Pathologic Treatment Effect and Survival in HPV-Negative HNSCC Following Neoadjuvant Nivolumab
Abstract
Importance
Neoadjuvant immunotherapy shows promise in the treatment of head and neck squamous cell carcinoma (HNSCC). Pathologic treatment effect (pTE) is one way to assess response to treatment; however, the association of this response with survival outcomes is not yet clear. The current study sought to determine whether treatment response to neoadjuvant nivolumab, as measured by pTE, correlates with survival outcomes.
Objective
To determine whether patients with HNSCC with pathologic response to neoadjuvant nivolumab have improved survival outcomes.
Design, Setting, and Participants
A cohort study performing a pooled analysis of 2 multi-institutional neoadjuvant clinical trials (NCT03238365, NCT03854032) enrolling patients from July 2017 to January 2022, was performed. Patients with resectable HNSCC enrolled in 1 of 2 clinical trials and treated with neoadjuvant immunotherapy and surgical resection were included in the analysis. Patients were followed up for a median (range) of 36 (4-72) months. Analysis took place on April 15, 2024.
Intervention
Patients were treated with neoadjuvant nivolumab with or without the addition of immunomodulating medications (tadalafil or indoleamine 2,3 dioxygenase inhibitor).
Main Outcome and Measure
Pooled analysis was performed to plot Kaplan-Meier 3-year survival outcomes for pTE responders and low or nonresponders. A pTE response threshold was determined using recursive partitioning analysis.
Results
Seventy-nine patients were included…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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