Details

Autor(en) / Beteiligte

• Wang, Xiao-Shan
• Bai, Yi-Feng
• Verma, Vivek
• Yu, Rui-Lian
• Tian, Wei
• Ao, Rui
• Deng, Ying
• Zhu, Xue-Qiang
• Liu, Hao
• Pan, Hai-Xia
• Yang, Lan
• Bai, Han-Song
• Luo, Xing
• Guo, Yan
• Zhou, Ming-Xiu
• Sun, Yue-Mei
• Zhang, Zi-Can
• Li, Si-Min
• Cheng, Xue
• Tan, Bang-Xian
• Han, Liang-Fu
• Liu, Ying-Yi
• Zhang, Kai
• Zeng, Fan-Xin
• Jia, Lin
• Hao, Xin-Bao
• Wang, You-Yu
• Feng, Gang
• Xie, Ke
• Lu, You
• Zeng, Ming

Titel

Randomized Trial of First-Line Tyrosine Kinase Inhibitor With or Without Radiotherapy for Synchronous Oligometastatic EGFR-Mutated Non-Small Cell Lung Cancer

Ist Teil von

• JNCI : Journal of the National Cancer Institute, 2023-06, Vol.115 (6), p.742-748

Ort / Verlag

United States: Oxford University Press

Erscheinungsjahr

2023

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• Abstract Background Adding radiotherapy (RT) to systemic therapy improves progression-free survival (PFS) and overall survival (OS) in oligometastatic non-small cell lung cancer (NSCLC). Whether these findings translate to epidermal growth factor receptor (EGFR)–mutated NSCLC remains unknown. The SINDAS trial (NCT02893332) evaluated first-line tyrosine kinase inhibitor (TKI) therapy for EGFR-mutated synchronous oligometastatic NSCLC and randomized to upfront RT vs no RT; we now report the prespecified interim analysis at 68% accrual. Methods Inclusion criteria were biopsy-proven EGFR-mutated adenocarcinoma (per amplification refractory mutation system or next generation sequencing), with synchronous (newly diagnosed, treatment naïve) oligometastatic (≤5 metastases; ≤2 lesions in any one organ) NSCLC without brain metastases. All patients received a first-generation TKI (gefitinib, erlotinib, or icotinib), and randomization was between no RT vs RT (25-40 Gy in 5 fractions depending on tumor size and location) to all metastases and the primary tumor/involved regional lymphatics. The primary endpoint (intention to treat) was PFS. Secondary endpoints included OS and toxicities. All statistical tests were 2-sided. Results A total of 133 patients (n = 65 TKI only, n = 68 TKI with RT) were enrolled (2016-2019). The median follow-up was 23.6 months. The respective median PFS was 12.5 months vs 20.2 months (P < .001), and the median OS was 17.4 months vs 25.5 months (P < .001) for TKI only vs TKI with RT. Treatment yielded no grade 5 events and a 6% rate of symptomatic grade 3-4 pneumonitis in the TKI with RT arm. Based on the efficacy results of this prespecified interim analysis, the ethics committee recommended premature cessation of this trial. Conclusions As compared with a first-line TKI alone, addition of upfront local therapy using RT statistically significantly improved PFS and OS for EGFR-mutated NSCLC.