作者
Seval Akpınar,Mehmet Hilmi Doğu,Serhat Çelik,Ömer Ekinci,İpek Yönal Hindilerden,Mehmet Sinan Dal,Eren Arslan Davulcu,Atakan Tekinalp,Fehmi Hindilerden,Busra Gokce Ozcan,Tuba Hacıbekiroğlu,Mehmet Ali Erkurt,Metin Bağcı,Sinem Namdaroğlu,Gülten Korkmaz,Oktay Bilgir,Gülsüm Akgün Çağlıyan,Hacer Berna Afacan Öztürk,İstemi Serin,Tarık Onur Tiryaki,Düzgün Özatlı,Serdal Korkmaz,Turgay Ulaş,Bülent Eser,Burhan Turgut,Fevzi Altuntaş
摘要
The emergence of novel agents targeting the B-cell receptor pathway and BCL-2 has significantly changed the therapeutic landscape of CLL. We evaluated the safety and efficacy of single-agent ibrutinib in relapsed/refractory CLL in real-world settings.A total of 200 relapsed/refractory CLL patients with a median age of 68 were included in this retrospective, multicenter, non-interventional study. Data of the study were captured from the patient charts of the participating centers.The median for lines of previous chemotherapy was 2 (1-6); 62 (31.8%) patients had del17p and/or p53 mutations (del17p+/p53mut). Of the study group, 146 (75%) patients achieved at least PR, while 16 (8.7%) patients discontinued ibrutinib due to TEA. The most common drug-related adverse events were neutropenia (n: 31; 17.4%) and thrombocytopenia (n: 40; 22.3%), which were ≥ grade 3 in 9 (5%) and 5 (3.9%) patients, respectively. Pneumonia (n: 42; 23.7%) was the most common nonhematologic TEA. Atrial fibrillation (n: 5; 2.8%) and bleeding (n: 11; 6.3%) were relatively rare during the study period. Within a median follow-up period of 17 (1-74) months, 42 (21%) patients died. The estimated median OS of the study cohort was 52 months. Only the response to ibrutinib (CR/PR vs. SD/PD) was significantly associated with OS.Our results indicate good safety and efficacy for single-agent ibrutinib in R/R CLL in daily practice.