Outcomes of second-line treatment in chronic lymphocytic leukemia – a population-based study from a well defined geographical region between 2003 and 2013
“…An additional phase 2 trial explored ibrutinib in a cohort of patients with del(17p)/ TP53 mutation with an ORR of 83% [ 12 ]. These data have been largely confirmed in two real-world setting studies performed in Sweden [ 13 ] and the UK/Ireland [ 14 ] but with significantly shorter PFS and OS among patients with del(17p) or TP53 mutation in the Swedish study.…”
Section: Introductionsupporting
confidence: 56%
“…The study included two patient cohorts: an observational, historical, but strictly defined real-world cohort (subsequently referred to as the “Stockholm cohort”) [ 13 ] and a trial cohort from the RESONATE study (the RESONATE cohort) [ 11 ].…”
Section: Methodsmentioning
confidence: 99%
“…These patients receive treatment and life-long follow-up in the region in which they are diagnosed. Therefore, comprehensive, consecutive records providing almost 100% coverage are available for these patients [ 13 ]. Patients included in the study originated from five facilities within the region: Karolinska University Hospital Solna, Karolinska University Hospital Huddinge, Danderyd Hospital, Södersjukhuset and Visby Hospital.…”
Section: Methodsmentioning
confidence: 99%
“…Patient-level data for the Stockholm cohort were obtained from an extended comprehensive retrospective review of patient files identified in the registry [ 13 ]. A total of 148 patients with relapsed or refractory CLL were identified, and their files were subject to an in-depth analysis from diagnosis until last treatment line or current line of treatment at last follow-up.…”
Section: Methodsmentioning
confidence: 99%
“…The main objective of this study was to estimate the relative efficacy of ibrutinib versus previous standard-of-care treatments used in routine healthcare as used in the RESONATE trial in previously treated CLL patients. This estimate is based on a comparison of patient-level data from two different sources: the phase 3 RESONATE study and a retrospective, observational cohort of strictly consecutive patients from a well-defined geographical region [ 13 ]. By using this patient sample, this study aims to minimise these issues as it utilised a well-defined cohort of consecutive patients with almost complete follow-up from the Stockholm region of Sweden with absence of external referrals and controlled for baseline prognostic factors.…”
This study explored the relative efficacy of ibrutinib versus previous standard-of-care treatments in relapsed/refractory patients with chronic lymphocytic leukaemia (CLL), using multivariate regression modelling to adjust for baseline prognostic factors. Individual patient data were collected from an observational Stockholm cohort of consecutive patients (n = 144) diagnosed with CLL between 2002 and 2013 who had received at least second-line treatment. Data were compared with results of the RESONATE clinical trial. A multivariate Cox proportional hazards regression model was used which estimated the hazard ratio (HR) of ibrutinib versus previous standard of care. The adjusted HR of ibrutinib versus the previous standard-of-care cohort was 0.15 (p < 0.0001) for progression-free survival (PFS) and 0.36 (p < 0.0001) for overall survival (OS). A similar difference was observed also when patients treated late in the period (2012-) were compared separately. Multivariate analysis showed that later line of therapy, male gender, older age and poor performance status were significant independent risk factors for worse PFS and OS. Our results suggest that PFS and OS with ibrutinib in the RESONATE study were significantly longer than with previous standard-of-care regimens used in second or later lines in routine healthcare. The approach used, which must be interpreted with caution, compares patient-level data from a clinical trial with outcomes observed in a daily clinical practice and may complement results from randomised trials or provide preliminary wider comparative information until phase 3 data exist.
