PMID- 31802944 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220411 IS - 1179-1322 (Print) IS - 1179-1322 (Electronic) IS - 1179-1322 (Linking) VI - 11 DP - 2019 TI - Real-World Data Of Osimertinib In Patients With Pretreated Non-Small Cell Lung Cancer: A Retrospective Study. PG - 9243-9251 LID - 10.2147/CMAR.S221434 [doi] AB - PURPOSE: Osimertinib is an oral, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeted for both EGFR sensitizing mutations and T790M resistance mutation in patients with non-small-cell lung cancer (NSCLC). We assessed efficacy and safety of osimertinib in patients with pretreated NSCLC in a real-world setting. PATIENTS AND METHODS: Ninety-four patients with advanced NSCLC who received osimertinib after progression of prior EGFR-TKIs or chemotherapy treatments were retrospectively collected. RESULTS: In patients evaluable for response analysis (n = 91), overall objective response rate (ORR) was 47.3%, and disease control rate (DCR) was 90.1%. Median duration of response (DoR) in responding patients was 12.5 months (95% confidence interval [CI], 10.7 to 14.3). Median progression-free survival (PFS) was 8.5 months (95% CI, 7.4 to 9.6) in 2nd line group, 9.1 months (95% CI, 6.6 to 11.6) in >/=3rd line group, and 8.6 months (95% CI, 7.2 to 10.0) in overall population. For subgroup analysis, DCR and median PFS were 91.9% and 8.6 months (95% CI, 7.2 to 10.0) in patients with detectable T790M mutation, respectively, while 80.0% and 3.2 months (95% CI, 0.5 to 5.9) for those without. Median PFS was significantly longer for T790M-positive patients co-occurring with exon19del than with L858R (17.9 months vs 7.3 months; P<0.001). Among 45 patients with metastases to the central nervous system (CNS), median systemic PFS was 8.8 months (95% CI, 6.9 to 10.7), while intracranial time to progression (iTTP) was not reached. Safety profile was acceptable, no adverse events (AEs) related deaths was observed. CONCLUSION: Osimertinib was highly active in patients with pretreated advanced NSCLC who harbored EGFR T790M mutation, with manageable side-effects. CI - (c) 2019 Mu et al. FAU - Mu, Yuxin AU - Mu Y AD - National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. FAU - Xing, Puyuan AU - Xing P AD - National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. FAU - Hao, Xuezhi AU - Hao X AD - National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. FAU - Wang, Yan AU - Wang Y AD - National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. FAU - Li, Junling AU - Li J AD - National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. LA - eng PT - Journal Article DEP - 20191030 PL - New Zealand TA - Cancer Manag Res JT - Cancer management and research JID - 101512700 PMC - PMC6826191 OTO - NOTNLM OT - efficacy OT - non-small-cell lung cancer OT - osimertinib OT - safety COIS- The authors report no conflicts of interest in this work. EDAT- 2019/12/06 06:00 MHDA- 2019/12/06 06:01 PMCR- 2019/10/30 CRDT- 2019/12/06 06:00 PHST- 2019/07/02 00:00 [received] PHST- 2019/10/10 00:00 [accepted] PHST- 2019/12/06 06:00 [entrez] PHST- 2019/12/06 06:00 [pubmed] PHST- 2019/12/06 06:01 [medline] PHST- 2019/10/30 00:00 [pmc-release] AID - 221434 [pii] AID - 10.2147/CMAR.S221434 [doi] PST - epublish SO - Cancer Manag Res. 2019 Oct 30;11:9243-9251. doi: 10.2147/CMAR.S221434. eCollection 2019.