International guidelines for intratumoral and intranodal injection of NBTXR3 nanoparticles in head and neck cancers

Author:

Liem Xavier1ORCID,de Baère Thierry23,Vivar Omar I.4,Seiwert Tanguy Y.5,Shen Colette6,Pápai Zsuzsanna7,Moreno Victor8,Takácsi‐Nagy Zoltán9,Helfferich Frigyes10,Thariat Juliette11,Gooi Zhen12,Yom Sue S.13,Bossi Paolo14,Ferris Robert L.15,Hackman Trevor G.16,Le Tourneau Christophe17ORCID,Rodriguez Joseph18,Hoffmann Caroline19

Affiliation:

1. Department of Radiotherapy‐Brachytherapy Unicancer‐Oscar Lambret Regional Cancer Center Lille France

2. Interventional Radiology Unit Institut Gustave Roussy Villejuif France

3. Université Paris‐Saclay, UFR Médecine Le Kremlin‐Bicêtre Le Kremlin Bicêtre France

4. Global Medical Affairs Department Nanobiotix Paris France

5. Head and Neck Cancer Center Johns Hopkins University Medical Center Baltimore Maryland USA

6. Department of Radiation Oncology University of North Carolina (UNC) Medical Center Chapel Hill North Carolina USA

7. Department of Oncology, Hungarian Defense Forces Military Hospital‐Honved Hospital Budapest Hungary

8. START Madrid‐FJD Phase I Clinical Trials Unit Fundación‐Jiménez Díaz University Hospital Madrid Spain

9. Department of Radiotherapy National Institute of Oncology Budapest Hungary

10. Department of Otolaryngology, Hungarian Defense Forces Military Hospital‐Honved Hospital Budapest Hungary

11. Radiotherapy and Brachytherapy Service, François Baclesse Center Caen France

12. Department of Surgery‐Section of Otolaryngology‐Head and Neck Surgery University of Chicago Medical Center Chicago Illinois USA

13. Department of Radiation Oncology University of California San Francisco (UCSF) Medical Center San Francisco California USA

14. Medical Oncology, Department of Medical and Surgical Specialties, Radiological Sciences, Public Health University of Brescia Brescia Italy

15. UPMC Hillman Cancer Center Pittsburgh Pennsylvania USA

16. Department of Otolaryngology‐Head and Neck Surgery University of North Carolina (UNC) Medical Center Chapel Hill North Carolina USA

17. Department of Drug Development and Innovation D3i, Institut Curie Paris‐Saclay University Paris France

18. ENT Surgical and Medical Service, Hospital Center of Valenciennes (CHV) Valenciennes France

19. Department of Head and Neck Surgical Oncology PSL University, Institut Curie Paris France

Abstract

AbstractBackgroundAn international multidisciplinary panel of experts aimed to provide consensus guidelines describing the optimal intratumoral and intranodal injection of NBTXR3 hafnium oxide nanoparticles in head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, and cervical lymph nodes and to review data concerning safety, feasibility, and procedural aspects of administration.MethodsThe Delphi method was used to determine consensus. A 4‐member steering committee and a 10‐member monitoring committee wrote and revised the guidelines, divided into eight sections. An independent 3‐member reading committee reviewed the recommendations.ResultsAfter two rounds of voting, strong consensus was obtained on all recommendations. Intratumoral and intranodal injection was deemed feasible. NBTXR3 volume calculation, choice of patients, preparation and injection procedure, potential side effects, post injection, and post treatment follow‐up were described in detail.ConclusionsBest practices for the injection of NBTXR3 were defined, thus enabling international standardization of intratumoral nanoparticle injection.

Publisher

Wiley

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