A BAYESIAN NETWORK META-ANALYSIS (NMA) OF IBRUTINIB VS BENDAMUSTINE-RITUXIMAB FOR TREATMENT NAÏVE CHRONIC LYMPHOCYTIC LEUKAEMIA (TN-CLL) PATIENTS WITH CIRS R 6 OR CLCR Z 60 ML/MIN
OBJECTIVES: Ibrutinib has demonstrated superiority in terms of efficacy and toler-ability to chlorambucil (Chi) for TN-CLL patients who are elderly or unfit (RESONATE-2). Within this trial there is a subgroup of less fragile patients, defined as those having a Cumulative Illness Rating Scale (QRS) s...
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| Veröffentlicht in: | Value in health 2017-05, Vol.20 (5), p.A211 |
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| creator | Sanden, SV Baculea, S Gabilondo, R Parra Gros, B Cote, S |
| description | OBJECTIVES: Ibrutinib has demonstrated superiority in terms of efficacy and toler-ability to chlorambucil (Chi) for TN-CLL patients who are elderly or unfit (RESONATE-2). Within this trial there is a subgroup of less fragile patients, defined as those having a Cumulative Illness Rating Scale (QRS) score ≤6 or Creatinine clearance (ClCr)≥60 ml/min that could be potential candidates for bendamustine-rituximab (BR) therapy. As no head-to-head comparison exists for this relatively fit subgroup, an NMA was conducted to compare the efficacy of ibrutinib vs. BR in patients suitable for chemoimmunotherapy. METHODS: Out of sixteen randomized controlled trials (RCTs) in TN-CLL patients identified in a systematic literature review, four RCTs were conducted in patients/subgroups of patients who were relatively younger or more fit (CLL8, Hallek 2010; CLL10, Eichorst 2016; LRF CLL4, Catowsky 2007; RESONATE-2, the less fragile subgroup, data at a median follow-up of 28.6 months). They are connected in a network of evidence that could inform the indirect comparison of interest. A Bayesian NMA was conducted to compare hazard ratios (HR) of overall survival (OS) and progression-free survival (PFS) of ibrutinib vs. BR, FC, FCR and Chi. A fixed effect model was used due to the limited size and structure of the network. RESULTS: Ibrutinib had favorable HRs and the highest pairwise probability of being the best treatment (P) in terms of PFS and OS versus BR (HR=0.36/0.55, P=100%/87%), FC (HR=0.33/0.36, P=100%/99%), FCR (HR=0.59/0.53, P=95V92%) and Chi (HR=0.14/0.40, P=100%/99%). Ibrutinib had the highest probability of being the best treatment in the network in terms of PFS (99%) and OS (94%). CONCLUSIONS: This analysis suggests that ibrutinib is a more effective treatment compared to BR in terms of survival outcomes PFS and OS in TN-CLL patients who are relatively younger or more fit, defined as having a CIRS≤6 or ClCr≥60 ml/min. |
| doi_str_mv | 10.1016/j.jval.2017.05.005 |
| format | Article |
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Within this trial there is a subgroup of less fragile patients, defined as those having a Cumulative Illness Rating Scale (QRS) score ≤6 or Creatinine clearance (ClCr)≥60 ml/min that could be potential candidates for bendamustine-rituximab (BR) therapy. As no head-to-head comparison exists for this relatively fit subgroup, an NMA was conducted to compare the efficacy of ibrutinib vs. BR in patients suitable for chemoimmunotherapy. METHODS: Out of sixteen randomized controlled trials (RCTs) in TN-CLL patients identified in a systematic literature review, four RCTs were conducted in patients/subgroups of patients who were relatively younger or more fit (CLL8, Hallek 2010; CLL10, Eichorst 2016; LRF