PMID- 36556319 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221225 IS - 2075-1729 (Print) IS - 2075-1729 (Electronic) IS - 2075-1729 (Linking) VI - 12 IP - 12 DP - 2022 Nov 22 TI - Efficacy and Failure Patterns of Early SBRT to the Primary Tumor in Advanced EGFR-Mutation-Positive Lung Cancer with EFGR-TKI Treatment: A Prospective, Single Arm, Phase II Study. LID - 10.3390/life12121954 [doi] LID - 1954 AB - Early stereotactic body radiation therapy (SBRT) to the primary tumor combined with epidermal growth factor receptor tyrosine kinase inhibitor (EFGR-TKI) treatment may increase progression-free survival (PFS) by delaying resistance in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). In this prospective, single arm, phase II study, patients with advanced NSCLC were treated with EGFR-TKI (icotinib 125 mg tid or gefitinib 250 mg qd) for one month followed by SBRT (40-60 Gy/5-8 F/5-10 d) to the primary tumor with concurrent EGFR-TKI until disease progression. The primary endpoint was PFS and the patterns of failure. Overall survival (OS) and adverse effects (AEs) were secondary endpoints. Overall, 41 advanced NSCLC patients with EGFR mutations received treatment with 24.42 months of median follow-up time. On average, SBRT was initiated 1.49 months after EGFR-TKI administration. Tumors were found to have an average shrinkage rate of 42.50%. Median PFS was 15.23 months (95% CI 13.10-17.36), while median OS was 27.57 months (95% CI 23.05-32.09). Thirty-three patients were found to have disease progression, of which new site failure (NF) (22 patients, 66.66%) was the most common pattern, followed by original site failure (OF) (7 patients, 21.21%) and simultaneous OF/NF (ONF) (4 patients, 12.12%). There were no Aes equal to or greater than grade 3, with the most frequent AE being radiation pneumonitis. Therefore, administering therapy targeted at the primary tumor using early SBRT after EGFR-TKI initiation is a new potentially safe and effective approach to treat EGFR-mutant advanced NSCLC. FAU - Shi, Yangyang AU - Shi Y AD - Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. AD - Department of Radiation Oncology, University of Arizona, Tucson, AZ 86721, USA. FAU - Xu, Hailing AU - Xu H AD - Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. AD - Department of Pulmonary Medicine, Enze Hospital, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. FAU - Raynor, William Y AU - Raynor WY AUID- ORCID: 0000-0002-4558-6805 AD - Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. AD - Department of Radiology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ 08901, USA. FAU - Ding, Jiapei AU - Ding J AD - Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. AD - Department of Radiation Oncology, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. FAU - Lin, Ling AU - Lin L AD - Department of Pulmonary Medicine, Enze Hospital, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. FAU - Zhou, Chao AU - Zhou C AD - Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. AD - Department of Radiation Oncology, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. FAU - Wang, Wei AU - Wang W AD - Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. AD - Department of Radiation Oncology, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. FAU - Meng, Yinnan AU - Meng Y AD - Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. AD - Department of Radiation Oncology, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. FAU - Wu, Xiaomai AU - Wu X AD - Department of Pulmonary Medicine, Enze Hospital, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. FAU - Chen, Xiaofeng AU - Chen X AD - Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. AD - Department of Radiation Oncology, Indiana University School of Medicine, Indianapolis, IN 46202, USA. FAU - Lv, Dongqing AU - Lv D AD - Department of Pulmonary Medicine, Enze Hospital, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. FAU - Yang, Haihua AU - Yang H AUID- ORCID: 0000-0001-5549-8633 AD - Key Laboratory of Radiation Oncology of Taizhou, Radiation Oncology Institute of Enze Medical Health Academy, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. AD - Department of Radiation Oncology, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou 317000, China. LA - eng GR - NSFC 81874221/Chinese National Science Foundation Projects/ GR - Number: jbzx-201801/a major research project on Zhejiang Lung Cancer center (ZLCC)/ PT - Journal Article DEP - 20221122 PL - Switzerland TA - Life (Basel) JT - Life (Basel, Switzerland) JID - 101580444 PMC - PMC9783042 OTO - NOTNLM OT - epidermal growth factor receptor mutation OT - non-small cell lung cancers OT - phase II study OT - stereotactic body radiation therapy OT - tyrosine kinase inhibitor COIS- The authors declare no conflict of interest. EDAT- 2022/12/24 06:00 MHDA- 2022/12/24 06:01 PMCR- 2022/11/22 CRDT- 2022/12/23 01:40 PHST- 2022/10/14 00:00 [received] PHST- 2022/11/12 00:00 [revised] PHST- 2022/11/15 00:00 [accepted] PHST- 2022/12/23 01:40 [entrez] PHST- 2022/12/24 06:00 [pubmed] PHST- 2022/12/24 06:01 [medline] PHST- 2022/11/22 00:00 [pmc-release] AID - life12121954 [pii] AID - life-12-01954 [pii] AID - 10.3390/life12121954 [doi] PST - epublish SO - Life (Basel). 2022 Nov 22;12(12):1954. doi: 10.3390/life12121954.