The real-life efficacy and safety of osimertinib in pretreated advanced non-small cell lung cancer patients with T790M mutation: a Turkish Oncology Group Study

• DOI: 10.1007/s00432-021-03748-7
• Publication Date: 2021-07-31T05:02:48Z
• Authors: Mutlu Hizal; Burak Bilgin; Nail Paksoy; Özgür Açıkgöz; Ahmet Sezer; Mustafa Gürbüz; Naziye Ak; Şebnem Yücel; Murat Ayhan; Cihan Erol; Aykut Demirkıran; Nil Molinas Mandel; Abdallah Shbair; İvo Gökmen; Tuğba Başoğlu; Semra Paydaş; Atike Gökçen Demiray; Yakup İriağaç; Teoman Şakalar; Esra Zeynelgil; Ali Murat Tatlı; Aykut Bahçeci; Deniz Can Güven; Burcu Caner; Alper Can; Ahmet Gülmez; Yusuf Karakaş; Bülent Yalçın; Ahmet Demirkazık; Ahmet Bilici; Adnan Aydıner; Perran Fulden Yumuk; Mehmet Ali Nahit ...
• Keywords: erlotinib; cancer patient; drug safety; Lung Neoplasms; Turkey; time to treatment; retrospective study; Non-small Cell Lung Cancer; afatinib; gefitinib; diarrhea; T790M; 0302 clinical medicine; Non-small cell lung cancer; Carcinoma, Non-Small-Cell Lung; advanced cancer; brain metastasis; exon; gene mutation; acrylamide derivative; cancer survival; Second Line; circulating tumor DNA; Aniline Compounds; protein kinase inhibitor; adult; treatment withdrawal; clinical trial; unclassified drug; 3. Good health; ErbB Receptors; female; aniline derivative; overall survival; EGFR; adverse drug reaction; 610; Article; Time; 03 medical and health sciences; male; follow up; pneumonia; Chemotherapy; Humans; controlled study; human; t790m protein; decreased appetite; Protein Kinase Inhibitors; Retrospective Studies; Second line; Acrylamides; non small cell lung cancer; Program; Egfr; treatment response; major clinical study; skin toxicity; clinical feature; Non-Small Cell Lung Cancer; drug efficacy; multicenter study; Mutation; fatigue; Therapy; epidermal growth factor receptor; protein; Osimertinib

Abstract Introduction: Osimertinib, an irreversible third-generation EGFR-TKI, is the standard of care for second-line treatment of T790M-mutant advanced NSCLC patients whose progressed after first-line EGFR-TKI therapy. In this multicenter study, we aimed to determine the real-life efficacy and safety of Osimertinib in pretreated advanced NSCLC patients with T790M mutation.Materials and Methods: This retrospective trial included advanced T790M-mutant pretreated NSCLC patients who received Osimertinib from 24 different centers in Turkey. Primary endpoint was time-to-treatment discontinuation (TTD). Secondary endpoints were objective response rate (ORR), overall survival (OS), and safety.Results: Of 163 patients 68.7% had EGFR exon 19 deletion and 22.7% had exon 21 L858R mutation. Osimertinib was given as second-line treatment in 96 patients (58.9%) and third-line in 48 patients (29.4%). After median of 13 months disease follow-up, median TTD was 21.6 months with an 82.2% ORR. Estimated median OS was 32.1 months. Grade 3-4 adverse events were seen in 11.7% of the patients. Conclusion: Osimertinib is a highly effective option in second or third-line treatment of NSCLC patients with T790M mutation, with a favorable safety profile.