !style="width: | + | !style="width: 15%"|Dates of enrollment |
− | !style="width: | + | !style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 17%"|Comparator |
+ | !style="width: 17%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | !style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1200/JCO.2000.18.14.2665 Ortega et al. 2000] |
− | | style="background-color:#1a9851" |Phase | + | |1989-1992 |
− | | | + | | style="background-color:#1a9851" |Phase 3 (E-switch-ic) |
− | | style="background-color:# | + | |[[#Cisplatin_.26_Fluorouracil_.28CF.29_.26_Vincristine_888|CF & Vincristine]] |
+ | | | ||
+ | | style="background-color:#d73027" |More toxic (primary endpoint) | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1200/jco.2000.18.22.3819 Pritchard et al. 2000 (SIOPEL 1)] |
− | | style="background-color:#1a9851" |Phase | + | |1990-1994 |
+ | | style="background-color:#91cf61" |Non-randomized | ||
+ | | style="background-color:#d3d3d3" | | ||
+ | | style="background-color:#d3d3d3" | | ||
+ | | style="background-color:#d3d3d3" | | ||
+ | |- | ||
+ | |[https://doi.org/10.1056/NEJMoa0810613 Perilongo et al. 2009 (SIOPEL 3)] | ||
+ | |1998-2006 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
|[[#Cisplatin_monotherapy|Cisplatin]] | |[[#Cisplatin_monotherapy|Cisplatin]] | ||
| style="background-color:#eeee01" |Non-inferior complete resection rate | | style="background-color:#eeee01" |Non-inferior complete resection rate | ||
+ | | | ||
|- | |- | ||
|} | |} | ||
+ | ''Note: the duration of cycles was not specified.''' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Cisplatin (Platinol)]] | + | *[[Cisplatin (Platinol)]] by the following age-based criteria: |
− | *[[Doxorubicin (Adriamycin)]] | + | **Younger than 1 year old: 3 mg/kg IV over 6 hours once on day 1, '''given first''' |
− | + | **1 year old or older: 90 mg/m<sup>2</sup> IV over 6 hours once on day 1, '''given first''' | |
+ | *[[Doxorubicin (Adriamycin)]] 20 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1, '''given second''' (total dose per cycle: 80 mg/m<sup>2</sup>) | ||
+ | '''4 cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # Ortega JA, Douglass EC, Feusner JH, Reynolds M, Quinn JJ, Finegold MJ, Haas JE, King DR, Liu-Mares W, Sensel MG, Krailo MD. Randomized comparison of cisplatin/vincristine/fluorouracil and cisplatin/continuous infusion doxorubicin for treatment of pediatric hepatoblastoma: a report from the Children's Cancer Group and the Pediatric Oncology Group. J Clin Oncol. 2000 Jul;18(14):2665-75. [ | + | # Ortega JA, Douglass EC, Feusner JH, Reynolds M, Quinn JJ, Finegold MJ, Haas JE, King DR, Liu-Mares W, Sensel MG, Krailo MD; Children's Cancer Group; Pediatric Oncology Group. Randomized comparison of cisplatin/vincristine/fluorouracil and cisplatin/continuous infusion doxorubicin for treatment of pediatric hepatoblastoma: a report from the Children's Cancer Group and the Pediatric Oncology Group. J Clin Oncol. 2000 Jul;18(14):2665-75. [https://doi.org/10.1200/JCO.2000.18.14.2665 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/10894865/ PubMed] |
− | # '''SIOPEL 3:''' Perilongo G, Maibach R, Shafford E, Brugieres L, Brock P, Morland B, de Camargo B, Zsiros J, Roebuck D, Zimmermann A, Aronson D, Childs M, Widing E, Laithier V, Plaschkes J, Pritchard J, Scopinaro M, MacKinlay G, Czauderna P. Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma. N Engl J Med. 2009 Oct 22;361(17):1662-70. [https:// | + | # '''SIOPEL 1:''' Pritchard J, Brown J, Shafford E, Perilongo G, Brock P, Dicks-Mireaux C, Keeling J, Phillips A, Vos A, Plaschkes J. Cisplatin, doxorubicin, and delayed surgery for childhood hepatoblastoma: a successful approach--results of the first prospective study of the International Society of Pediatric Oncology. J Clin Oncol. 2000 Nov 15;18(22):3819-28. [https://doi.org/10.1200/jco.2000.18.22.3819 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11078495/ PubMed] |
