A recent phase III clinical trial conducted in China suggests that radiation therapy alone may be as effective as concurrent chemoradiation in treating patients with low-risk nasopharyngeal carcinoma. The study, presented at the 2024 ASCO Breakthrough meeting, indicates that radiation alone provides comparable survival and disease control with less toxicity.
Study Design and Patient Population
The multicenter, open-label, randomized trial enrolled 341 adults with low-risk nasopharyngeal carcinoma across five Chinese hospitals between 2015 and 2020 (ClinicalTrials.gov identifier NCT02633202). Low-risk disease was defined as stage II or T3N0 with limited lymph node spread, low Epstein-Barr virus (EBV) DNA (< 4,000 copies/mL), and no adverse features such as nodes < 3 cm, absence of level IV or Vb nodes, and no extranodal extension.
Efficacy and Safety Results
Patients were randomized to receive either intensity-modulated radiotherapy (IMRT) alone (n = 172) or concurrent chemoradiotherapy (IMRT with cisplatin, n = 169). After a median follow-up of 70.1 months, the 5-year overall survival was 95.2% in the IMRT-alone group and 98.2% in the chemoradiotherapy group (hazard ratio = 2.27; 95% CI = 0.70–7.40; P = .16). Failure-free survival was 86.2% in the IMRT-alone group and 88.4% in the chemoradiotherapy group (hazard ratio = 1.16; 95% CI = 0.64–2.07; P = .63).
Notably, the incidence of grade 3 or 4 adverse events was significantly lower in the IMRT-alone group. Hearing impairment, assessed via the Hearing Handicap Inventory for Adults, was reported in 23.3% of patients receiving IMRT alone compared to 30.9% in the chemoradiotherapy group. Overall, 26.9% of patients developed hearing impairment, with 21.6% experiencing mild hearing impairment.
Clinical Implications
According to lead author Dr. Rui Guo from Sun Yat-sen University Cancer Center, Guangzhou, China, "Radiotherapy alone provides comparable survival or disease control and less toxicity compared [with concurrent chemoradiotherapy] in low-risk nasopharyngeal carcinoma." Dr. Guo further stated that IMRT alone is effective and safe for low-risk nasopharyngeal cancer, with patients reporting significantly better quality-of-life scores during treatment.
The findings suggest that in the era of IMRT, radiation alone could be a preferred treatment option for low-risk nasopharyngeal carcinoma, potentially reducing the burden of severe side effects associated with chemoradiation.
