Outcomes in chronic lymphocytic leukemia patients on novel agents in the US Veterans Health Administration System

Frei, Christopher R.; Le, Hannah; McHugh, Daniel; Ryan, Kellie; Jones, Xavier; Galley, Samantha; Franklin, Kathleen; Baus, Courtney J.; Tavera, Juan; Janania-Martinez, Michelle; Gregorio, David; Ananth, Snegha; Uribe, Ricardo; Surapaneni, Prathibha; Espinoza-Gutarra, Manuel Ricardo; Song, Michael; Teng, Chengwen; Obodozie-Ofoegbu, Obiageri O; Nooruddin, Zohra

doi:10.1080/10428194.2021.1876863

Cited by 9 publications

(9 citation statements)

References 24 publications

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“…The most common reason for treatment discontinuation was AE/toxicity. This observation is in line with the majority of real-world studies that identified AEs as the main reason for discontinuing ibrutinib [ 18 , 24 , 26 , 27 , 28 , 29 , 41 ] and possibly other BTKi [ 43 ]. Conversely, disease progression was the most frequent cause of treatment discontinuation recorded in RTCs.…”

Section: Discussionsupporting

confidence: 88%

“…Several observational studies have confirmed ibrutinib as a highly effective and generally well-tolerated drug when administered in routine clinical practice [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 ]. However, the real-world evidence is predominantly derived from retrospective studies conducted mostly on pretreated patients, including those treated in compassionate-use programs of ibrutinib [ 20 , 22 ] and single-institution patient cohorts [ 25 , 33 , 34 ].…”

Section: Introductionmentioning

confidence: 99%

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Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study

Mauro,

Scalzulli,

Scarfò

et al. 2024

Cancers

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Real-world data in clinical practice are needed to confirm the efficacy and safety that ibrutinib has demonstrated in clinical trials of patients with chronic lymphocytic leukemia (CLL). We described the real-world persistence rate, patterns of use, and clinical outcomes in 309 patients with CLL receiving single-agent ibrutinib in first line (1L, n = 118), 2L (n = 127) and ≥3L (n = 64) in the prospective, real-world, Italian EVIdeNCE study. After a median follow-up of 23.9 months, 29.8% of patients discontinued ibrutinib (1L: 24.6%, 2L: 29.9%, ≥3L: 39.1%), mainly owing to adverse events (AEs)/toxicity (14.2%). The most common AEs leading to discontinuation were infections (1L, ≥3L) and cardiac events (2L). The 2-year retention rate was 70.2% in the whole cohort (1L: 75.4%, 2L: 70.1%, ≥3L: 60.9%). The 2-year PFS and OS were, respectively, 85.4% and 91.7% in 1L, 80.0% and 86.2% in 2L, and 70.1% and 80.0% in ≥3L. Cardiovascular conditions did not impact patients’ clinical outcomes. The most common AEs were infections (30.7%), bleeding (12.9%), fatigue (10.0%), and neutropenia (9.7%), while grade 3–4 atrial fibrillation occurred in 3.9% of patients. No new safety signals were detected. These results strongly support ibrutinib as a valuable treatment option for CLL.

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Section: Discussionsupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study

Mauro,

Scalzulli,

Scarfò

et al. 2024

Cancers

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“…Investigators found a higher discontinuation rate and rate of adverse events in patients on ibrutinib compared to national clinical trials. 17…”

Section: Methodsmentioning

confidence: 99%

Incidence of invasive fungal infections in patients with chronic lymphocytic leukemia receiving ibrutinib within the veteran’s healthcare administration