“…An additional phase 2 trial explored ibrutinib in a cohort of patients with del(17p)/ TP53 mutation with an ORR of 83% [ 12 ]. These data have been largely confirmed in two real-world setting studies performed in Sweden [ 13 ] and the UK/Ireland [ 14 ] but with significantly shorter PFS and OS among patients with del(17p) or TP53 mutation in the Swedish study.…”
Section: Introductionsupporting
confidence: 56%
“…The study included two patient cohorts: an observational, historical, but strictly defined real-world cohort (subsequently referred to as the “Stockholm cohort”) [ 13 ] and a trial cohort from the RESONATE study (the RESONATE cohort) [ 11 ].…”
Section: Methodsmentioning
confidence: 99%
“…These patients receive treatment and life-long follow-up in the region in which they are diagnosed. Therefore, comprehensive, consecutive records providing almost 100% coverage are available for these patients [ 13 ]. Patients included in the study originated from five facilities within the region: Karolinska University Hospital Solna, Karolinska University Hospital Huddinge, Danderyd Hospital, Södersjukhuset and Visby Hospital.…”
Section: Methodsmentioning
confidence: 99%
“…Patient-level data for the Stockholm cohort were obtained from an extended comprehensive retrospective review of patient files identified in the registry [ 13 ]. A total of 148 patients with relapsed or refractory CLL were identified, and their files were subject to an in-depth analysis from diagnosis until last treatment line or current line of treatment at last follow-up.…”
Section: Methodsmentioning
confidence: 99%
“…The main objective of this study was to estimate the relative efficacy of ibrutinib versus previous standard-of-care treatments used in routine healthcare as used in the RESONATE trial in previously treated CLL patients. This estimate is based on a comparison of patient-level data from two different sources: the phase 3 RESONATE study and a retrospective, observational cohort of strictly consecutive patients from a well-defined geographical region [ 13 ]. By using this patient sample, this study aims to minimise these issues as it utilised a well-defined cohort of consecutive patients with almost complete follow-up from the Stockholm region of Sweden with absence of external referrals and controlled for baseline prognostic factors.…”
This study explored the relative efficacy of ibrutinib versus previous standard-of-care treatments in relapsed/refractory patients with chronic lymphocytic leukaemia (CLL), using multivariate regression modelling to adjust for baseline prognostic factors. Individual patient data were collected from an observational Stockholm cohort of consecutive patients (n = 144) diagnosed with CLL between 2002 and 2013 who had received at least second-line treatment. Data were compared with results of the RESONATE clinical trial. A multivariate Cox proportional hazards regression model was used which estimated the hazard ratio (HR) of ibrutinib versus previous standard of care. The adjusted HR of ibrutinib versus the previous standard-of-care cohort was 0.15 (p < 0.0001) for progression-free survival (PFS) and 0.36 (p < 0.0001) for overall survival (OS). A similar difference was observed also when patients treated late in the period (2012-) were compared separately. Multivariate analysis showed that later line of therapy, male gender, older age and poor performance status were significant independent risk factors for worse PFS and OS. Our results suggest that PFS and OS with ibrutinib in the RESONATE study were significantly longer than with previous standard-of-care regimens used in second or later lines in routine healthcare. The approach used, which must be interpreted with caution, compares patient-level data from a clinical trial with outcomes observed in a daily clinical practice and may complement results from randomised trials or provide preliminary wider comparative information until phase 3 data exist.
Objectives: We conducted this retrospective study to characterize the change in chronic lymphocytic leukemia (CLL) treatment patterns between 2005 and 2019, to understand the treatment sequencing across the course of the disease, and to investigate how targeted agents and prognostic testing were implemented into the patient care. Methods: This study included adult patients with CLL treated at the Hospital District of Southwest Finland during the study period. Data were collected from the Turku University Hospital data lake. Results: In total, 122 and 60 patients received first-and second-line treatments for CLL, respectively. The shift from conventional chemoimmunotherapy to targeted treatments in recent years (2014-2019) was observed. The median overall survival times were not reached in patients treated with targeted agents compared to conventional standard treatments in first-and second-line settings and improved toward the end of the study period. Prognostic testing increased during the study follow-up and patients with unmutated immunoglobulin heavy-chain variable showed significantly poorer overall survival and time-to-next-treatment outcomes than patients with mutated immunoglobulin heavy-chain variable.Conclusions: This real-world study implicated added value of targeted chemofree therapies as reported in randomized clinical trials, and highlighted the necessity of prognostic testing in order to improve treatment selection and patient outcomes.
Objectives
We aimed to describe treatment patterns of chronic lymphocytic leukaemia (CLL) patients in routine practice settings, compare overall survival and time‐to‐next‐treatment among patients treated in different time periods (2005‐2008, 2009‐2013, 2014‐2015), and explore associated factors.
Methods
This retrospective cohort study included adult CLL patients from the Finnish Hematology Registry.
Results
In total, 124 and 64 CLL patients received first‐ and second‐line treatments, respectively. The use of first‐ and second‐line treatments with bendamustine‐rituximab (BR) increased, while chlorambucil‐based treatments decreased over time. Patients treated in more recent years showed a trend towards longer first‐ and second‐line survival. A trend towards inferior overall survival was detected in first‐ and second‐line treatment with B/BR. First‐line time‐to‐next‐treatment was longer for patients treated in the later years towards 2015, while second‐line time‐to‐next‐treatment did not improve over time.
Conclusions
This study identified that improved treatment outcomes over time were likely influenced by patient characteristics and treatments, but also through other factors unexplored in this study. Hence, further research on the factors influencing patients’ survival over time is needed. In particular, research on using B/BR in clinical practice is warranted.
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