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Article: Randomized Trial of Two Induction Therapy Regimens for High-Risk Neuroblastoma: HR-NBL1.5 International Society of Pediatric Oncology European Neuroblastoma Group Study

TitleRandomized Trial of Two Induction Therapy Regimens for High-Risk Neuroblastoma: HR-NBL1.5 International Society of Pediatric Oncology European Neuroblastoma Group Study
Authors
Issue Date2021
PublisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/
Citation
Journal of Clinical Oncology, 2021, v. 39 n. 23, p. 2552-2563 How to Cite?
AbstractPURPOSE: Induction therapy is a critical component of the therapy of high-risk neuroblastoma. We aimed to assess if the Memorial Sloan Kettering Cancer Center (MSKCC) N5 induction regimen (MSKCC-N5) would improve metastatic complete response (mCR) rate and 3-year event-free survival (EFS) compared with rapid COJEC (rCOJEC; cisplatin [C], vincristine [O], carboplatin [J], etoposide [E], and cyclophosphamide [C]). PATIENTS AND METHODS: Patients (age 1-20 years) with stage 4 neuroblastoma or stage 4/4s aged < 1 year with MYCN amplification were eligible for random assignment to rCOJEC or MSKCC-N5. Random assignment was stratified according to national group and metastatic sites. Following induction, therapy comprised primary tumor resection, high-dose busulfan and melphalan, radiotherapy to the primary tumor site, and isotretinoin with ch14.18/CHO (dinutuximab beta) antibody with or without interleukin-2 immunotherapy. The primary end points were mCR rate and 3-year EFS. RESULTS: A total of six hundred thirty patients were randomly assigned to receive rCOJEC (n = 313) or MSKCC-N5 (n = 317). Median age at diagnosis was 3.2 years (range, 1 month to 20 years), and 16 were younger than 1 year of age with MYCN amplification. mCR rate following rCOJEC induction (32%, 86/272 evaluable patients) was not significantly different from 35% (99/281) with MSKCC-N5 (P = .368), and 3-year EFS was 44% ± 3% for rCOJEC compared with 47% ± 3% for MSKCC-N5 (P = .527). Three-year overall survival was 60% ± 3% for rCOJEC compared with 65% ± 3% for MSKCC-N5 (P = .379). Toxic death rates with both regimens were 1%. However, nonhematologic CTC grade 3 and 4 toxicities were higher with MSKCC-N5: 68% (193/283) versus 48% (129/268) (P < .001); infection 35% versus 25% (P = .011); stomatitis 25% versus 3% (P < .001); nausea and vomiting 17% versus 7% (P < .001); and diarrhea 7% versus 3% (P = .011). CONCLUSION: No difference in outcome was observed between rCOJEC and MSKCC-N5; however, acute toxicity was less with rCOJEC, and therefore rCOJEC is the preferred induction regimen for International Society of Pediatric Oncology European Neuroblastoma Group. © 2021 by American Society of Clinical Oncology
Persistent Identifierhttp://hdl.handle.net/10722/306722
ISSN
2023 Impact Factor: 42.1
2023 SCImago Journal Rankings: 10.639
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorGaraventa, A-
dc.contributor.authorPoetschger, U-
dc.contributor.authorValteau-Couanet, D-
dc.contributor.authorLuksch, R-
dc.contributor.authorCastel, V-
dc.contributor.authorElliott, M-
dc.contributor.authorAsh, S-
dc.contributor.authorChan, GCF-
dc.contributor.authorLaureys, G-
dc.contributor.authorBeck-Popovic, M-
dc.contributor.authorVettenranta, K-
dc.contributor.authorBalwierz, W-
dc.contributor.authorSchroeder, H-
dc.contributor.authorOwens, C-
dc.contributor.authorCesen, M-
dc.contributor.authorPapadakis, V-
dc.contributor.authorTrahair, T-
dc.contributor.authorSchleiermacher, G-
dc.contributor.authorAmbros, P-
dc.contributor.authorSorrentino, S-
dc.contributor.authorPearson, ADJ-
dc.contributor.authorLadenstein, RL-
dc.date.accessioned2021-10-22T07:38:40Z-
dc.date.available2021-10-22T07:38:40Z-
dc.date.issued2021-
dc.identifier.citationJournal of Clinical Oncology, 2021, v. 39 n. 23, p. 2552-2563-
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/306722-
dc.description.abstractPURPOSE: Induction therapy is a critical component of the therapy of high-risk neuroblastoma. We aimed to assess if the Memorial Sloan Kettering Cancer Center (MSKCC) N5 induction regimen (MSKCC-N5) would improve metastatic complete response (mCR) rate and 3-year event-free survival (EFS) compared with rapid COJEC (rCOJEC; cisplatin [C], vincristine [O], carboplatin [J], etoposide [E], and cyclophosphamide [C]). PATIENTS AND METHODS: Patients (age 1-20 years) with stage 4 neuroblastoma or stage 4/4s aged < 1 year with MYCN amplification were eligible for random assignment to rCOJEC or MSKCC-N5. Random assignment was stratified according to national group and metastatic sites. Following induction, therapy comprised primary tumor resection, high-dose busulfan and melphalan, radiotherapy to the primary tumor site, and isotretinoin with ch14.18/CHO (dinutuximab beta) antibody with or without interleukin-2 immunotherapy. The primary end points were mCR rate and 3-year EFS. RESULTS: A total of six hundred thirty patients were randomly assigned to receive rCOJEC (n = 313) or MSKCC-N5 (n = 317). Median age at diagnosis was 3.2 years (range, 1 month to 20 years), and 16 were younger than 1 year of age with MYCN amplification. mCR rate following rCOJEC induction (32%, 86/272 evaluable patients) was not significantly different from 35% (99/281) with MSKCC-N5 (P = .368), and 3-year EFS was 44% ± 3% for rCOJEC compared with 47% ± 3% for MSKCC-N5 (P = .527). Three-year overall survival was 60% ± 3% for rCOJEC compared with 65% ± 3% for MSKCC-N5 (P = .379). Toxic death rates with both regimens were 1%. However, nonhematologic CTC grade 3 and 4 toxicities were higher with MSKCC-N5: 68% (193/283) versus 48% (129/268) (P < .001); infection 35% versus 25% (P = .011); stomatitis 25% versus 3% (P < .001); nausea and vomiting 17% versus 7% (P < .001); and diarrhea 7% versus 3% (P = .011). CONCLUSION: No difference in outcome was observed between rCOJEC and MSKCC-N5; however, acute toxicity was less with rCOJEC, and therefore rCOJEC is the preferred induction regimen for International Society of Pediatric Oncology European Neuroblastoma Group. © 2021 by American Society of Clinical Oncology-
dc.languageeng-
dc.publisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/-
dc.relation.ispartofJournal of Clinical Oncology-
dc.titleRandomized Trial of Two Induction Therapy Regimens for High-Risk Neuroblastoma: HR-NBL1.5 International Society of Pediatric Oncology European Neuroblastoma Group Study-
dc.typeArticle-
dc.identifier.emailChan, GCF: gcfchan@hku.hk-
dc.identifier.authorityChan, GCF=rp00431-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1200/JCO.20.03144-
dc.identifier.pmid34152804-
dc.identifier.scopuseid_2-s2.0-85114066243-
dc.identifier.hkuros328578-
dc.identifier.volume39-
dc.identifier.issue23-
dc.identifier.spage2552-
dc.identifier.epage2563-
dc.identifier.isiWOS:000708050000006-
dc.publisher.placeUnited States-

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