التفاصيل البيبلوغرافية
| العنوان: |
Randomized Trial of First-Line Tyrosine Kinase Inhibitor With or Without Radiotherapy for Synchronous Oligometastatic EGFR-Mutated Non-Small Cell Lung Cancer. |
| المؤلفون: |
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 |
| المصدر: |
JNCI: Journal of the National Cancer Institute; Jun2023, Vol. 115 Issue 6, p742-748, 7p |
| مصطلحات موضوعية: |
NON-small-cell lung carcinoma, PROTEIN-tyrosine kinase inhibitors, RADIOTHERAPY, NUCLEOTIDE sequencing, EPIDERMAL growth factor receptors |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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