Reduced-dose RT with Cisplatin improves outcomes for HPV-associated oropharyngeal carcinoma

NRG-HN002 randomly assigned 306 eligible patients to either the experimental arm of 60 Gy of IMRT for 6 weeks with concurrent weekly cisplatin (IMRT+C) or the control arm of 60 Gy of IMRT for five weeks. In order to establish acceptability as compared to the standard of care, at least one arm had to achieve a 2-year progression-free survival (PFS) rate above the historical control rate of 85% as well as a 1-year mean composite score of 60 or greater based on the MD Anderson Dysphagia Inventory (MDADI).

Data indicated that the IMRT+C arm yielded a 2-year PFS rate of 90.5% (p=0.04, rejecting the null hypothesis of 2-year PFS ? 85%) compared to 87.3% (p=0.23) in the IMRT alone arm. 1-year mean MDADI scores were 85.30 for the IMRT+C arm versus 81.76 for the IMRT alone arm. 2-year overall survival rates were 96.7% and 97.3% for the IMRT+C and the IMRT alone arms, respectively. While more grade 3-4 acute toxicities were discovered for the IMRT+C arm (79.6% vs. 52.4%; p<0.001), rates of grade 3-4 late toxicities were similar (21.3% vs. 18.1%; p=0.56).

"Our next step is a Phase II-III trial in which we intend to compare disease control rates using reduced-dose radiation with cisplatin or nivolumab against the standard of care," added Dr. Yom.