A phase 2 study of rituximab plus lenalidomide for mucosa-associated lymphoid tissue lymphoma

Kiesewetter, Barbara; Willenbacher, Ella; Willenbacher, Wolfgang; Egle, Alexander; Neumeister, Peter; Voskova, Daniela; Mayerhoefer, Marius E.; Simonitsch‐Klupp, Ingrid; Melchardt, Thomas; Greil, Richard; Raderer, Markus

doi:10.1182/blood-2016-06-720599

Cited by 53 publications

(45 citation statements)

References 16 publications

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“…Consistent with prior data on R monotherapy, the CR rate of 50% appeared lower than remission rates achieved with chemotherapy‐containing strategies in MALT lymphoma; however, it is very much in line with our experience with further immunomodulatory treatment approaches for this distinct disease, i. e., bortezomib‐ or lenalidomide‐based treatment . While follow‐up is currently short at 25 months, only 1 patient has relapsed so far, suggesting durable responses in the majority of patients.…”

Section: Discussionsupporting

confidence: 90%

“…Proteasome inhibitor bortezomib has been evaluated in different treatment schedules and resulted in overall response rates (ORRs) up to 80% but substantial toxicities were reported including a high incidence of grades III to IV neutropenia requiring dose reduction in the majority of patients and more than 65% of treated subjects developing peripheral neuropathy . Lenalidomide has recently been assessed +/− addition of R and achieved a response rate of 80% (95% CI, 69‐92) in the R‐combination trial with 50% complete remissions (CRs) and acceptable toxicity . Further current concepts investigate the activity of clarithromycin independently of HP status in advanced MALT lymphoma based on the assumption that this compound combines both immunomodulatory and direct tumor‐suicidal effects.…”

Section: Introductionmentioning

confidence: 99%

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A pilot phase II study of ofatumumab monotherapy for extranodal marginal zone B‐cell lymphoma of the mucosa‐associated lymphoid tissue (MALT) lymphoma

Kiesewetter

Neuper

Mayerhoefer

et al. 2017

Hematological Oncology

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These are the final results of the Ofatumumab in MALT lymphoma study (O‐MA 1), a pilot phase II trial evaluating the capacity and safety of ofatumumab to induce objective responses in patients with Helicobacter pylori eradication refractory or extragastric MALT lymphoma. Ofatumumab was given at 4 weekly doses (1000 mg) followed by 4 doses at 2‐month intervals starting at week 8. According to protocol, a total of 16 patients were recruited (median age 69 years; range 38‐85). Thirty one percent (5/16) of patients had primary gastric MALT lymphoma while the remaining 69% (11/16) presented with extragastric manifestations. Seventy‐five percent (12/16) had localized lymphoma and 4 patients disseminated disease. The overall response rate to treatment with ofatumumab was 81% (13/16), with the median time to best response being 5.5 months. In detail, 50% (8/16) achieved complete remission; 31% (5/16), partial remission; and 19% (3/16), disease stabilization as best response. However, 1 patient with gastric lymphoma and complete remission at second restaging had a relapse at final assessment but ongoing complete remission during further follow‐up. Tolerability was excellent accept low‐grade infusion reactions occurring in 86% (14/16). At a median follow‐up time of 25 months only 1 patient has relapsed suggesting durable responses in the majority of patients. This pilot trial shows clearly that ofatumumab is active and safe for the treatment of MALT lymphoma.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

A pilot phase II study of ofatumumab monotherapy for extranodal marginal zone B‐cell lymphoma of the mucosa‐associated lymphoid tissue (MALT) lymphoma

Kiesewetter

Neuper

Mayerhoefer

et al. 2017

Hematological Oncology

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“…As LEN is currently not approved for the treatment of extranodal MZL in Austria, all patients were treated within phase II trials approved by the ethical committee of the Medical University of Vienna and so was the current retrospective analysis. Initial outcome of treatment/studies has been published as referenced, but the current investigation assessed only those patients treated and followed at our center, excluding patients from the multicenter AGMT‐MALT2 trial managed at other institutions. Current (follow‐up) data have been extracted from electronical and/or paper‐based medical records routinely captured and stored at the Medical University of Vienna.…”

