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

Publication ,  Journal Article
Yom, SS; Torres-Saavedra, P; Caudell, JJ; Waldron, JN; Gillison, ML; Xia, P; Truong, MT; Kong, C; Jordan, R; Subramaniam, RM; Yao, M; Chan, JW ...
Published in: J Clin Oncol
March 20, 2021

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.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

March 20, 2021

Volume

39

Issue

9

Start / End Page

956 / 965

Location

United States

Related Subject Headings

  • Survival Rate
  • Squamous Cell Carcinoma of Head and Neck
  • Radiotherapy, Intensity-Modulated
  • Radiotherapy Dosage
  • Prognosis
  • Papillomavirus Infections
  • Papillomaviridae
  • Oropharyngeal Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged
 

Citation

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Yom, S. S., Torres-Saavedra, P., Caudell, J. J., Waldron, J. N., Gillison, M. L., Xia, P., … Le, Q.-T. (2021). Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002). J Clin Oncol, 39(9), 956–965. https://doi.org/10.1200/JCO.20.03128
Yom, Sue S., Pedro Torres-Saavedra, Jimmy J. Caudell, John N. Waldron, Maura L. Gillison, Ping Xia, Minh T. Truong, et al. “Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002).J Clin Oncol 39, no. 9 (March 20, 2021): 956–65. https://doi.org/10.1200/JCO.20.03128.
Yom SS, Torres-Saavedra P, Caudell JJ, Waldron JN, Gillison ML, Xia P, et al. Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002). J Clin Oncol. 2021 Mar 20;39(9):956–65.
Yom, Sue S., et al. “Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002).J Clin Oncol, vol. 39, no. 9, Mar. 2021, pp. 956–65. Pubmed, doi:10.1200/JCO.20.03128.
Yom SS, Torres-Saavedra P, Caudell JJ, Waldron JN, Gillison ML, Xia P, Truong MT, Kong C, Jordan R, Subramaniam RM, Yao M, Chung CH, Geiger JL, Chan JW, O’Sullivan B, Blakaj DM, Mell LK, Thorstad WL, Jones CU, Banerjee RN, Lominska C, Le Q-T. Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002). J Clin Oncol. 2021 Mar 20;39(9):956–965.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

March 20, 2021

Volume

39

Issue

9

Start / End Page

956 / 965

Location

United States

Related Subject Headings

  • Survival Rate
  • Squamous Cell Carcinoma of Head and Neck
  • Radiotherapy, Intensity-Modulated
  • Radiotherapy Dosage
  • Prognosis
  • Papillomavirus Infections
  • Papillomaviridae
  • Oropharyngeal Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged