PMID- 33507809
OWN - NLM
STAT- MEDLINE
DCOM- 20210927
LR  - 20221217
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 39
IP  - 9
DP  - 2021 Mar 20
TI  - Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG 
      Oncology HN002).
PG  - 956-965
LID - 10.1200/JCO.20.03128 [doi]
AB  - PURPOSE: Reducing 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 
      METHODS: In 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). 
      RESULTS: Three 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). CONCLUSION: The 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.
FAU - Yom, Sue S
AU  - Yom SS
AUID- ORCID: 0000-0002-0779-7476
AD  - University of California San Francisco, San Francisco, CA.
FAU - Torres-Saavedra, Pedro
AU  - Torres-Saavedra P
AD  - NRG Oncology Statistics and Data Management Center, Philadelphia, PA.
FAU - Caudell, Jimmy J
AU  - Caudell JJ
AD  - Moffitt Cancer Center, Tampa, FL.
FAU - Waldron, John N
AU  - Waldron JN
AD  - University Health Network-Princess Margaret Hospital, Toronto, ON, Canada.
FAU - Gillison, Maura L
AU  - Gillison ML
AD  - M D Anderson Cancer Center, Houston, TX.
FAU - Xia, Ping
AU  - Xia P
AD  - Cleveland Clinic, Cleveland, OH.
FAU - Truong, Minh T
AU  - Truong MT
AD  - Boston Medical Center, Boston, MA.
FAU - Kong, Christina
AU  - Kong C
AD  - Stanford Cancer Institute Palo Alto, Stanford, CA.
FAU - Jordan, Richard
AU  - Jordan R
AD  - University of California San Francisco, San Francisco, CA.
FAU - Subramaniam, Rathan M
AU  - Subramaniam RM
AD  - Otago Medical School, Dunedin, New Zealand.
FAU - Yao, Min
AU  - Yao M
AUID- ORCID: 0000-0001-7462-1318
AD  - University Hospitals Cleveland, Cleveland, OH.
FAU - Chung, Christine H
AU  - Chung CH
AUID- ORCID: 0000-0001-5199-4306
AD  - Moffitt Cancer Center, Tampa, FL.
FAU - Geiger, Jessica L
AU  - Geiger JL
AD  - Cleveland Clinic, Cleveland, OH.
FAU - Chan, Jason W
AU  - Chan JW
AUID- ORCID: 0000-0002-3152-1023
AD  - University of California San Francisco, San Francisco, CA.
FAU - O'Sullivan, Brian
AU  - O'Sullivan B
AUID- ORCID: 0000-0001-8887-843X
AD  - University Health Network-Princess Margaret Hospital, Toronto, ON, Canada.
FAU - Blakaj, Dukagjin M
AU  - Blakaj DM
AD  - The Ohio State University Comprehensive Cancer Center, Columbus, OH.
FAU - Mell, Loren K
AU  - Mell LK
AUID- ORCID: 0000-0003-2277-6080
AD  - UC San Diego Moores Cancer Center, La Jolla, CA.
FAU - Thorstad, Wade L
AU  - Thorstad WL
AD  - Washington University School of Medicine, Saint Louis, MO.
FAU - Jones, Christopher U
AU  - Jones CU
AUID- ORCID: 0000-0001-8880-5636
AD  - Sutter Cancer Research Consortium, Sacramento, CA.
FAU - Banerjee, Robyn N
AU  - Banerjee RN
AD  - Tom Baker Cancer Centre, Calgary, AB, Canada.
FAU - Lominska, Christopher
AU  - Lominska C
AD  - University of Kansas Cancer Center, Kansas City, KS.
FAU - Le, Quynh-Thu
AU  - Le QT
AUID- ORCID: 0000-0002-3682-1439
AD  - Stanford University, Stanford, CA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02254278
GR  - U10 CA180868/CA/NCI NIH HHS/United States
GR  - U10 CA180850/CA/NCI NIH HHS/United States
GR  - U24 CA196067/CA/NCI NIH HHS/United States
GR  - U24 CA180803/CA/NCI NIH HHS/United States
GR  - U10 CA180822/CA/NCI NIH HHS/United States
GR  - UG1 CA189867/CA/NCI NIH HHS/United States
GR  - UG1 CA233331/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20210128
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
SB  - IM
CIN - J Clin Oncol. 2021 Mar 20;39(9):947-949. PMID: 33577355
CIN - J Clin Oncol. 2021 Aug 20;39(24):2732-2733. PMID: 34043410
CIN - J Clin Oncol. 2021 Aug 20;39(24):2733-2734. PMID: 34043416
CIN - J Clin Oncol. 2021 Aug 20;39(24):2734-2735. PMID: 34043429
CIN - Strahlenther Onkol. 2021 Oct;197(10):950-952. PMID: 34312699
CIN - Int J Radiat Oncol Biol Phys. 2021 Sep 1;111(1):1-8. PMID: 34348102
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Chemoradiotherapy/*mortality
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Oropharyngeal Neoplasms/pathology/*radiotherapy/therapy/virology
MH  - Papillomaviridae/isolation & purification
MH  - Papillomavirus Infections/*complications/virology
MH  - Prognosis
MH  - Radiotherapy Dosage
MH  - Radiotherapy, Intensity-Modulated/*mortality
MH  - Squamous Cell Carcinoma of Head and Neck/pathology/*radiotherapy/therapy/virology
MH  - Survival Rate
PMC - PMC8078254
EDAT- 2021/01/29 06:00
MHDA- 2021/09/28 06:00
PMCR- 2022/03/20
CRDT- 2021/01/28 17:14
PHST- 2021/01/29 06:00 [pubmed]
PHST- 2021/09/28 06:00 [medline]
PHST- 2021/01/28 17:14 [entrez]
PHST- 2022/03/20 00:00 [pmc-release]
AID - JCO.20.03128 [pii]
AID - 10.1200/JCO.20.03128 [doi]
PST - ppublish
SO  - J Clin Oncol. 2021 Mar 20;39(9):956-965. doi: 10.1200/JCO.20.03128. Epub 2021 Jan 
      28.