CLL4, Catowsky 2007; RESONATE-2, the less fragile subgroup, data at a median follow-up of 28.6 months). They are connected in a network of evidence that could inform the indirect comparison of interest. A Bayesian NMA was conducted to compare hazard ratios (HR) of overall survival (OS) and progression-free survival (PFS) of ibrutinib vs. BR, FC, FCR and Chi. A fixed effect model was used due to the limited size and structure of the network. RESULTS: Ibrutinib had favorable HRs and the highest pairwise probability of being the best treatment (P) in terms of PFS and OS versus BR (HR=0.36/0.55, P=100%/87%), FC (HR=0.33/0.36, P=100%/99%), FCR (HR=0.59/0.53, P=95V92%) and Chi (HR=0.14/0.40, P=100%/99%). Ibrutinib had the highest probability of being the best treatment in the network in terms of PFS (99%) and OS (94%). CONCLUSIONS: This analysis suggests that ibrutinib is a more effective treatment compared to BR in terms of survival outcomes PFS and OS in TN-CLL patients who are relatively younger or more fit, defined as having a CIRS≤6 or ClCr≥60 ml/min.</description><identifier>ISSN: 1098-3015</identifier><identifier>EISSN: 1524-4733</identifier><identifier>DOI: 10.1016/j.jval.2017.05.005</identifier><language>eng</language><publisher>Lawrenceville: Elsevier Science Ltd</publisher><subject>Bayesian analysis ; Candidates ; Chemotherapy ; Chlorambucil ; Chronic lymphocytic leukemia ; Clinical trials ; Creatinine ; Dominance ; Efficacy ; Geriatrics ; Immunotherapy ; Inhibitor drugs ; Leukemia ; Literature reviews ; Medical treatment ; Meta-analysis ; Monoclonal antibodies ; Older people ; Patients ; Rituximab ; Survival ; Targeted cancer therapy</subject><ispartof>Value in health, 2017-05, Vol.20 (5), p.A211</ispartof><rights>Copyright Elsevier Science Ltd. May 2017</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902,30976</link.rule.ids></links><search><creatorcontrib>Sanden, SV</creatorcontrib><creatorcontrib>Baculea, S</creatorcontrib><creatorcontrib>Gabilondo, R Parra</creatorcontrib><creatorcontrib>Gros, B</creatorcontrib><creatorcontrib>Cote, S</creatorcontrib><title>A BAYESIAN NETWORK META-ANALYSIS (NMA) OF IBRUTINIB VS BENDAMUSTINE-RITUXIMAB FOR TREATMENT NAÏVE CHRONIC LYMPHOCYTIC LEUKAEMIA (TN-CLL) PATIENTS WITH CIRS R 6 OR CLCR Z 60 ML/MIN</title><title>Value in health</title><description>OBJECTIVES: Ibrutinib has demonstrated superiority in terms of efficacy and toler-ability to chlorambucil (Chi) for TN-CLL patients who are elderly or unfit (RESONATE-2). Within this trial there is a subgroup of less fragile patients, defined as those having a Cumulative Illness Rating Scale (QRS) score ≤6 or Creatinine clearance (ClCr)≥60 ml/min that could be potential candidates for bendamustine-rituximab (BR) therapy. As no head-to-head comparison exists for this relatively fit subgroup, an NMA was conducted to compare the efficacy of ibrutinib vs. BR in patients suitable for chemoimmunotherapy. METHODS: Out of sixteen randomized controlled trials (RCTs) in TN-CLL patients identified in a systematic literature review, four RCTs were conducted in patients/subgroups of patients who were relatively younger or more fit (CLL8, Hallek 2010; CLL10, Eichorst 2016; LRF CLL4, Catowsky 2007; RESONATE-2, the less fragile subgroup, data at a median follow-up of 28.6 months). They are connected in a network of evidence that could inform the indirect comparison of interest. A Bayesian NMA was conducted to compare hazard ratios (HR) of overall survival (OS) and progression-free