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Clinical Trial
. 2021 Mar 20;39(9):956-965.
doi: 10.1200/JCO.20.03128. Epub 2021 Jan 28.

Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002)

Sue S Yom  1 , Pedro Torres-Saavedra  2 , Jimmy J Caudell  3 , John N Waldron  4 , Maura L Gillison  5 , Ping Xia  6 , Minh T Truong  7 , Christina Kong  8 , Richard Jordan  1 , Rathan M Subramaniam  9 , Min Yao  10 , Christine H Chung  3 , Jessica L Geiger  6 , Jason W Chan  1 , Brian O'Sullivan  4 , Dukagjin M Blakaj  11 , Loren K Mell  12 , Wade L Thorstad  13 , Christopher U Jones  14 , Robyn N Banerjee  15 , Christopher Lominska  16 , Quynh-Thu Le  17
Affiliations
Clinical Trial

Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002)

Sue S Yom et al. J Clin Oncol. .

Abstract

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.

Trial registration: ClinicalTrials.gov NCT02254278.

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Figures

FIG 1.
FIG 1.
CONSORT Flow Diagram for NRG-HN002. IMRT, intensity-modulated radiation therapy; MDADI, MD Anderson Dysphagia Inventory; PFS, progression-free survival.
FIG 2.
FIG 2.
NRG-HN002 progression-free (A) and overall survival (B), local-regional failure (C), and distant metastasis (D). HR, hazard ratio; IMRT, intensity-modulated radiation therapy.
FIG A1.
FIG A1.
High-grade adverse event rates over time by treatment arm.
FIG A2.
FIG A2.
Feeding tube rates over time by treatment arm.
See this image and copyright information in PMC

Comment in

References

    1. Chaturvedi AK Engels EA Pfeiffer RM, et al. : Human papillomavirus and rising oropharyngeal cancer incidence in the United States. J Clin Oncol 29:4294-4301, 2011 - PMC - PubMed
    1. D'Souza G Kreimer AR Viscidi R, et al. : Case-control study of human papillomavirus and oropharyngeal cancer. N Engl J Med 356:1944-1956, 2007 - PubMed
    1. Herrero R: Human papillomavirus and oral cancer: The International Agency for Research on Cancer multicenter study. J Natl Cancer Inst 95:1772-1783, 2003 - PubMed
    1. Fakhry C Westra WH Li S, et al. : Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst 100:261-269, 2008 - PubMed
    1. Fakhry C Zhang Q Nguyen-Tan PF, et al. : Human papillomavirus and overall survival after progression of oropharyngeal squamous cell carcinoma. J Clin Oncol 32:3365-3373, 2014 - PMC - PubMed

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