J Clin Oncol: Low-dose radiotherapy combined with cisplatin is effective in treating HPV-related oral and pharyngophageal cancer

Reducing the dose of radiotherapy can improve the quality of life (QOL) in patients with high-risk human papillomavirus (HPV)-related oral squamous cancer (OPSCC).
, it has not been confirmed whether the reduced dose of radiation produces disease control and quality of life comparable to standard chemotherapy.
random Phase II trial recruited OPSCC patients who were p16-positive, T1-T2 N1-N2b M0, or T3 N0-N2b M0, and required the subjects to smoke ≤10 packs/year, underwent 60Gy intensive radiation therapy (IMRT) plus cisplatin (C) or 5 weeks 60Gy IMRT within 6 weeks.
to enter Phase III, the treatment group's 2-year progress-free survival rate (PFS) must be higher than the historical control rate of 85% and the 1-year average MD Anderson Dysphagy Index (MDADI≥60.
306 eligible patients were randomly divided into two groups after the prognosis of treatment.
two-year survival rate of intensive radiotherapy and chemotherapy was 90.5%, excluding the invalid hypothesis that the two-year survival rate was ≤85% (p-0.04).
2-year tumor-free survival rate of intensive radiotherapy was 87.6% (p-0.23).
MDADI scores of 85.30 and 81.76, respectively, for the IMRT-C group and the IMRT group.
two-year total survival rates were 96.7 per cent and 97.3 per cent, respectively, for the IMRT-C group and the IMRT group.
(AE) is defined as an event that occurs within 180 days of treatment.
imRT-C group 3-4 AE more (79.6% vs 52.4% ;p .lt;0.001).
3-4 late-stage AE in the IMRT-C group and the IMRT group were 21.3% and 18.1%, respectively.
, the IMRT-C group reached two predetermined endpoints, proving that it is available for Phase III studies.
note that the risk of acute adverse reactions ≥ level 3 in the IMRT-C group is high.