An Open-Label Expanded-Access Trial of Bendamustine in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia: BEND-ACT

Kouroukis, C. Tom; Crump, Michael; MacDonald, David; Larouche, Jean-François; Stewart, Douglas A.; Johnston, James B.; Sauvageau, Stéphanie; Beausoleil, E.; Sage, Paulette Bioulac; Dubois, Sydney; Christofides, Anna; Clemente, S. Di; Sehn, Laurie H.

doi:10.3747/co.22.2431

Cited by 5 publications

(5 citation statements)

References 34 publications

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“…Indolent lymphomas such as follicular lymphoma, the most frequent, comprise 40% of all NHL subtypes. 2,3) Indolent lymphomas can follow a chronic relapse-remission disease course; thus, patients may receive several different treatments over successive courses. Meanwhile, Mantle-cell lymphoma (MCL), another type of NHL, comprises about 3-10% of all NHL cases and has a worse prognosis than those of other types of NHL.…”

Section: Introductionmentioning

confidence: 99%

Risk Factors for Skin Toxicities Associated with Bendamustine-Based Chemotherapy in Patients with Non-Hodgkin Lymphoma

Uchida

Mori

Akiba

et al. 2020

Biological & Pharmaceutical Bulletin

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Bendamustine plays an especially important role as a treatment for non-Hodgkin lymphoma (NHL). However, patients administered bendamustine alone or in combination with rituximab (BR) may experience drug-associated skin toxicities that can profoundly impact their health-related QOL through both physical discomfort and psychological distress. Moreover, worsening skin symptoms may lead to dose reduction or termination in the management of cancer chemotherapy. We retrospectively investigated patient backgrounds and pretreatment characteristics from medical records of NHL patients treated with bendamustine alone or BR therapy and identified predictive factors for skin toxicities at the start of chemotherapy. Patients were eligible for the study if they were 20 years older, diagnosed with NHL, and received bendamustine alone or BR therapy at the Department of Hematology, Kobe City Medical Center General Hospital, between April 1, 2011, and March 31, 2018. This study included 95 patients with newly diagnosed or refractory or relapsed NHL. Multivariate stepwise logistic regression analysis with backward selection revealed that baseline non-prior chemotherapy (odds ratio (OR), 15.72; 95% confidence interval (CI), 4.24-83.13, p < 0.001) was a significant factor influencing the occurrence of skin toxicity. Our results demonstrated that non-prior chemotherapy was a significant risk factor for skin toxicities in patients with NHL receiving bendamustine alone or BR therapy. No patient experience serious side effects of grade 3 or higher and that bendamustine is very useful as a first-line treatment.

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Section: Introductionmentioning

confidence: 99%

Risk Factors for Skin Toxicities Associated with Bendamustine-Based Chemotherapy in Patients with Non-Hodgkin Lymphoma

Uchida

Mori

Akiba

et al. 2020

Biological & Pharmaceutical Bulletin

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“…In a recent publication describing the use of B‐R treatment in 90 patients with NHL and CLL (BEND‐ACT clinical trial), neutropenia during induction treatment was found in 32% of patients (mostly grade 3 or 4). The LON after the completion of treatment was not reported in this prospective cohort …”

Section: Discussionmentioning

confidence: 70%

Description of late onset neutropenia in indolent lymphoma patients treated with bendamustine plus rituximab

