Immunotherapy is included in the therapeutic algorithm for head and neck cancer.

In recent years, the inclusion of immunotherapy in the therapeutic algorithm of patients with PD-L1-positive advanced head and neck cancer has significantly increased the survival of these patients. This has been highlighted by the Spanish Society of Medical Oncology in the communication campaign “In oncology, every PROGRESS is written in capital letters”.

In recognition of World Head and Neck Cancer Day last Saturday, SEOM highlights that it is currently the seventh most common cancer.or, it is estimated that in 2024 in Spain there will be around 10,700 new cases and 3,660 registered deaths. According to the report “Cancer figures in Spain 2024” and the latest data from the National Statistics Institute (INE).

Tobacco and alcohol They are the main causative agents of head and neck cancer, accounting for about 75-85% of cases, although there is a progressive increase in tumors associated with human papillomavirus (HPV), which may account for 30-35% of cases, although there is great geographic variability.

These tumors arise in an anatomically complex area, where local treatment with curative intent is associated with serious physical consequences that are highly stigmatizing and have a major impact on quality of life and functionality of the triple sphere of phonation, swallowing and breathing. In addition, these patients often have problems with malnutrition due to the tumor, treatment and comorbidities that must be addressed and treated from the time of diagnosis.

According to them, a major advance in the treatment of head and neck tumors was the inclusion of immunotherapy in their therapeutic algorithm. Before that, there was a gap in therapeutic treatment in cases refractory to cisplatin, especially in patients. refractory to EXTREME treatment, until 2016, when the FDA approved immunotherapy for these cases with two anti-PD-1 drugs, the main benefit of which is long-term survival of patients who respond to treatment.

The FDA accelerated approval of nivolumab in April 2016 following the presentation of data from the first pivotal phase III CHECKMATE 141 trial, in which nivolumab demonstrated an overall survival (OS) benefit compared with investigator’s choice of chemotherapy in patients who crossed over to platinum-based treatment for localized disease. There was an improvement in OS (7.7 vs. 3.3 months), but most striking was that more than 10% of patients in the nivolumab group were alive at 3 years.

On September 1, 2016, the FDA granted accelerated approval to pembrolizumab based on data from the nonrandomized Phase Ib KEYNOTE-012 trial. Most patients in the study had previously received at least two different cycles of treatment. A median overall survival of 8 months was achieved, with 38% of patients still alive one year after starting treatment. A Phase II trial (KEYNOTE-055) subsequently confirmed these data in a 2017 publication in the Journal Clinical Oncology.

In 2018, results from the KEYNOTE-048 study were published demonstrating the superiority of pembrolizumab as monotherapy and pembrolizumab in combination with cisplatin-based chemotherapy in first-line patients with recurrent and/or metastatic disease with platinum-sensitive disease and a positive PDL1 result.. Since 2021, it has been included in the standard treatment of this group of PDL1-positive patients, and this is reflected in the SEOM Guidelines for the treatment of these tumors. But perhaps the most impressive aspect is the reduction in mortality risk that has been observed with the introduction of these drugs.

In an updated study published in 2023 with a 4-year follow-up period, treatment with pembrolizumab showed a reduction in the risk of death compared with standard chemotherapy by 26–39% depending on PD-L1 expression and a combination of chemotherapy and pembrolizumab by 38%.