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Efficacy of Carboplatin and Isotretinoin in Children With High-risk Medulloblastoma: A Randomized Clinical Trial From the Children’s Oncology Group
Open accessAbstract
IMPORTANCE: Brain tumors are the leading cause of disease-related death in children. Medulloblastoma is the most common malignant embryonal brain tumor, and strategies to increase survival are needed. OBJECTIVE: To evaluate therapy intensification with carboplatin as a radiosensitizer and isotretinoin as a proapoptotic agent in children with high-risk medulloblastoma in a randomized clinical trial and, with a correlative biology study, facilitate planned subgroup analysis according to World Health Organization consensus molecular subgroups of medulloblastoma. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical phase 3 trial was conducted from March 2007 to September 2018. Analysis was completed in September 2020. Patients aged 3 to 21 years with newly diagnosed high-risk medulloblastoma from Children's Oncology Group institutions within the US, Canada, Australia, and New Zealand were included. High-risk features included metastasis, residual disease, or diffuse anaplasia. INTERVENTIONS: Patients were randomized to receive 36-Gy craniospinal radiation therapy and weekly vincristine with or without daily carboplatin followed by 6 cycles of maintenance chemotherapy with cisplatin, cyclophosphamide, and vincristine with or without 12 cycles of isotretinoin during and following maintenance. MAIN OUTCOMES AND MEASURES: The primary clinical trial end point was event-free survival, using the log-rank test to compare arms. The primary biology study end point was molecular subgroup classification by DNA methylation array. RESULTS: Of 294 patients with medulloblastoma, 261 were evaluable after central radiologic and pathologic review; median age, 8.6 years (range, 3.3-21.2); 183 (70%) male; 189 (72%) with metastatic disease; 58 (22%) with diffuse anaplasia; and 14 (5%) with greater than 1.5-cm2 residual disease. For all participants, the 5-year event-free survival was 62.9% (95% CI, 55.6%-70.2%) and overall survival was 73.4% (95% CI, 66.7%-80.1%). Isotretinoin randomization was closed early owing to futility. Five-year event-free survival was 66.4% (95% CI, 56.4%-76.4%) with carboplatin vs 59.2% (95% CI, 48.8%-69.6%) without carboplatin (P = .11), with the effect exclusively observed in group 3 subgroup patients: 73.2% (95% CI, 56.9%-89.5%) with carboplatin vs 53.7% (95% CI, 35.3%-72.1%) without (P = .047). Five-year overall survival differed by molecular subgroup (P = .006): WNT pathway activated, 100% (95% CI, 100%-100%); SHH pathway activated, 53.6% (95% CI, 33.0%-74.2%); group 3, 73.7% (95% CI, 61.9%-85.5%); and group 4, 76.9% (95% CI, 67.3%-86.5%). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, therapy intensification with carboplatin improved event-free survival by 19% at 5 years for children with high-risk group 3 medulloblastoma. These findings further support the value of an integrated clinical and molecular risk stratification for medulloblastoma. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00392327.
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“we developed the Medulloblastoma Meta-Analysis (MB-meta) portal, which integrates clinical, genomic, and survival data from 898 patients across three major medulloblastoma clinical trials (16–18).”
From The Medulloblastoma Meta-Analysis Portal Enables Integrative Exploration of Clinical and Genomic Data from Patients (2025) · cites this paper as [16]
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Metadata
- Authors
- Leary, S. E. S., Packer, R. J., Li, Y., Billups, C. A., Smith, K. S., Jaju, A., Heier, L., Burger, P., Walsh, K., Han, Y., Embry, L., Hadley, J., Kumar, R., Michalski, J., Hwang, E., Gajjar, A., Pollack, I. F., Fouladi, M., Northcott, P. A., & Olson, J. M.
- Affiliations
- Seattle Children's Hospital (US)
- Children's National (US)
- St. Jude Children's Research Hospital (US)
- Lurie Children's Hospital (US)
- Weill Cornell Medicine (US)
- Johns Hopkins University (US)
- The University of Texas at San Antonio Health Science Center (US)
- Washington University in St. Louis (US)
- Children's Hospital of Pittsburgh (US)
- Nationwide Children's Hospital (US)
- Corresponding author
- Leary, Sarah E. S.
- ORCID
- Venue
- JAMA Oncology
- Publisher
- American Medical Association (AMA)
- Published
- 2021-09-01
- Volume
- 7
- Issue
- 9
- Pages
- 1313
- ISSN
- 2374-2437 (ISSN-L)
- PMC
- PMC8299367
- OpenAlex
- W3184618654
- Cited by
- 164
- References
- 34
- Citations by year
- 2026: 25 · 2025: 50 · 2024: 27 · 2023: 34 · 2022: 17 · 2021: 11
- FWCI
- 12.90
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Oncology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Brain Tumour Charity (GN-000575)
- National Cancer Institute (R01CA114567, U10CA180899, U10CA180886)
- Topics
- Health Sciences › Medicine › Oncology › Glioma Diagnosis and Treatment
- Health Sciences › Medicine › Hematology › Acute Lymphoblastic Leukemia research
- Health Sciences › Medicine › Oncology › Neuroblastoma Research and Treatments
- Keywords
- high-risk medulloblastoma, carboplatin, isotretinoin, radiosensitization, event-free survival, overall survival, DNA methylation, pediatric brain tumors, maintenance chemotherapy, futility, metastatic disease, residual disease
- MeSH terms
- Adolescent, Adult, Antineoplastic Combined Chemotherapy Protocols, Cerebellar Neoplasms, Child, Child, Preschool, Humans, Male, Medulloblastoma, Isotretinoin, Carboplatin, Disease-Free Survival, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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