Verrière

Gastaud

Chamorey

et al. 2017

Hematological Oncology

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Bendamustine (B) associated with rituximab (R) is widely described in literature for the management of patients with chronic lymphoid leukaemia (CLL) and indolent non-Hodgkin lymphoma. Safety data regarding late hematotoxicity such as late onset neutropenia (LON) are scarce. The aim of our study was to assess the incidence and to identify risk factors for LON in patients with indolent non-Hodgkin lymphoma and CLL treated with B and R (B-R). One hundred forty five patients were treated with B-R as first or second line. Patients with neutropenia prior induction treatment, treated beyond second line and relapsing within 3 months after the end of induction treatment, were excluded. Patients receiving at least 1 cycle of B-R and having LON during follow-up period were included and considered as eligible for toxicity assessment. A complete blood count was performed 4 weeks after the last cycle of induction treatment and thereafter every 3 months for 1 year. Thirty six patients were identified in our cohort (incidence of 25%), mostly affected by CLL (n = 11) and follicular lymphoma (FL) (n = 15). During follow-up, 84 events of LON were recorded, 61% and 39% were of grades 1/2 and 3/4, respectively. No episode of febrile neutropenia was documented. Amongst 13 of the 15 patients with FL undergoing R maintenance, 8 had treatment discontinuation because of LON. Median time for LON (grade > 2) and time to recovery (grade < 3) were of 11.2 and 17.3 weeks, respectively. One year after B-R induction, LON persisted in 4 patients. The risk of LON was increased both in patients with FL or CLL and performance status >1. The LON in B-R treated patients is clinically relevant. Close clinical and biological follow-up and treatment prophylaxis (eg, valaciclovir and cotrimoxazole) especially for FL patients undergoing maintenance with R monotherapy seems relevant.

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“…Based on data from a population-based cohort study of patients diagnosed with cll in Manitoba between 1998 and 2003, the estimated 5-year survival rate is 80% in men and 85% in women 4 . Despite a promising prognosis, most patients with cll are older and have other comorbidities that limit treatment options 5 . The median age of patients with cll is 72 years, and 75% are 65 years of age or older, with at least 3 other comorbidities 5,6 .…”

Section: Introductionmentioning

confidence: 99%

“…Despite a promising prognosis, most patients with cll are older and have other comorbidities that limit treatment options 5 . The median age of patients with cll is 72 years, and 75% are 65 years of age or older, with at least 3 other comorbidities 5,6 .…”

Section: Introductionmentioning

confidence: 99%

“…For younger patients without del(17p) or a TP53 mutation, the recommended frontline treatment is fludarabine-cyclophosphamide-rituximab (fcr). 2 However, fcr is associated with significant toxicities and is therefore suitable only for patients who are medically fit 5 . For patients more than 65 years of age without del(17p) or TP53 mutation, bendamustine-rituximab (br) is recommended because it is associated with an improved safety profile compared with fcr 2 .…”

Section: Introductionmentioning

confidence: 99%

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Updates from the American Society of Hematology 2019 Annual Meeting: Practice-Changing Studies in Treatment-Naïve Chronic Lymphocytic Leukemia

et al. 2020

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The 2019 annual meeting of the American Society of Hematology took place 7–10 December in Orlando, Florida. At the meeting, results from key studies in treatment-naïve chronic lymphocytic leukemia were presented. Of those studies, phase III oral presentations focused on the efficacy and safety of therapy with Bruton tyrosine kinase (BTK) and B-cell lymphoma-2 (BCL-2) inhibitors. One presentation reported updated results of the ECOG 1912 trial comparing the efficacy and safety of ibrutinib plus rituximab to fludarabine, cyclophosphamide, rituximab in patients with CLL younger than 70 years of age. A second presentation reported interim results of the ELEVATE-TN trial, which is investigating the efficacy and safety of acalabrutinib plus obinutuzumab or acalabrutinib monotherapy versus chlorambucil plus obinutuzumab. A third presentation reported on the single-agent zanubrutinib arm of the SEQUOIA trial in patients with del(17p). The final presentation reported a data update from the CLL14 trial, which is evaluating fixed-duration venetoclax and obinutuzumab versus chlorambucil and obinutuzumab, including the association of minimal residual disease status on progression-free survival. Our meeting report describes the foregoing studies and presents interviews with investigators and commentaries by Canadian hematologists about potential effects on Canadian practice.

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An Open-Label Expanded-Access Trial of Bendamustine in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia: BEND-ACT

Abstract: Background Bendamustine is a bifunctional alkylating agent with unique properties that distinguish it from other

Cited by 5 publications

References 34 publications

Risk Factors for Skin Toxicities Associated with Bendamustine-Based Chemotherapy in Patients with Non-Hodgkin Lymphoma

Risk Factors for Skin Toxicities Associated with Bendamustine-Based Chemotherapy in Patients with Non-Hodgkin Lymphoma

Description of late onset neutropenia in indolent lymphoma patients treated with bendamustine plus rituximab

Updates from the American Society of Hematology 2019 Annual Meeting: Practice-Changing Studies in Treatment-Naïve Chronic Lymphocytic Leukemia

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