GORTEC Announces Landmark Success in Phase 3 Study for Head and Neck Cancer

GORTEC Reports Groundbreaking Outcomes for Head and Neck Cancer Treatment

GORTEC, known as the Head and Neck Radiation Oncology Group, has achieved a significant milestone in oncology with the announcement of successful outcomes from their randomized Phase-3 study, NIVOPOSTOP GORTEC 2018-01. This trial investigated the use of Nivolumab, a PD-1 immune checkpoint inhibitor developed by Bristol Myers Squibb, as an adjunct therapy following surgery in patients at high risk for recurrence of locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

The primary goal of the study was to assess improvements in disease-free survival (DFS) among those receiving Nivolumab compared to those receiving standard radiation therapy and Cisplatin alone. The results showcased a statistically significant improvement in DFS for patients treated with Nivolumab, marking a pivotal moment in cancer treatment strategies. This is especially critical as it is a first in decades for high-risk LA-SCCHN patients, diverging from traditional Cisplatin and radiation treatments that had dominated the field.

Prof. Jean Bourhis, the study director and medical director at GORTEC, highlighted the potential impact of these findings: "This is the first time in decades that a therapy in high-risk LA-SCCHN patients has shown superiority over standard regimens involving Cisplatin and radiation therapy."

Both Dr. Yoann Pointreau, GORTEC’s president, and Dr. Yun Gan Tao, the designated president, also noted how these clinically significant results could potentially transform treatment protocols for patients requiring adjuvant therapy after surgery.

In addition to DFS, a favorable trend towards improved overall survival (OS) was observed, which will undergo final analysis once the predetermined number of death events is reached. This aspect signals promising long-term implications for patient survival rates in future applications of this treatment.

Background on Head and Neck Cancer

H&N cancers encompass malignant tumors originating in the oral cavity, nasopharynx, oropharynx, hypopharynx, and larynx. According to global data from 2022, they accounted for 891,453 new cases and 458,107 deaths, making them the sixth most prevalent cancer type worldwide. A substantial number of these are squamous cell carcinomas, with approximately 60% of patients diagnosed at a locally advanced stage.

Current treatment guidelines typically stipulate surgical resection, followed by radiation therapy or a combination with Cisplatin based on high-risk pathological findings after surgery. However, many patients still face local or regional recurrences or distant metastases within two years post-treatment.

The Role of Nivolumab

Nivolumab operates as a programmed death receptor-1 (PD-1) immune checkpoint inhibitor, designed to leverage the immune system to enhance anti-tumor responses. It is approved for various cancer types, demonstrating a versatile application across multiple domains in oncotherapy, including colorectal, lung, head and neck cancers, and several others.

The NIVOPOSTOP GORTEC 2018-01 (NCT03576417) study was meticulously designed with a focus on high-risk recurrence indicators, necessitating comprehensive participation from 680 patients who were randomized post-surgery. They were assigned either to standard chemotherapy with radiation or to receive Nivolumab as an adjunct therapy. The safety profile was consistent with prior studies, indicating similar compliance across treatment arms.

For medical professionals and patients alike, these findings pave an exciting route forward, offering new hope in the fight against head and neck cancers, thereby enhancing clinical outcomes and addressing a dire need for more effective post-surgical treatment options. Following these results, GORTEC continues to lead the charge in innovative practices within head and neck oncology, demonstrating the critical nature of collaborative research in advancing cancer therapies.

Sources: Bray, F., Global Cancer Statistics 2022, CA Cancer J Clin 2024; 74(3) 229-63.