Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202

Ibrutinib has superior progression-free survival compared with bendamustine plus rituximab (BR) in older CLL patients, however, differences in treatment duration, six monthly BR cycles versus continuous ibrutinib, complicate adverse event (AE) comparisons. We introduce the AE burden score ( AE sc )...

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Bibliographic Details
Published in:Leukemia 2021-10, Vol.35 (10), p.2854-2861
Main Authors: Ruppert, Amy S., Booth, Allison M., Ding, Wei, Bartlett, Nancy L., Brander, Danielle M., Coutre, Steven, Brown, Jennifer R., Nattam, Sreenivasa, Larson, Richard A., Erba, Harry, Litzow, Mark, Owen, Carolyn, Kuzma, Charles S., Abramson, Jeremy S., Little, Richard F., Smith, Scott E., Stone, Richard M., Byrd, John C., Mandrekar, Sumithra J., Woyach, Jennifer A.
Format: Article
Language:English
Subjects:
631/67/1990/283/1895
692/308/2779/109/2154
Adenine - administration & dosage
Adenine - analogs & derivatives
Adverse events
Aged
Aged patients
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Atrial Fibrillation - chemically induced
Atrial Fibrillation - epidemiology
Atrial Fibrillation - pathology
Bendamustine
Bendamustine Hydrochloride - administration & dosage
Cancer Research
Cancer therapies
Cardiac arrhythmia
Care and treatment
Chemotherapy
Chronic lymphocytic leukemia
Complications and side effects
Critical Care Medicine
Female
Fibrillation
Follow-Up Studies
Hematology
Humans
Hypertension
Hypertension - chemically induced
Hypertension - epidemiology
Hypertension - pathology
Immunotherapy
Infections
Infections - chemically induced
Infections - epidemiology
Infections - pathology
Inhibitor drugs
Intensive
Internal Medicine
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy
Leukemia, Lymphocytic, Chronic, B-Cell - pathology
Male
Medicine
Medicine & Public Health
Monoclonal antibodies
Oncology
Patient outcomes
Patients
Piperidines - administration & dosage
Prognosis
Rituximab
Rituximab - administration & dosage
Survival Rate
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Items that cite this one
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Description
Summary:Ibrutinib has superior progression-free survival compared with bendamustine plus rituximab (BR) in older CLL patients, however, differences in treatment duration, six monthly BR cycles versus continuous ibrutinib, complicate adverse event (AE) comparisons. We introduce the AE burden score ( AE sc ) to compare AEs, calculated for each patient by summing over products of reporting period length and grade for each all-cause grade 1–4 AE and dividing by the length of time over which AEs are assessed. A total of 176 patients received BR and 361 ibrutinib alone or with six cycles of rituximab. At 38 months median follow-up, 64% remained on ibrutinib. Median AE sc was higher with BR versus ibrutinib in the first six cycles (7.2 versus 4.9, p  
ISSN:0887-6924
1476-5551
DOI:10.1038/s41375-021-01342-x