Post‐remission cytopenia management in patients with AML treated with venetoclax in combination with hypomethylating agents: Pre‐ versus post‐VIALE‐A real‐world experience from a predominantly US community setting
Abstract Background This retrospective cohort study used an electronic health record‐derived, de‐identified, US patient‐level database to better understand the real‐world treatment experience, in a predominantly community setting (80.3% of patients), of venetoclax+hypomethylating agents (HMAs) in ro...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-09-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.6430 |
| _version_ | 1827805681523097600 |
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| author | Pankit Vachhani Esprit Ma Tao Xu Melissa Montez Sarah Worth Archibong Yellow‐Duke Wei‐Han Cheng Michael E. Werner Jonathan Abbas William Donnellan |
| author_facet | Pankit Vachhani Esprit Ma Tao Xu Melissa Montez Sarah Worth Archibong Yellow‐Duke Wei‐Han Cheng Michael E. Werner Jonathan Abbas William Donnellan |
| author_sort | Pankit Vachhani |
| collection | DOAJ |
| description | Abstract Background This retrospective cohort study used an electronic health record‐derived, de‐identified, US patient‐level database to better understand the real‐world treatment experience, in a predominantly community setting (80.3% of patients), of venetoclax+hypomethylating agents (HMAs) in routine clinical care, pre‐ and post‐VIALE‐A, to determine whether the post‐remission cytopenia management insight from VIALE‐A was reflected in real‐world clinical practice. Methods Patients with newly diagnosed acute myeloid leukemia (AML; N = 498), who initiated venetoclax+HMA ≤30 days from AML diagnosis from June 1, 2018, to March 31, 2021, were stratified into pre‐(n = 330) and post‐(n = 168) VIALE‐A cohorts. Results More patients in the post‐(61%) versus pre‐(45%) VIALE‐A cohort had their first biopsy by 28 ± 14 days post‐treatment initiation. Patients underwent bone marrow (BM) assessment earlier in the post‐ versus pre‐VIALE‐A cohort, and first identification of response was also earlier (2.5 vs 5.1 months, respectively). More venetoclax schedule modifications post‐remission occurred among post‐(82.1%) versus pre‐(73.8%) VIALE‐A responders; the most common reason for modification was treatment toxicities, specifically cytopenia. Treatment survival outcomes were comparable with or without venetoclax schedule modifications. Conclusions Findings suggest that venetoclax schedule modifications can be used to manage cytopenia events without adversely affecting outcomes. Opportunities remain to improve earlier BM assessment to determine venetoclax schedule modifications, providing the best chance for optimal treatment outcomes. |
| first_indexed | 2024-03-11T21:29:43Z |
| format | Article |
| id | doaj.art-3fb93e699c154e0782e4f2e27479dc7b |
| institution | Directory Open Access Journal |
| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-03-11T21:29:43Z |
| publishDate | 2023-09-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-3fb93e699c154e0782e4f2e27479dc7b2023-09-27T11:46:08ZengWileyCancer Medicine2045-76342023-09-011217179141792310.1002/cam4.6430Post‐remission cytopenia management in patients with AML treated with venetoclax in combination with hypomethylating agents: Pre‐ versus post‐VIALE‐A real‐world experience from a predominantly US community settingPankit Vachhani0Esprit Ma1Tao Xu2Melissa Montez3Sarah Worth4Archibong Yellow‐Duke5Wei‐Han Cheng6Michael E. Werner7Jonathan Abbas8William Donnellan9O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham Birmingham Alabama USAGenentech, Inc. South San Francisco California USAF. Hoffmann‐La Roche Ltd Basel SwitzerlandGenentech, Inc. South San Francisco California USAO'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham Birmingham Alabama USAGenentech, Inc. South San Francisco California USAAbbVie, Inc. North Chicago Illinois USAAbbVie, Inc. North Chicago Illinois USATennessee Oncology Nashville Tennessee USATennessee Oncology Nashville Tennessee USAAbstract Background This retrospective cohort study used an electronic health record‐derived, de‐identified, US patient‐level database to better understand the real‐world treatment experience, in a predominantly community setting (80.3% of patients), of venetoclax+hypomethylating agents (HMAs) in routine clinical care, pre‐ and post‐VIALE‐A, to determine whether the post‐remission cytopenia management insight from VIALE‐A was reflected in real‐world clinical practice. Methods Patients with newly diagnosed acute myeloid leukemia (AML; N = 498), who initiated venetoclax+HMA ≤30 days from AML diagnosis from June 1, 2018, to March 31, 2021, were stratified into pre‐(n = 330) and post‐(n = 168) VIALE‐A cohorts. Results More patients in the post‐(61%) versus pre‐(45%) VIALE‐A cohort had their first biopsy by 28 ± 14 days post‐treatment initiation. Patients underwent bone marrow (BM) assessment earlier in the post‐ versus pre‐VIALE‐A cohort, and first identification of response was also earlier (2.5 vs 5.1 months, respectively). More venetoclax schedule modifications post‐remission occurred among post‐(82.1%) versus pre‐(73.8%) VIALE‐A responders; the most common reason for modification was treatment toxicities, specifically cytopenia. Treatment survival outcomes were comparable with or without venetoclax schedule modifications. Conclusions Findings suggest that venetoclax schedule modifications can be used to manage cytopenia events without adversely affecting outcomes. Opportunities remain to improve earlier BM assessment to determine venetoclax schedule modifications, providing the best chance for optimal treatment outcomes.https://doi.org/10.1002/cam4.6430acute myeloid leukemiabone marrow assessmenthypomethylating agentsreal‐worldschedule modificationssurvival outcomes |
| spellingShingle | Pankit Vachhani Esprit Ma Tao Xu Melissa Montez Sarah Worth Archibong Yellow‐Duke Wei‐Han Cheng Michael E. Werner Jonathan Abbas William Donnellan Post‐remission cytopenia management in patients with AML treated with venetoclax in combination with hypomethylating agents: Pre‐ versus post‐VIALE‐A real‐world experience from a predominantly US community setting Cancer Medicine acute myeloid leukemia bone marrow assessment hypomethylating agents real‐world schedule modifications survival outcomes |
| title | Post‐remission cytopenia management in patients with AML treated with venetoclax in combination with hypomethylating agents: Pre‐ versus post‐VIALE‐A real‐world experience from a predominantly US community setting |
| title_full | Post‐remission cytopenia management in patients with AML treated with venetoclax in combination with hypomethylating agents: Pre‐ versus post‐VIALE‐A real‐world experience from a predominantly US community setting |
| title_fullStr | Post‐remission cytopenia management in patients with AML treated with venetoclax in combination with hypomethylating agents: Pre‐ versus post‐VIALE‐A real‐world experience from a predominantly US community setting |
| title_full_unstemmed | Post‐remission cytopenia management in patients with AML treated with venetoclax in combination with hypomethylating agents: Pre‐ versus post‐VIALE‐A real‐world experience from a predominantly US community setting |
| title_short | Post‐remission cytopenia management in patients with AML treated with venetoclax in combination with hypomethylating agents: Pre‐ versus post‐VIALE‐A real‐world experience from a predominantly US community setting |
| title_sort | post remission cytopenia management in patients with aml treated with venetoclax in combination with hypomethylating agents pre versus post viale a real world experience from a predominantly us community setting |
| topic | acute myeloid leukemia bone marrow assessment hypomethylating agents real‐world schedule modifications survival outcomes |
| url | https://doi.org/10.1002/cam4.6430 |
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