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Phase I/II study of (131)I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma
BACKGROUND: (131)I-metaiodobenzylguanidine (MIBG) is an active radiopharmaceutical in neuroblastoma. A previous study demonstrated that MIBG could be combined with vincristine and prolonged irinotecan, although 25% of first courses had grade 3 diarrhoea. The current phase I/II study evaluated MIBG w...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Nature Publishing Group
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4333502/ https://www.ncbi.nlm.nih.gov/pubmed/25602966 http://dx.doi.org/10.1038/bjc.2015.12 |
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author | DuBois, S G Allen, S Bent, M Hilton, J F Hollinger, F Hawkins, R Courtier, J Mosse, Y P Matthay, K K |
author_facet | DuBois, S G Allen, S Bent, M Hilton, J F Hollinger, F Hawkins, R Courtier, J Mosse, Y P Matthay, K K |
author_sort | DuBois, S G |
collection | PubMed |
description | BACKGROUND: (131)I-metaiodobenzylguanidine (MIBG) is an active radiopharmaceutical in neuroblastoma. A previous study demonstrated that MIBG could be combined with vincristine and prolonged irinotecan, although 25% of first courses had grade 3 diarrhoea. The current phase I/II study evaluated MIBG with vincristine and 5 days of higher-dose irinotecan. METHODS: Patients 1–30 years old with advanced neuroblastoma were eligible. Patients received cefixime on days −1 to +6, irinotecan (50 mg m(−2) per dose IV) on days 0–4, vincristine (2 mg m(−2)) on day 0, MIBG (555 or 666 MBq kg(−1)) on day 1, and peripheral blood stem cells on day 13. UGT1A1 genotyping was performed in consenting patients. RESULTS: Thirty-two patients (12 phase I ; 20 phase II) received 42 courses. No dose-limiting toxicities were seen during dose escalation and the recommended administered activity was 666 MBq kg(−1). Myelosuppression and diarrhoea were the most common toxicities, with grade 3 diarrhoea in 6% of first courses. Patients homozygous for UGT1A1*28 had more grade 4 thrombocytopenia (80% vs 37% P=0.14). Responses (five complete and four partial) occurred in 9 out of 32 (28%) patients. CONCLUSIONS: MIBG (666 MBq kg(−1)) with vincristine and this irinotecan schedule is tolerable and active, with less severe diarrhoea compared with a regimen using more protracted irinotecan. |
format | Online Article Text |
id | pubmed-4333502 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-43335022016-02-17 Phase I/II study of (131)I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma DuBois, S G Allen, S Bent, M Hilton, J F Hollinger, F Hawkins, R Courtier, J Mosse, Y P Matthay, K K Br J Cancer Clinical Study BACKGROUND: (131)I-metaiodobenzylguanidine (MIBG) is an active radiopharmaceutical in neuroblastoma. A previous study demonstrated that MIBG could be combined with vincristine and prolonged irinotecan, although 25% of first courses had grade 3 diarrhoea. The current phase I/II study evaluated MIBG with vincristine and 5 days of higher-dose irinotecan. METHODS: Patients 1–30 years old with advanced neuroblastoma were eligible. Patients received cefixime on days −1 to +6, irinotecan (50 mg m(−2) per dose IV) on days 0–4, vincristine (2 mg m(−2)) on day 0, MIBG (555 or 666 MBq kg(−1)) on day 1, and peripheral blood stem cells on day 13. UGT1A1 genotyping was performed in consenting patients. RESULTS: Thirty-two patients (12 phase I ; 20 phase II) received 42 courses. No dose-limiting toxicities were seen during dose escalation and the recommended administered activity was 666 MBq kg(−1). Myelosuppression and diarrhoea were the most common toxicities, with grade 3 diarrhoea in 6% of first courses. Patients homozygous for UGT1A1*28 had more grade 4 thrombocytopenia (80% vs 37% P=0.14). Responses (five complete and four partial) occurred in 9 out of 32 (28%) patients. CONCLUSIONS: MIBG (666 MBq kg(−1)) with vincristine and this irinotecan schedule is tolerable and active, with less severe diarrhoea compared with a regimen using more protracted irinotecan. Nature Publishing Group 2015-02-17 2015-01-20 /pmc/articles/PMC4333502/ /pubmed/25602966 http://dx.doi.org/10.1038/bjc.2015.12 Text en Copyright © 2015 Cancer Research UK http://creativecommons.org/licenses/by-nc-sa/3.0/ From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/ |
spellingShingle | Clinical Study DuBois, S G Allen, S Bent, M Hilton, J F Hollinger, F Hawkins, R Courtier, J Mosse, Y P Matthay, K K Phase I/II study of (131)I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma |
title | Phase I/II study of (131)I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma |
title_full | Phase I/II study of (131)I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma |
title_fullStr | Phase I/II study of (131)I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma |
title_full_unstemmed | Phase I/II study of (131)I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma |
title_short | Phase I/II study of (131)I-MIBG with vincristine and 5 days of irinotecan for advanced neuroblastoma |
title_sort | phase i/ii study of (131)i-mibg with vincristine and 5 days of irinotecan for advanced neuroblastoma |
topic | Clinical Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4333502/ https://www.ncbi.nlm.nih.gov/pubmed/25602966 http://dx.doi.org/10.1038/bjc.2015.12 |
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