+ | # '''SIOPEL 3:''' Perilongo G, Maibach R, Shafford E, Brugieres L, Brock P, Morland B, de Camargo B, Zsiros J, Roebuck D, Zimmermann A, Aronson D, Childs M, Widing E, Laithier V, Plaschkes J, Pritchard J, Scopinaro M, MacKinlay G, Czauderna P. Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma. N Engl J Med. 2009 Oct 22;361(17):1662-70. [https://doi.org/10.1056/NEJMoa0810613 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19846851/ PubMed] [https://clinicaltrials.gov/study/NCT00003912 NCT00003912] | ||
+ | [[Category:Hepatoblastoma regimens]] | ||
+ | [[Category:Disease-specific pages]] | ||
+ | [[Category:Pediatric solid tumors]] |
Latest revision as of 12:26, 15 July 2024
Section editor | |
---|---|
Elaine Fan, MD KU School of Medicine Wichita, KS, USA |
7 regimens on this page
7 variants on this page
|
High-risk, upfront therapy
COG AHEP0731 protocol H - responders
Regimen
Chemotherapy, VIT portion (cycles 1 & 2)
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8
- Irinotecan (Camptosar) by the following weight-based criteria:
- Less than 10 kg: 1.67 mg/kg (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5
- 10 kg or more: 50 mg/m2 (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5
Targeted therapy, VIT portion (cycles 1 & 2)
- Temsirolimus (Torisel) by the following weight-based criteria:
- Less than 10 kg: 1.2 mg/kg IV over 30 minutes once per day on days 1 & 8
- 10 kg or more: 35 mg/m2 IV over 30 minutes once per day on days 1 & 8
Chemotherapy, C5VD portion (cycles 3 to 6)
- Cisplatin (Platinol) by the following weight-based criteria:
- Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1
- 10 kg or more: 100 mg/m2 IV once over 6 hours on day 1
- Fluorouracil (5-FU) by the following weight-based criteria:
- Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2
- 10 kg or more: 600 mg/m2 IV push over 2 to 4 minutes once on day 2
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- Doxorubicin (Adriamycin) by the following weight-based criteria:
- Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2
- 10 kg or more: 30 mg/m2 IV over 15 minutes once per day on days 1 & 2
Chemotherapy, VIT portion (cycle 7)
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8
- Irinotecan (Camptosar) by the following weight-based criteria:
- Less than 10 kg: 1.67 mg/kg (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5
- 10 kg or more: 50 mg/m2 (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5
Targeted therapy, VIT portion (cycle 7)
- Temsirolimus (Torisel) by the following weight-based criteria:
- Less than 10 kg: 1.2 mg/kg IV over 30 minutes once per day on days 1 & 8
- 10 kg or more: 35 mg/m2 IV over 30 minutes once per day on days 1 & 8
Chemotherapy, C5VD portion (cycles 8 & 9)
- Cisplatin (Platinol) by the following weight-based criteria:
- Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1
- 10 kg or more: 100 mg/m2 IV once over 6 hours on day 1
- Fluorouracil (5-FU) by the following weight-based criteria:
- Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2
- 10 kg or more: 600 mg/m2 IV push over 2 to 4 minutes once on day 2
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- Doxorubicin (Adriamycin) by the following weight-based criteria:
- Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2
- 10 kg or more: 30 mg/m2 IV over 15 minutes once per day on days 1 & 2
Supportive therapy, C5VD portion (cycles 8 & 9)
- Dexrazoxane (Zinecard) by the following weight-based criteria:
- Less than 10 kg: 10 mg/kg IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2
- 10 kg or more: 300 mg/m2 IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2
Chemotherapy, VIT portion (cycle 10)
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8
- Irinotecan (Camptosar) by the following weight-based criteria:
- Less than 10 kg: 1.67 mg/kg (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5
- 10 kg or more: 50 mg/m2 (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5
Targeted therapy, VIT portion (cycle 10)
- Temsirolimus (Torisel) by the following weight-based criteria:
- Less than 10 kg: 1.2 mg/kg IV over 30 minutes once per day on days 1 & 8
- 10 kg or more: 35 mg/m2 IV over 30 minutes once per day on days 1 & 8
