{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T16:07:42Z","timestamp":1791389262609,"version":"4.3.3"},"reference-count":26,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"3","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,1,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Outcomes for children with relapsed and refractory high-risk neuroblastoma (RR-HR-NBL) remain dismal. Here, we investigate addition of the anti-GD2 monoclonal antibody, dinutuximab beta (dB), to temozolomide (T)-based chemotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>MATERIALS AND METHODS<\/jats:title>\n                    <jats:p>\n                      Patients with RR-HR-NBL were randomly assigned in a 1:2 ratio to receive chemotherapy alone or chemotherapy with dB, given concurrently as a 7-day infusion (10 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      \/24 h). The trial had a factorial design, with some patients also randomly assigned between chemotherapy regimens (T\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      T-topotecan [TTo]). Crossover to dB with To\/cyclophosphamide was allowed for patients randomly assigned to chemotherapy alone with disease progression (PD). The primary outcome was best objective response (complete or partial) rate (overall response rate [ORR]) during six cycles of treatment. Progression-free (PFS), overall survival (OS), and safety were secondary outcomes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Sixty-five patients were randomly assigned to chemotherapy alone (3 T, 19 TTo) or with dB (6 dBT, 37 dBTTo). The median age was 4 years; 28 and 37 patients had refractory and relapsed diseases, respectively. Baseline characteristics were balanced between arms. The ORR was 30.2% (13 of 43) and 18.2% (4 of 22) in dB and non-dB arms, the median PFS was 11.1 months (95% CI, 4.3 to 15.5) for dB patients and 3.8 months (95% CI, 1.9 to 7.9) for non-dB patients, respectively. The median OS was 25.7 months (95% CI, 11.4 to not reached [NR]) for dB patients and 17.1 months (95% CI, 7.6 to 54.6) for non-dB patients (upper 95% CI, NR in dB arm). Thirteen of 22 patients in the non-dB arm crossed over to dB with cyclophosphamide\/To because of PD. Neurotoxicity was more common in the dB arm (grade 1 and 2: 26%\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      9%, grade 3: 2.3%\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      4.5%), but other toxicities were similar.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Within a randomized phase II setting, results observed with addition of dB to T-based chemotherapy in RR-HR-NB warrant further evaluation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-01868","type":"journal-article","created":{"date-parts":[[2025,12,12]],"date-time":"2025-12-12T20:59:08Z","timestamp":1765573148000},"page":"176-187","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":12,"title":["Dinutuximab Beta Added to Temozolomide-Based Chemotherapy for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON Immuno Phase II Trial"],"prefix":"10.1200","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5652-4722","authenticated-orcid":true,"given":"Juliet C.","family":"Gray","sequence":"first","affiliation":[{"name":"Centre for Cancer Immunology, University of Southampton, Southampton, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7884-1884","authenticated-orcid":true,"given":"Rebekah","family":"Weston","sequence":"additional","affiliation":[{"name":"Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cormac","family":"Owens","sequence":"additional","affiliation":[{"name":"Our Lady's Children's Hospital, Dublin, Republic of Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5669-5097","authenticated-orcid":true,"given":"Adela","family":"Canete","sequence":"additional","affiliation":[{"name":"Unidad de Oncologia Pediatrica, Institute de Investigaci\u00f3n Sanitaria La Fe, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4364-5170","authenticated-orcid":true,"given":"Marion","family":"Gambart","sequence":"additional","affiliation":[{"name":"H\u00f4pital des Enfants, Toulouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0213-1322","authenticated-orcid":true,"given":"Bram","family":"De Wilde","sequence":"additional","affiliation":[{"name":"Universitair Hospital Gent, Gent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2935-0058","authenticated-orcid":true,"given":"Karsten","family":"Nysom","sequence":"additional","affiliation":[{"name":"Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0526-3737","authenticated-orcid":true,"given":"Natasha","family":"van Eijkelenburg","sequence":"additional","affiliation":[{"name":"Princess M\u00e1xima Centre for Paediatric Oncology, Utrecht, The Netherlands"},{"name":"Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6548-3873","authenticated-orcid":true,"given":"Ruth","family":"Ladenstein","sequence":"additional","affiliation":[{"name":"Department of Studies and Statistics for Integrated Research and Projects, Department of Paediatrics, St 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