Fatal reactivation of hepatitis B virus infection in a patient with adult T‐cell leukemia–lymphoma receiving the anti‐CC chemokine receptor 4 antibody mogamulizumab

Ifuku, H; Kusumoto, Shigeru; Tanaka, Yasuhito; Totani, Haruhito; Ishida, Takashi; Okada, Masaya; Murakami, Shuko; Mizokami, Masashi; Ueda, Ryuzo; Iida, Shinsuke

doi:10.1111/hepr.12513

Cited by 49 publications

(26 citation statements)

References 32 publications

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“…However, long‐term, follow‐up information on the OS and the PFS of patients who received mogamulizumab remains unclear. In addition, useful biomarkers predicting the therapeutic efficacies of mogamulizumab remain unidentified, whereas fatal AE caused by mogamulizumab have been reported in some patients . Herein, we report an up‐to‐date, follow‐up analysis of our prior two prospective clinical trials of mogamulizumab.…”

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confidence: 99%

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Mogamulizumab for relapsed adult T‐cell leukemia–lymphoma: Updated follow‐up analysis of phase I and II studies

Ishida¹,

Utsunomiya²,

Jo³

et al. 2017

Cancer Science

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The present study sought to elucidate the prognosis of adult T‐cell leukemia–lymphoma (ATL) patients receiving mogamulizumab, a defucosylated anti‐CCR4 monoclonal antibody. Progression‐free survival (PFS) and overall survival (OS) of ATL patients enrolled in two studies are herein updated, namely NCT00355472 (phase I study of mogamulizumab in relapsed patients with ATL and peripheral T‐cell lymphoma) and NCT00920790 (phase II study for relapsed ATL). Of 13 patients with relapsed aggressive ATL in the phase I study, four (31%) survived >3 years. For 26 relapsed patients with aggressive ATL in the phase II study, median PFS was 5.2 months and 1‐year PFS was 26%, whereas median OS was 14.4 months, and 3‐year OS was 23%. For patients without a rash or who developed a grade 1 rash only, median PFS was 0.8 months, and 1‐year PFS was zero, with a median OS of 6.0 months, and 3‐year OS of 8%. In contrast, for patients who developed a rash ≥grade 2, median PFS was 11.7 months, and 1‐year PFS was 50%, with a median OS of 25.6 months, and 3‐year OS of 36%. Thus, we conclude that mogamulizumab monotherapy may improve PFS and OS in some patients with relapsed aggressive ATL, especially those who develop a skin rash as a moderate immune‐related adverse event. Therefore, further investigation is warranted to validate the present observations and to clarify the mechanisms involved in the activity of mogamulizumab.

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confidence: 99%

“…In addition, useful biomarkers predicting the therapeutic efficacies of mogamulizumab remain unidentified, whereas fatal AE caused by mogamulizumab have been reported in some patients. (17,18) Herein, we report an up-to-date, follow-up analysis of our prior two prospective clinical trials of mogamulizumab. Patients and study design.…”

mentioning

confidence: 99%

Mogamulizumab for relapsed adult T‐cell leukemia–lymphoma: Updated follow‐up analysis of phase I and II studies

Ishida¹,

Utsunomiya²,

Jo³

et al. 2017

Cancer Science

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“…Major/frequent toxicities reported include cytopenias which are generally not dose-limiting, cytokine-like infusion reactions, skin rash (including a case of Stevens-Johnson syndrome), and there have been case reports of more serious/fatal complications such as lethal hepatitis b reactivation despite antiviral prophylaxis, opportunistic infections including lethal CMV reactivation and panbronchiolitis [31][32][33].…”

Section: Mogamulizumabmentioning

confidence: 99%

Targets, Toxins, and T Cells—a Review of New Monoclonal Antibodies in the Treatment of Peripheral T Cell Lymphomas

Hebb

Kohrt

2015

Curr Hematol Malig Rep

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The peripheral T cell lymphomas (PTCLs) are a heterogeneous group of neoplasms for which standardized treatment approaches remain elusive. A number of new therapeutic agents have become available, of which monoclonal antibodies (MAbs) represent a powerful tool for targeted treatment of PTCLs. Therapeutic MAbs vary in their structure, targets, and mechanisms of action. Common mechanisms of action include antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, direct apoptosis, blocking of receptors or signaling pathways, delivery of cytotoxic agents to tumor cells, and binding to and blocking biologically active molecules. This review will focus on recent published evidence for the various MAbs used in the treatment of PTCLs. The results overall have been very promising, and the future will see more trials with these antibodies alone and in various therapy combinations, as well as newer ones with novel modifications, conjugates, and targets.

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“…7,8 Studies have documented fulminant liver failure among patients for whom latent HBV virus was reactivated during chemotherapy, including in cases where modern targeted therapies were used. 9,10,11 Acute reactivation of HCV following chemotherapy has been documented. 12 The rates of viral prevalence among those with cancer are largely unknown.…”

Section: Introductionmentioning

confidence: 99%

Stepwise Development of a Cancer Care Delivery Research Study to Evaluate the Prevalence of Virus Infections in Cancer Patients

et al. 2016

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Background:SWOG initiated a cancer care delivery research study of virus infection rates among newly diagnosed cancer patients. This study will inform viral screening guidelines in oncology clinics.Methods:In a first step ‘vanguard’ phase, we evaluated the feasibility of multiple study procedures. Site investigators were surveyed to obtain feedback on study implementation.Results:Much higher enrollment occurred at sites where all physicians participated and viral testing was performed as routine practice. These procedures will be required going forward. Additional protocol changes based on site investigator input were implemented.Conclusion:This multistep protocol design process illustrates how cancer care delivery research studies can adapt to real-world strategies and procedures that exist at community clinics where the predominance of cancer patients are treated.

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Fatal reactivation of hepatitis B virus infection in a patient with adult T‐cell leukemia–lymphoma receiving the anti‐CC chemokine receptor 4 antibody mogamulizumab

Cited by 49 publications

References 32 publications

Mogamulizumab for relapsed adult T‐cell leukemia–lymphoma: Updated follow‐up analysis of phase I and II studies

Mogamulizumab for relapsed adult T‐cell leukemia–lymphoma: Updated follow‐up analysis of phase I and II studies

Targets, Toxins, and T Cells—a Review of New Monoclonal Antibodies in the Treatment of Peripheral T Cell Lymphomas

Stepwise Development of a Cancer Care Delivery Research Study to Evaluate the Prevalence of Virus Infections in Cancer Patients

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