Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström’s Macroglobulinemia

Dimopoulos, Meletios A.; Tedeschi, Alessandra; Trotman, Judith; García‐Sanz, Ramón; Macdonald, D. Blair; Leblond, Véronique; Mahé, Béatrice; Herbaux, Charles; Tam, Constantine S.; Orsucci, Lorella; Palomba, M. Lia; Matous, Jeffrey; Shustik, Chaim; Kastritis, Efstathios; Treon, Steven P.; Li, Jianling; Salman, Zeena; Graef, Thorsten; Buske, Christian

doi:10.1056/nejmoa1802917

Cited by 308 publications

(289 citation statements)

References 27 publications

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“…Recently, the phase III randomized trial comparing ibrutinib plus rituximab or placebo plus rituximab showed a longer PFS in patients treated with the combination (82% vs 28% at 30 months) . After a median follow‐up of 26.5 months, the best response rate resulted significantly higher with the combination treatment (92% vs 47%, P < 0.001).…”

Section: Monoclonal Gammopathy Of Undetermined Significance (Mgus)mentioning

confidence: 99%

Diagnostic framing of IgM monoclonal gammopathy: Focus on Waldenström macroglobulinemia

Tedeschi

Conticello

Rizzi

et al. 2018

Hematological Oncology

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The finding of an IgM monoclonal gammopathy often represents a diagnostic challenge. In fact, there are many pathological disorders associated with this condition, each of which has distinctive characteristics and requires specific clinical, instrumental, and laboratory assessments to set the appropriate treatment. This review has two aims. Firstly, to provide a framework of the broad spectrum of IgM-associated disorders: (1) monoclonal gammopathy of undetermined significance (MGUS); (2) Waldenström macroglobulinemia (WM); (3) IgM-related disorders (among which hyperviscosity syndrome, light chain amyloidosis, cold agglutinin disease, cryoglobulinaemia, IgM neuropathy, Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome, Castleman disease); (4) IgM-secreting multiple myeloma (IgM-MM); and (5) other lymphoproliferative disorders which may be associated with IgM (such as chronic lymphocytic leukemia, small lymphocytic lymphoma, and B-cell non Hodgkin lymphoma). Secondly, to give a detailed insight regarding diagnosis and treatment of WM.

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Section: Monoclonal Gammopathy Of Undetermined Significance (Mgus)mentioning

confidence: 99%

Diagnostic framing of IgM monoclonal gammopathy: Focus on Waldenström macroglobulinemia

Tedeschi

Conticello

Rizzi

et al. 2018

Hematological Oncology

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“…The current meta‐analysis involves mostly patients receiving chemoimmunotherapy or anti‐CD20 monoclonal antibodies. Many novel agents for the treatment of hematological malignancies have been developed in the past decade and have shown promising results . The risk of HBV reactivation with these agents is currently unknown, and hence we usually monitor HBV DNA levels regularly during treatment so that we can rapidly implement preemptive antiviral treatment at the first sign of reactivation.…”

Section: Discussionmentioning

confidence: 99%

“…The small molecule Bruton's tyrosine kinase (BTK) inhibitors, for example, ibrutinib, have shown promising results in the treatment of lymphoma and chronic lymphocytic leukemia . These agents block B‐cell antigen receptor signaling, which prevents the growth of malignant B cells and induces apoptosis .…”

Section: Discussionmentioning

confidence: 99%

Prevention of hepatitis B virus reactivation in patients with hematological malignancies and resolved hepatitis B virus infection: a systematic review and meta‐analysis

Cheung

Law

Chao

et al. 2020

J of Digest Diseases

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Objective Patients with resolved hepatitis B virus (HBV) infection are at risk of HBV reactivation during treatment for hematological malignancies. We conducted a systematic review and meta‐analysis of the data on the efficacy of antiviral prophylaxis for the prevention of HBV reactivation in this group of patients. Methods We conducted a systemic literature search of PubMed including MEDLINE and EMBASE databases to 31 January 2019 to identify studies published in English comparing antiviral prophylaxis with no prophylaxis for HBV reactivation in patients treated for hematological malignancies. The search terms used were (“occult hepatitis B” OR “resolved hepatitis B”) AND (“reactivation”) AND (“haematological malignancy” OR “hematological malignancy” OR “chemotherapy” OR “immunotherapy” OR “chemoimmunotherapy” OR “lymphoma” OR “leukemia” OR “transplant”). The primary outcome was the reactivation of HBV infection. Pooled estimates of relative risk (RR) were calculated. Results We identified 13 relevant studies including two randomized controlled trials (RCT), one post hoc analysis from RCT and 10 cohort studies. There was a trend towards a lower rate of HBV reactivation using antiviral prophylaxis, but the difference was not significant (RR 0.57, 95% confidence interval [CI] 0.23–1.40, P = 0.22). When limiting the analysis to the three prospective studies of patients receiving anti‐CD20 monoclonal antibodies, we found antiviral prophylaxis was associated with a significantly lower risk of HBV reactivation (RR 0.17, 95% CI 0.06–0.49, P = 0.001). Conclusion Antiviral prophylaxis reduced the risk of HBV reactivation in patients receiving anti‐CD20 monoclonal antibodies for hematological malignancies but not in a broader group of patients receiving anticancer therapy.

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“…There are scant data comparing outcomes between patients treated with rituximab alone or in combination. The recently published INNOVATE study showed deeper responses and higher 30‐month PFS rates with the combination of ibrutinib and rituximab versus placebo and rituximab (Dimopoulos et al , ). However, in this large randomized study, no OS difference could be detected between the groups.…”

Section: Clinical Characteristics At Diagnosis and At Primary Therapymentioning

confidence: 99%

“…With a 10‐year OS rate of 86% in young WM patients, one could argue that OS might not be an optimal outcome of interest in these patients. Not surprisingly, OS benefits have not been apparent with any intervention in population‐based or randomized studies (Olszewski et al , ; Dimopoulos et al , ). Despite the limitations of this study (i.e.…”

Section: Clinical Characteristics At Diagnosis and At Primary Therapymentioning

confidence: 99%

Long survival in patients with Waldenström macroglobulinaemia diagnosed at a young age

et al. 2018

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Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström’s Macroglobulinemia

Cited by 308 publications

References 27 publications

Diagnostic framing of IgM monoclonal gammopathy: Focus on Waldenström macroglobulinemia

Diagnostic framing of IgM monoclonal gammopathy: Focus on Waldenström macroglobulinemia

Prevention of hepatitis B virus reactivation in patients with hematological malignancies and resolved hepatitis B virus infection: a systematic review and meta‐analysis

Long survival in patients with Waldenström macroglobulinaemia diagnosed at a young age

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