Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials

Summary Comorbidities influence survival in patients with chronic lymphocytic leukaemia (CLL) treated with chemo‐immunotherapy or ibrutinib. While idelalisib has been studied in patients with comorbidities, their impact has not been investigated. We analysed 481 patients treated with idelalisib on t...

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Published in:British journal of haematology 2021-02, Vol.192 (4), p.720-728
Main Authors: Gordon, Max J., Huang, Julie, Chan, Rebecca J., Bhargava, Pankaj, Danilov, Alexey V.
Format: Article
Language:English
Subjects:
CD20 antigen
chronic lymphocytic leukaemia
Chronic lymphocytic leukemia
Clinical trials
comorbidities
cumulative illness rating scale
Hematology
idelalisib
Immunotherapy
Leukemia
Monoclonal antibodies
outcomes
Patients
Rituximab
Survival
Targeted cancer therapy
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container_title British journal of haematology
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creator Gordon, Max J.
Huang, Julie
Chan, Rebecca J.
Bhargava, Pankaj
Danilov, Alexey V.
description Summary Comorbidities influence survival in patients with chronic lymphocytic leukaemia (CLL) treated with chemo‐immunotherapy or ibrutinib. While idelalisib has been studied in patients with comorbidities, their impact has not been investigated. We analysed 481 patients treated with idelalisib on two randomised trials (NCT01659021 and NCT01539512). Comorbidities were assessed using the Cumulative Illness Risk Scale (CIRS). Patients received idelalisib + anti‐CD20 (rituximab or ofatumumab; n = 284) or anti‐CD20 alone (n = 197). The median age was 69 years. We found that comorbidities did not significantly affect outcomes of idelalisib therapy. The objective response rate (ORR) was 79·3% versus 85·8%, the median progression‐free survival (PFS) was 16·3 versus 19·1 months, and the median overall survival (OS) was 39·8 versus 49·8 months in patients treated with idelalisib who had a CIRS score of >6 versus ≤6, correspondingly. Treatment with idelalisib + anti‐CD20 was associated with superior PFS and ORR when compared to anti‐CD20 monotherapy in patients who had high comorbidities (CIRS score of >6) or at least one severe comorbidity (median PFS 16·3 vs. 6·9 months and 16·6 vs. 6·5 months; odds ratio 20·1 and 33·2; P 
doi_str_mv 10.1111/bjh.16879
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While idelalisib has been studied in patients with comorbidities, their impact has not been investigated. We analysed 481 patients treated with idelalisib on two randomised trials (NCT01659021 and NCT01539512). Comorbidities were assessed using the Cumulative Illness Risk Scale (CIRS). Patients received idelalisib + anti‐CD20 (rituximab or ofatumumab; n = 284) or anti‐CD20 alone (n = 197). The median age was 69 years. We found that comorbidities did not significantly affect outcomes of idelalisib therapy. The objective response rate (ORR) was 79·3% versus 85·8%, the median progression‐free survival (PFS) was 16·3 versus 19·1 months, and the median overall survival (OS) was 39·8 versus 49·8 months in patients treated with idelalisib who had a CIRS score of &gt;6 versus ≤6, correspondingly. Treatment with idelalisib + anti‐CD20 was associated with superior PFS and ORR when compared to anti‐CD20 monotherapy in patients who had high comorbidities (CIRS score of &gt;6) or at least one severe comorbidity (median PFS 16·3 vs. 6·9 months and 16·6 vs. 6·5 months; odds ratio 20·1 and 33·2; P &lt; 0·0001). 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While idelalisib has been studied in patients with comorbidities, their impact has not been investigated. We analysed 481 patients treated with idelalisib on two randomised trials (NCT01659021 and NCT01539512). Comorbidities were assessed using the Cumulative Illness Risk Scale (CIRS). Patients received idelalisib + anti‐CD20 (rituximab or ofatumumab; n = 284) or anti‐CD20 alone (n = 197). The median age was 69 years. We found that comorbidities did not significantly affect outcomes of idelalisib therapy. The objective response rate (ORR) was 79·3% versus 85·8%, the median progression‐free survival (PFS) was 16·3 versus 19·1 months, and the median overall survival (OS) was 39·8 versus 49·8 months in patients treated with idelalisib who had a CIRS score of &gt;6 versus ≤6, correspondingly. Treatment with idelalisib + anti‐CD20 was associated with superior PFS and ORR when compared to anti‐CD20 monotherapy in patients who had high comorbidities (CIRS score of &gt;6) or at least one severe comorbidity (median PFS 16·3 vs. 6·9 months and 16·6 vs. 6·5 months; odds ratio 20·1 and 33·2; P &lt; 0·0001). Thus, comorbidities do not portend inferior outcomes in patients with CLL treated with idelalisib in combination with anti‐CD20 therapy.