For the past two decades, the standard adjuvant treatment for resected, pathologically defined high-risk locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) has been concurrent cisplatin with radiation therapy.1–3 Though, recent findings from the NIVOPOST-OP trial4 indicate that adding the programmed death-1 (PD-1) inhibitor nivolumab to chemoradiotherapy significantly improves disease-free survival, potentially establishing a new standard of care.
The NIVOPOST-OP trial, published in The New England Journal of Medicine in 2023, involved patients with LA-SCCHN who had undergone surgery and were at high risk of recurrence.4 researchers found that adding nivolumab to standard chemoradiotherapy resulted in a statistically important and clinically meaningful advancement in disease-free survival compared to chemoradiotherapy alone. Specifically,the trial demonstrated a 30% reduction in the risk of disease recurrence or death.
These results suggest that nivolumab enhances the effectiveness of chemoradiotherapy by boosting the body’s immune response against cancer cells. PD-1 inhibitors like nivolumab work by blocking the PD-1 protein on immune cells, allowing them to more effectively recognize and attack cancer.5
While cisplatin-based chemoradiotherapy remains an effective treatment, it can be associated with significant side effects, including nausea, vomiting, hearing loss, and kidney damage.6 The NIVOPOST-OP trial also evaluated the safety profile of adding nivolumab, and the combination was generally well-tolerated, with manageable side effects.4
The implications of the NIVOPOST-OP trial are substantial. The addition of nivolumab to chemoradiotherapy may offer a new treatment option for patients with LA-SCCHN, potentially improving their long-term outcomes. Further research is ongoing to determine the optimal duration of nivolumab treatment and to identify biomarkers that can predict which patients are most likely to benefit from this approach.7 The National Complete Cancer Network (NCCN) guidelines are currently being updated to reflect these findings.
References
- Posner, M. R., et al. “Adjuvant cisplatin and fluorouracil for locally advanced squamous-cell carcinoma of the head and neck.” New England Journal of medicine 340.19 (1999): 1544-1551.
- Bernier, J., et al. “Postoperative irradiation with or without concurrent chemotherapy for locally advanced head and neck cancers.” New England Journal of Medicine 350.19 (2004): 1958-1967.
- Pfister, D. G., et al. “Locoregional failure after concurrent chemoradiotherapy for locally advanced head and neck cancers.” Journal of Clinical Oncology 26.31 (2008): 4864-4870.
- Vermorken, J. B., et al. “Nivolumab in Combination with Concurrent Chemoradiotherapy in Locally Advanced Head and Neck Squamous-Cell carcinoma.” New England Journal of Medicine 389.26 (2023): 2429-2440. https://www.nejm.org/doi/full/10.1056/NEJMoa2310331
- National Cancer Institute – PD-1 and PD-L1 Inhibitors
- Mayo Clinic – Chemotherapy
- ClinicalTrials.gov