Walker

Horowitz

Nooruddin

et al. 2023

J Oncol Pharm Pract

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Purpose Ibrutinib is a tyrosine kinase inhibitor that is increasingly prescribed in chronic lymphocytic leukemia (CLL). Invasive fungal infections (IFIs) have been reported early after ibrutinib initiation. Timing of IFIs is within 6 months and commonly reported fungal infections include Cryptococcus, Aspergillus, and Pneumocystis. Currently, there are no recommendations for routine prophylaxis against IFIs in patients receiving ibrutinib for CLL. Objective The objective of this study was to evaluate the incidence of IFIs in patients receiving ibrutinib for CLL in first-line and relapsed/refractory (R/R) settings. Methods This was a retrospective, cohort study of patients diagnosed with CLL and initiated on ibrutinib in the Veterans Health Administration (VHA) from October 1, 2013 to March 31, 2018. Patients were included if diagnosed with a proven or probable IFI from the start date of ibrutinib to 30 days after the last dose of ibrutinib. Results Fourteen out of 1069 patients met inclusion criteria for IFI while on ibrutinib for CLL. All patients included were male with a median age of 78 years. Fifty percent of patients were initiated on ibrutinib within 3 months of last chemotherapy. IFIs occurred within 3 months (50%) and 6 months (71%) of ibrutinib initiation. Seventy-one percent of patients were continued on ibrutinib with concurrent IFI diagnosis. Conclusion The reported IFI incidence of 1.3% is comparable to current estimates of 1.2%. Future studies should examine the relationship of ibrutinib and incidence of IFIs in first-line and R/R settings in addition to identifying clinical risk factors predisposing patients to IFIs.

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“…These repositories include data from both hospital and outpatient clinic settings. A more complete description of the VHA data is in Frei et al [ 21 ] Four national Veterans Affairs (VA) databases, namely the VA Medical SAS ® Datasets (both inpatient and outpatient), the VA Vital Status File, the VA Decision Support System Datasets, and the VA Assistant Deputy Under Secretary of Health Annual Enrollment Files, were linked using a unique patient identifier to develop an analytic dataset.…”

Section: Methodsmentioning

confidence: 99%

Durvalumab Treatment Patterns for Patients with Unresectable Stage III Non-Small Cell Lung Cancer in the Veterans Health Administration (VHA): A Nationwide, Real-World Study

Moore,

Nooruddin,

Reveles

et al. 2023

Current Oncology

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Background: Durvalumab is approved for the treatment of adults with unresectable stage III non-small cell lung cancer (NSCLC) post-chemoradiotherapy (CRT). This real-world study describes patient characteristics and durvalumab treatment patterns (number of doses and therapy duration; treatment initiation delays, interruptions, discontinuations, and associated reasons) among VHA-treated patients. Methods: This was a retrospective cohort study of adults with unresectable stage III NSCLC receiving durvalumab at the VHA between 1 January 2017 and 30 June 2020. Patient characteristics and treatment patterns were presented descriptively. Results: A total of 935 patients were included (median age: 69 years; 95% males; 21% Blacks; 46% current smokers; 16% ECOG performance scores ≥ 2; 50% squamous histology). Durvalumab initiation was delayed in 39% of patients (n = 367). Among the 200 patients with recorded reasons, delays were mainly due to physician preference (20%) and CRT toxicity (11%). Overall, patients received a median (interquartile range) of 16 (7–24) doses of durvalumab over 9.0 (2.9–11.8) months. Treatment interruptions were experienced by 19% of patients (n = 180), with toxicity (7.8%) and social reasons (2.6%) being the most cited reasons. Early discontinuation occurred in 59% of patients (n = 551), largely due to disease progression (24.2%) and toxicity (18.2%). Conclusions: These real-world analyses corroborate PACIFIC study results in terms of the main reasons for treatment discontinuation in a VHA population with worse prognostic factors, including older age, predominantly male sex, and poorer performance score. One of the main reasons for durvalumab initiation delays, treatment interruptions, or discontinuations was due to toxicities. Patients could benefit from improved strategies to prevent, identify, and manage CRT and durvalumab toxicities timely and effectively.

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Outcomes in chronic lymphocytic leukemia patients on novel agents in the US Veterans Health Administration System

Cited by 9 publications

References 24 publications

Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study

Real-World Outcome of Treatment with Single-Agent Ibrutinib in Italian Patients with Chronic Lymphocytic Leukemia: Final Results of the EVIdeNCE Study

Incidence of invasive fungal infections in patients with chronic lymphocytic leukemia receiving ibrutinib within the veteran’s healthcare administration

Durvalumab Treatment Patterns for Patients with Unresectable Stage III Non-Small Cell Lung Cancer in the Veterans Health Administration (VHA): A Nationwide, Real-World Study

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