Treatment option of bendamustine in combination with rituximab in elderly and frail patients with aggressive B-non-Hodgkin lymphoma: rational, efficacy, and tolerance

Horn, Julia; Kleber, Martina; Hieke, Stefanie; Schmitt‐Gräff, Annette; Wäsch, Ralph; Engelhardt, Monika

doi:10.1007/s00277-012-1503-5

Cited by 29 publications

(26 citation statements)

References 28 publications

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“…However, in both reports, the myelosuppression, due to bone marrow invasion by disease in all patients, and the association with Rituximab could have negatively affected the haematological toxicity. Finally, in a phase II trial in a small cohort of 20 elderly and frail patients affected by Diffuse Large B-Cell Lymphoma (DLBCL), with a mean age of 72 (51–86), Be was administered at a dose of 90 mg/m 2 on days 1 and 2 in association with Rituximab on day 0, every 28 days 43. The relative dose intensity (RDI) was 100%.…”

Section: New Drugsmentioning

confidence: 99%

Hodgkin Lymphoma in Older Patients: An Orphan Disease?

Thyss¹,

Saâda²,

Gastaud³

et al. 2014

Mediterr J Hematol Infect Dis

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Hodgkin Lymphoma HL can be cured in the large majority of younger patients, but prognosis for older patients, especially those with advanced-stage disease, has not improved substantially. The percentage of HL patients aged over 60 ranges between 15% and 35%. A minority of them is enrolled into clinical trials. HL in the elderly have some specificities: more frequent male sex, B-symptoms, advanced stage, sub diaphragmatic presentation, higher percentage of mixed cellularity, up to 50% of advanced cases associated to EBV. Very old age (>70) and comorbidities are factor of further worsening prognosis. Like in younger patients, ABVD is the most used protocol, but treatment outcome remains much inferior with more frequent, severe and sometimes specific toxicities. Few prospective studies with specific protocols are available. The main data have been published by the Italian Lymphoma Group with the VEPEMB schedule and the German Hodgkin Study Group with the PVAG regimen. Recently, the Scotland and Newcastle Lymphoma Study Group published the SHIELD program associating a prospective phase 2 trial with VEPEMB and a prospective registration of others patients. Patients over 60y with early-stage disease received three cycles plus radiotherapy and had 81% of 3-year overall survival (OS). Those with advanced-stage disease received six cycles, with 3-year OS of 66%. The role of geriatric and comorbidity assessment in the treatment’s choice for HL in the elderly is a major challenge. The combination of loss of activities of daily living combined with the age stratification more or less 70y has been shown as a simple and effective survival model. Hopes come from promising new agents like brentuximab-vedotin (BV) a novel antibody-drug conjugate. The use of TEP to adapt the combination of chemotherapy and radiotherapy according to the metabolic response could also be way for prospective studies.

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Section: New Drugsmentioning

confidence: 99%

Hodgkin Lymphoma in Older Patients: An Orphan Disease?

Thyss¹,

Saâda²,

Gastaud³

et al. 2014

Mediterr J Hematol Infect Dis

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“…Thus, with regard to efficacy, the results of our study are comparable to these reports. Due to their retrospective nature, systematically recorded toxicity data are not available for the analyses reported by Walter et al (2012) and Horn et al (2012) precluding a reliable comparison of treatment tolerability.…”

Section: Discussionmentioning

confidence: 99%

Rituximab, bendamustine and lenalidomide in patients with aggressive B‐cell lymphoma not eligible for anthracycline‐based therapy or intensive salvage chemotherapy – SAKK 38/08

et al. 2016

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An increasing number of older patients are suffering from aggressive lymphoma. Effective and more tolerable treatment regimens are urgently needed for this growing patient population. Patients with aggressive lymphoma not eligible for anthracycline-based first-line therapy or intensive salvage regimens were treated with the rituximab-bendamustine-lenalidomide (R-BL) regimen (rituximab 375 mg/m(2) day 1, bendamustine 70 mg/m(2) d 1, 2, lenalidomide 10 mg d 1-21) for six cycles every 4 weeks. Forty-one patients with a median age of 75 (range 40-94) years were enrolled: 33 patients had substantial co-morbidities. 13 patients were not eligible for anthracycline-based first-line chemotherapy, 28 patients had relapsed/refractory disease. The primary endpoint, overall response, was achieved by 25 (61%) patients (95% confidence interval 45-76%). Grade ≥ 3 toxicity comprised haematological (59%), skin (15%), constitutional (15%) and neurological (12%) events. 9 patients died during trial treatment: 5 from lymphoma progression, 2 from toxicity, 2 with sudden death. After a median follow-up of 25·9 (interquartile range 20·4-31·6) months, 13 patients were still alive. Median overall survival was 14·5 months. In conclusion, R-BL can be considered a treatment option for elderly patients with treatment naïve or relapsed/refractory aggressive lymphoma not eligible for standard aggressive regimens.

