Reduced-Dose Radiation Therapy for HPV-Associated Oropharyng
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A combination of reduced-dose radiotherapy using intensity-modulated radiotherapy (IMRT) combined with concurrent cisplatin met the threshold for disease control and quality of life compared to the standard of care for good-risk patients with HPV-associated oropharyngeal SCC on NRG Oncology HN002 clinical trial. The outcomes justify the advancement of the reduced radiotherapy dose with cisplatin to a Phase III clinical trial setting.

The study was purposed to evaluate whether reduced-dose radiation produces disease control and quality of life (QOL) equivalent to standard chemoradiation.

In this randomized, phase II trial, patients with p16-positive, T1-T2 N1-N2b M0, or T3 N0-N2b M0 OPSCC with ≤ 10 pack-years of smoking received 60 Gy of IMRT over 6 weeks with concurrent weekly cisplatin (C) or 60 Gy IMRT over 5 weeks. To be considered for a phase III study, an arm had to achieve a 2-year progression-free survival (PFS) rate superior to a historical control rate of 85% and a 1-year mean composite score ≥ 60 on the MD Anderson Dysphagia Inventory (MDADI).

306 patients were randomly assigned and eligible.

--Two-year PFS for IMRT + C was 90.5% rejecting the null hypothesis of 2-year PFS ≤ 85%. For IMRT, 2-year PFS was 87.6%.

--One-year MDADI mean scores were 85.30 and 81.76 for IMRT + C and IMRT, respectively.

--Two-year overall survival rates were 96.7% for IMRT + C and 97.3% for IMRT.

--Acute adverse events (AEs) were defined as those occurring within 180 days from the end of treatment. There were more grade 3-4 acute AEs for IMRT + C. Rates of grade 3-4 late AEs were 21.3% and 18.1%.

Conclusively, the IMRT + C arm met both prespecified endpoints justifying advancement to a phase III study. Higher rates of grade ≥ 3 acute AEs were reported in the IMRT + C arm.

Journal of Clinical Oncology