Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations - 25/06/24

Doi : 10.1016/S1470-2045(24)00068-8

Annette M Lim, PhD ^a,^b,⁎ , Christophe Le Tourneau, ProfMD ^c,^d,^e, Chris Hurt, MSc ^f, Sarbani G Laskar, ProfMD ^g, Conor E Steuer, MD ^h, Velda L Y Chow, FCSHK ^j, Petr Szturz, PhD ^k, Christina Henson, MD ^l, Andrew T Day, MD ^m, James E Bates, MD ⁱ, Smaro Lazarakis, BEd[Sec]-Lib ⁿ, Lachlan McDowell, FRANZCR ^o,^p, Hisham Mehanna, ProfPhD ^q, Sue S Yom, ProfPhD ^r,^s,⁎
on behalf of
the HNCIG

^a Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia

^b Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia

^c Department of Drug Development and Innovation (D3i), Institut Curie, Paris, France

^d INSERM U900 Research unit, Institut Curie, Paris, France

^e Paris-Saclay University, Paris, France

^f Southampton Clinical Trials Unit, University of Southampton, Southampton, UK

^g Department of Radiation Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra, India

^h Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA

ⁱ Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA

^j Division of Head and Neck Surgery, Department of Surgery, The University of Hong Kong, Queen Mary Hospital, Pok Fu Lam, Hong Kong Special Administrative Region, China

^k Department of Oncology, University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland

^l Department of Radiation Oncology, Stephenson Cancer Center, University of Oklahoma, OK, USA

^m Department of Otolaryngology–Head and Neck Surgery, University of Texas Southwestern Medical Center, TX, USA

ⁿ Health Sciences Library, Royal Melbourne Hospital, Melbourne, VIC, Australia

^o Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, QLD, Australia

^p Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia

^q Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, Edgbaston, Birmingham, UK

^r Department of Radiation Oncology, University of California, San Francisco, CA, USA

^s Department of Otolaryngology–Head and Neck Surgery, University of California, San Francisco, CA, USA

^* Correspondence to: Annette M Lim, Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC 3000, Australia Department of Medical Oncology Peter MacCallum Cancer Centre Melbourne VIC 3000 Australia ^** Prof Sue S Yom, Department of Radiation Oncology, University of California San Francisco, San Francisco, CA 94143, USA Department of Radiation Oncology University of California San Francisco San Francisco CA 94143 USA

Summary

Transparent and precise endpoint definitions are a crucial aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions across oncological clinical trials. Here, the Head and Neck Cancer International Group assessed endpoint definitions from phase 3 trials or trials considered practice-changing for patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma, published between 2008 and 2021. We identify considerable and global heterogeneity in endpoint definitions, which undermines the interpretation of results and development of future studies. We show how fundamental components of even incontrovertible endpoints such as overall survival vary widely, highlighting an urgent need for increased rigour in reporting and harmonisation of endpoints.

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Vol 25 - N° 7

P. e308-e317 - juillet 2024 Retour au numéro

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Criteria for the diagnosis of extranodal extension detected on radiological imaging in head and neck cancer: Head and Neck Cancer International Group consensus recommendations
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Assessment of endpoint definitions in curative-intent trials for mucosal head and neck squamous cell carcinomas: Head and Neck Cancer International Group consensus recommendations
Annette M Lim, Lachlan McDowell, Chris Hurt, Christophe Le Tourneau, Akihiro Homma, George Shenouda, David J Thomson, Antoine Moya-Plana, Christina Henson, Petr Szturz, Andrew T Day, James E Bates, Smaro Lazarakis, Juliette Thariat, Amanda Psyrri, Hisham Mehanna, Sue S Yom, the HNCIG

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Assessment of endpoint definitions in recurrent and metastatic mucosal head and neck squamous cell carcinoma trials: Head and Neck Cancer International Group consensus recommendations - 25/06/24

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