</description><subject>CD20 antigen</subject><subject>chronic lymphocytic leukaemia</subject><subject>Chronic lymphocytic leukemia</subject><subject>Clinical trials</subject><subject>comorbidities</subject><subject>cumulative illness rating scale</subject><subject>Hematology</subject><subject>idelalisib</subject><subject>Immunotherapy</subject><subject>Leukemia</subject><subject>Monoclonal antibodies</subject><subject>outcomes</subject><subject>Patients</subject><subject>Rituximab</subject><subject>Survival</subject><subject>Targeted cancer therapy</subject><issn>0007-1048</issn><issn>1365-2141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp1kc9u1DAQhy0EokvhwAsgS1zgkNaOncThViqgVEVc4Bz5z5j14sSL7WiVl-CZ8Talh0qdy8zh8zdj_RB6TckZLXWudtsz2oquf4I2lLVNVVNOn6INIaSrKOHiBL1IaUcIZaShz9EJq5u-b5tmg_5-A-O09FiHMUTljMsOEnYT3ssyTTnhg8tbrLcxTE5jv4z7bdBLPs4w_5YwOolzBJnBrKgz4KV3yakPWE7SL8klHCzOh4C9jL8ARzmZMLpUXmjvptv9OTrp00v0zJYGr-76Kfr5-dOPy6vq5vuXr5cXN5VmQvSVlowoqS2rgSkOPTOyt0RZYNY0qmusoAQUV62sFScCWlrbrmed4ZIXrman6N3q3cfwZ4aUh3KOBu_lBGFOQ81pT0TbCVLQtw_QXZhj-deREoK3nLOj8P1K6RhSimCHfXSjjMtAyXAMaSghDbchFfbNnXFWI5h78n8qBThfgYPzsDxuGj5eX63Kf6Arnu4</recordid><startdate>202102</startdate><enddate>202102</enddate><creator>Gordon, Max J.</creator><creator>Huang, Julie</creator><creator>Chan, Rebecca J.</creator><creator>Bhargava, Pankaj</creator><creator>Danilov, Alexey V.</creator><general>Blackwell Publishing Ltd</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-3940-4451</orcidid></search><sort><creationdate>202102</creationdate><title>Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials</title><author>Gordon, Max J. ; Huang, Julie ; Chan, Rebecca J. ; Bhargava, Pankaj ; Danilov, Alexey V.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3889-ca30bacf32e3b4e93da9f0bfe3fd5b75f810eb4b6a2b408e612f7937d4a4f0b23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>CD20 antigen</topic><topic>chronic lymphocytic leukaemia</topic><topic>Chronic lymphocytic leukemia</topic><topic>Clinical trials</topic><topic>comorbidities</topic><topic>cumulative illness rating scale</topic><topic>Hematology</topic><topic>idelalisib</topic><topic>Immunotherapy</topic><topic>Leukemia</topic><topic>Monoclonal antibodies</topic><topic>outcomes</topic><topic>Patients</topic><topic>Rituximab</topic><topic>Survival</topic><topic>Targeted cancer therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gordon, Max J.</creatorcontrib><creatorcontrib>Huang, Julie</creatorcontrib><creatorcontrib>Chan, Rebecca J.</creatorcontrib><creatorcontrib>Bhargava, Pankaj</creatorcontrib><creatorcontrib>Danilov, Alexey V.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>British journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gordon, Max J.</au><au>Huang, Julie</au><au>Chan, Rebecca J.</au><au>Bhargava, Pankaj</au><au>Danilov, Alexey V.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials</atitle><jtitle>British journal of haematology</jtitle><addtitle>Br J Haematol</addtitle><date>2021-02</date><risdate>2021</risdate><volume>192</volume><issue>4</issue><spage>720</spage><epage>728</epage><pages>720-728</pages><issn>0007-1048</issn><eissn>1365-2141</eissn><abstract>Summary Comorbidities influence survival in patients with chronic lymphocytic leukaemia (CLL) treated with chemo‐immunotherapy or ibrutinib. While idelalisib has been studied in patients with comorbidities, their impact has not been investigated. We analysed 481 patients treated with idelalisib on two randomised trials (NCT01659021 and NCT01539512). Comorbidities were assessed using the Cumulative Illness Risk Scale (CIRS). Patients received idelalisib + anti‐CD20 (rituximab or ofatumumab; n = 284) or anti‐CD20 alone (n = 197). The median age was 69 years. We found that comorbidities did not significantly affect outcomes of idelalisib therapy. The objective response rate (ORR) was 79·3% versus 85·8%, the median progression‐free survival (PFS) was 16·3 versus 19·1 months, and the median overall survival (OS) was 39·8 versus 49·8 months in patients treated with idelalisib who had a CIRS score of &gt;6 versus ≤6, correspondingly. Treatment with idelalisib + anti‐CD20 was associated with superior PFS and ORR when compared to anti‐CD20 monotherapy in patients who had high comorbidities (CIRS score of &gt;6) or at least one severe comorbidity (median PFS 16·3 vs. 6·9 months and 16·6 vs. 6·5 months; odds ratio 20·1 and 33·2; P &lt; 0·0001). Thus, comorbidities do not portend inferior outcomes in patients with CLL treated with idelalisib in combination with anti‐CD20 therapy.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>32599655</pmid><doi>10.1111/bjh.16879</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-3940-4451</orcidid><oa>free_for_read</oa></addata></record>
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subjects CD20 antigen
chronic lymphocytic leukaemia
Chronic lymphocytic leukemia
Clinical trials
comorbidities
cumulative illness rating scale
Hematology
idelalisib
Immunotherapy
Leukemia
Monoclonal antibodies
outcomes
Patients
Rituximab
Survival
Targeted cancer therapy
title Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials
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