{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T15:46:40Z","timestamp":1788536800254,"version":"build-2803163510"},"reference-count":46,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T00:00:00Z","timestamp":1768003200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T00:00:00Z","timestamp":1768003200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["P30 CA008748"],"award-info":[{"award-number":["P30 CA008748"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100020812","name":"Robert K Steel Family Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020812","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl Journal of Cancer"],"published-print":{"date-parts":[[2026,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Naxitamab\u2009+\u2009GM\u2010CSF was effective against chemo\u2010resistant high\u2010risk neuroblastoma (HR\u2010NB), leading to approval by the Food and Drug Administration. We now describe toxicity and outcome of patients treated in first complete remission (CR) with naxitamab plus novel dosing of GM\u2010CSF (nGM\u2010CSF), initiated in February 2021, based on pharmacologic data. Treatment also included an anti\u2010NB vaccine but no prior myeloablative therapy (MAT). This retrospective study covers all first CR HR\u2010NB patients who started the novel naxitamab\u2009+\u2009nGM\u2010CSF regimen from February 22, 2021 to December 11, 2023. As before, naxitamab (3\u2009mg\/kg) was infused on days 1\u20133\u20135 (i.e., 3 doses\/cycle). Previously, priming doses of GM\u2010CSF 250\u2009\u03bcg\/m\n                    <jats:sup>2<\/jats:sup>\n                    \/day were subcutaneously administered \u00d75 (days \u22124 to 0), followed by step\u2010up to 500\u2009\u03bcg\/m\n                    <jats:sup>2<\/jats:sup>\n                    \/day \u00d75 (days 1 to 5), but now priming doses were \u00d73 (days \u22122 to 0) and stepped\u2010up dosing was \u00d77 (days 1 to 7), that is, through 2\u2009days after the last dose of naxitamab. After completing antibody treatment (5 monthly cycles), patients could receive vaccine. Event\u2010free survival (EFS) and overall survival (OS) were calculated from start of naxitamab\u2009+\u2009nGM\u2010CSF. Forty\u2010three patients received 157\u2009cycles. Acute toxicities were generally manageable, allowing outpatient treatment. Stepped\u2010up dosing and extended administration of GM\u2010CSF had no associated toxicity, hematological or otherwise. Human anti\u2010human antibody developed in 5\/43 (12%) patients. Thirty\u2010four (79%) patients received the vaccine; 9 did not due to relapse (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20094) and parental choice (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20095). EFS\/OS rates at 24\u2009months were 88%\/95% and at 36\u2009months were 80%\/95%. Naxitamab\u2009+\u2009nGM\u2010CSF is a good option to consolidate first CR of HR\u2010NB patients, including those who did not undergo MAT.\n                  <\/jats:p>","DOI":"10.1002\/ijc.70329","type":"journal-article","created":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T12:00:07Z","timestamp":1768046407000},"page":"2928-2935","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Naxitamab with novel scheduling and stepped\u2010up dosing of\n                    <scp>GM<\/scp>\n                    \u2010\n                    <scp>CSF<\/scp>\n                    plus vaccine, but no myeloablative therapy for patients with high\u2010risk neuroblastoma in first complete remission"],"prefix":"10.1002","volume":"158","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8916-0697","authenticated-orcid":false,"given":"Brian H.","family":"Kushner","sequence":"first","affiliation":[{"name":"Department of Pediatrics Memorial Sloan Kettering Cancer Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlie","family":"White","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Epidemiology Memorial Sloan Kettering Cancer Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Audrey","family":"Mauguen","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Epidemiology Memorial Sloan Kettering Cancer Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiorella Iglesias","family":"Cardenas","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Memorial Sloan Kettering Cancer Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen M.","family":"Basu","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Memorial Sloan Kettering Cancer Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Memorial Sloan Kettering Cancer Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Kramer","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Memorial Sloan Kettering Cancer Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7280-1726","authenticated-orcid":false,"given":"Shakeel","family":"Modak","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Memorial Sloan Kettering