Nasopharyngeal carcinoma is a rare and aggressive malignant head and neck cancer that is highly prevalent in the southern and southwestern provinces of China. Although the incidence of the cancer is less than 1 per 100,000 in Europe, the United States, and the Pacific, data from the International Agency for Research on Cancer showed that, in 2020, there were about 133,354 new cases of nasopharyngeal carcinoma in the world, with the highest incidence occurring in China. In 2020, there were about 60,000 newly diagnosed cases of nasopharyngeal carcinoma in China, accounting for 46.8% of global cases, making the cancer a major public health problem in China.
Rui Guo, MD
Although treatment of nasopharyngeal carcinoma typically includes concurrent chemoradiation, which can cause serious side effects (such as hearing loss and severe weight loss), a randomized phase III clinical trial conducted in China found that radiation therapy alone provided comparable survival or disease control and less toxicity compared with concurrent chemoradiation therapy in patients with low-risk nasopharyngeal cancer. The study will be presented by Rui Guo, MD, and colleagues at the 2024 ASCO Breakthrough meeting in Yokohama, Japan (Abstract 142).
Study Methodology
A multicenter, open-label, randomized, phase III, noninferiority clinical trial was conducted at five Chinese hospitals and included 341 adults with low-risk nasopharyngeal cancer, who were enrolled between 2015 and 2020. In this study, low-risk disease was defined as stage II disease or T3N0, which is cancer that has limited spread to the lymph nodes and low Epstein-Barr virus DNA without adverse features (all nodes < 3 cm, no level IV/Vb nodes; no extranodal extension; Epstein-Barr virus DNA < 4,000 copies/mL).
Key Results
Patients were assigned to be treated with intensity-modulated radiotherapy (IMRT) alone (n = 172) or with concurrent chemoradiotherapy (IMRT with cisplatin, n = 169). With a median follow-up of 70.1 months, the IMRT-alone group had similar 5-year overall survival (95.2% vs 98.2%; hazard ratio [HR] = 2.27, 95% confidence interval [CI] = 0.70–7.40, P = .16) and failure-free survival (86.2% vs 88.4%; HR = 1.16, 95% CI = 0.64–2.07, P = .63) compared with the concurrent chemoradiotherapy group.
Hearing impairment data, assessed by the Hearing Handicap Inventory for Adults, were collected from 86 patients in the IMRT-alone group and 81 patients in the concurrent chemoradiotherapy group. The researchers found that 45 patients (26.9%) developed hearing impairment (IMRT alone vs concurrent chemoradiotherapy: 20 [23.3%] vs 25 [30.9%]), among which 36 (21.6%) had mild hearing impairment (IMRT alone vs concurrent chemoradiotherapy: 15 [17.4%] vs 21 [25.9%]).
“Radiotherapy alone provides comparable survival or disease control and less toxicity compared [with] concurrent chemoradiotherapy in low-risk nasopharyngeal carcinoma,” concluded the study authors.
Clinical Significance
“In this era of IMRT for low-risk nasopharyngeal cancer, IMRT alone is effective and safe,” said lead study author Dr. Guo, of Sun Yat-sen University Cancer Center in Guangzhou, China, in a statement. “Patients in the IMRT-alone group had a significantly lower incidence of reported grade 3 or 4 adverse events compared to those who received concurrent chemoradiation. Additionally, patients in the IMRT-alone group reported significantly better quality-of-life scores during treatment.”
Disclosure: For full disclosures of the study authors, visit coi.asco.org.