High Incidence of Veno-Occlusive Disease With Myeloablative Chemotherapy Following Craniospinal Irradiation in Children With Newly Diagnosed High-Risk CNS Embryonal Tumors: A Report From the Children's Oncology Group (CCG-99702)
Background The outcomes with high‐risk central nervous system (CNS) embryonal tumors remain relatively poor despite aggressive treatment. The purposes of this study using postirradiation myeloablative chemotherapy with autologous hematopoietic stem cell rescue (ASCR) were to document feasibility and...
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| Published in | Pediatric blood & cancer Vol. 63; no. 9; pp. 1563 - 1570 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Blackwell Publishing Ltd
01.09.2016
Wiley Subscription Services, Inc |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1545-5009 1545-5017 1545-5017 |
| DOI | 10.1002/pbc.26074 |
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| Abstract | Background
The outcomes with high‐risk central nervous system (CNS) embryonal tumors remain relatively poor despite aggressive treatment. The purposes of this study using postirradiation myeloablative chemotherapy with autologous hematopoietic stem cell rescue (ASCR) were to document feasibility and describe toxicities of the regimen, establish the appropriate dose of thiotepa, and estimate the overall survival (OS) and event‐free survival (EFS).
Procedure
The Children's Cancer Group conducted this pilot study in children and adolescents with CNS embryonal tumors. The treatment consisted of induction chemotherapy to mobilize hematopoietic stem cells, chemoradiotherapy, and myeloablative consolidation chemotherapy with ASCR.
Results
The study accrued 25 subjects in 40 months and was closed early due to toxicity, namely, veno‐occlusive disease (VOD) of the liver, more recently termed sinusoidal obstructive syndrome (SOS). Of 24 eligible subjects, three of 11 (27%) receiving thiotepa Dose Level 1 (150 mg/m2/day × 3 days) and three of 12 (25%) receiving de‐escalated Dose Level 0 (100 mg/m2/day × 3 days) experienced VOD/SOS. One additional subject experienced toxic death attributed to septic shock; postmortem examination revealed clinically undiagnosed VOD/SOS. The 2‐year EFS and OS were 54 ± 10% and 71 ± 9%, respectively. The 5‐year EFS and OS were 46 ± 11% and 50 ± 11%.
Conclusions
The treatment regimen was deemed to have an unacceptable rate of VOD/SOS. There was complete recovery in all six cases. The overall therapeutic strategy using a regimen less likely to cause VOD/SOS may merit further evaluation for the highest risk patients. |
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| AbstractList | The outcomes with high-risk central nervous system (CNS) embryonal tumors remain relatively poor despite aggressive treatment. The purposes of this study using postirradiation myeloablative chemotherapy with autologous hematopoietic stem cell rescue (ASCR) were to document feasibility and describe toxicities of the regimen, establish the appropriate dose of thiotepa, and estimate the overall survival (OS) and event-free survival (EFS).
The Children's Cancer Group conducted this pilot study in children and adolescents with CNS embryonal tumors. The treatment consisted of induction chemotherapy to mobilize hematopoietic stem cells, chemoradiotherapy, and myeloablative consolidation chemotherapy with ASCR.
The study accrued 25 subjects in 40 months and was closed early due to toxicity, namely, veno-occlusive disease (VOD) of the liver, more recently termed sinusoidal obstructive syndrome (SOS). Of 24 eligible subjects, three of 11 (27%) receiving thiotepa Dose Level 1 (150 mg/m(2) /day × 3 days) and three of 12 (25%) receiving de-escalated Dose Level 0 (100 mg/m(2) /day × 3 days) experienced VOD/SOS. One additional subject experienced toxic death attributed to septic shock; postmortem examination revealed clinically undiagnosed VOD/SOS. The 2-year EFS and OS were 54 ± 10% and 71 ± 9%, respectively. The 5-year EFS and OS were 46 ± 11% and 50 ± 11%.
