The real-life efficacy and safety of osimertinib in pretreated advanced

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 disease 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-month 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.

C1 [Hizal, Mutlu] Ankara City Hosp, Dept Med Oncol, Ankara, Turkey.

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[Paksoy, Nail; Aydiner, Adnan] Istanbul Univ, Dept Med Oncol, Istanbul Fac Med, Istanbul, Turkey.

[Acikgoz, Ozgur; Bilici, Ahmet] Medipol Univ, Dept Med Oncol, Fac Med, Istanbul, Turkey.

[Sezer, Ahmet] Baskent Univ, Dept Med Oncol, Fac Med, Adana, Turkey.

[Gurbuz, Mustafa; Demirkazik, Ahmet] Ankara Univ, Dept Med Oncol, Fac Med, Ankara, Turkey.

[Ak, Naziye] Yozgat City Hosp, Dept Med Oncol, Yozgat, Turkey.

[Ayhan, Murat] Kartal Lutfi Kirdar City Hosp, Dept Med Oncol, Istanbul, Turkey.

[Erol, Cihan; Yalcin, Bulent; Sendur, Mehmet Ali Nahit] Yildirim Beyazit Univ, Dept Med Oncol, Fac Med, Ankara, Turkey.

[Demirkiran, Aykut] Necmeddin Erbakan Univ, Meram Fac Med, Dept Med Oncol, Konya, Turkey.

[Mandel, Nil Molinas] Amer Hosp, Dept Med Oncol, Istanbul, Turkey.

[Shbair, Abdallah] Bezmialem Univ, Dept Med Oncol, Fac Med, Istanbul, Turkey.

[Gokmen, Ivo] Trakya Univ, Dept Med Oncol, Fac Med, Edirne, Turkey.

[Basoglu, Tugba; Yumuk, Perran Fulden] Marmara Univ, Div Med Oncol, Sch Med, Istanbul, Turkey.

[Paydas, Semra] Cukurova Univ, Dept Med Oncol, Fac Med, Adana, Turkey.

[Demiray, Atike Gokcen] Pamukkale Univ, Dept Med Oncol, Fac Med, Denizli, Turkey.

[Iriagac, Yakup] Namik Kemal Univ, Dept Med Oncol, Fac Med, Tekirdag, Turkey.

[Sakalar, Teoman] Necip Fazil City Hosp, Dept Med Oncol, Kahramanmaras, Turkey.

[Zeynelgil, Esra] Diskapi Educ & Res Hosp, Dept Med Oncol, Ankara, Turkey.

[Tatli, Ali Murat] Akdeniz Univ, Dept Med Oncol, Fac Med, Antalya, Turkey.

[Bahceci, Aykut] Ersin Arslan Educ & Res Hosp, Dept Med Oncol, Gaziantep, Turkey.

[Guven, Deniz Can] Hacettepe Univ, Dept Med Oncol, Fac Med, Ankara, Turkey.

[Caner, Burcu] Uludag Univ, Dept Med Oncol, Fac Med, Bursa, Turkey.

[Can, Alper] Istinye Univ, Dept Med Oncol, Fac Med, Istanbul, Turkey.

[Gulmez, Ahmet] Inonu Univ, Dept Med Oncol, Fac Med, Malatya, Turkey.

[Karakas, Yusuf] Bodrum Acibadem Hosp, Dept Med Oncol, Mugla, Turkey.