Appropriate use of bendamustine in first-line therapy of chronic lymphocytic leukemia. Recommendations from SIE, SIES, GITMO Group

Cuneo, Antonio; Marchetti, Monia; Barosi, Giovanni; Billio, Atto; Brugiatelli, Maura; Ciolli, Stefania; Laurenti, Luca; Mauro, Francesca Romana; Molica, Stefano; Montillo, Marco; Zinzani, Pier Luigi; Tura, S

doi:10.1016/j.leukres.2014.06.017

Cited by 13 publications

(7 citation statements)

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“…Статистическая обработка данных выполнена с использованием компьютерных программ «R» (R Foundation for Statistical Computing, Vienna, Austria) и «SPSS v. 26 Стратификация риска по модифицированной системе стадирования K. Rai [46] Из всех 405 пациентов, получавших терапию, у 211 (52,1 %) проведена только 1-я линия терапии, 89 (22,0 %) -2 линии, 105 (27,0 %) -3 и более линии. АллоТГСК выполнена 5 пациентам после достижения ответа на 1-ю линию терапии выполнена (2 -после 6 циклов FCR, 3 -после ИБТК).…”

Section: методы и материалыunclassified

“…Кроме того, серьезными лимитирующими факторами применения флударабин-содержащих режимов являются гемолитические осложнения [22,23], снижение клиренса креатинина [24] и развитие аутоиммунных цитопений, в частности, парциальной красноклеточной аплазии кроветворения [25]. Бендамустин-содержащие режимы имеют меньше ограничений [26], тем не менее проведение комбинированных иммунохимиотерапевтических режимов сопряжено с высоким риском развития глубоких нейтропений и инфекционных осложнений, особенно в группе пожилых пациентов [27]. В отсутствие терапевтической альтернативы используются различные модификации режимов FCR (Флударабин, Циклофосфамид, Ритуксимаб) и BR (Бендамустин, Ритуксимаб) с вынужденным снижением интенсивности доз [28,29].…”

Section: Introductionunclassified

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Prognostic factors and effectiveness of the first-line therapy for chronic lymphocytic leukemia: results of 10-year follow-up

Kalashnikova¹,

Ivanova²,

Volkov³

et al. 2021

The Scientific Notes of the Pavlov university

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Introduction.The biological heterogeneity of chronic lymphocytic leukemia (CLL) is reflected in the rate of progression, the need for therapy, and the response to treatment. Analysis of prognostic factors contributes to improving the quality of treatment and rational distribution of healthcare resources.Materials and methods. Among 890 patients with documented stage of CLL, 405 (45.5 %) received treatment. As the first-line of treatment, 173 patients received intensive regimens (FCR or BR), 6 – new agents, and 226 – all other regimens. The initial stage of the disease, mutation status of IGHV, del17p with or without complex karyotype were analyzed as prognostic markers.Results. Immunochemotherapeutic regimens were shown to be highly effective in case planned amount of treatment was completed. The combination of such prognostic parameters as the initial stage of the disease, the mutation status of IGHV, and the presence of del17p and/or complex karyotype allows us to clearly identify a group of patients with an unfavorable prognosis, for which it is advisable to use either intensive programs or new agents in the first-line therapy.

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Section: методы и материалыunclassified

Section: Introductionunclassified

Prognostic factors and effectiveness of the first-line therapy for chronic lymphocytic leukemia: results of 10-year follow-up

Kalashnikova¹,

Ivanova²,

Volkov³

et al. 2021

The Scientific Notes of the Pavlov university

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show abstract

“…The Italian CLL guidelines therefore recommend that elderly and comorbid patients should receive a reduced bendamustine dose of 70 mg/m 2 for up to six cycles. The minimum effective dose of bendamustine is approximately 50 mg/m 2 [Cheson, 2014, Cuneo et al 2014].…”

Section: Management Of Chronic Lymphocytic Leukaemia In Elderly or Unmentioning

confidence: 99%

Bendamustine and its role in the treatment of unfit patients with chronic lymphocytic leukaemia: a perspective review

Al‐Sawaf

Cramer

Goede

et al. 2017

Therapeutic Advances in Hematology

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Patients with a high comorbidity burden (i.e. a CIRS score higher than 6) or relevant organ impairment should receive a therapy adapted to their physical status. This includes agents like chlorambucil in combination with a CD20 antibody, that is, rituximab, obinutuzumab or ofatumumab, bendamustine, and as of late, the bruton-tyrosine kinase inhibitor ibrutinib. For patients with del17p and possibly TP53 mutations, frontline treatment should be initiated with

