Critical reviews in oncology/hematology · 2026
Systematic review of real-world data on the effectiveness and safety profiles of first-line therapies in chronic lymphocytic leukemia.
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Stożek-Tutro Anita, Małowicka Monika, Janiszewska Klaudia, Kawalec Paweł
Аннотация
OBJECTIVE: To assess the real-world effectiveness of first-line targeted therapies (1LTT) for chronic lymphocytic leukemia (CLL) and compare these outcomes with those reported in randomized controlled trials (RCT).
METHODS: A systematic review of MEDLINE and EMBASE was conducted to identify real-world data (RWD). Key endpoints included progression-free survival (PFS), overall survival (OS), time-to-next treatment (TTNT), and treatment discontinuation due to adverse events (TdAE). CRD42024549185.
RESULTS: Ibrutinib (IBR) demonstrated consistent effectiveness in multiple RWD studies, with 12- and 24-month OS rates of 87-100% and 78-100%, respectively, and PFS rates of 76-94% and 68-94%, respectively, aligning with the results of the RESONATE-2 trial. Zanubrutinib (ZAN) showed a 36-month OS rate of 92% and a PFS rate of 84%, consistent with the outcomes of the SEQUOIA trial. For acalabrutinib (ACA), 12- and 24-month OS was 86-94% and 76-88%, PFS 92% and 81%, respectively, in line with the ELEVATE-TN trial, similarly, for venetoclax+obinutuzumab (VEN+OBI), 12-and 24-month OS was 94% and 86-94%, PFS 94% and 88%-92%, consistent with the CLL14 trial results. In contrast, idelalisib+rituximab (IDE+RTX) was associated with lower 24-month OS (77%), PFS (68%), and the highest TdAE rate (63%).
CONCLUSIONS: Among 1LTT for CLL, IBR has the most extensive and consistent RWD, with results mirroring RCT outcomes. ZAN, ACA and VEN+OBI show promising results based on RWD, however, these data are less extensive but consistent with RCT outcomes. Findings highlight the value of RWD and the need for more robust data on newer agents.
METHODS: A systematic review of MEDLINE and EMBASE was conducted to identify real-world data (RWD). Key endpoints included progression-free survival (PFS), overall survival (OS), time-to-next treatment (TTNT), and treatment discontinuation due to adverse events (TdAE). CRD42024549185.
RESULTS: Ibrutinib (IBR) demonstrated consistent effectiveness in multiple RWD studies, with 12- and 24-month OS rates of 87-100% and 78-100%, respectively, and PFS rates of 76-94% and 68-94%, respectively, aligning with the results of the RESONATE-2 trial. Zanubrutinib (ZAN) showed a 36-month OS rate of 92% and a PFS rate of 84%, consistent with the outcomes of the SEQUOIA trial. For acalabrutinib (ACA), 12- and 24-month OS was 86-94% and 76-88%, PFS 92% and 81%, respectively, in line with the ELEVATE-TN trial, similarly, for venetoclax+obinutuzumab (VEN+OBI), 12-and 24-month OS was 94% and 86-94%, PFS 94% and 88%-92%, consistent with the CLL14 trial results. In contrast, idelalisib+rituximab (IDE+RTX) was associated with lower 24-month OS (77%), PFS (68%), and the highest TdAE rate (63%).
CONCLUSIONS: Among 1LTT for CLL, IBR has the most extensive and consistent RWD, with results mirroring RCT outcomes. ZAN, ACA and VEN+OBI show promising results based on RWD, however, these data are less extensive but consistent with RCT outcomes. Findings highlight the value of RWD and the need for more robust data on newer agents.