Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Abstract Background and Objective Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, has demonstrated efficacy as a first-line treatment for chronic lymphocytic leukemia in multiple, phase III, randomized clinical trials. This systematic literature review assessed the clinical effectiveness of i...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2022-12-01
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| Series: | Drugs - Real World Outcomes |
| Online Access: | https://doi.org/10.1007/s40801-022-00332-4 |
| _version_ | 1797863378251677696 |
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| author | Philip Lee Kristin D. Kistler Luc Douyon Raisa Volodarsky Alex Young Sudeep Karve Swetha Challagulla |
| author_facet | Philip Lee Kristin D. Kistler Luc Douyon Raisa Volodarsky Alex Young Sudeep Karve Swetha Challagulla |
| author_sort | Philip Lee |
| collection | DOAJ |
| description | Abstract Background and Objective Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, has demonstrated efficacy as a first-line treatment for chronic lymphocytic leukemia in multiple, phase III, randomized clinical trials. This systematic literature review assessed the clinical effectiveness of ibrutinib in the first-line treatment of chronic lymphocytic leukemia in real-world clinical settings. Methods MEDLINE, EMBASE, and relevant conference websites were searched for articles published in the USA from 1 January, 2014 to 30 June, 2020. Overall survival, progression-free survival, overall response rate, and time to next treatment were summarized. Results This analysis included a total of 12 publications representing data from 112 to 2033 patients from community and academic centers, and the multicenter informCLL registry. Patients were predominantly male (60–99%) with a median age range from 62 to 77 years, and included those with high-risk genomic features (del[17p]: 21–33%; del[11q]: 33%; and unmutated immunoglobulin heavy chain variable gene: 59%). Real-world effectiveness with ibrutinib complemented the efficacy demonstrated in randomized clinical trials. Across various studies, the 12-month overall survival rates ranged from 95% to 96%; 18-month overall survival rates were similarly high (91%). Twelve-month progression-free survival rates ranged from 89% to 93%, and the overall response rate ranged from 71% to 90% across four studies. In the studies that reported time to next treatment, 91% and 87% of patients treated with first-line ibrutinib did not initiate new treatment at 12 months and 24 months, respectively. Conclusions This systematic literature review confirms the benefit of ibrutinib as a first-line treatment in patients with chronic lymphocytic leukemia in real-world clinical settings and is consistent with results from randomized clinical trials, including in patients with high-risk genomic features. |
| first_indexed | 2024-04-09T22:35:44Z |
| format | Article |
| id | doaj.art-16ba9421dbbd4f00b9e281a928f13250 |
| institution | Directory Open Access Journal |
| issn | 2199-1154 2198-9788 |
| language | English |
| last_indexed | 2024-04-09T22:35:44Z |
| publishDate | 2022-12-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Drugs - Real World Outcomes |
| spelling | doaj.art-16ba9421dbbd4f00b9e281a928f132502023-03-22T12:30:19ZengAdis, Springer HealthcareDrugs - Real World Outcomes2199-11542198-97882022-12-01101112210.1007/s40801-022-00332-4Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic LymphomaPhilip Lee0Kristin D. Kistler1Luc Douyon2Raisa Volodarsky3Alex Young4Sudeep Karve5Swetha Challagulla6Pharmacyclics LLC, an AbbVie CompanyXcendaXcendaPharmacyclics LLC, an AbbVie CompanyPharmacyclics LLC, an AbbVie CompanyAbbViePharmacyclics LLC, an AbbVie CompanyAbstract Background and Objective Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, has demonstrated efficacy as a first-line treatment for chronic lymphocytic leukemia in multiple, phase III, randomized clinical trials. This systematic literature review assessed the clinical effectiveness of ibrutinib in the first-line treatment of chronic lymphocytic leukemia in real-world clinical settings. Methods MEDLINE, EMBASE, and relevant conference websites were searched for articles published in the USA from 1 January, 2014 to 30 June, 2020. Overall survival, progression-free survival, overall response rate, and time to next treatment were summarized. Results This analysis included a total of 12 publications representing data from 112 to 2033 patients from community and academic centers, and the multicenter informCLL registry. Patients were predominantly male (60–99%) with a median age range from 62 to 77 years, and included those with high-risk genomic features (del[17p]: 21–33%; del[11q]: 33%; and unmutated immunoglobulin heavy chain variable gene: 59%). Real-world effectiveness with ibrutinib complemented the efficacy demonstrated in randomized clinical trials. Across various studies, the 12-month overall survival rates ranged from 95% to 96%; 18-month overall survival rates were similarly high (91%). Twelve-month progression-free survival rates ranged from 89% to 93%, and the overall response rate ranged from 71% to 90% across four studies. In the studies that reported time to next treatment, 91% and 87% of patients treated with first-line ibrutinib did not initiate new treatment at 12 months and 24 months, respectively. Conclusions This systematic literature review confirms the benefit of ibrutinib as a first-line treatment in patients with chronic lymphocytic leukemia in real-world clinical settings and is consistent with results from randomized clinical trials, including in patients with high-risk genomic features.https://doi.org/10.1007/s40801-022-00332-4 |
| spellingShingle | Philip Lee Kristin D. Kistler Luc Douyon Raisa Volodarsky Alex Young Sudeep Karve Swetha Challagulla Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Drugs - Real World Outcomes |
| title | Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
| title_full | Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
| title_fullStr | Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
| title_full_unstemmed | Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
| title_short | Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
| title_sort | systematic literature review of real world effectiveness results data for first line ibrutinib in chronic lymphocytic leukemia and small lymphocytic lymphoma |
| url | https://doi.org/10.1007/s40801-022-00332-4 |
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