Cancer Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,1,10]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0911123"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-20-3909"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.11642"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30578-3"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers12020309"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19910715)68:2<242::AID-CNCR2820680204>3.0.CO;2-P"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1991.9.2.274"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bmt.1705253"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.41.3807"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.6393"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.20513"},{"key":"e_1_2_11_13_1","article-title":"Prolonged progression\u2010free survival after consolidating second or later remissions of neuroblastoma with anti\u2010GD2 immunotherapy and isotretinoin: a prospective phase II study","volume":"4","author":"Kushner BH","year":"2015","journal-title":"Onco Targets Ther"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.28851"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.20.01892"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2022.5999"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers10100387"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41416\u2010023\u201002457\u2010x"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.02478"},{"key":"e_1_2_11_20_1","first-page":"477","article-title":"Humanizing murine IgG3 anti\u2010GD2 antibody m3F8 substantially improves antibody\u2010dependent cell\u2010mediated cytotoxicity while retaining targeting in vivo","volume":"1","author":"Cheung N\u2010KV","year":"2012","journal-title":"Onco Targets Ther"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V73.7.1936.1936"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.37.6236"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2018.4005"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.20.00203"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.01375"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-025-56619-x"},{"key":"e_1_2_11_27_1","article-title":"Phase I trial of anti\u2010GD2 monoclonal antibody hu3F8 plus GM\u2010CSF: impact of body weight, immunogenicity and anti\u2010GD2 response on pharmacokinetics and survival","volume":"6","author":"Cheung IY","year":"2017","journal-title":"Onco Targets Ther"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-24-3427"},{"key":"e_1_2_11_29_1","article-title":"Naxitamab plus stepped\u2010up dosing of granulocyte\u2010macrophage colony\u2010stimulating factor for primary refractory high\u2010risk neuroblastoma: results of a phase I\/II trial.","author":"Kushner BH","journal-title":"J Hematol Oncol"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/cnr2.1627"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.17.6107"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2016.72.0177"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1200\/PO\u201025\u201000074"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2004.02.101"},{"key":"e_1_2_11_35_1","article-title":"Novel shortenedinduction chemotherapy for high\u2010risk neuroblastoma: tolerability, response, and outcome without myeloablative therapy","author":"Kushner BH","year":"2025","journal-title":"Presented at Advances in Neuroblastoma Research"},{"key":"e_1_2_11_36_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers15092535"},{"key":"e_1_2_11_37_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-15-2644"},{"key":"e_1_2_11_38_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrclinonc.2016.211"},{"key":"e_1_2_11_39_1","doi-asserted-by":"publisher","DOI":"10.1136\/jitc\u20102022\u2010004834"},{"key":"e_1_2_11_40_1","doi-asserted-by":"publisher","DOI":"10.1111\/1754\u20109485.13441"},{"key":"e_1_2_11_41_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199910143411601"},{"key":"e_1_2_11_42_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.20219"},{"key":"e_1_2_11_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(05)70291-6"},{"key":"e_1_2_11_44_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2020003455"},{"key":"e_1_2_11_45_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41409-021-01258-1"},{"key":"e_1_2_11_46_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djae062"},{"key":"e_1_2_11_47_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078\u20100432.ccr\u20101147\u20103"}],"container-title":["International Journal of Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ijc.70329","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ijc.70329","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ijc.70329","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T16:07:19Z","timestamp":1787760439000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ijc.70329"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,10]]},"references-count":46,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2026,6,1]]}},"alternative-id":["10.1002\/ijc.70329"],"URL":"https:\/\/doi.org\/10.1002\/ijc.70329","archive":["Portico"],"relation":{},"ISSN":["0020-7136","1097-0215"],"issn-type":[{"value":"0020-7136","type":"print"},{"value":"1097-0215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,10]]},"assertion":[{"value":"2025-09-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-30","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-10","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}