Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials

Gentile, Massimo; Zirlik, Katja; Ciolli, Stefania; Mauro, Francesca Romana; Renzo, Nicola Di; Mastrullo, Lucia; Angrilli, Francesco; Molica, Stefano; Tripepi, Giovanni; Giordano, Annamaria; Raimondo, Francesco Di; Selleri, Carmine; Coscia, Marta; Musso, Maurizio; Orsucci, Lorella; Mannina, Donato; Rago, Angela; Giannotta, Angela; Ferrara, Felicetto; Herishanu, Yair; Shvidel, Lev; Tadmor, Tamar; Scortechini, Ilaria; Ilariucci, Fiorella; Murru, Roberta; Giacosa, Attilio; Musuraca, Gerardo; Mineo, Giuseppe; Vincelli, Iolanda Donatella; Arcari, Annalisa; Tarantini, Giuseppe; Caparrotti, Giuseppe; Chiarenza, Annalisa; Villa, Maria Rosaria; Paolis, Maria Rosaria De; Zinzani, Pier Luigi; Polliack, Aaron; Morabito, Fortunato

doi:10.1016/j.ejca.2016.03.069

Cited by 23 publications

(19 citation statements)

References 25 publications

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“…The frequencies of hematologic AEs in this study were generally similar to those in previously published reports of CLL treatments, but the frequencies of nonhematologic AEs were generally higher than those in other published studies involving chemoimmunotherapy regimens . The finding that the mean monthly per‐patient costs increased gradually with the number of unique AEs highlights the substantial economic burden associated with toxicities.…”

Section: Discussionsupporting

confidence: 85%

“…21,24 The frequencies of hematologic AEs in this study were generally similar to those in previously published reports of CLL treatments, but the frequencies of nonhematologic AEs were generally higher than those in other published studies involving chemoimmunotherapy regimens. 12,[25][26][27] The finding that the mean monthly per-patient costs increased gradually with the number of unique AEs highlights the substantial economic burden associated with toxicities. Because fewer than only one-third of patients received a CLL-directed treatment during the observation period, it is also likely that the increases in number of AEs and associated costs are correlated with the receipt as well as the nature of CLL-directed therapies.…”

Section: Discussionmentioning

confidence: 99%

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Treatment patterns, adverse events, and economic burden in a privately insured population of patients with chronic lymphocytic leukemia in the United States

Kabadi

Nagar

et al. 2019

Cancer Medicine

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Introduction Contemporary data describing treatment patterns, adverse events (AEs), and outcomes in patients with chronic lymphocytic leukemia (CLL) in clinical practice are lacking. We conducted a retrospective cohort study and assessed treatment patterns, AEs, health‐care resource use (HCRU), and costs in patients with diagnosis of CLL. Methods Using a nationally representative population of privately insured patients in the US, adult patients with CLL diagnosis (July 2012‐June 2015) were selected if they had continuous health plan enrollment for ≥12 months before the first CLL diagnosis without any evidence of any CLL‐directed treatment. Treatment patterns up to four lines of therapy (LOT) and occurrence of AEs during CLL therapies were assessed. Mean per‐patient monthly HCRU and costs were assessed overall and by number of unique AEs. Results Of all patients meeting the selection criteria (n = 7,639; median age, 66 years), 18% (n = 1,379) received a systemic therapy during study follow‐up. Of these, bendamustine/rituximab (BR) was the most common first observed regimen (28.1%), while ibrutinib was the most common therapy in the second (20.8%) and third (25.5%) observed regimens. The mean monthly all‐cause and CLL‐related costs, among patients treated with a systemic therapy, were $7,943 (SD = $15,757) and $5,185 (SD = $9,935), respectively. Mean monthly all‐cause costs increased by the number of AEs (from $905 [SD = $1,865] among those with no AEs to $6,032 [SD = $13,290] among those with ≥6 AEs). Conclusions Chemoimmunotherapy, particularly BR, was the most common first observed therapy for CLL, whereas ibrutinib was most preferred in the second and third observed lines of therapy during the study period. Findings demonstrate that the economic burden of AEs in CLL is substantial.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Treatment patterns, adverse events, and economic burden in a privately insured population of patients with chronic lymphocytic leukemia in the United States

Kabadi

Nagar

et al. 2019

Cancer Medicine

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“…Our data are in line with those of Goede et al 6 who reported that groups with different PFS could be distinguished in a cohort of elderly unfit CLL patients receiving CLB or CLB plus an anti-CD20 antibody as first-line treatment (CLL11 trial), based upon the CLL-IPI criteria. These findings are also consistent with the observation that TP53 disruption, IGHV unmutated status, or β2M levels, when considered as single parameters, are also associated with treatment outcomes after chemo-immunotherapy [8][9][10][11][12][13][14]. Moreover, when the CLL-IPI was forced in a multivariate modeltogether with the chemo-immunotherapy regimen (FCR/PCR/PCO vs BR), both parameters remained significantly associated with PFS (CLL-IPI, HR 1.58; 95% CI 1.41-1.77, P < 0.0001; FCR-PCR-PCO vs BR, HR 1.31; 95% CI 1.02-1.67, P = 0.033), showing that the CLL-IPI score allows of predicting the risk of progression regardless of the different chemo-immunotherapy approach.…”

supporting

confidence: 90%

Predictive value of the CLL‐IPI in CLL patients receiving chemo‐immunotherapy as first‐line treatment

Gentile

Shanafelt

Mauro

et al. 2018

European J of Haematology

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“…Bendamustine is commonly used with rituximab and has good response rates in treatment-naive patients without del(17p) 137 , although no randomized trials comparing bendamustine and rituximab versus bendamustine alone have been conducted. Bendamustine has also been used in combination with obinutuzumab, which showed highly encouraging results 138 and is being evaluated in larger clinical trials.…”

Section: Managementmentioning

confidence: 99%

Chronic lymphocytic leukaemia

Kipps

Stevenson

et al. 2017

Nat Rev Dis Primers

411

437

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Chronic lymphocytic leukaemia (CLL) is a malignancy of CD5+ B cells that is characterized by the accumulation of small, mature-appearing lymphocytes in the blood, marrow and lymphoid tissues. Signalling via surface immunoglobulin, which constitutes the major part of the B cell receptor, and several genetic alterations play a part in CLL pathogenesis, in addition to interactions between CLL cells and other cell types, such as stromal cells, T cells and nurse-like cells in the lymph nodes. The clinical progression of CLL is heterogeneous and ranges from patients who require treatment soon after diagnosis to others who do not require therapy for many years, if at all. Several factors, including the immunoglobulin heavy-chain variable region gene (IGHV) mutational status, genomic changes, patient age and the presence of comorbidities, should be considered when defining the optimal management strategies, which include chemotherapy, chemoimmunotherapy and/or drugs targeting B cell receptor signalling or inhibitors of apoptosis, such as BCL-2. Research on the biology of CLL has profoundly enhanced our ability to identify patients who are at higher risk for disease progression and our capacity to treat patients with drugs that selectively target distinctive phenotypic or physiological features of CLL. How these and other advances have shaped our current understanding and treatment of patients with CLL is the subject of this Primer.

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Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials

Cited by 23 publications

References 25 publications

Treatment patterns, adverse events, and economic burden in a privately insured population of patients with chronic lymphocytic leukemia in the United States

Treatment patterns, adverse events, and economic burden in a privately insured population of patients with chronic lymphocytic leukemia in the United States

Predictive value of the CLL‐IPI in CLL patients receiving chemo‐immunotherapy as first‐line treatment

Chronic lymphocytic leukaemia

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