The treatment regimen was deemed to have an unacceptable rate of VOD/SOS. There was complete recovery in all six cases. The overall therapeutic strategy using a regimen less likely to cause VOD/SOS may merit further evaluation for the highest risk patients. Background The outcomes with high‐risk central nervous system (CNS) embryonal tumors remain relatively poor despite aggressive treatment. The purposes of this study using postirradiation myeloablative chemotherapy with autologous hematopoietic stem cell rescue (ASCR) were to document feasibility and describe toxicities of the regimen, establish the appropriate dose of thiotepa, and estimate the overall survival (OS) and event‐free survival (EFS). Procedure The Children's Cancer Group conducted this pilot study in children and adolescents with CNS embryonal tumors. The treatment consisted of induction chemotherapy to mobilize hematopoietic stem cells, chemoradiotherapy, and myeloablative consolidation chemotherapy with ASCR. Results The study accrued 25 subjects in 40 months and was closed early due to toxicity, namely, veno‐occlusive disease (VOD) of the liver, more recently termed sinusoidal obstructive syndrome (SOS). Of 24 eligible subjects, three of 11 (27%) receiving thiotepa Dose Level 1 (150 mg/m2/day × 3 days) and three of 12 (25%) receiving de‐escalated Dose Level 0 (100 mg/m2/day × 3 days) experienced VOD/SOS. One additional subject experienced toxic death attributed to septic shock; postmortem examination revealed clinically undiagnosed VOD/SOS. The 2‐year EFS and OS were 54 ± 10% and 71 ± 9%, respectively. The 5‐year EFS and OS were 46 ± 11% and 50 ± 11%. Conclusions The treatment regimen was deemed to have an unacceptable rate of VOD/SOS. There was complete recovery in all six cases. The overall therapeutic strategy using a regimen less likely to cause VOD/SOS may merit further evaluation for the highest risk patients. Background The outcomes with high-risk central nervous system (CNS) embryonal tumors remain relatively poor despite aggressive treatment. The purposes of this study using postirradiation myeloablative chemotherapy with autologous hematopoietic stem cell rescue (ASCR) were to document feasibility and describe toxicities of the regimen, establish the appropriate dose of thiotepa, and estimate the overall survival (OS) and event-free survival (EFS). Procedure The Children's Cancer Group conducted this pilot study in children and adolescents with CNS embryonal tumors. The treatment consisted of induction chemotherapy to mobilize hematopoietic stem cells, chemoradiotherapy, and myeloablative consolidation chemotherapy with ASCR. Results The study accrued 25 subjects in 40 months and was closed early due to toxicity, namely, veno-occlusive disease (VOD) of the liver, more recently termed sinusoidal obstructive syndrome (SOS). Of 24 eligible subjects, three of 11 (27%) receiving thiotepa Dose Level 1 (150 mg/m2/day × 3 days) and three of 12 (25%) receiving de-escalated Dose Level 0 (100 mg/m2/day × 3 days) experienced VOD/SOS. One additional subject experienced toxic death attributed to septic shock; postmortem examination revealed clinically undiagnosed VOD/SOS. The 2-year EFS and OS were 54 ± 10% and 71 ± 9%, respectively. The 5-year EFS and OS were 46 ± 11% and 50 ± 11%. Conclusions The treatment regimen was deemed to have an unacceptable rate of VOD/SOS. There was complete recovery in all six cases. The overall therapeutic strategy using a regimen less likely to cause VOD/SOS may merit further evaluation for the highest risk patients. Background The outcomes with high-risk central nervous system (CNS) embryonal tumors remain relatively poor despite aggressive treatment. The purposes of this study using postirradiation myeloablative chemotherapy with autologous hematopoietic stem cell rescue (ASCR) were to document feasibility and describe toxicities of the regimen, establish the appropriate dose of thiotepa, and estimate the overall survival (OS) and event-free survival (EFS). Procedure The Children's Cancer Group conducted this pilot study in children and adolescents with CNS embryonal tumors. The treatment consisted of induction chemotherapy to mobilize hematopoietic stem cells, chemoradiotherapy, and myeloablative consolidation chemotherapy with ASCR. Results The study accrued 25 subjects in 40 months and was closed early due to toxicity, namely, veno-occlusive disease (VOD) of the liver, more recently termed sinusoidal obstructive syndrome (SOS). Of 24 eligible subjects, three of 11 (27%) receiving thiotepa Dose Level 1 (150 mg/m super(2)/day 3 days) and three of 12 (25%) receiving de-escalated Dose Level 0 (100 mg/m super(2)/day 3 days) experienced VOD/SOS. One additional subject experienced toxic death attributed to septic shock; postmortem examination revealed clinically undiagnosed VOD/SOS. The 2-year EFS and OS were 54 plus or minus 10% and 71 plus or minus 9%, respectively. The 5-year EFS and OS were 46 plus or minus 11% and 50 plus or minus 11%. Conclusions The treatment regimen was deemed to have an unacceptable rate of VOD/SOS. There was complete recovery in all six cases. The overall therapeutic strategy using a regimen less likely to cause VOD/SOS may merit further evaluation for the highest risk patients. |
