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Randomized Trial of First-Line Tyrosine Kinase Inhibitor With or Without Radiotherapy for Synchronous Oligometastatic EGFR-Mutated NSCLC.

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机构： [1]Cancer Center, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China. [2]Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, NE, USA. [3]School of Medicine, University of Electronic Science and Technology of China, Chengdu, China. [4]Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan Province, China. [5]Southwest Medical University, Luzhou City, Sichuan Province, China. [6]Boao Evergrande International Hospital, Qionghai, Hainan Province, China. [7]Cancer Center, Sichuan Friendship Hospital, Chengdu, Sichuan Province, China. [8]Cancer Center, Ziyang People's Hospital, Ziyang, Sichuan Province, China. [9]Dazhou Central Hospital, Dazhou, Sichuan Province, China. [10]Third Hospital of Mianyang (Sichuan Mental Health Center), Mianyang, Sichuan Province, China. [11]Cancer Center, First Affiliated Hospital of Hainan Medical College, National Drug Clinical Trial Institute, Haikou, Hainan Province, China. [12]Cancer Center, West China Hospital, Chengdu, Sichuan Province, China.

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关键词： oligometastasis non-small cell lung cancer EGFR mutation radiation therapy tyrosine kinase inhibitor

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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 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 up-front RT vs. no RT; we now report the pre-specified interim analysis at 68% accrual.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/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.A total of 133 patients (n = 65 TKI only, n = 68 TKI+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+RT. Treatment yielded no grade 5 events and a 6% rate of symptomatic grade 3-4 pneumonitis in the TKI+RT arm. Based on the efficacy results of this pre-specified interim analysis, the ethics committee recommended premature cessation of this trial.As compared to a first-line TKI alone, addition of up-front local therapy using RT statistically significantly improved PFS and OS for EGFR-mutated NSCLC.© The Author(s) (2022). Published by Oxford University Press.

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大类 | 1 区

医学

小类 | 1 区肿瘤学

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大类 | 1 区

医学

小类 | 1 区肿瘤学

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Q1 ONCOLOGY

最新[2023]版：

Q1 ONCOLOGY

影响因子： 10 最新[2023版] 10.5 最新五年平均 10 出版当年[2023版] 10.5 出版当年五年平均 10.3 出版前一年[2022版]

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第一作者机构： [1]Cancer Center, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.

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通讯机构： [1]Cancer Center, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China. [*1]Cancer Center, Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of China, Chengdu, China

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Randomized Trial of First-Line Tyrosine Kinase Inhibitor With or Without Radiotherapy for Synchronous Oligometastatic EGFR-Mutated NSCLC.