Browsing by Author "Davulcu, EA"

Now showing 1 - 4 of 4
  • No Thumbnail Available
    Item
    The Real-World Experience With Single Agent Ibrutinib in Relapsed/Refractory CLL
    Akpinar, S; Dogu, MH; Celik, S; Ekinci, O; Hindilerden, IY; Dal, MS; Davulcu, EA; Tekinalp, A; Hindilerden, F; Ozcan, BG; Hacibekiroglu, T; Erkurt, MA; Bagci, M; Namdaroglu, S; Korkmaz, G; Bilgir, O; Cagliyan, GA; Ozturk, HBA; Serin, I; Tiryaki, TO; Ozatli, D; Korkmaz, S; Ulas, T; Eser, B; Turgut, B; Altuntas, F
    We evaluated the safety and efficacy of single-agent ibrutinib in 200 patients presenting with relapsed/refractory CLL in real-world settings. With an estimated median OS of 52 months, 146 patients (75%) achieved at least PR; 16 (8.7%) patients discontinued ibrutinib due to adverse events. The results indicate good safety and efficacy for single-agent ibrutinib in R/R CLL in daily practice. Introduction/Background: 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. Patients/Methods: 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 par ticipating centers. Results: 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. Atr ial fibrillation (n: 5; 2.8%) and bleeding (n: 11; 6.3%) were relatively rare dur ing 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. Conclusion: Our results indicate good safety and efficacy for single-agent ibrutinib in R/R CLL in daily practice. (C) 2021 Elsevier Inc. All rights reserved.
  • No Thumbnail Available
    Item
    Acquired Hemophilia A In Adults: A Multicenter Study from Turkey
    Davulcu, EA; Demirci, Z; Yilmaz, U; Ar, MC; Teke, HÜ; Karakus, V; Çiftçiler, R; Selim, C; Yavasoglu, I; Durusoy, SS; Okan, V; Akdeniz, A; Yolcu, A; Aydogdu, I; Güney, T; Yilmaz, AF; Sahin, F
    Acquired hemophilia A (AHA) is a rare disease caused by autoantibodies inhibiting factor VIII (FVIII) activity. Although the conditionis usually idiopathic, there may be other underlying diseases. Treatment consists of two steps: treatment of acute bleeding and immunosuppression. In this multicenter study, we aimed to demonstrate the clinical characteristics, management details, and survival of AHA patients in Turkey. Data was collected from eleven centers in Turkey. aPTT, FVIII, FVIII inhibitor, and hemoglobin (HB) levels, mixing test results, and demographics at diagnosis, treatment information, adverse events, bleeding episodes during follow-up, relapses, and outcome were analyzed. Twenty-nine patients were analyzed (58.6% female). No underlying disorder could be detected in 14 patients. The most prevalent etiologies were pregnancy, malignancy and infections. The median FVIII activity and FVIII inhibitor titer at diagnosis were 0.7% (0.0-29.4%) and 32.6 BU (0.6-135.6 BU) respectively. Bleeding was severe in 44.8% of patients. The HB value was significantly lower in patients with severe bleeding. Most of the patients (n = 25, 86.2%) had only one bleeding episode without relapse, three patients (10.3%) had two bleeding episodes, and one patient had more than three bleedings. 21 (75%) patients received hemostatic therapy. The use of recombinant FVIIa was slightly higher than activated prothrombin complex concentrate (15 versus 10 patients). Immunosuppressive treatment was initiated in 26 (93%) patients. Regimens containing steroid, cyclophosphamide, and rituximab in different combinations were the most preferred. The median follow-up period was 13 months (2-156 months). Median overall survival was 154.97 months. Four and six-year survival were 90.9 +/- 0.8% and 77.9 +/- 14.1% respectively. This is a unique study that investigated the demographic characteristics, treatment approaches, and patient survival of AHA in Turkey.
