Immunotherapy with pembrolizumab, administered both before and after surgery, significantly improves the prognosis of patients with advanced head and neck cancer, according to an international study involving 714 patients.
The results, published in the New England Journal of Medicine, could reshape current standards of care.
The study was conducted at 192 centres across Europe, the Americas, Asia, and Australia. One of the participating institutions was the Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice, Poland.
“One of the basic treatment methods for advanced head and neck cancer is surgery, which, according to the current standard of care, is usually supplemented with radiotherapy or radiochemotherapy,” said Tomasz Rutkowski, PhD, MD, Deputy Science Director, Head of the Clinical Research Support Centre at the National Research Institute of Oncology in Gliwice and co-author of the publication.
“The study described in the New England Journal of Medicine aimed to demonstrate that adding pembrolizumab – a monoclonal antibody targeting the programmed cell death receptor, already used in the treatment of patients with other malignancies – significantly improves treatment outcomes for patients with head and neck cancer,” he continued.
He added that, until now, immunotherapy was the standard only for cases of recurrence or distant metastasis and that immunotherapy is already the standard treatment for this indication. However, in the group of patients treated for the first time with curative intent, it has not yet been proven effective.
The study was designed as a randomised, two-arm trial. In the first group, 351 patients received the current standard of care: surgery followed by radiotherapy or radiochemotherapy. In the second group, 363 patients received two cycles of pembrolizumab before surgery and 15 additional cycles post-surgery, in combination with adjuvant therapy.
After a three-year follow-up, 59.8% of patients in the pembrolizumab group were alive without evidence of disease, compared to 45.9% in the standard treatment group. The difference was statistically significant. Median progression-, relapse-, and metastasis-free survival was 59.7 months in the immunotherapy group versus 26.9 months in the control group.
Side effects of grade 3 severity – including gastritis, neutropenia, and radiation dermatitis – were reported in 44.6% of patients treated with pembrolizumab and in 42.9% of those in the control group.
“As you can see, the difference is insignificant, meaning that pembrolizumab was well tolerated by patients and did not increase treatment toxicity compared to the current therapy,” Rutkowski said.
At the Gliwice branch of the National Research Institute of Oncology, 37 patients were initially qualified for the study, with 22 ultimately randomised.
According to Rutkowski, the complex, multi-stage treatment was made possible by strong collaboration between clinical and diagnostic teams.
“The treatment was a three-stage process. First, we had to qualify the patient for surgery by scheduling a hospitalisation date in the surgical ward, and then plan and conduct neoadjuvant treatment with pembrolizumab in coordination with the previously scheduled surgery date,” he said.
“The quickly obtained postoperative histopathology results allowed for a consultation to qualify the patient for radiotherapy or adjuvant radiochemotherapy. Simultaneously with this adjuvant treatment, we began adjuvant immunotherapy with pembrolizumab. Effective implementation of this multi-stage treatment requires good cooperation and coordination,” he added.
Researchers at the National Research Institute of Oncology in Gliwice also conduct other studies on the treatment of head and neck cancers. (PAP)
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