Oropharyngeal Cancer

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

In the February 12, 2021 edition of Journal of Clinical Oncology, Sue S. Yom and colleagues report the results of the NRG Oncology HN002 trial.

PURPOSE

Patients with good-risk HPV – associated oropharyngeal squamous cell carcinoma can experience improved quality of life if offered lower total radiation therapy dose, while still maintaining efficacy.

METHODS:

A randomized, phase 2 clinical trial was developed, for patients with p16+, T1-T2 N1-N2b M0, or T3 N0-N2b M0 oropharyngeal squamous cell carcinoma with at least 10 pack-years of smoking where they were administered 60 Gy of intensity-modulated radiation therapy (IMRT) over the course of 6 weeks along with weekly cisplatin or 60 Gy IMRT over the course of 5 weeks.  If patients have achieved a 2-year progression-free survival rate superior to a historical control rate of 85% and a 1-year mean composite score ≥ 60 on the MD Anderson Dysphagia Inventory (MDADI), then they were allowed to participate in the phase 3 portion of the clinical trial.

RESULTS

306 patients were randomized . Two-year progression free survival for intensity modulated radiotherapy plus cis-platinum was 90.5% which resulted in a rejection of the null hypothesis of 2-year progression free survival achieving a maximum of 85% (P = .04). For intensity modulated radiotherapy, the 2-year progression free survival was 87.6% (P = .23). The 1-year MDADI mean scores were 85.30 and 81.76 for intensity modulated radiotherapy and cis-platinum and intensity modulated radiotherapy, respectively. 2-year OS rates were 96.7% for the radiotherapy plus chemo arm and and 97.3% for radiotherapy alone arm.  Adverse events occurring within 180 days from the end of treatment were defined as acute adverse events.  The investigators reported more grade 3 and 4 acute adverse events for the combination arm (79.6% v 52.4%; P < .001), while late AEs were 21.3% and 18.1% (P = .56).

The authors concluded “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.”

https://ascopubs.org/doi/full/10.1200/JCO.20.03128

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