| Author | Kocak, Mehmet Packer, Roger J. Nazemi, Kellie J. Lafond, Deborah Nicholson, H. Stacy Finlay, Jonathan L. Shen, Violet Gardner, Sharon L. Boyett, James |
| Author_xml | – sequence: 1 givenname: Kellie J. surname: Nazemi fullname: Nazemi, Kellie J. email: Correspondence to: Kellie J. Nazemi, Division of Pediatric Hematology-Oncology, Department of Pediatrics, Doernbecher Children's Hospital, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, CDRC-P, Portland, OR 97239., nazemik@ohsu.edu organization: Division of Pediatric Hematology-Oncology, Department of Pediatrics, Doernbecher Children's Hospital, Oregon Health & Science University, PortlandOregon – sequence: 2 givenname: Violet surname: Shen fullname: Shen, Violet organization: Children's Hospital of Orange County, Cancer Institute, California, Orange – sequence: 3 givenname: Jonathan L. surname: Finlay fullname: Finlay, Jonathan L. organization: Children's Hospital of Los Angeles, Neuro-Oncology Program, Los Angeles, California – sequence: 4 givenname: James surname: Boyett fullname: Boyett, James organization: Department of Biostatistics, Saint Jude Children's Research Hospital, Tennessee, Memphis – sequence: 5 givenname: Mehmet surname: Kocak fullname: Kocak, Mehmet organization: Department of Preventive Medicine, University of Tennessee Health Science Center, Tennessee, Memphis – sequence: 6 givenname: Deborah surname: Lafond fullname: Lafond, Deborah organization: Department of Hematology-Oncology, Children's National Health System, District of Columbia, Washington – sequence: 7 givenname: Sharon L. surname: Gardner fullname: Gardner, Sharon L. organization: Hassenfeld Children's Center, Langone Medical Center, New York University, New York, New York – sequence: 8 givenname: Roger J. surname: Packer fullname: Packer, Roger J. organization: Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, District of Columbia, Washington – sequence: 9 givenname: H. Stacy surname: Nicholson fullname: Nicholson, H. Stacy organization: Division of Pediatric Hematology-Oncology, Department of Pediatrics, Doernbecher Children's Hospital, Oregon Health & Science University, PortlandOregon |
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| Keywords | CCG-99702 veno-occlusive disease (VOD) primitive neuroectodermal tumor (PNET) high-risk medulloblastoma (MB) sinusoidal obstructive syndrome (SOS) myeloablative chemotherapy |
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| Notes | Children's Cancer Group and subsequently Children's Oncology Group (COG) National Cancer Institute COG Chairman's Grant - No. U10 CA98543-01 to H.S.N ArticleID:PBC26074 ark:/67375/WNG-7HZRZTRG-N istex:A9ACC2281F2D731631216871167596DBB7F2A98B Grant sponsor: Children's Cancer Group and subsequently Children's Oncology Group (COG); Grant sponsor: National Cancer Institute COG Chairman's Grant; Grant number: U10 CA98543‐01 (to H.S.N). Conflict of interest: Nothing to declare. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Current Address: Nationwide Children's Hospital, Division of Hematology, Oncology and BMT, 700 Children's Drive, ED544, Columbus, OH 43205 Current address: Phoenix Children's Hospital, Pediatric Hematology/Oncology, 1919 E. Thomas Road, Phoenix, AZ 85016 |
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The outcomes with high‐risk central nervous system (CNS) embryonal tumors remain relatively poor despite aggressive treatment. The purposes of this... The outcomes with high-risk central nervous system (CNS) embryonal tumors remain relatively poor despite aggressive treatment. The purposes of this study using... Background The outcomes with high-risk central nervous system (CNS) embryonal tumors remain relatively poor despite aggressive treatment. The purposes of this... |
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| SubjectTerms | Adolescent CCG-99702 Central Nervous System Neoplasms - mortality Central Nervous System Neoplasms - therapy Chemoradiotherapy - adverse effects Child Child, Preschool Craniospinal Irradiation - adverse effects Female Hematology Hepatic Veno-Occlusive Disease - epidemiology high-risk medulloblastoma (MB) Humans Incidence Induction Chemotherapy - adverse effects Male myeloablative chemotherapy Neoplasms, Germ Cell and Embryonal - mortality Neoplasms, Germ Cell and Embryonal - therapy Oncology Pediatrics primitive neuroectodermal tumor (PNET) sinusoidal obstructive syndrome (SOS) veno-occlusive disease (VOD) |
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| Title | High Incidence of Veno-Occlusive Disease With Myeloablative Chemotherapy Following Craniospinal Irradiation in Children With Newly Diagnosed High-Risk CNS Embryonal Tumors: A Report From the Children's Oncology Group (CCG-99702) |
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