Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002)
| Autor: | Jessica L. Geiger, John Waldron, Robyn Banerjee, Pedro A. Torres-Saavedra, Maura L. Gillison, Christine H. Chung, Minh Tam Truong, Richard C.K. Jordan, Quynh-Thu Le, Loren K. Mell, Jimmy J. Caudell, Rathan M. Subramaniam, Brian O'Sullivan, Dukagjin Blakaj, C.E. Lominska, Christina S. Kong, Sue S. Yom, Min Yao, Christopher U. Jones, Jason Chan, Wade L. Thorstad, Ping Xia |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Oncology Male Cancer Research medicine.medical_treatment 0302 clinical medicine Intensity-Modulated 80 and over Oropharyngeal squamous cell carcinoma Papillomaviridae Cancer Radiotherapy Dosage Chemoradiotherapy Middle Aged Reduced dose Prognosis 6.5 Radiotherapy and other non-invasive therapies Survival Rate Oropharyngeal Neoplasms Treatment dose 030220 oncology & carcinogenesis 6.1 Pharmaceuticals HIV/AIDS Female Adult medicine.medical_specialty Clinical Trials and Supportive Activities Clinical Sciences Oncology and Carcinogenesis 03 medical and health sciences Clinical Research Internal medicine medicine otorhinolaryngologic diseases Humans Oncology & Carcinogenesis Dental/Oral and Craniofacial Disease neoplasms Aged Radiotherapy business.industry Squamous Cell Carcinoma of Head and Neck Papillomavirus Infections Evaluation of treatments and therapeutic interventions Radiation therapy stomatognathic diseases 030104 developmental biology Oropharyngeal Carcinoma business Digestive Diseases Follow-Up Studies |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol 39, iss 9 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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