Section: Methodsmentioning

confidence: 99%

Prolonged follow‐up on lenalidomide‐based treatment for mucosa‐associated lymphoid tissue lymphoma (MALT lymphoma)—Real‐world data from the Medical University of Vienna

Kiesewetter

Lamm

Neuper

et al. 2019

Hematological Oncology

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Based on results of two pilot trials, lenalidomide (LEN) was found to be active and safe as monotherapy and showed an increased response rate of 80% in combination with rituximab (R) for patients with mucosa‐associated lymphoid tissue (MALT) lymphoma. While initial results were promising, there are currently no data on long‐term outcome, and larger international phase II/III trials on LEN for indolent lymphoma lack specific subgroup analyses. Thus, we have systematically analyzed 50 patients treated with LEN‐based therapy (LEN‐monotherapy n = 16, R‐LEN n = 34) at the Medical University of Vienna 2009 to 2019 and investigated long‐term outcome and relapse patterns. At a follow‐up of more than 5 years (median 68 months), 54% of patients are free of relapse, and estimated median progression‐free survival (PFS) was 72 months (95%CI 49‐96). There was no difference in PFS according to stage of disease, i.e. localized versus disseminated disease (P = .67) and previous systemic treatment (P = .16). Interestingly, but with the caveat of the limited number of patients included in this series, primary extragastric disease had a superior PFS compared with gastric lymphoma (P = .04) and also depth of response, i.e. complete or partial response versus stable disease was associated with significantly prolonged PFS (P = .01). We documented four patients (8%) with pronounced improvement of response during follow‐up including three patients initially rated as partial remission and finally achieving complete remission at 12 to 32 months. This highlights the potential of delayed responses to LEN treatment. Estimated overall survival at 5 years was excellent at 92%. These “real‐world” data confirm long‐term activity of LEN in MALT lymphoma.

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“…Ibrutinib was offered as a single agent to treat MALT lymphoma based on a recent multicentre, open label study 15. Also, rituximab and lenalidomide were considered as a treatment for MALT lymphoma based on a phase 2 multicentre study, however, the patient and her family declined any further treatment after a thorough multidisciplinary discussion on prognosis 16. The patient received palliative measures after withdrawal of all invasive interventions.…”

Section: Outcome and Follow-upmentioning

confidence: 99%

Nodular pulmonary amyloidosis: a complex disease with malignancy association

Core

Alsaad²,

Jiang

et al. 2017

BMJ Case Reports

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Pulmonary amyloidosis is a rare disease that incorporates deposition of amyloid microfibril material in the lung parenchyma. The condition generally presents as an indolent subacute-to-chronic pulmonary disease and requires tissue biopsy to establish the diagnosis. Nodular pulmonary amyloidosis, a subtype of pulmonary amyloidosis, is characterised by special radiographic and pathological features. While the disease can be associated with inflammatory conditions; its association with mucosal-associated lymphoid tissue (MALT lymphoma) is unusual and carries management challenges. Herein, we illustrate a case study of nodular pulmonary amyloidosis associated with underlying MALT lymphoma in a patient with known systemic lupus erythematosus. The aim of this article is to share the management experience of this complex condition with the medical community and to conduct an up-to-date literature review on nodular pulmonary amyloidosis.

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A phase 2 study of rituximab plus lenalidomide for mucosa-associated lymphoid tissue lymphoma

Cited by 53 publications

References 16 publications

A pilot phase II study of ofatumumab monotherapy for extranodal marginal zone B‐cell lymphoma of the mucosa‐associated lymphoid tissue (MALT) lymphoma

A pilot phase II study of ofatumumab monotherapy for extranodal marginal zone B‐cell lymphoma of the mucosa‐associated lymphoid tissue (MALT) lymphoma

Prolonged follow‐up on lenalidomide‐based treatment for mucosa‐associated lymphoid tissue lymphoma (MALT lymphoma)—Real‐world data from the Medical University of Vienna

Nodular pulmonary amyloidosis: a complex disease with malignancy association

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