An international study opens the door to a new standard treatment for head and neck cancer

• Combining immunotherapy with nivolumab and the standard treatment of radiotherapy and chemotherapy after surgery improves disease-free survival and could transform clinical practice after more than 20 years without significant progress for patients with the poorest prognosis.

The combination of the drug nivolumab with chemotherapy improves survival in patients with high-risk head and neck cancer and could become the new standard treatment, according to the results of an international trial led by professionals from Institut Català d'Oncologia (ICO) at the Badalona and L'Hospitalet centres, the Germans Trias i Pujol Research Institute (IGTP) and the Bellvitge Biomedical Research Institute (IDIBELL).

This Phase III study has shown that adding nivolumab-based immunotherapy to the standard cisplatin and radiotherapy treatment after surgery significantly increases disease-free survival. The results, recently published in the scientific journal The Lancet, represent the first major breakthrough in this field in more than two decades.

A new treatment that could become the new therapeutic standard

The research involved 680 patients across six European countries. After three years of follow-up, 63.1% of the patients treated with the combination of nivolumab, cisplatin and radiotherapy remained disease-free, compared to 52.5% of those who received only the standard treatment.

This benefit was observed consistently across all patients, regardless of PD-L1 biomarker expression. Although a moderate increase in severe adverse effects was initially recorded, this difference evened out in later follow-up assessments.

"This is the first clinically meaningful advance in over 20 years in the treatment of high-risk operated squamous cell carcinoma of the head and neck", says Dr Ricard Mesía, head of the Medical Oncology Department at ICO Badalona, co-leader of the B·ARGO group at IGTP, and co-author of the study. According to Mesía, "immunotherapy has clearly improved the outcomes of a treatment that had been the standard since 2004. These results could change clinical practice and bring new hope to patients at higher risk of relapse".

Reference

Bourhis J, Aupérin A, Borel C, Lefebvre G, Racadot S, Geoffrois L, Sun XS, Saada E, Cirauqui B, Rutkowski T, Henry S, Modesto A, Johnson A, Chapet S, Calderon B, Sire C, Malard O, Bainaud M, Da Silva Motta A, Thureau S, Pointreau Y, Blanchard P, Buiret G, Bozec L, Lopez S, Vanbockstael J, Bosset M, Greilsamer C, Daste A, Bruna A, N'Guyen F, Plana M, Iruarrizaga E, Temam S, Even C, Perez Ruiz E, Bert M, Karamouza E, Thariat J, Kazmierska J, Psyrri A, Mesia R, Tao Y. Nivolumab added to cisplatin-radiotherapy versus cisplatin-radiotherapy alone after surgery for patients with squamous cell carcinoma of the head and neck at high risk of relapse (GORTEC 2018-01 NIVOPOST-OP): a randomised, open-label, phase 3 trial. The Lancet. 2025.