TY - JOUR
T1 - Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002)
AU - Yom, Sue S.
AU - Torres-Saavedra, Pedro
AU - Caudell, Jimmy J.
AU - Waldron, John N.
AU - Gillison, Maura L.
AU - Xia, Ping
AU - Truong, Minh T.
AU - Kong, Christina
AU - Jordan, Richard
AU - Subramaniam, Rathan M.
AU - Yao, Min
AU - Chung, Christine H.
AU - Geiger, Jessica L.
AU - Chan, Jason W.
AU - O'Sullivan, Brian
AU - Blakaj, Dukagjin M.
AU - Mell, Loren K.
AU - Thorstad, Wade L.
AU - Jones, Christopher U.
AU - Banerjee, Robyn N.
AU - Lominska, Christopher
AU - Le, Quynh Thu
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2021/3/20
Y1 - 2021/3/20
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85103229020&partnerID=8YFLogxK
U2 - 10.1200/JCO.20.03128
DO - 10.1200/JCO.20.03128
M3 - Article
C2 - 33507809
AN - SCOPUS:85103229020
SN - 0732-183X
VL - 39
SP - 956
EP - 965
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 9
ER -