survival (PFS) of ibrutinib vs. BR, FC, FCR and Chi. A fixed effect model was used due to the limited size and structure of the network. RESULTS: Ibrutinib had favorable HRs and the highest pairwise probability of being the best treatment (P) in terms of PFS and OS versus BR (HR=0.36/0.55, P=100%/87%), FC (HR=0.33/0.36, P=100%/99%), FCR (HR=0.59/0.53, P=95V92%) and Chi (HR=0.14/0.40, P=100%/99%). Ibrutinib had the highest probability of being the best treatment in the network in terms of PFS (99%) and OS (94%). CONCLUSIONS: This analysis suggests that ibrutinib is a more effective treatment compared to BR in terms of survival outcomes PFS and OS in TN-CLL patients who are relatively younger or more fit, defined as having a CIRS≤6 or ClCr≥60 ml/min.</description><subject>Bayesian analysis</subject><subject>Candidates</subject><subject>Chemotherapy</subject><subject>Chlorambucil</subject><subject>Chronic lymphocytic leukemia</subject><subject>Clinical trials</subject><subject>Creatinine</subject><subject>Dominance</subject><subject>Efficacy</subject><subject>Geriatrics</subject><subject>Immunotherapy</subject><subject>Inhibitor drugs</subject><subject>Leukemia</subject><subject>Literature reviews</subject><subject>Medical treatment</subject><subject>Meta-analysis</subject><subject>Monoclonal antibodies</subject><subject>Older people</subject><subject>Patients</subject><subject>Rituximab</subject><subject>Survival</subject><subject>Targeted cancer therapy</subject><issn>1098-3015</issn><issn>1524-4733</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>7QJ</sourceid><recordid>eNqNjEtOwzAURS0EEuWzAUZPYtIOkr4kzafDF-MoVmOnsp2WMKk6KIOootBQtsFm2AEbI0gsgNE9uj_G7gL0AwySaed3H9u9H2KQ-hj7iPEZGwVxOPNmaRSdD4zzzIswiC_ZVd93iJhEYTxiXwQ5tcJK0qCFW9dmAUo48khT1VppYawVTaAuQOamcVLLHFYWcqEfSDV2MIRnpGsepaIcitqAM4KcEtqBpu_PlQBemlpLDlWrlmXNW_fLolmQUJJg7LTHq2oCS3JyWFlYS1cCl8aCgQSGR15xA0-QIKhqqqS-YRfP232_u_3Ta3ZfCMdL7_V4eDvt-vdNdzgdX4ZoE-I8TZIMszD6X-sHv6dZkA</recordid><startdate>20170501</startdate><enddate>20170501</enddate><creator>Sanden, SV</creator><creator>Baculea, S</creator><creator>Gabilondo, R Parra</creator><creator>Gros, B</creator><creator>Cote, S</creator><general>Elsevier Science Ltd</general><scope>7QJ</scope></search><sort><creationdate>20170501</creationdate><title>A BAYESIAN NETWORK META-ANALYSIS (NMA) OF IBRUTINIB VS BENDAMUSTINE-RITUXIMAB FOR TREATMENT NAÏVE CHRONIC LYMPHOCYTIC LEUKAEMIA (TN-CLL) PATIENTS WITH CIRS R 6 OR CLCR Z 60 ML/MIN</title><author>Sanden, SV ; Baculea, S ; Gabilondo, R Parra ; Gros, B ; Cote, S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-proquest_journals_20976680823</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Bayesian analysis</topic><topic>Candidates</topic><topic>Chemotherapy</topic><topic>Chlorambucil</topic><topic>Chronic lymphocytic leukemia</topic><topic>Clinical trials</topic><topic>Creatinine</topic><topic>Dominance</topic><topic>Efficacy</topic><topic>Geriatrics</topic><topic>Immunotherapy</topic><topic>Inhibitor drugs</topic><topic>Leukemia</topic><topic>Literature reviews</topic><topic>Medical treatment</topic><topic>Meta-analysis</topic><topic>Monoclonal antibodies</topic><topic>Older people</topic><topic>Patients</topic><topic>Rituximab</topic><topic>Survival</topic><topic>Targeted cancer therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sanden, SV</creatorcontrib><creatorcontrib>Baculea, S</creatorcontrib><creatorcontrib>Gabilondo, R