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“…La scelta dei trattamenti di prima e seconda linea in questa analisi trova fondamento nella considerazione che, sebbene il regime rituximab più bendamustina sia ampiamente utilizzato nella pratica clinica, l'evidenza che ne supporta l'impiego in prima linea nel paziente unfit è di qualità molto bassa (14) con solo 39 pazienti valutabili in un trial clinico. In linea con le più recenti linee guida abbiamo invece considerato il regime rituximab più bendamustina tra le possibili opzioni di seconda linea nei pazienti unfit (11,12).…”

Section: Trattamentiunclassified

Una Valutazione Economica Delle Sequenze Terapeutiche nel Trattamento di Prima Linea Della Leucemia Linfatica Cronica in Pazienti Unfit non Pretrattati

Cuneo¹,

Ravasio²,

Mazzanti

2017

Global & Regional Health Technology Assessment

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Economic evaluation of therapeutic sequences in the treatment of patients with chronic lymphocytic leukemia and coexisting conditions Introduction: Chronic lymphocytic leukemia (CLL) is a chronic lymphoproliferative syndrome and it is the most common hematological malignancy in Western countries. It has a tendency to develop subsequent relapses, so affected patients are likely to undergo more than one line of treatment. Methods: Rather than evaluating the cost-effectiveness of individual therapeutic agents, it becomes therefore recommendable for decision-makers to identify an optimal sequencing of such agents. A four-year cost-consequence analysis was conducted, comparing three alternative strategies for the first-line treatment of patients with previously untreated CLL and coexisting conditions: i) obinutuzumab with chlorambucil (Obi-Clb), ii) rituximab with chlorambucil (Rtx-Clb), and iii) ofatumumab with chlorambucil (Ofa-Clb). Only drug costs were considered in the analysis. Results: In two trials, median time to next treatment (TTNT) was longer in Obi-Clb (51.1 months) as compared toRtx-Clb (38.2 months) or to Ofa-Clb (39.8 months). Therefore, during a 48-month time horizon, patients treated with Obi-Clb would maintain on average the first line treatment; on the contrary, patients treated with Rtx-Clb or with Ofa-Clb would receive on average a second line treatment consisting in the majority of cases of ibrutinib monotherapy, or rituximab with idelalisib or rituximab with bendamustine. The sequence using Obi-Clb regimen in first line showed the lower mean cost of treatment: €22,958 over the 48-month time horizon. Sensitivity analyses on a couple of scenarios provided similar conclusions in terms of overall costs. Conclusion: Obi-Clb as first-line treatment appears a recommendable strategy in terms of drug costs in the treatment of patients with previously untreated CLL and coexisting conditions. Keywords: Chronic lymphocytic leukemia, Cost, Economic, Therapeutic sequences, Obinutuzumab, Time to next treatment IntroduzioneLa leucemia linfatica cronica (Chronic Lymphocytic Leukemia, CLL) è una sindrome linfoproliferativa progressiva (1). L'età media alla diagnosi è di circa 65 anni e meno del 15% dei casi viene diagnosticato prima dei 60 anni (2). La CLL rappresenta la neoplasia ematologica più comune nel mondo occidentale (1). Ogni anno essa colpisce circa 5 persone su 100.000 con un'incidenza che cresce all'aumentare dell'età (2). In Italia si stimano circa 1600 nuovi casi all'anno tra gli uomini e 1150 tra le donne (2).Il decorso della CLL varia da paziente a paziente; in alcuni casi può mantenersi stabile per più di 10 anni e in altri determinare una rapida progressione della malattia. L'identificazione di fattori prognostici e predittivi, fondamentale per la scelta della terapia, viene fatta valutando la stadiazione della malattia e altri parametri biologici quali, ad esempio, il tempo di raddoppiamento del numero dei linfociti, il dosaggio della beta-2 microglobulina, la presenza di delezioni e/o mutazi...

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Appropriate use of bendamustine in first-line therapy of chronic lymphocytic leukemia. Recommendations from SIE, SIES, GITMO Group

Cited by 13 publications

References 42 publications

Prognostic factors and effectiveness of the first-line therapy for chronic lymphocytic leukemia: results of 10-year follow-up

Prognostic factors and effectiveness of the first-line therapy for chronic lymphocytic leukemia: results of 10-year follow-up

Bendamustine and its role in the treatment of unfit patients with chronic lymphocytic leukaemia: a perspective review

Una Valutazione Economica Delle Sequenze Terapeutiche nel Trattamento di Prima Linea Della Leucemia Linfatica Cronica in Pazienti Unfit non Pretrattati

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