  • No Thumbnail Available
    Item
    Efficacy and Safety of Ibrutinib Use in Patients with Chronic Lymphocytic Leukemia in Real World Experiences: Results of a Prospective Multicenter Study
    Tombak, A; Tanrikulu, FP; Durusoy, SS; Gurkan, E; Kaya, E; Umit, EG; Yavasoglu, I; Mehtap, O; Deveci, B; Ozcan, MA; Terzi, H; Okay, M; Sayinalp, N; Yilmaz, M; Okan, V; Kizikli, A; Ozcan, O; Cetin, G; Demircioglu, S; Aydogdu, I; Saydam, G; Davulcu, EA; Ilhan, G; Ucar, MA; Ozet, G; Akpinar, S; Turgut, B; Berber, I; Kurtoglu, E; Sonmez, M; Batur, DS; Yildirim, R; Ozkocaman, V; Gunes, AK; Sahip, B; Ertop, S; Akay, M; Basturk, A; Dogu, MH; Akdeniz, A; Unal, A; Seyhanli, A; Ferhanoglu, B
  • No Thumbnail Available
    Item
    Efficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia: Retrospective Analysis of Real-Life Data
    Tombak, A; Tanrikulu, FP; Durusoy, SS; Dinçyürek, HD; Kaya, E; Ümit, EG; Yavasoglu, I; Mehtap, Ö; Deveci, B; Özcan, MA; Terzi, H; Okay, M; Sayinalp, N; Yilmaz, M; Okan, V; Kizikli, A; Özcan, Ö; Çetin, G; Demircioglu, S; Aydogdu, I; Saydam, G; Davulcu, EA; Ilhan, G; Uçar, MA; Özet, G; Akpinar, S; Turgut, B; Berber, I; Kurtoglu, E; Sönmez, M; Batur, DS; Yildirim, R; Özkocamaz, V; Günes, AK; Sahip, B; Ertop, S; Akay, OM; Bastürk, A; Dogu, MH; Akdeniz, A; Ünal, A; Seyhanli, A; Gürkan, E; Çekdemir, D; Ferhanoglu, B
    Objective: This study aimed to retrospectively evaluate the efficacy, safety, and survival outcome of single-agent ibrutinib therapy in chronic lymphocytic leukemia patients. Materials and Methods: A total of 136 patients (mean age +/- standard deviation: 64.6 +/- 10.3 years, 66.9% males) who had received at least one dose of ibrutinib were included in this retrospective multicenter, noninterventional hospital-registry study conducted at 33 centers across Turkey. Data on patient demographics, baseline characteristics, laboratory findings, and leukemia-cell cytogenetics were retrieved. Treatment response, survival outcome including overall survival (OS) and progression-free survival (PFS), and safety data were analyzed. Results: Overall, 36.7% of patients were categorized as Eastern Cooperative Oncology Group (ECOG) class 2-3, while 44.9% were in Rai stage 4. Fluorescence in situ hybridization revealed the presence of del(17p) in 39.8% of the patients. Patients received a median of 2.0 (range: 0-7) lines of pre-ibrutinib therapy. Median duration of therapy was 8.8 months (range: 0.4-58.0 months). The 1-year PFS and OS rates were 82.2% and 84.6%, respectively, while median PFS time was 30.0 (standard error, 95% confidence interval: 5.1, 20.0-40.0) months and median OS time was 37.9 (3.2, 31.5-44.2) months. Treatment response (complete or partial response), PFS time, and OS time were better with 0-2 lines versus 3-7 lines of prior therapy (p<0.001, p=0.001, and p<0.001, respectively), with ECOG class 0-1 versus class 2-3 (p=0.006, p=0.011, and p=0.001, respectively), and with Rai stage 0-2 versus 3-4 (p=0.002, p=0.001, and p=0.002, respectively). No significant difference was noted in treatment response rates or survival outcome with respect to the presence of comorbidity, bulky disease, or del(17p). While 176 adverse events (AEs) were reported in 74 (54.4%) patients, 46 of those 176 AEs were grade 3-4, including pneumonia (n=12), neutropenia (n=11), anemia (n=5), thrombocytopenia (n=5), and fever (n=5). Conclusion: This real-life analysis confirms the favorable efficacy and safety profile of long-term ibrutinib treatment while emphasizing the potential adverse impacts of poorer ECOG performance status, heavy treatment prior to ibrutinib, and advanced Rai stage on patient compliance, treatment response, and survival outcomes.