Parra</creatorcontrib><creatorcontrib>Gros, B</creatorcontrib><creatorcontrib>Cote, S</creatorcontrib><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><jtitle>Value in health</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sanden, SV</au><au>Baculea, S</au><au>Gabilondo, R Parra</au><au>Gros, B</au><au>Cote, S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A BAYESIAN NETWORK META-ANALYSIS (NMA) OF IBRUTINIB VS BENDAMUSTINE-RITUXIMAB FOR TREATMENT NAÏVE CHRONIC LYMPHOCYTIC LEUKAEMIA (TN-CLL) PATIENTS WITH CIRS R 6 OR CLCR Z 60 ML/MIN</atitle><jtitle>Value in health</jtitle><date>2017-05-01</date><risdate>2017</risdate><volume>20</volume><issue>5</issue><spage>A211</spage><pages>A211-</pages><issn>1098-3015</issn><eissn>1524-4733</eissn><abstract>OBJECTIVES: Ibrutinib has demonstrated superiority in terms of efficacy and toler-ability to chlorambucil (Chi) for TN-CLL patients who are elderly or unfit (RESONATE-2). Within this trial there is a subgroup of less fragile patients, defined as those having a Cumulative Illness Rating Scale (QRS) score ≤6 or Creatinine clearance (ClCr)≥60 ml/min that could be potential candidates for bendamustine-rituximab (BR) therapy. As no head-to-head comparison exists for this relatively fit subgroup, an NMA was conducted to compare the efficacy of ibrutinib vs. BR in patients suitable for chemoimmunotherapy. METHODS: Out of sixteen randomized controlled trials (RCTs) in TN-CLL patients identified in a systematic literature review, four RCTs were conducted in patients/subgroups of patients who were relatively younger or more fit (CLL8, Hallek 2010; CLL10, Eichorst 2016; LRF CLL4, Catowsky 2007; RESONATE-2, the less fragile subgroup, data at a median follow-up of 28.6 months). They are connected in a network of evidence that could inform the indirect comparison of interest. A Bayesian NMA was conducted to compare hazard ratios (HR) of overall survival (OS) and progression-free survival (PFS) of ibrutinib vs. BR, FC, FCR and Chi. A fixed effect model was used due to the limited size and structure of the network. RESULTS: Ibrutinib had favorable HRs and the highest pairwise probability of being the best treatment (P) in terms of PFS and OS versus BR (HR=0.36/0.55, P=100%/87%), FC (HR=0.33/0.36, P=100%/99%), FCR (HR=0.59/0.53, P=95V92%) and Chi (HR=0.14/0.40, P=100%/99%). Ibrutinib had the highest probability of being the best treatment in the network in terms of PFS (99%) and OS (94%). CONCLUSIONS: This analysis suggests that ibrutinib is a more effective treatment compared to BR in terms of survival outcomes PFS and OS in TN-CLL patients who are relatively younger or more fit, defined as having a CIRS≤6 or ClCr≥60 ml/min.</abstract><cop>Lawrenceville</cop><pub>Elsevier Science Ltd</pub><doi>10.1016/j.jval.2017.05.005</doi></addata></record> |
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| source | Applied Social Sciences Index & Abstracts (ASSIA); Elsevier ScienceDirect Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Bayesian analysis Candidates Chemotherapy Chlorambucil Chronic lymphocytic leukemia Clinical trials Creatinine Dominance Efficacy Geriatrics Immunotherapy Inhibitor drugs Leukemia Literature reviews Medical treatment Meta-analysis Monoclonal antibodies Older people Patients Rituximab Survival Targeted cancer therapy |
| title | A BAYESIAN NETWORK META-ANALYSIS (NMA) OF IBRUTINIB VS BENDAMUSTINE-RITUXIMAB FOR TREATMENT NAÏVE CHRONIC LYMPHOCYTIC LEUKAEMIA (TN-CLL) PATIENTS WITH CIRS R 6 OR CLCR Z 60 ML/MIN |
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