In a Chinese phase III trial reported in JAMA, Tang et al found that radiotherapy alone was noninferior to concurrent chemoradiotherapy in failure-free survival in patients with low-risk nasopharyngeal carcinoma.
Study Details
In the open-label multicenter trial, 341 patients were randomly assigned between November 2015 and August 2020 to receive intensity-modulated radiation therapy (IMRT) alone at 68 to 70 Gy in 2.0 to 2.2 Gy fractions given once per day 5 days per week (n = 172) or IMRT with concurrent cisplatin at 100 mg/m2 every 3 weeks for three cycles. Low-risk disease was defined as stage II/T3N0M0 without adverse features (all nodes < 3 cm, no level IV/Vb nodes, no extranodal extension, Epstein-Barr virus DNA < 4,000 copies/mL).
The primary endpoint was 3-year failure-free survival, with a noninferiority margin of 10%.
Failure-Free Survival
Median follow-up was 46 months (interquartile range = 34–58 months). Failure-free survival at 3 years was 90.5% in the radiotherapy-alone group vs 91.9% in the chemoradiotherapy group (difference = −1.4%, 1-sided 95% confidence interval [CI] = −7.4% to ∞, P < .001 for noninferiority). The adjusted hazard ratio was 1.36 (95% CI = 0.70–2.66, P = .85).
KEY POINTS
- IMRT alone was noninferior to IMRT with concurrent chemotherapy in failure-free survival.
- No differences in overall survival, locoregional relapse–free survival, or distant metastasis–free survival were observed.
At 3 years, overall survival was 98.2% vs 98.6% (difference = −0.4%, 95% CI = −3.1% to 2.3%, P = .31), locoregional relapse–free survival was 94.0% vs 94.3% (difference = −0.3%, 95% CI = −5.3% to 4.7%, P = .43), and distant metastasis–free survival was 95.8% vs 97.6% (difference = −1.8%, 95% CI = −5.6% to 2.0%, P = .22).
Adverse Events
Grade 3 or 4 adverse events occurred in 17% of patients in the radiotherapy group vs 46% of the chemoradiotherapy group (P < .001), including leukopenia (1% vs 10%), neutropenia (2% vs 7%), nausea (1% vs 13%), vomiting (1% vs 15%), anorexia (5% vs 29%), weight loss (1% vs 5%), and mucositis (10% vs 19%). Late grade 3 or 4 toxicity occurred in 4% vs 2% of patients (P = .48). No treatment-related deaths were reported.
The radiotherapy alone group had significantly better scores during radiotherapy on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30, including in the domains of global health status, social functioning, fatigue, nausea and vomiting, pain, insomnia, appetite loss, and constipation.
The investigators concluded, “Among patients with low-risk nasopharyngeal carcinoma, treatment with IMRT alone resulted in 3-year failure-free survival that was not inferior to concurrent chemoradiotherapy.”
Jun Ma, MD, of the Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, is the corresponding author for the JAMA article.
Disclosure: The study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Guangdong Province, and others. For full disclosures of the study authors, visit jamanetwork.com.
