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

Annette M Lim¹, Christophe Le Tourneau², Chris Hurt³, Sarbani G Laskar⁴, Conor E Steuer⁵, Velda L Y Chow⁶, Petr Szturz⁷, Christina Henson⁸, Andrew T Day⁹, James E Bates¹⁰, Smaro Lazarakis¹¹, Lachlan McDowell¹², Hisham Mehanna¹³, Sue S Yom¹⁴; HNCIG

Affiliations

¹ Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia. Electronic address: annette.lim@petermac.org.
² Department of Drug Development and Innovation (D3i), Institut Curie, Paris, France; INSERM U900 Research unit, Institut Curie, Paris, France; Paris-Saclay University, Paris, France.
³ Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.
⁴ Department of Radiation Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra, India.
⁵ Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
⁶ 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.
⁷ Department of Oncology, University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland.
⁸ Department of Radiation Oncology, Stephenson Cancer Center, University of Oklahoma, OK, USA.
⁹ Department of Otolaryngology-Head and Neck Surgery, University of Texas Southwestern Medical Center, TX, USA.
¹⁰ Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
¹¹ Health Sciences Library, Royal Melbourne Hospital, Melbourne, VIC, Australia.
¹² Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, QLD, Australia; Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.
¹³ Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, Edgbaston, Birmingham, UK.
¹⁴ Department of Radiation Oncology, University of California, San Francisco, CA, USA; Department of Otolaryngology-Head and Neck Surgery, University of California, San Francisco, CA, USA. Electronic address: sue.yom@ucsf.edu.

PMID: 38936389
DOI: 10.1016/S1470-2045(24)00068-8

Review

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

Annette M Lim et al. Lancet Oncol. 2024 Jul.

. 2024 Jul;25(7):e308-e317.

doi: 10.1016/S1470-2045(24)00068-8.

Authors

Affiliations

¹ Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia. Electronic address: annette.lim@petermac.org.
² Department of Drug Development and Innovation (D3i), Institut Curie, Paris, France; INSERM U900 Research unit, Institut Curie, Paris, France; Paris-Saclay University, Paris, France.
³ Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.
⁴ Department of Radiation Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra, India.
⁵ Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
⁶ 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.
⁷ Department of Oncology, University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland.
⁸ Department of Radiation Oncology, Stephenson Cancer Center, University of Oklahoma, OK, USA.
⁹ Department of Otolaryngology-Head and Neck Surgery, University of Texas Southwestern Medical Center, TX, USA.
¹⁰ Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
¹¹ Health Sciences Library, Royal Melbourne Hospital, Melbourne, VIC, Australia.
¹² Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, QLD, Australia; Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.
¹³ Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, Edgbaston, Birmingham, UK.
¹⁴ Department of Radiation Oncology, University of California, San Francisco, CA, USA; Department of Otolaryngology-Head and Neck Surgery, University of California, San Francisco, CA, USA. Electronic address: sue.yom@ucsf.edu.

PMID: 38936389
DOI: 10.1016/S1470-2045(24)00068-8

Abstract

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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Conflict of interest statement

Declaration of interests AML reports uncompensated consultancy for Eisai; received support from a Peter MacCallum Cancer Centre Discovery Partner Fellowship; and received institutional research funding support from Sanofi Regeneron Pharmaceuticals. CLT has participated in advisory boards for Merck Sharp & Dohme (MSD), Roche, Merck Serono, ALX Oncology, Excientia, Seagen, Kumar Therapeutics, MaxiVax, BMS, PCI Biotech, Nanobiotix, Onxeo, MVX-ONCO, Seattle Genetics, Rakuten, GSK, Celgene, and AstraZeneca. CES has received honoraria for advisory boards for Abbvie, Merck, Bergen Bio, Armo, Mirati, Caris, Sanofi Regeneron, Daiichi, Novocure; and is part of the steering committee for Daiichi. PS has advisory relationships with Merck Serono, Servier, and MSD. JEB has participated in advisory boards for Galera Therapeutics and Castle Biosciences. HM reports grants from the UK National Institute of Health research, Cancer Research UK, the UK Medical Research Council UK, and AstraZeneca; has received advisory board fees from AstraZeneca, MSD, Merck, Nanobiotix, and Seagen; and is Director of Warwickshire Head Neck Clinic and Docspert Health. LM participated in an advisory board for MSD. SSY reports clinical trial research grants from Bristol Myers Squibb, EMD Serono, and Nanobiotix; honoraria for editorial work from Elsevier and ASTRO; and publishing royalties from Sprinter and Up To Date. All other authors declare no competing interests.

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

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Full Text Sources

Medical