PMID- 31040256 OWN - NLM STAT- MEDLINE DCOM- 20200724 LR - 20200724 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 24 IP - 8 DP - 2019 Aug TI - Concurrent EGFR-TKI and Thoracic Radiotherapy as First-Line Treatment for Stage IV Non-Small Cell Lung Cancer Harboring EGFR Active Mutations. PG - 1031-e612 LID - 10.1634/theoncologist.2019-0285 [doi] AB - LESSONS LEARNED: This single-arm, phase II study shows that concurrent EGFR-tyrosine kinase inhibitor plus thoracic radiotherapy as the first-line treatment for stage IV non-small cell lung cancer harboring EGFR active mutations provides long-term control for the primary lung lesion, and 1-year progression-free survival (PFS) rate and median PFS are numerically higher than those of the erlotinib monotherapy.Serious adverse events are acceptable, although grade >3 radiation pneumonitis occurred in 20% of patients. BACKGROUND: Studies show effective local control by EGFR-tyrosine kinase inhibitor (TKI) combined with radiotherapy at metastatic sites in advanced lung cancer harboring EGFR active mutations. Salvage local radiotherapy is associated with prolonged progression-free survival (PFS) in local disease during EGFR-TKI treatment. However, no prospective study has been reported on concurrent EGFR-TKI and radiotherapy for primary lung lesions. This study investigated the efficacy and safety of first-line EGFR-TKI combined with thoracic radiotherapy in treating stage IV non-small cell lung cancer (NSCLC) harboring EGFR active mutations. METHODS: We conducted a single-arm, phase II clinical trial. Each patient received EGFR-TKI (erlotinib 150 mg or gefitinib 250 mg per day) plus thoracic radiotherapy (54-60 Gy/27-30 F/5.5-6 w) within 2 weeks of beginning EGFR-TKI therapy until either disease progression or intolerable adverse events (AEs) appeared. RESULTS: From January 2015 to March 2018, 401 patients were screened, and 10 patients (5 male and 5 female) were eligible. These patients had a median age of 55 years (40-75) and median follow-up of 19.8 months (5.8-34). The 1-year PFS rate was 57.1%, median PFS was 13 months, and median time to progression of irradiated lesion (iTTP) was 20.5 months. Objective response rate (ORR), was 50% and disease control rate (DCR) was 100%. The most common grade >/=3 AEs were radiation pneumonitis (20%) and rash (10%). One patient died after rejecting treatment for pneumonitis. The others received a full, systematic course of glucocorticoid therapy. Pneumonitis was all well controlled and did not relapse. CONCLUSION: Concurrent EGFR-TKI plus thoracic radiotherapy as the first-line treatment for stage IV NSCLC harboring EGFR active mutations shows a long-term control of primary lung lesion. The 1-year PFS rate and median PFS of this combined therapy are numerically higher than those of the erlotinib monotherapy. The risk of serious adverse events is acceptable. CI - (c) AlphaMed Press; the data published online to support this summary are the property of the authors. FAU - Zheng, LinPeng AU - Zheng L AD - Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Wang, Yanmei AU - Wang Y AD - Department of Oncology, Ya'an People's Hospital, Ya'an, Sichuan, People's Republic of China. FAU - Xu, Zihan AU - Xu Z AD - Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Yang, Qiao AU - Yang Q AD - Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Zhu, Guangkuo AU - Zhu G AD - Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Liao, Xing-Yun AU - Liao XY AD - Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China. FAU - Chen, Xiewan AU - Chen X AD - Medical English Department, College of Basic Medicine, Army Medical University, Chongqing, People's Republic of China. FAU - Zhu, Bo AU - Zhu B AD - Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China sunjg09@aliyun.com duanyuzhong@sina.com bo.zhu@tmmu.edu.cn. FAU - Duan, Yuzhong AU - Duan Y AD - Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China sunjg09@aliyun.com duanyuzhong@sina.com bo.zhu@tmmu.edu.cn. FAU - Sun, Jianguo AU - Sun J AD - Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China sunjg09@aliyun.com duanyuzhong@sina.com bo.zhu@tmmu.edu.cn. LA - eng SI - ClinicalTrials.gov/NCT02353741 PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190430 PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - 0 (Glucocorticoids) RN - 0 (Protein Kinase Inhibitors) RN - DA87705X9K (Erlotinib Hydrochloride) RN - EC 2.7.10.1 (EGFR protein, human) RN - EC 2.7.10.1 (ErbB Receptors) RN - S65743JHBS (Gefitinib) SB - IM MH - Adult MH - Aged MH - Carcinoma, Non-Small-Cell Lung/genetics/mortality/pathology/*therapy MH - Chemoradiotherapy/adverse effects/*methods MH - Dose Fractionation, Radiation MH - ErbB Receptors/antagonists & inhibitors/genetics MH - Erlotinib Hydrochloride/administration & dosage/adverse effects MH - Exanthema/drug therapy/epidemiology/etiology MH - Female MH - Follow-Up Studies MH - Gefitinib/administration & dosage/adverse effects MH - Glucocorticoids/therapeutic use MH - Humans MH - Lung Neoplasms/genetics/mortality/pathology/*therapy MH - Male MH - Middle Aged MH - Neoplasm Recurrence, Local MH - Neoplasm Staging MH - Pneumonia/drug therapy/epidemiology/etiology MH - Progression-Free Survival MH - Protein Kinase Inhibitors/*administration & dosage/adverse effects MH - Radiation Injuries/drug therapy/*epidemiology/etiology PMC - PMC6693693 EDAT- 2019/05/02 06:00 MHDA- 2020/07/25 06:00 PMCR- 2019/04/30 CRDT- 2019/05/02 06:00 PHST- 2018/11/18 00:00 [received] PHST- 2019/04/06 00:00 [accepted] PHST- 2019/05/02 06:00 [pubmed] PHST- 2020/07/25 06:00 [medline] PHST- 2019/05/02 06:00 [entrez] PHST- 2019/04/30 00:00 [pmc-release] AID - theoncologist.2019-0285 [pii] AID - ONCO12964 [pii] AID - 10.1634/theoncologist.2019-0285 [doi] PST - ppublish SO - Oncologist. 2019 Aug;24(8):1031-e612. doi: 10.1634/theoncologist.2019-0285. Epub 2019 Apr 30.