GORTEC's Phase 3 Trial Demonstrates Breakthrough in Head and Neck Cancer Treatment
On January 7, 2025, GORTEC (the Head and Neck Radiation Oncology Group) made a significant announcement regarding its recent clinical trial results that have the potential to reshape treatment protocols for patients with head and neck cancer. The Phase 3 randomized trial known as NIVOPOSTOP GORTEC 2018-01, which evaluated the addition of nivolumab—a PD-1 inhibitor developed by Bristol Myers Squibb—as part of postoperative therapy for patients diagnosed with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN), has achieved its primary endpoint: disease-free survival (DFS).
The trial specifically observed the efficacy of nivolumab administered alongside the standard treatment of radiotherapy and cisplatin compared to the conventional approach of using only radiotherapy and cisplatin. Results indicated a statistically significant and clinically meaningful improvement in DFS among patients treated with nivolumab. Furthermore, the safety profile of nivolumab was consistent with previous findings, and adherence to standard treatments remained comparable across both study groups.
Professor Jean Bourhis, the lead investigator and medical director at GORTEC, remarked, "This milestone marks the first time in decades that a therapy has demonstrated superiority over the existing treatment standard of radiotherapy with cisplatin for high-risk patients with LA-SCCHN. These clinically significant findings could change the treatment landscape for high-risk head and neck cancer patients receiving adjuvant therapy."
As the study continues, a trend toward improved overall survival (OS)—a key secondary endpoint—has also been noted with nivolumab. This survival data will undergo final analysis once the previously set number of deaths has been recorded.
The implications of these findings are extensive, particularly given the statistics surrounding head and neck cancers, which collectively represent the sixth most common cancer globally, with approximately 891,453 new cases and 458,107 deaths reported worldwide in 2022. The majority of these cancers are classified as squamous cell carcinomas (SCCHN), and nearly 60% of patients are diagnosed with locally advanced stages.
Current treatment protocols for LA-SCCHN typically involve surgical resection followed by radiotherapy or radiotherapy combined with cisplatin, especially when high-risk pathological findings are present following surgery. Unfortunately, a significant proportion of patients still experience locoregional recurrence or distant metastasis within two years following completion of their treatment.
Nivolumab represents a promising avenue of therapy, being an immune checkpoint inhibitor specifically designed to enhance the body’s immune response against tumors. It is already approved for use in treating ten different cancer types, including colorectal cancer, non-small cell lung cancer, head and neck cancer, gastric cancer, melanoma, and several others.
The NIVOPOSTOP GORTEC 2018-01 trial, registered as NCT03576417, is a randomized, open-label study focusing on using nivolumab as an adjuvant treatment for resected LA-SCCHN patients at high risk of recurrence. Key inclusion criteria highlight the presence of extracapsular lymph node spread, multiple lymph nodes affected, significant perineural invasion, and/or positive tumor margins post-surgery. The primary endpoint of the trial centers on DFS, while secondary endpoints include OS, quality of life assessments, and safety evaluations. A total of 680 patients were randomized post-surgery to receive either a regimen of 66 Gy radiotherapy and cisplatin (100 mg/m² every three weeks for three cycles) or a combination of nivolumab (240 mg), followed by nivolumab (360 mg every three weeks during radiotherapy) and subsequently six cycles of nivolumab (480 mg every four weeks).
These groundbreaking results are poised to not only enhance patient outcomes but also revolutionize treatment methodologies in the field of head and neck oncology.
The trial specifically observed the efficacy of nivolumab administered alongside the standard treatment of radiotherapy and cisplatin compared to the conventional approach of using only radiotherapy and cisplatin. Results indicated a statistically significant and clinically meaningful improvement in DFS among patients treated with nivolumab. Furthermore, the safety profile of nivolumab was consistent with previous findings, and adherence to standard treatments remained comparable across both study groups.
Professor Jean Bourhis, the lead investigator and medical director at GORTEC, remarked, "This milestone marks the first time in decades that a therapy has demonstrated superiority over the existing treatment standard of radiotherapy with cisplatin for high-risk patients with LA-SCCHN. These clinically significant findings could change the treatment landscape for high-risk head and neck cancer patients receiving adjuvant therapy."
As the study continues, a trend toward improved overall survival (OS)—a key secondary endpoint—has also been noted with nivolumab. This survival data will undergo final analysis once the previously set number of deaths has been recorded.
The implications of these findings are extensive, particularly given the statistics surrounding head and neck cancers, which collectively represent the sixth most common cancer globally, with approximately 891,453 new cases and 458,107 deaths reported worldwide in 2022. The majority of these cancers are classified as squamous cell carcinomas (SCCHN), and nearly 60% of patients are diagnosed with locally advanced stages.
Current treatment protocols for LA-SCCHN typically involve surgical resection followed by radiotherapy or radiotherapy combined with cisplatin, especially when high-risk pathological findings are present following surgery. Unfortunately, a significant proportion of patients still experience locoregional recurrence or distant metastasis within two years following completion of their treatment.
Nivolumab represents a promising avenue of therapy, being an immune checkpoint inhibitor specifically designed to enhance the body’s immune response against tumors. It is already approved for use in treating ten different cancer types, including colorectal cancer, non-small cell lung cancer, head and neck cancer, gastric cancer, melanoma, and several others.
The NIVOPOSTOP GORTEC 2018-01 trial, registered as NCT03576417, is a randomized, open-label study focusing on using nivolumab as an adjuvant treatment for resected LA-SCCHN patients at high risk of recurrence. Key inclusion criteria highlight the presence of extracapsular lymph node spread, multiple lymph nodes affected, significant perineural invasion, and/or positive tumor margins post-surgery. The primary endpoint of the trial centers on DFS, while secondary endpoints include OS, quality of life assessments, and safety evaluations. A total of 680 patients were randomized post-surgery to receive either a regimen of 66 Gy radiotherapy and cisplatin (100 mg/m² every three weeks for three cycles) or a combination of nivolumab (240 mg), followed by nivolumab (360 mg every three weeks during radiotherapy) and subsequently six cycles of nivolumab (480 mg every four weeks).
These groundbreaking results are poised to not only enhance patient outcomes but also revolutionize treatment methodologies in the field of head and neck oncology.
Topics Health）
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