Immunotherapy will revolutionize head and neck cancer treatment - promising research results
Pembrolizumab is effective and well-tolerated in the treatment of advanced head and neck cancer, according to researchers from 192 medical centers participating in a study involving 714 patients, recently published in the New England Journal of Medicine (NEJM). One of the Polish centers participating in this study was the Gliwice branch of the National Institute of Oncology.
" One of the basic treatments for advanced head and neck cancer is surgery, which, according to the current standard of care, is usually supplemented with radiotherapy or radiochemotherapy. The study, published in the New England Journal of Medicine, aimed to demonstrate that adding pembrolizumab—a monoclonal antibody directed against the programmed cell death receptor, already used in the treatment of patients with other malignancies (including lung cancer, kidney cancer, breast cancer, and melanoma)—significantly improves treatment outcomes for patients with head and neck cancer, " emphasizes the lead Polish researcher , Dr. Tomasz Rutkowski, MD , PhD, Deputy Director for Scientific Affairs and Head of the Clinical Research Support Center at the National Institute of Oncology in Gliwice, and a Polish co-author of the NEJM publication.
He adds that so far, the use of immunotherapy in patients with head and neck cancer has been proven effective only in the treatment of failures, i.e. in situations where the patient experienced recurrence or distant metastases after primary treatment.
"Immunotherapy is already standard treatment for this indication. However, in patients initially treated with the intent of curing, it has not yet been proven effective, " says Dr. Tomasz Rutkowski .
The randomized trial, conducted at 192 centers in Europe, the Americas, Asia, and Australia and published in the June 18, 2025 issue of NEJM , used pembrolizumab as both neoadjuvant and adjuvant treatment. Participants were divided into two groups.
" The study was a two-arm study. One arm, which enrolled 351 patients, used the current standard of care—surgery and radiotherapy or radiochemotherapy as an adjunct to surgery. In the other arm, 363 patients received pembrolizumab in addition to standard treatment, receiving two cycles of the drug three weeks apart before surgery and 15 cycles after surgery, supplemented with radiotherapy or radiochemotherapy, " explains Dr. Tomasz Rutkowski .
The study lasted from December 2018 to October 2023. After three years of follow-up, during which the time from randomization to disease progression, recurrence, distant metastases, or death from any cause was assessed, it turned out that in the control group, treated according to the current standard of care, 45.9% of patients were alive without cancer, while in the study group (receiving pembrolizumab ), the figure was significantly higher – 59.8%. The median progression-free, recurrence-free, or distant metastasis-free survival was also significantly higher in the pembrolizumab group compared to patients treated according to the current standard of care (59.7 months vs 26.9 months, respectively, p=0.004).
Importantly, treatment with pembrolizumab was well tolerated. Grade III side effects (the most common being gastritis, neutropenia, and radiation dermatitis) occurred in 44.6% of patients in the study group and in 42.9% in the control group. " As you can see, the difference is insignificant, meaning that pembrolizumab was well tolerated by patients and did not increase the toxicity of the treatment compared to the previously used therapy ," comments Dr. Tomasz Rutkowski .
At the National Institute of Oncology in Gliwice, 37 patients were qualified for the study, and 22 were ultimately randomized. As the principal investigator emphasizes, this multi-stage treatment could only be carried out efficiently thanks to the exemplary cooperation between the 1st Clinic of Radiotherapy and Chemotherapy headed by prof. dr hab. n. med. Krzysztof Składowski , which specializes in radiotherapy and radiochemotherapy for patients with head and neck cancer, the 1st Department of Surgical Oncology headed by dr n. med. Cezary Szymczyk , the Department of Tumor Pathology headed by dr hab. n. med. Ewa Chmielik , and the Department of Radiology and Diagnostic Imaging headed by prof. dr hab. n. med. Barbara Bobek-Billewicz .
" The treatment was a three-stage process. First, we had to qualify the patient for surgery by scheduling a hospitalization date in the surgical ward, and then plan and conduct neoadjuvant treatment with pembrolizumab, coordinated with the previously scheduled surgery date. The quickly obtained results of the postoperative histopathological examination allowed us to conduct a consultation to qualify the patient for radiotherapy or adjuvant radiochemotherapy. Simultaneously with this adjuvant treatment, we began adjuvant immunotherapy with pembrolizumab. Successful implementation of this multistage treatment requires good cooperation and coordination. And while this is nothing new, as modern cancer therapy is based on this approach, I am very pleased that patients with head and neck cancer have also joined this group, " explains Dr. Tomasz Rutkowski .
The National Institute of Oncology in Gliwice conducts numerous studies dedicated to patients with head and neck cancer .
– Please contact us to obtain detailed information on this topic – encourages Dr. Tomasz Rutkowski, MD .
NIO press materials from Gliwice
Updated: 28/07/2025 06:30
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