Reduced dose radiotherapy with cisplatin gives good results for HPV-related oropharyngeal cancer

A combination of reduced-dose radiotherapy using intensive radiotherapy (IMRT) combined with concomitant cisplatin met the threshold for disease control and quality of life compared with the standard of care for high-risk patients with squamous cell carcinoma HPV-related oropharyngeal on the NRG Oncology Clinical Trial NRG-HN002. The results from these data justify the promotion of the reduced dose of radiotherapy with cisplatin to a Phase III clinical trial setting in this population. These results were recently published in the Journal of Clinical Oncology.

“Currently, patients with HPV-associated oropharyngeal cancer are treated with 70 Gy of radiotherapy with concomitant platinum chemotherapy, but this treatment is usually associated with very short-term and long-term toxins. time. NRG-HN002 was designed as a Phase II trial evaluating a treatment modality using a reduced dose of radiotherapy with or without cisplatin based on preclinical data and data from one-arm studies to see if this yielded good outcomes for this patient population. , ”Said Sue S. Yom, MD, of the University of California, San Francisco, and lead author of the NRG-HN002 manuscript.

NRG-HN002 randomized 306 patients to a 60 Gy experimental arm of IMRT for 6 weeks with a concomitant weekly cisplatin (IMRT + C) or a 60 Gy control arm of IMRT for five weeks. To establish suitability relative to the standard of care, at least one arm had to achieve a 2-year non-progressive survival rate (SDP) above the historical control level of 85% in addition to an average survival score of 1%. years of 60 or more based on the MD Anderson Dysphagia Inventory (MDADI).

Data showed that the IMRT + C arm yielded a 2-year PFS rating of 90.5% (p = 0.04, rejecting the null prediction of 2-year PFS ≤ 85%) compared to 87.3% (p = 0.23) in the IMRT arm only. MDADI 1-year average scores were 85.30 for IMRT + C arm versus 81.76 for IMRT arm alone. Overall 2-year survival rates were 96.7% and 97.3% for the IMRT + C and IMRT arms alone, respectively. While more level 3-4 hard toxins were detected for IMRT + C arm (79.6% vs. 52.4%; p <0.001), levels of late stage 3-4 toxins were similar (21.3% vs. 18.1%; p = 0.56).

Our next step is a Phase II-III test in which we plan to compare disease control levels with the use of lower dose radiation with cisplatin or nivolumab compared to the standard of care. ”

Dr. Sue S. Yom, MD, University of California, San Francisco