21-day cycle for 10 cycles
References
- None yet identified
COG AHEP0731 protocol H - non-responders
Regimen
Chemotherapy, VIT portion (cycles 1 & 2)
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 1 & 8
- Irinotecan (Camptosar) by the following weight-based criteria:
- Less than 10 kg: 1.67 mg/kg (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5
- 10 kg or more: 50 mg/m2 (maximum dose of 100 mg) IV over 90 minutes once per day on days 1 to 5
Targeted therapy, VIT portion (cycles 1 & 2)
- Temsirolimus (Torisel) by the following weight-based criteria:
- Less than 10 kg: 1.2 mg/kg IV over 30 minutes once per day on days 1 & 8
- 10 kg or more: 35 mg/m2 IV over 30 minutes once per day on days 1 & 8
Chemotherapy, C5VD portion (cycles 3 to 6)
- Cisplatin (Platinol) by the following weight-based criteria:
- Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1
- 10 kg or more: 100 mg/m2 IV once over 6 hours on day 1
- Fluorouracil (5-FU) by the following weight-based criteria:
- Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2
- 10 kg or more: 600 mg/m2 IV push over 2 to 4 minutes once on day 2
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- Doxorubicin (Adriamycin) by the following weight-based criteria:
- Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2
- 10 kg or more: 30 mg/m2 IV over 15 minutes once per day on days 1 & 2
Chemotherapy, C5VD portion (cycles 7 to 8)
- Cisplatin (Platinol) by the following weight-based criteria:
- Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1
- 10 kg or more: 100 mg/m2 IV once over 6 hours on day 1
- Fluorouracil (5-FU) by the following weight-based criteria:
- Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2
- 10 kg or more: 600 mg/m2 IV push over 2 to 4 minutes once on day 2
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- Doxorubicin (Adriamycin) by the following weight-based criteria:
- Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2
- 10 kg or more: 30 mg/m2 IV over 15 minutes once per day on days 1 & 2
Supportive therapy, C5VD portion (cycles 7 to 8)
- Dexrazoxane (Zinecard) by the following weight-based criteria:
- Less than 10 kg: 10 mg/kg IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2
- 10 kg or more: 300 mg/m2 IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2
21-day cycle for 8 cycles
References
- None yet identified
COG AHEP0731 protocol W
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Katzenstein et al. 2017 (COG AHEP0731 HR) | 2009-09 to 2012-02 | Non-randomized |
Chemotherapy
- Irinotecan (Camptosar) by the following weight-based criteria:
- Less than 10 kg: 1.67 mg/kg IV over 90 minutes once per day on days 1 to 5
- 10 kg or more: 50 mg/m2 IV over 90 minutes once per day on days 1 to 5
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg IV once per day on days 1 & 8
- 10 kg or more: 1.5 mg/m2 IV once per day on days 1 & 8
21-day cycle for 2 cycles
Subsequent treatment
- Depends on response; see paper for details
References
- COG AHEP0731 HR: Katzenstein HM, Furman WL, Malogolowkin MH, Krailo MD, McCarville MB, Towbin AJ, Tiao GM, Finegold MJ, Ranganathan S, Dunn SP, Langham MR, McGahren ED, Rodriguez-Galindo C, Meyers RL. Upfront window vincristine/irinotecan treatment of high-risk hepatoblastoma: A report from the Children's Oncology Group AHEP0731 study committee. Cancer. 2017 Jun 15;123(12):2360-2367. Epub 2017 Feb 17. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT00980460
SIOPEL-4 protocol, resectable after A3
Study | Dates of enrollment | Evidence |
---|---|---|
Zsiros et al. 2013 (SIOPEL-4) | 2005-01-01 to 2009-08-31 | Non-randomized |
Neoadjuvant, "Cycles A1, A2, A3"
Chemotherapy
- Cisplatin (Platinol) as follows:
- Cycle 1: 80 mg/m2 IV continuous infusion over 24 hours, started on day 1, then 70 mg/m2 IV continuous infusion over 24 hours, started on days 8 & 15 (total dose: 220 mg/m2)
- Cycle 2: 70 mg/m2 IV continuous infusion over 24 hours, started on days 1, 8, 15 (total dose: 210 mg/m2)
- Cycle 3: 70 mg/m2 IV continuous infusion over 24 hours, started on days 1 & 8 (total dose: 140 mg/m2)
