Window Studies in Squamous Cell Carcinoma of the Head and Neck: Values and Limits
In head and neck cancer, we continue to work towards a more personalized approach to treatment of patients, where analysis of a patient’s tumor guides targeting of molecular or immunologic pathways. Critically important to this pursuit is a better understanding of the direct biologic effect of a drug or combination on the tumor microenvironment in humans, as well as biomarker discovery. These goals are consistent with the primary purpose of a “window of opportunity” trial and while conduct of these trials requires a careful balance of benefits and potential risks, to date these trials have been both feasible and safe in HNSCC in the curative intent setting. In the era of immunotherapy, with countless possible combinations and ongoing clinical trials, window trials are even more important for informing clinical trial design and appropriate combination therapy, and ultimately a more personalized approach to our patients that leads to improvement in outcomes.
KeywordsWindow trial HNSCC Neoadjuvant Anti-PD-1 Immunotherapy Targeted therapy Cetuximab
Compliance with Ethical Standards
Conflict of Interest
Dan P. Zandberg has received research support for role as PI for clinical trials conducted by Merck, Bristol-Myers Squibb, and AstraZeneca.
Robert L. Ferris has received research funding for clinical trials conducted by AstraZeneca/MedImmune, Bristol-Myers Squibb, Merck, Tesaro, and VentiRx Pharmaceuticals, and has served on advisory boards for Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, EMD Serono, PPD, Lilly, Merck, Pfizer, and Tesaro.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
References and Recommended Reading
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