Efficacy of a bendamustine and rituximab combination in first-line therapy for chronic lymphocytic leukemia: Results of the BEN-001 study

Stadnik, Elena; Strugov, VV; To, Andreeva; Yv, Virts; Am, Rumyantsev; Mirolyubova, Yuliya; Butylin, Pavel; Ay, Zaritsky

doi:10.17116/terarkh201789757-64

Cited by 3 publications

(2 citation statements)

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“…We also excluded 11 publications that presented EQ-5D results (descriptive system or EQ VAS) without EQ-Index scores. [82][83][84][85][86][87][88][89][90][91][92] Characteristics of the studies included in this review are presented in Figure 2 and Appendix Table 4 in Supplemental Materials (in the following order: leukemias, lymphomas, MM, and other hematologic malignancies [HM]), together with a quality assessment of the included studies in Appendix Table 5 in Supplemental Materials. The list of 77 publications read in full text, but excluded from the review, is presented in Appendix Table 6 in Supplemental Materials.…”

Section: Resultsmentioning

confidence: 99%

EQ-5D–Derived Health State Utility Values in Hematologic Malignancies: A Catalog of 796 Utilities Based on a Systematic Review

Golicki

Jaśkowiak²,

Wójcik³

et al. 2020

Value in Health

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Objectives: We performed a systematic review of health state utility values (HSUVs) obtained using the EQ-5D questionnaire for patients with hematologic malignancies. Methods:The following databases were searched up to September 2018: MEDLINE, EMBASE, The Cochrane Library, and the EQ-5D publications database on the EuroQol website. Additional references were extracted from reviewed articles. Only studies presenting EQ-Index results were incorporated. In view of the heterogeneity across the included publications, we limited ourselves to a narrative synthesis of original HSUVs found.Results: Fifty-nine studies (described in 63 articles) met the inclusion criteria. Data from 21 635 respondents provided 796 HSUV estimates for hematologic malignancy patients. EQ-Index scores ranged from -0.025 to 0.980. The most represented area was multiple myeloma (4 studies, 11 112 patients, and 249 HSUVs). In clinical areas such as chronic myeloid leukemia, acute myeloid leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, and mantle cell lymphoma, we described over 50 health utilities in each. In contrast, we identified only 13 HSUVs (based on 4 studies and the data of 166 patients) for Hodgkin lymphoma. Areas without EQ-5D-based health utilities comprised: polycythemia vera, primary myelofibrosis, essential thrombocythemia, mastocytosis, myeloid sarcoma, chronic myelomonocytic, eosinophilic leukemia, and neutrophilic leukemia. Conclusions:There is a wide range of HSUVs available for hematologic cancer patients with different indications. The review provides a catalog of utility values for use in cost-effectiveness models for hematologic malignancies.

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Section: Resultsmentioning

confidence: 99%

EQ-5D–Derived Health State Utility Values in Hematologic Malignancies: A Catalog of 796 Utilities Based on a Systematic Review

Golicki

Jaśkowiak²,

Wójcik³

et al. 2020

Value in Health

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“…Before the introduction of ibrutinib, chemoimmunotherapy regimens, such as FCR 39 and BR 40 , were standard of care and widely used for patients with CLL. FCR was considered the gold-standard first-line therapy for physically fit young patients with CLL 39,41,42 , and BR was an option for elderly patients with comorbidities 40,43,44 . Unfortunately, patients with del(17p) or TP53 mutations respond poorly to chemoimmunotherapy and typically have short remissions 45 .…”

Section: Ibrutinib and Chemoimmunotherapymentioning

confidence: 99%

Ibrutinib combinations in CLL therapy: scientific rationale and clinical results

Timofeeva

Gandhi

2021

Blood Cancer J.

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Ibrutinib has revolutionized the treatment of chronic lymphocytic leukemia (CLL). This drug irreversibly inhibits Bruton tyrosine kinase (BTK) by covalently binding to the C481 residue in the BTK kinase domain. BTK is a pivotal protein for B cell receptor signaling and tissue homing of CLL cells. Preclinical investigations have established the importance of the B cell receptor pathway in the maintenance and survival of normal and malignant B cells, underscoring the importance of targeting this axis for CLL. Clinical trials demonstrated overall and progression-free survival benefit with ibrutinib in multiple CLL subgroups, including patients with relapsed or refractory disease, patients with 17p deletion, elderly patients, and treatment-naïve patients. Consequently, ibrutinib was approved by the US Food and Drug Administration for newly diagnosed and relapsed disease. Ibrutinib has transformed the treatment of CLL; however, several limitations have been identified, including low complete remission rates, development of resistance, and uncommon substantial toxicities. Further, ibrutinib must be used until disease progression, which imposes a financial burden on patients and society. These limitations were the impetus for the development of ibrutinib combinations. Four strategies have been tested in recent years: combinations of ibrutinib with immunotherapy, chemoimmunotherapy, cell therapy, and other targeted therapy. Here, we review the scientific rationale for and clinical outcome of each strategy. Among these strategies, ibrutinib with targeted agent venetoclax results in high complete response rates and, importantly, high rates of undetectable minimal residual disease. Although we concentrate here on ibrutinib, similar combinations are expected or ongoing with acalabrutinib, tirabrutinib, and zanubrutinib, second-generation BTK inhibitors. Future investigations will focus on the feasibility of discontinuing ibrutinib combinations after a defined time; the therapeutic benefit of adding a third agent to ibrutinib-containing combinations; and profiling of resistant clones that develop after combination treatment. A new standard of care for CLL is expected to emerge from these investigations.