- Doxorubicin (Adriamycin) as follows:
- Cycles 1 & 2: 30 mg/m2/day IV continuous infusion over 48 hours, started on day 8 (total dose per cycle: 60 mg/m2)
- Cycle 3: 30 mg/m2/day IV continuous infusion over 48 hours, started on day 1 (total dose: 60 mg/m2)
28-day cycle for 3 cycles, followed by determination of resectability, then:
Definitive
Local therapy
- Surgical resection, including liver transplantation and metastasectomy, if needed
Adjuvant, "Cycle C"
Chemotherapy
- Carboplatin (Paraplatin) AUC 6.6 IV over 60 minutes once on day 1
- Doxorubicin (Adriamycin) 20 mg/m2/day IV continuous infusion over 48 hours, started on day 1 (total dose per cycle: 40 mg/m2)
21-day cycle for 3 cycles
References
- SIOPEL-4: Zsiros J, Brugieres L, Brock P, Roebuck D, Maibach R, Zimmermann A, Childs M, Pariente D, Laithier V, Otte JB, Branchereau S, Aronson D, Rangaswami A, Ronghe M, Casanova M, Sullivan M, Morland B, Czauderna P, Perilongo G; International Childhood Liver Tumours Strategy Group (SIOPEL). Dose-dense cisplatin-based chemotherapy and surgery for children with high-risk hepatoblastoma (SIOPEL-4): a prospective, single-arm, feasibility study. Lancet Oncol. 2013 Aug;14(9):834-42. Epub 2013 Jul 4. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT00077389
SIOPEL-4 protocol, unresectable after A3
Study | Dates of enrollment | Evidence |
---|---|---|
Zsiros et al. 2013 (SIOPEL-4) | 2005-01-01 to 2009-08-31 | Non-randomized |
Neoadjuvant, "Cycles A1, A2, A3"
Chemotherapy
- Cisplatin (Platinol) as follows:
- Cycle 1: 80 mg/m2 IV continuous infusion over 24 hours, started on day 1, then 70 mg/m2 IV continuous infusion over 24 hours, started on days 8 & 15 (total dose: 220 mg/m2)
- Cycle 2: 70 mg/m2 IV continuous infusion over 24 hours, started on days 1, 8, 15 (total dose: 210 mg/m2)
- Cycle 3: 70 mg/m2 IV continuous infusion over 24 hours, started on days 1 & 8 (total dose: 140 mg/m2)
- Doxorubicin (Adriamycin) as follows:
- Cycles 1 & 2: 30 mg/m2/day IV continuous infusion over 48 hours, started on day 8 (total dose per cycle: 60 mg/m2)
- Cycle 3: 30 mg/m2/day IV continuous infusion over 48 hours, started on day 1 (total dose: 60 mg/m2)
28-day cycle for 3 cycles, followed by determination of unresectability, then:
Neoadjuvant, "Cycle B"
Chemotherapy
- Carboplatin (Paraplatin) AUC 10.6 IV over 60 minutes once on day 1
- Doxorubicin (Adriamycin) 25 mg/m2/day IV continuous infusion over 72 hours, started on day 1 (total dose per cycle: 75 mg/m2)
21-day cycle for 2 cycles, followed by:
Definitive
Local therapy
- Surgical resection, including liver transplantation and metastasectomy, if needed
References
- SIOPEL-4: Zsiros J, Brugieres L, Brock P, Roebuck D, Maibach R, Zimmermann A, Childs M, Pariente D, Laithier V, Otte JB, Branchereau S, Aronson D, Rangaswami A, Ronghe M, Casanova M, Sullivan M, Morland B, Czauderna P, Perilongo G; International Childhood Liver Tumours Strategy Group (SIOPEL). Dose-dense cisplatin-based chemotherapy and surgery for children with high-risk hepatoblastoma (SIOPEL-4): a prospective, single-arm, feasibility study. Lancet Oncol. 2013 Aug;14(9):834-42. Epub 2013 Jul 4. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT00077389
Intermediate-risk, upfront therapy
COG AHEP0731 protocol F
Regimen
Chemotherapy, C5VD portion (cycles 1 to 4)
- Cisplatin (Platinol) by the following weight-based criteria:
- Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1
- 10 kg or more: 100 mg/m2 IV once over 6 hours on day 1
- Fluorouracil (5-FU) by the following weight-based criteria:
- Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2
- 10 kg or more: 600 mg/m2 IV push over 2 to 4 minutes once on day 2
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- Doxorubicin (Adriamycin) by the following weight-based criteria:
- Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2
- 10 kg or more: 30 mg/m2 IV over 15 minutes once per day on days 1 & 2
Chemotherapy, C5VD portion (cycles 5 & 6)
- Cisplatin (Platinol) by the following weight-based criteria:
- Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1
- 10 kg or more: 100 mg/m2 IV once over 6 hours on day 1
- Fluorouracil (5-FU) by the following weight-based criteria:
- Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2
- 10 kg or more: 600 mg/m2 IV push over 2 to 4 minutes once on day 2
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- Doxorubicin (Adriamycin) by the following weight-based criteria:
- Less than 10 kg: 1 mg/kg IV over 15 minutes once per day on days 1 & 2
- 10 kg or more: 30 mg/m2 IV over 15 minutes once per day on days 1 & 2
Supportive therapy, C5VD portion (cycles 5 & 6)
- Dexrazoxane (Zinecard) by the following weight-based criteria:
- Less than 10 kg: 10 mg/kg IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2
- 10 kg or more: 300 mg/m2 IV over 5 to 15 minutes immediately prior to doxorubicin on days 1 & 2
21-day cycle for 6 cycles
References
- Not yet identified
Low-risk, upfront therapy
COG AHEP0731 protocol T
Regimen
Preceding treatment
Chemotherapy
- Cisplatin (Platinol) by the following weight-based criteria:
- Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1
- 10 kg or more: 100 mg/m2 IV once over 6 hours on day 1
- Fluorouracil (5-FU) by the following weight-based criteria:
- Less than 10 kg: 20 mg/kg IV push over 2 to 4 minutes once on day 2
- 10 kg or more: 600 mg/m2 IV push over 2 to 4 minutes once on day 2
- Vincristine (Oncovin) by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV push or infusion once per day on days 2, 9, 16
21-day cycle for 2 cycles
References
- COG AHEP0731: Katzenstein HM, Langham MR, Malogolowkin MH, Krailo MD, Towbin AJ, McCarville MB, Finegold MJ, Ranganathan S, Dunn S, McGahren ED, Tiao GM, O'Neill AF, Qayed M, Furman WL, Xia C, Rodriguez-Galindo C, Meyers RL; Children's Oncology Group. Minimal adjuvant chemotherapy for children with hepatoblastoma resected at diagnosis (AHEP0731): a Children's Oncology Group, multicentre, phase 3 trial. Lancet Oncology. 2019 May 1. 20(5) 719-727. Epub 2019 Apr 8. link to original article link to PMC article PubMed NCT00980460
Neoadjuvant therapy
Cisplatin monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
---|---|---|---|---|---|
Perilongo et al. 2009 (SIOPEL 3) | 1998-2006 | Phase 3 (E-de-esc) | Cisplatin & Doxorubicin | Non-inferior complete resection rate (primary endpoint) | |
Brock et al. 2018 (SIOPEL 6) | 2007-2014 | Phase 3 (C) | Cisplatin & Sodium thiosulfate | More hearing loss |
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV continuous infusion over 24 hours, started on day 1
14-day cycle for 4 cycles
References
- SIOPEL 3: Perilongo G, Maibach R, Shafford E, Brugieres L, Brock P, Morland B, de Camargo B, Zsiros J, Roebuck D, Zimmermann A, Aronson D, Childs M, Widing E, Laithier V, Plaschkes J, Pritchard J, Scopinaro M, MacKinlay G, Czauderna P. Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma. N Engl J Med. 2009 Oct 22;361(17):1662-70. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00003912
- SIOPEL 6: Brock PR, Maibach R, Childs M, Rajput K, Roebuck D, Sullivan MJ, Laithier V, Ronghe M, Dall'Igna P, Hiyama E, Brichard B, Skeen J, Mateos ME, Capra M, Rangaswami AA, Ansari M, Rechnitzer C, Veal GJ, Covezzoli A, Brugières L, Perilongo G, Czauderna P, Morland B, Neuwelt EA. Sodium Thiosulfate for Protection from Cisplatin-Induced Hearing Loss. N Engl J Med. 2018 Jun 21;378(25):2376-2385. link to original article link to PMC article PubMed NCT00652132
Adjuvant therapy
Cisplatin & Fluorouracil (CF) & Vincristine
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Katzenstein et al. 2019 (COG AHEP0731) | 2010-2014 | Phase 3 (E-esc) | Observation | Seems to have superior EFS (primary endpoint) |
For stage 1 or 2 hepatoblastoma without 100% pure fetal stage I or small-cell undifferentiated histology with complete resection at diagnosis and no history of prior chemotherapy or liver directed therapy. Eligible patients include: patients< 21 years old, elevated serum α-fetoprotein level (>100 ng/mL), at least 50% Karnofsky (patients >16 years) or Lansky (patients ≤16 years) performance status.
