Overall survival of patients with CLL treated with ibrutinib in the first line compared to second-line ibrutinib after chemotherapy/chemoimmunotherapy
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu srovnávací studie, časopisecké články
- Klíčová slova
- Chronic lymphocytic leukemia, ibrutinib, overall survival, real-world data, treatment sequencing, trial emulation,
- MeSH
- adenin * analogy a deriváty terapeutické užití MeSH
- chronická lymfatická leukemie * farmakoterapie mortalita MeSH
- imunoterapie metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- míra přežití MeSH
- piperidiny * terapeutické užití aplikace a dávkování MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití aplikace a dávkování MeSH
- pyrazoly * terapeutické užití aplikace a dávkování MeSH
- pyrimidiny * terapeutické užití aplikace a dávkování MeSH
- randomizované kontrolované studie jako téma MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
- Názvy látek
- adenin * MeSH
- ibrutinib MeSH Prohlížeč
- piperidiny * MeSH
- pyrazoly * MeSH
- pyrimidiny * MeSH
OBJECTIVE: To evaluate the overall survival (OS) of patients with chronic lymphocytic leukemia (CLL) receiving either ibrutinib monotherapy as a first-line (1L) treatment or chemotherapy/chemoimmunotherapy-based (CT/CIT) regimens in 1L followed by ibrutinib in the second line (1L CT/CIT-2L ibrutinib) after disease progression by emulating a randomized trial comparing both treatment sequences. METHODS: Patient-level data from the RESONATE-2 trial (NCT01722487) and real-world PHEDRA databases were analyzed. Three scenarios were considered using the following data sources: (1) RESONATE-2, (2) combined RESONATE-2/PHEDRA, (3) combined RESONATE-2/PHEDRA for 1L ibrutinib and PHEDRA for 1L CT/CIT-2L ibrutinib. Propensity score-based weights and inverse probability of censoring weighting were used to adjust for baseline (Scenarios 2 and 3) and time-dependent confounding (all scenarios), and to address potential biases. A weighted Cox proportional hazards model was used to estimate the OS hazard ratio (HR) and 95% confidence interval (CI) for 1L ibrutinib versus 1L CT/CIT-2L ibrutinib. RESULTS: Results from Scenario 1 showed a significantly lower risk of death with 1L ibrutinib compared with 1L chlorambucil followed by 2L ibrutinib (HR 0.35 [95% CI 0.20-0.62]). Results from Scenarios 2 and 3 demonstrated a reduced risk of death with 1L ibrutinib compared with 1L CT/CIT-2L ibrutinib (HR 0.35 [0.21-0.61] and 0.64 [0.39-1.04], respectively). CONCLUSION: The analyses consistently showed a reduced risk of death when ibrutinib was used as a 1L treatment in CLL compared with delaying its use until 2L after CT/CIT regimens, which suggests that initiating ibrutinib in 1L is advantageous for improving survival outcomes.
Department of Hematology Hôpital Lyon Sud Lyon France
Department of Hematology Medical University of Lodz Copernicus Memorial Hospital Lodz Poland
Internal Medicine Hematology and Oncology Department University Hospital Brno Brno Czech Republic
Janssen Cilag GmbH Neuss Germany
Janssen Pharmaceutica NV Beerse Belgium
Janssen Sciences Ireland UC Cork Ireland
Citace poskytuje Crossref.org
