Robert Ferris, MD, PhD
Investigators are evaluating the safety of chemoradiation in combination with nivolumab (Opdivo) in intermediate and high-risk head and neck squamous cell carcinoma (RTOG 3504, NCT02764593).
at the 2017 ASCO Annual Meeting, Robert Ferris, MD, PhD, vice chair for Clinical Operations, associate director for Translational Research, and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute, discussed the RTOG 3504 trial, as well as the utility of immunotherapy agents in this landscape.
OncLive: Please provide an overview of this study.
At ASCO , we demonstrated that anti–PD-1 therapy as a monotherapy was better than standard of care chemotherapy. Demonstrating that head and neck cancer was an immune-responsive disease led to the natural application of anti–PD-1 therapy, such as nivolumab, into earlier stages of disease.
every 21 days. There are 2 standards of care for adding cisplatin to radiation, so we needed to test the addition of nivolumab to both standard of care regimens for locally advanced head and neck cancer.
What is the significance of this trial?
In head and neck cancer, we have HPV-positive disease, which tends to do better, and HPV-negative disease, which really has not seen any improvements in survival despite intensification with multiple chemotherapies, or even better radiation techniques. So, what we’ve done in the RTOG 3504 trial is to ask whether adding an immunotherapy on top of concurrent chemoradiation—which is really the most efficacious therapy for locally advanced disease—improves survival for the intermediate and high-risk patients who have really not seen a benefit in survival. So, we can randomize nivolumab monotherapy versus chemotherapy in recurrent metastatic disease, but by applying it to earlier stages—such as the locally advanced setting—we have the potential to actually elevate the survival curve and cure more patients in the intermediate and high-risk setting, which have not seen benefits in some decades regarding survival.
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