Abstract
PURPOSEReducing radiation treatment dose could improve the quality of life (QOL) of patients with good-risk human papillomavirus-Associated oropharyngeal squamous cell carcinoma (OPSCC). Whether reduced-dose radiation produces disease control and QOL equivalent to standard chemoradiation is not proven.PATIENTS AND METHODSIn this randomized, phase II trial, patients with p16-positive, T1-T2 N1-N2b M0, or T3 N0-N2b M0 OPSCC (7th edition staging) with ≤ 10 pack-years of smoking received 60 Gy of intensity-modulated radiation therapy (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).RESULTSThree hundred six patients were randomly assigned and eligible. Two-year PFS for IMRT + C was 90.5% rejecting the null hypothesis of 2-year PFS ≤ 85% (P =.04). For IMRT, 2-year PFS was 87.6% (P =.23). 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 (79.6% v 52.4%; P <.001). Rates of grade 3-4 late AEs were 21.3% and 18.1% (P =.56).CONCLUSIONThe IMRT + C arm met both prespecified end points justifying advancement to a phase III study. Higher rates of grade ≥ 3 acute AEs were reported in the IMRT + C arm.
Original language | English (US) |
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Pages (from-to) | 956-965 |
Number of pages | 10 |
Journal | Journal of Clinical Oncology |
Volume | 39 |
Issue number | 9 |
DOIs | |
State | Published - Mar 20 2021 |
All Science Journal Classification (ASJC) codes
- Oncology
- Cancer Research