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Proffered Paper – Haematological malignancies & pediatric oncology

4267 - Bevacizumab for children with relapsed & refractory high risk neuroblastoma (RR-HRNB). Results of the BEACON-Neuroblastoma randomized phase 2 trial, a European ITCC-SIOPEN trial

Date

28 Sep 2019

Session

Proffered Paper – Haematological malignancies & pediatric oncology

Presenters

Lucas Moreno

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

L. Moreno1, V. Moroz2, C. Owens3, D. Valteau-Couanet4, M. Gambart5, V. Castel6, N. van Eijkelenburg7, A. Castellano8, K. Nysom9, N. Gerber10, G. Laureys11, R. Ladenstein12, E. Thebaud13, D. Murphy14, B. Morland15, S. Vaidya16, M. Elliott17, A.D. Pearson18, K. Wheatley2

Author affiliations

  • 1 Paediatric Oncology, Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 2 Cancer Research Uk Clinical Trials Unit (crctu), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham/GB
  • 3 Paediatric Oncology, Our Lady Children’s Hospital, Dublin/IE
  • 4 Paediatrics, Institut Gustave Roussy, Villejuif/FR
  • 5 Oncology And Haematology, CHU de Toulouse - Hôpital des Enfants, Toulouse/FR
  • 6 Paediatric Oncology, Instituto de Investigacion Sanitaria La Fe, Valencia/ES
  • 7 Clinical Trials, Princess Maxima Center for Pediatric Oncology, Utrecht/NL
  • 8 Paediatric Oncology, Ospedale Bambino Gesu, Rome/IT
  • 9 Paediatric Oncology, Rigshospitalet, DK-2100 - Copenhagen/DK
  • 10 Oncology, University Children’s Hospital, Zurich/CH
  • 11 Paediatric Oncology, Ghent University Hospital, Ghent/BE
  • 12 Children’s Cancer Research Institute, St. Anna Children's Hospital, Vienna/AT
  • 13 Oncology And Haematology, CHU Nantes - Hôpital Mère-Enfant, 44093 - Nantes/FR
  • 14 Paediatric Oncology, NHS Greater Glasgow and Clyde, Glasgow/GB
  • 15 Oncology And Haematology, Birmingham Children's Hospital, Birmingham/GB
  • 16 Children And Young People's Unit, Royal Marsden NHS Foundation Trust, London/GB
  • 17 Paediatric Oncology, Leeds Teaching Hospitals, Leeds/GB
  • 18 Paediatric Oncology, Institute of Cancer Research (retired), London/GB
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Abstract 4267

Background

BEACON-Neuroblastoma is a randomized phase II trial to assess the activity of backbone chemotherapy regimens for children with RR-HRNB and to determine if inhibiting angiogenesis with bevacizumab adds to the activity of this chemotherapy.

Methods

Patients aged 1-21 years with RR-HRNB with adequate organ function and performance status were randomized in a factorial design to: temozolomide (T) versus irinotecan-temozolomide (IT) or topotecan-temozolomide (TTo), with or without bevacizumab (Bev). The Bev randomization (Bev versus no-Bev) had two parts: Part 1 had a 2-stage Minimax Jung design with overall response (OR) as primary endpoint. Part 1 success criterion was ≥4 more responses in Bev arm compared to no-Bev. Protocol was amended to incorporate Part 2 (40 additional patients), including progression-free survival (PFS) as co-primary endpoint. OR was defined as complete or partial response (CR, PR) by RECIST (INRC for patients without measurable disease). OR and toxicity data for the Bev randomization is reported.

Results

For Part 1 (n = 106), 17 of 52 pts on Bev had responses [33%] and 8 of 54 pts on no-Bev had responses [15%]. The trial success criterion for the primary endpoint of ORR was met. Including Part 2 (total n = 154), 21 of 77 patients on Bev (7CR, 14PR) and 13 of 77 patients on no-Bev (1CR, 12PR) had responses. Response data was not available for 6 patients; 13 patients not assessable for response (discontinued before first assessment) were considered to be non-responders. OR rate [with 90% CI] was 27% [18-35%] for patients on Bev and 17% [10-24%] for patients on no-Bev. In subgroup analysis, there was no interaction between T, IT and TTo and treatment with/without Bev (heterogeneity test, p = 0.8). 86% Bev and 58% no-Bev patients had grade ≥3 toxicities as per CTCAE v4.0; the most common grade ≥3 toxicities associated with Bev were platelet count decrease and anemia.

Conclusions

Bev reached the Phase II success criterion for OR within Part 1 of the trial when added to temozolomide-based chemotherapy in RR-HRNB. The toxicity profile for Bev is acceptable. Longer follow-up is needed before assessing whether it impacts PFS or overall survival.

Clinical trial identification

NCT02308527; EudraCT: 2012-000072-42.

Editorial acknowledgement

Legal entity responsible for the study

University of Birmingham.

Funding

Roche.

Disclosure

L. Moreno: Honoraria (self), Travel / Accommodation / Expenses: Celgene; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Advisory / Consultancy, Travel / Accommodation / Expenses: Mundipharma; Licensing / Royalties, I am member of Siopen Executive Committee, Siopen receives royalties for the sales of dinutuximab beta: Eusa Pharma. D. Valteau-Couanet: Advisory / Consultancy, Travel / Accommodation / Expenses, Licensing / Royalties, Member of Siopen Executive Committee, SIOPEN receives royalties for the sales of dinutuximab beta: Eusa Pharma; Research grant / Funding (institution): Ophelia; Travel / Accommodation / Expenses: Jazz Pharma. K. Nysom: Advisory / Consultancy: Bayer. N. Gerber: Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Loxo; Research grant / Funding (institution): Novartis. R. Ladenstein: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses, Licensing / Royalties, Royalties to the institution for dinutuximab beta: Apeiron; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses, Licensing / Royalties, Royalties to the institution for dinutuximab beta: Eusa Pharma; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim. A.D. Pearson: Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Genentech. All other authors have declared no conflicts of interest.

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