Salute e Benessere
GORTEC Announces New Trial Success for Head and Neck Cancer Treatment
" said Prof Jean Bourhis , Principal Investigator of the study and Medical Director of the GORTEC.
" " added both Dr Yoann Pointreau , President and Dr Yun Gan Tao , President-Elect of the GORTEC.
A trend toward improvement in overall survival (OS), a key secondary endpoint, was observed for nivolumab. OS will be evaluated at the final analysis, once the pre-specified number of deaths has been reached.
GORTEC is a cooperative group dedicated to Head and Neck Oncology. GORTEC has a long-standing experience of large scale international innovative phase III trials relying on a robust high-quality study management and a strong multidisciplinary network of investigators and experts in the field of head and neck cancers.
Head and neck cancer includes malignancies of the oral cavity, nasopharynx, oropharynx, hypopharynx, and larynx, and is collectively the sixth most common cancer worldwide, having accounted for 891,453 new cases and 458,107 deaths globally in 2022*. Most of these cancers are squamous cell carcinomas (SCCHN), and approximately 60% of patients are diagnosed with locally advanced (LA) disease. Current treatment guidelines for LA-SCCHN recommend surgical resection followed by radiotherapy or cisplatin-radiotherapy (if high-risk pathological findings after resection). Despite these definitive treatments, a large proportion of LA-SCCHN patients develop locoregional recurrence and/or distant metastases within 2 years of completing treatment.
Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. Nivolumab is approved for the treatment of 10 different cancer types including colorectal, non-small cell lung, head and neck, gastric and gastro-esophageal junction cancers, melanoma, esophageal squamous cell carcinoma or adenocarcinoma, mesothelioma, renal cell carcinoma.
It is a randomized controlled, open-label Phase 3 trial (NCT03576417) evaluating nivolumab as adjuvant treatment in patients with resected LA-SCCHN. The main inclusion criteria were high-risk of relapse as defined by nodal extra capsular extension, multiple nodal involvement, multiple peri-neural invasion and/or positive tumor margins after surgery. The primary endpoint was DFS, and secondary endpoints include OS, QOL and safety. The study enrolled 680 patients who were randomized after surgery to receive either SOC 66 Gy radiotherapy and cisplatin (100 mg/m2 Q3W for three cycles) or nivolumab 240 mg, followed by SOC cisplatin-radiotherapy with nivolumab 360 mg Q3W every 3 weeks during cisplatin-radiotherapy and followed by 6 cycles of nivolumab 480 mg every 4 weeks.
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Media Contact: Jean Bourhis : jean.bourhis@gortec.fr
View original content: https://www.prnewswire.co.uk/news-releases/gortec-announces-new-trial-success-for-head-and-neck-cancer-treatment-302344120.html