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Ibrutinib in the Treatment of Relapsed Chronic Lymphocytic Leukemia

Stadnik¹,

Тимофеева²,

Strugov³

et al. 2018

Клиническая онкогематология

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РЕФЕРАТЦель. Оценить эффективность ибрутиниба при первых ранних рецидивах хронического лимфолейкоза (ХЛЛ) и у больных, получивших 2 линии и более предшествую-щей терапии. Анализ результатов лечения у пациентов с del(17p), мониторинг минимальной остаточной болезни (МОБ) и профиля безопасности ибрутиниба. Материалы и методы. Анализу подвергнуты результаты терапии ибрутинибом у 31 пациента c ХЛЛ. Бендамустин-и флударабин-содержащие режимы получили 28 чело-век. Медиана линий предшествующей терапии была 2 (диапазон 1-10). Показанием к началу лечения служил первый ранний рецидив (51 %, n = 16) и рецидив после 2 линий и более (49 %, n = 15). Ибрутиниб использовал-ся в монорежиме (n = 15), в комбинации с ритуксимабом (n = 14) и в сочетании с режимом R-BAC (n = 2). Методом FISH del(17p) выявлена у 9 (34 %) пациентов. Результаты. При медиане наблюдения 18 мес. (диапазон 7-42+ мес.) общая выживаемость (ОВ) составила 87 %, выживаемость без прогрессирования (ВБП) -77 %. Наи-более низкая МОБ через 1 год от начала терапии ибрути-нибом отмечалась при комбинированном использовании препарата с режимами иммунохимиотерапии (например, R-BAC). На срок 18 мес. ОВ в группе первых ранних реци-дивов составила 100 %, а в группе после 2 линий терапии и более -66 % (p = 0,02). ВБП на этот же срок наблюдения была значимо выше в группе первых ранних рецидивов (94 %) по сравнению с пациентами с предшествующим ле-чением (60 %) (p = 0,034). Наиболее частые нежелатель-ные явления: геморрагический диатез I-II степени (30 %), диарея I-II степени (10 %), пароксизмы фибрилляции пред-сердий (10 %) и артериальная гипертензия (10 %). У 3 (6 %) пациентов зарегистрированы тяжелые инфекционные ос-ложнения, успешно разрешившиеся на фоне комбиниро-ванной антибактериальной и антимикотической терапии. Заключение. Ибрутиниб эффективен при рецидивах ХЛЛ. Показатели ОВ и ВБП статистически значимо лучше у больных с первыми ранними рецидивами по сравнению с пациентами после 2 и более линий пред-шествующей ибрутинибу терапии. Наиболее глубокая элиминация опухолевого клона наблюдается при ис-пользовании комбинированных режимов иммунохи-миотерапии с ибрутинибом. Отмечалась удовлетвори-тельная переносимость препарата при приемлемом профиле токсичности. Летальных исходов от инфекци-онных осложнений не наблюдалось. ABSTRACTAim. To estimate ibrutinib effi cacy in the treatment of fi rst early CLL relapses and in patients with ≥ 2 lines of preceding therapy. Analysis of treatment results in patients with del(17p) and monitoring of minimal residual disease (MRD) and ibrutinib safety profi le. Materials & Methods. The analysis included the results of ibrutinib treatment in 31 patients with CLL. Twenty eight patients were treated by bendamustine and fl udarabine containing regimens. The median prior treatment lines were 2 (range 1-10). The indications for the treatment initiation were the fi rst early relapse in 51 % of cases (n = 16) and a relapse after 2 and more lines of therapy in 49 % of cases (n = 15). Ibrutinib was administered in mono-(n = 15) and combined therapy (n...

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Efficacy of a bendamustine and rituximab combination in first-line therapy for chronic lymphocytic leukemia: Results of the BEN-001 study

Cited by 3 publications

References 14 publications

EQ-5D–Derived Health State Utility Values in Hematologic Malignancies: A Catalog of 796 Utilities Based on a Systematic Review

EQ-5D–Derived Health State Utility Values in Hematologic Malignancies: A Catalog of 796 Utilities Based on a Systematic Review

Ibrutinib combinations in CLL therapy: scientific rationale and clinical results

Ibrutinib in the Treatment of Relapsed Chronic Lymphocytic Leukemia

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