In a Chinese phase III trial (Northern Radiation Oncology Group of China-002) reported in the Journal of Clinical Oncology, Sun et al found that the addition of thoracic radiotherapy to EGFR tyrosine kinase inhibitor (TKI) treatment improved progression-free survival in first-line treatment of EGFR-mutated oligo-organ metastatic non–small cell lung cancer (NSCLC).
Study Details
In the multicenter trial, 118 patients enrolled between April 2016 and February 2022 were randomly assigned to receive icotinib at 125 mg three times daily until disease progression or unacceptable toxicity with (n = 59) or without (n = 59) thoracic radiotherapy at 60 Gy in 30 daily fractions to primary lung tumor and positive regional lymph nodes by three-dimensional conformal radiotherapy or intensity-modulated radiotherapy. Radiotherapy to metastases at other sites was at the discretion of clinicians. A total of 27 patients in the TKI group and 34 patients given thoracic radiotherapy plus TKI treatment received radiotherapy to metastatic sites. The primary endpoint was progression-free survival.
Key Findings
Median follow-up for progression-free survival was 27.5 months. Median progression-free survival was 17.1 months (95% confidence interval [CI] = 11.9–23.4 months) with thoracic radiotherapy plus TKI treatment vs 10.6 months (95% CI = 8.8–16.6 months) with TKI treatment (hazard ratio [HR] = 0.57, P = .004). Rates at 1, 3, and 5 years were 61.0% vs 47.5%, 21.3% vs 7.2%, and 11.4% vs 2.7%, respectively.
Median overall survival was 34.4 months (95% CI = 30.4–52.2 months) with thoracic radiotherapy plus TKI treatment vs 26.2 months (95% CI = 23.1–30.7 months) with TKI treatment (HR = 0.62, P = .029). Rates at 1, 3, and 5 years were 91.5% vs 88.1%, 44.5% vs 27.7%, ad 24.9% vs 12.8%, respectively.
Treatment-related grade 3 or 4 adverse events were reported in 11.9% of those who received thoracic radiotherapy plus TKI treatment vs 5.1% of those given the TKI treatment, including radiation esophagitis (6.8% vs 0%) and radiation pneumonitis (5.1% vs 0%).
The investigators concluded: “For patients with EGFR-mutated oligo-organ metastatic NSCLC treated with first-line EGFR-TKIs, concurrent thoracic radiotherapy improves… [progression-free survival and overall survival], and [treatment-related adverse events] are acceptable and tolerable.”
Baosheng Li, MD, of the Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Jinan, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by the National Natural Science Foundation of China, National Key Research and Development Program of China, and others. For full disclosures of the study authors, visit ascopubs.org.