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“…Bendamustine with or without rituximab has demonstrated efficacy in a wide variety of hematologic malignancies (11), including both treated and untreated CLL (17–19, 33), indolent B-cell NHL and mantle cell lymphoma (MCL) (11, 20, 21, 34–36), aggressive B-cell NHL (37, 38), T-cell lymphomas (35), acute myeloid and lymphocytic leukemia and myelodysplastic syndrome (39), Hodgkin’s lymphoma (40), and multiple myeloma (41–43). In many of these settings it has demonstrated safety and efficacy in heavily pretreated patients and in older populations without major toxicities.…”

Section: Discussionmentioning

confidence: 99%

“…Although detailed accounts of excessive toxicity with the higher dose level have not been published, more recently reported trials have employed the intermediate dose level of 90 mg/m 2 /dose every 4 weeks for 6 cycles for untreated CLL (18) and untreated or relapsed aggressive NHL (37). This dose and schedule in combination with bortezomib was also used for relapsed indolent NHL and MCL (21) and for multiple myeloma (41).…”

Section: Discussionmentioning

confidence: 99%

Bendamustine and Rituximab in Relapsed and Refractory Hairy Cell Leukemia

Burotto

Stetler‐Stevenson

Arons

et al. 2013

Clinical Cancer Research

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Purpose To determine tolerability and for the first time explore efficacy of bendamustine plus rituximab (BR) in multiply relapsed/refractory hairy cell leukemia (HCL), using 2 different dose levels of bendamustine. Experimental design HCL patients with ≥2 prior therapies requiring treatment received rituximab 375 mg/m2 days 1 and 15, plus bendamustine 70 (n=6) or 90 (n=6) mg/m2, days 1 and 2, for 6 cycles at 4-week intervals. Results At 70 and 90 mg/m2/dose of bendamustine, overall response rate was 100%, with 3 (50%) and 4 (67%) complete remissions (CR) in each respective group. Minimal residual disease (MRD) was absent in 67% and 100% of CRs, respectively. All 6 without MRD remain in CR at 30–35 (median 31) months of follow-up. Soluble CD22 and CD25 levels decreased with all responses, with median values decreasing from 17.7 and 42 ng/ml at baseline to undetectable and 2 ng/ml after CR, respectively (p<0.001). Of 12 patients receiving 72 cycles of BR, the most common toxicities were hematologic, including thrombocytopenia (83%), lymphopenia (75%), leukopenia (58%) and neutropenia (42%). Grade 3–4 hematologic toxicity included lymphopenia and thrombocytopenia (each 75%), leukopenia (58%), and neutropenia (25%). No significant dose-related differences were detected in response or toxicity. Conclusion BR has significant activity in HCL. Bendamustine at either 70 or 90 mg/m2/dose was highly effective in multiply relapsed/refractory HCL, and could be considered for achieving durable CRs without MRD in patients after failure of standard therapies. Since it was not dose-limiting, 90 mg/m2/dose was chosen for future testing.

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Treatment option of bendamustine in combination with rituximab in elderly and frail patients with aggressive B-non-Hodgkin lymphoma: rational, efficacy, and tolerance

Cited by 29 publications

References 28 publications

Hodgkin Lymphoma in Older Patients: An Orphan Disease?

Hodgkin Lymphoma in Older Patients: An Orphan Disease?

Rituximab, bendamustine and lenalidomide in patients with aggressive B‐cell lymphoma not eligible for anthracycline‐based therapy or intensive salvage chemotherapy – SAKK 38/08

Bendamustine and Rituximab in Relapsed and Refractory Hairy Cell Leukemia

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