Preceding treatment
- Curative surgical resection
Chemotherapy
- Cisplatin (Platinol) by the following weight-based criteria:
- Less than 10 kg: 3.3 mg/kg IV over 6 hours once on day 1
- 10 kg or more: 100 mg/m2 over 6 hours once on day 1
- Fluorouracil by the following weight-based criteria:
- Less than 10 kg: 20 mg/kg IV once on day 2
- 10 kg or more: 600 mg/m2 IV once on day 2
- Vincristine by the following weight-based criteria:
- Less than 10 kg: 0.05 mg/kg IV once per day on days 2, 9, 16
- 10 kg or more: 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 2, 9, 16
21-day course; to be given within 42 days of resection
References
- COG AHEP0731: Katzenstein HM, Langham MR, Malogolowkin MH, Krailo MD, Towbin AJ, McCarville MB, Finegold MJ, Ranganathan S, Dunn S, McGahren ED, Tiao GM, O'Neill AF, Qayed M, Furman WL, Xia C, Rodriguez-Galindo C, Meyers RL; Children's Oncology Group. Minimal adjuvant chemotherapy for children with hepatoblastoma resected at diagnosis (AHEP0731): a Children's Oncology Group, multicentre, phase 3 trial. Lancet Oncology. 2019 May 1. 20(5) 719-727. Epub 2019 Apr 8. link to original article link to PMC article PubMed NCT00980460
All lines of therapy
Cisplatin & Doxorubicin
PLADO: PLAtinol (Cisplatin) & DOxorubicin
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
---|---|---|---|---|---|
Ortega et al. 2000 | 1989-1992 | Phase 3 (E-switch-ic) | CF & Vincristine | More toxic (primary endpoint) | |
Pritchard et al. 2000 (SIOPEL 1) | 1990-1994 | Non-randomized | |||
Perilongo et al. 2009 (SIOPEL 3) | 1998-2006 | Phase 3 (C) | Cisplatin | Non-inferior complete resection rate |
Note: the duration of cycles was not specified.'
Chemotherapy
- Cisplatin (Platinol) by the following age-based criteria:
- Younger than 1 year old: 3 mg/kg IV over 6 hours once on day 1, given first
- 1 year old or older: 90 mg/m2 IV over 6 hours once on day 1, given first
- Doxorubicin (Adriamycin) 20 mg/m2/day IV continuous infusion over 96 hours, started on day 1, given second (total dose per cycle: 80 mg/m2)
4 cycles
References
- Ortega JA, Douglass EC, Feusner JH, Reynolds M, Quinn JJ, Finegold MJ, Haas JE, King DR, Liu-Mares W, Sensel MG, Krailo MD; Children's Cancer Group; Pediatric Oncology Group. Randomized comparison of cisplatin/vincristine/fluorouracil and cisplatin/continuous infusion doxorubicin for treatment of pediatric hepatoblastoma: a report from the Children's Cancer Group and the Pediatric Oncology Group. J Clin Oncol. 2000 Jul;18(14):2665-75. link to original article dosing details in manuscript have been reviewed by our editors PubMed
- SIOPEL 1: Pritchard J, Brown J, Shafford E, Perilongo G, Brock P, Dicks-Mireaux C, Keeling J, Phillips A, Vos A, Plaschkes J. Cisplatin, doxorubicin, and delayed surgery for childhood hepatoblastoma: a successful approach--results of the first prospective study of the International Society of Pediatric Oncology. J Clin Oncol. 2000 Nov 15;18(22):3819-28. link to original article PubMed
- SIOPEL 3: Perilongo G, Maibach R, Shafford E, Brugieres L, Brock P, Morland B, de Camargo B, Zsiros J, Roebuck D, Zimmermann A, Aronson D, Childs M, Widing E, Laithier V, Plaschkes J, Pritchard J, Scopinaro M, MacKinlay G, Czauderna P. Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma. N Engl J Med. 2009 Oct 22;361(17):1662-70. link to original article PubMed NCT00003912