PMID- 30613959 OWN - NLM STAT- MEDLINE DCOM- 20191028 LR - 20220603 IS - 1097-0215 (Electronic) IS - 0020-7136 (Print) IS - 0020-7136 (Linking) VI - 145 IP - 1 DP - 2019 Jul 1 TI - Efficacy and safety of osimertinib in treating EGFR-mutated advanced NSCLC: A meta-analysis. PG - 284-294 LID - 10.1002/ijc.32097 [doi] AB - Osimertinib is the only Food and Drug Administration-approved third-generation epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI). A meta-analysis was performed to aggregate the mixed results of published clinical trials to assess the efficacy and safety of osimertinib. A systematic search of the PubMed, Web of Science, and Cochrane Library electronic databases was performed to identify eligible literature. The primary endpoints were overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and adverse events (AEs). A total of 3,086 advanced nonsmall cell lung cancer (NSCLC) patients from 11 studies have been identified. The aggregate efficacy parameters for treatment-naive patients with EGFR-TKI-sensitizing mutations are as follows: ORR 79% (95% CI 75-84%), DCR 97% (95% CI 95-99%), 6-month PFS 83% (95% CI 80-87%), and 12-month PFS 64% (95% CI 59-69%). The aggregate efficacy parameters for advanced NSCLC harboring T790M mutations after earlier-generation EGFR-TKI therapy are as follows: ORR 58% (95% CI 46-71%), DCR 80% (95% CI 63-98%), 6-month PFS 63% (95% CI 58-69%), and 12-month PFS 32% (95% CI 17-47%). EGFR-TKI-naive patients with EGFR-positive mutations tend to have longer median PFS than EGFR-TKI-pretreated counterparts (19.17 vs. 10.58 months). The most common AEs were diarrhea and rash, of which the pooled incidences were 44 and 42%, respectively. Generally, osimertinib is a favorable treatment option for previously treated T790M mutation-positive advanced NSCLC as well as a preferable therapy for untreated EGFR mutation-positive advanced NSCLC. Additionally, osimertinib is well tolerated by most patients. CI - (c) 2019 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC. FAU - Yi, Lilan AU - Yi L AD - Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China. FAU - Fan, Junsheng AU - Fan J AD - Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China. AD - Department of Respiratory Medicine, Shanghai Tenth People's Hospital, Tongji University, Shanghai, People's Republic of China. FAU - Qian, Ruolan AU - Qian R AD - Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China. FAU - Luo, Peng AU - Luo P AUID- ORCID: 0000-0002-8215-2045 AD - Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China. FAU - Zhang, Jian AU - Zhang J AUID- ORCID: 0000-0001-7217-0111 AD - Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, People's Republic of China. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20190120 PL - United States TA - Int J Cancer JT - International journal of cancer JID - 0042124 RN - 0 (Acrylamides) RN - 0 (Aniline Compounds) RN - 0 (Antineoplastic Agents) RN - 0 (Protein Kinase Inhibitors) RN - 3C06JJ0Z2O (osimertinib) RN - EC 2.7.10.1 (EGFR protein, human) RN - EC 2.7.10.1 (ErbB Receptors) SB - IM CIN - Int J Cancer. 2019 Oct 1;145(7):2006-2007. PMID: 31074838 CIN - Int J Cancer. 2019 Oct 1;145(7):2003-2005. PMID: 31081942 MH - Acrylamides/adverse effects/pharmacology/*therapeutic use MH - Aniline Compounds/adverse effects/pharmacology/*therapeutic use MH - Animals MH - Antineoplastic Agents/adverse effects/pharmacology/therapeutic use MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/enzymology/genetics MH - ErbB Receptors/genetics MH - Humans MH - Lung Neoplasms/*drug therapy/enzymology/genetics MH - *Mutation MH - Protein Kinase Inhibitors/adverse effects/pharmacology/therapeutic use MH - Randomized Controlled Trials as Topic PMC - PMC6590181 OTO - NOTNLM OT - EGFR OT - T790M OT - meta-analysis OT - nonsmall cell lung cancer OT - osimertinib EDAT- 2019/01/08 06:00 MHDA- 2019/10/29 06:00 PMCR- 2019/06/24 CRDT- 2019/01/08 06:00 PHST- 2018/10/23 00:00 [received] PHST- 2018/11/22 00:00 [revised] PHST- 2018/12/12 00:00 [accepted] PHST- 2019/01/08 06:00 [pubmed] PHST- 2019/10/29 06:00 [medline] PHST- 2019/01/08 06:00 [entrez] PHST- 2019/06/24 00:00 [pmc-release] AID - IJC32097 [pii] AID - 10.1002/ijc.32097 [doi] PST - ppublish SO - Int J Cancer. 2019 Jul 1;145(1):284-294. doi: 10.1002/ijc.32097. Epub 2019 Jan 20.