Real-world effectiveness and safety of fixed-duration frontline venetoclax–obinutuzumab for chronic lymphocytic leukemia: A nationwide multicenter retrospective cohort study
Leukemia Research, cilt.171, 2026 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 171
- Basım Tarihi: 2026
- Doi Numarası: 10.1016/j.leukres.2026.108342
- Dergi Adı: Leukemia Research
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, EMBASE, MEDLINE
- Anahtar Kelimeler: Chronic lymphocytic leukemia, Frontline treatment, Obinutuzumab, Progression-free survival, Real-world evidence, Venetoclax
- Ankara Üniversitesi Adresli: Evet
Özet
Background/Aims Fixed-duration venetoclax–obinutuzumab (Ven-Obi) is a standard frontline treatment for chronic lymphocytic leukemia (CLL), but nationwide real-world data from outside Western Europe and North America remain limited. We evaluated its effectiveness and safety in routine practice in Türkiye. Materials and Methods This retrospective study included 105 treatment-naive CLL patients receiving first-line Ven-Obi across 20 Turkish hematology centers. Response was assessed by investigators at 12 months; progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan–Meier method. Results Median age at treatment was 64 years; only 34.3% met CLL14 fitness criteria. High-risk features were common (unmutated IGHV 65.6%, TP53 mutation 18.0%, del(17p) 15.1%). Ninety-six patients (91.4%) completed 12 months of venetoclax. The overall response rate was 97.9% (investigator-assessed clinical complete response, 94.8%). With a median follow-up of 18.4 months, 24-month PFS and OS were 88.3% and 88.7%. Neutropenia (45.7%) was the most common adverse event; tumor lysis syndrome occurred in 17.1% (clinical, 1.9%), all during obinutuzumab administration. Five of 10 deaths occurred within four months, mostly in patients with ECOG performance status 2. ECOG ≥ 2 was associated with inferior OS in univariate analysis (HR, 4.50; p = 0.021), but not after exploratory adjustment for TLS risk (HR, 3.52; p = 0.079). Conclusion Frontline Ven-Obi achieved high response rates and encouraging early survival in a population younger and less comorbid than that of CLL14. Early deaths in patients with poor performance status highlight the need for careful selection and supportive care.