Dinutuximab Beta Added to Temozolomide-Based Chemotherapy for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON Immuno Phase II Trial.
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Gray Juliet C, Weston Rebekah, Owens Cormac, Canete Adela, Gambart Marion, De Wilde Bram, Nysom Karsten, van Eijkelenburg Natasha, Ladenstein Ruth, Castellano Aurora, Gerber Nicolas U, Marshall Lynley V, Barone Giuseppe, Rubio-San-Simon Alba, Ng Antony, Vaidya Sucheta, Gallego Soledad, Makin Guy, Burke G A Amos, McCarthy Anthony, Murphy Dermot, Zwaan C Michel, López-Almaraz Ricardo, Jannier Sarah, Thebaud Estelle, Corradini Nadege, Yeomanson Dan, Howell Lisa, Tweddle Deborah A, Elliott Martin, Hobin Dave, Valteau-Couanet Dominique, Schleiermacher Gudrun, Chastagner Pascal, Defachelles Anne Sophie, Brichard Benedicte, George Sally, Chesler Louis, Laidler Jennifer, Firth Charlotte, Holt Grace, Moroz Veronica, Pearson Andrew D J, Gates Simon, Wheatley Keith, Kearns Pam, Moreno Lucas
Аннотация
MATERIALS AND METHODS: 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/m2/24 h). The trial had a factorial design, with some patients also randomly assigned between chemotherapy regimens (T v 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.
RESULTS: 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% v 9%, grade 3: 2.3% v 4.5%), but other toxicities were similar.
CONCLUSION: Within a randomized phase II setting, results observed with addition of dB to T-based chemotherapy in RR-HR-NB warrant further evaluation.