Outcomes of patients with relapsed aggressive adult T-cell leukemia-lymphoma: clinical effectiveness of anti-CCR4 antibody and allogeneic hematopoietic stem cell transplantation

Fuji, Shigeo; Utsunomiya, Atae; Inoue, Yoshitaka; Miyagi, Takashi; Owatari, Satsuki; Sawayama, Yasushi; Moriuchi, Yukiyoshi; Choi, Ilseung; Shindo, Takero; Yoshida, Shigeo; Yamasaki, Satoshi; Yamaguchi, Takuhiro; Fukuda, Takahiro

doi:10.3324/haematol.2017.184564

Cited by 28 publications

(31 citation statements)

References 13 publications

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“…This could possibly be due to the inclusion of patients with poor conditions such as unfavorable laboratory findings, PS of 3‐4, and poor response to prior therapy, as this postmarketing surveillance did not have prespecified eligibility criteria for patients unlike the prospective clinical trial. According to retrospective studies analyzing data from clinical practice for patients with r/r ATL who received various treatments, including mogamulizumab, the median OS was reported to be within the range of 3.9‐5.4 months, which was consistent with our results. Of note, some of the previous publications suggested a survival benefit of mogamulizumab in patients who received mogamulizumab therapy compared with those who did not based on the result from the subgroup analyses; however, the sample sizes of the mogamulizumab‐treated populations in these studies were small (<100 patients).…”

Section: Discussionsupporting

confidence: 90%

“…According to retrospective studies analyzing data from clinical practice for patients with r/r ATL who received various treatments, including mogamulizumab, the median OS was reported to be within the range of 3.9‐5.4 months, which was consistent with our results. Of note, some of the previous publications suggested a survival benefit of mogamulizumab in patients who received mogamulizumab therapy compared with those who did not based on the result from the subgroup analyses; however, the sample sizes of the mogamulizumab‐treated populations in these studies were small (<100 patients). In addition, some articles have demonstrated that mogamulizumab administration before allogeneic HSCT may be associated with increased risks of severe GVHD.…”

Section: Discussionsupporting

confidence: 90%

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Safety and effectiveness of mogamulizumab in relapsed or refractory adult T‐cell leukemia‐lymphoma

Ishitsuka

Yurimoto

Tsuji

et al. 2019

European J of Haematology

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ObjectiveThis prospective, observational, postmarketing surveillance was conducted to evaluate the safety and effectiveness of mogamulizumab, an anti‐CC chemokine receptor 4 (CCR4) monoclonal antibody, in patients with CCR4‐positive, relapsed or refractory (r/r) adult T‐cell leukemia‐lymphoma (ATL) in Japan.MethodAll patients were scheduled to receive intravenous infusions of mogamulizumab 1.0 mg/kg once weekly for 8 weeks, alone or in combination with other modalities.ResultsIn the safety analysis population comprising 572 patients, mogamulizumab therapy was started between May 29, 2012, and April 30, 2013, and adverse drug reactions (ADRs) were reported in 73.4% (38.6% serious cases) of patients. The most common ADRs were skin disorders (33.2% [10.8% serious cases]), infusion‐related reactions (30.1% [4.7% serious cases]), and infections (22.0% [14.7% serious cases]). In the effectiveness analysis population comprising 523 patients, the best overall response rate and the response rate at the end of therapy were 57.9% and 42.0%, respectively. The median overall survival was 5.5 months. Safety and effectiveness results were similar between patients aged ≥70 and <70 years.ConclusionThis postmarketing surveillance confirmed the safety and effectiveness of mogamulizumab for the treatment of patients with r/r ATL, including elderly patients, in clinical practice.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 90%

Safety and effectiveness of mogamulizumab in relapsed or refractory adult T‐cell leukemia‐lymphoma

Ishitsuka

Yurimoto

Tsuji

et al. 2019

European J of Haematology

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“…Once relapsed, conventional salvage chemotherapy is usually ineffective in patients with ATL, as it is often ineffective in relapsed PTCL in general . Therefore, it is important to offer up‐front allo‐HSCT while ATL is under control with induction chemotherapy, because disease status at the time of allo‐HSCT is an important prognostic factor …”

Section: Other Types Of T‐cell Lymphomamentioning

confidence: 99%

Hematopoietic stem cell transplantation for T-cell lymphoma

Shichijo

Fuji

2018

Adv Cell Gene Ther

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As peripheral T-cell lymphomas (PTCL) are rare and heterogeneous groups of non-Hodgkin lymphomas, it is practically difficult to conduct randomized controlled trials to establish standard treatment strategies. There is still no consensus regarding the optimal treatment strategy for patients with PTCL. Moreover, the survival outcomes of PTCL, excluding anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma, remain disappointing although novel agents have become available recent years. The aim of this review is to summarize the information regarding hematopoietic stem cell transplantation (HSCT) for PTCL including both autologous (auto-) and allogeneic (allo-) HSCT. In the first-line setting, up-front auto-HSCT is generally recommended for patients with PTCL, especially with complete remission 1 (CR1). On the other hand, up-front allo-HSCT might be recommended for patients with highrisk PTCL, although the study incorporating up-front allo-HSCT is limited. In the salvage setting, auto-HSCT might be considered in patients with chemosensitive disease, especially with CR. Allo-HSCT might also be considered, although the data of allo-HSCT in the salvage setting is still limited. Further investigation to optimize the application of HSCT in patients with PTCL is warranted in the future.

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“…Patients with aggressive ATL have a dismal outcome following intensive chemotherapy . Allogeneic hematopoietic stem cell transplantation (allo‐HSCT) is a promising treatment option for patients with aggressive ATL, as previously reported . However, the clinical outcome after allo‐HSCT for ATL is still unsatisfactory, mainly due to a high risk of relapse or progression of ATL.…”

Section: Introductionmentioning

confidence: 97%

Does an increased probability of graft‐vs‐host disease improve the survival of patients with adult T‐cell leukemia‐lymphoma? A simulation analysis using a Markov model

Fuji¹,

Kurosawa²,

Inamoto³

et al. 2019

Adv Cell Gene Ther

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Adult T-cell leukemia-lymphoma (ATL) is a peripheral T-cell lymphoma caused by human T-cell lymphotropic virus type I. Previous retrospective studies suggested the presence of graft-vs-ATL (GV-ATL) effects associated with acute graft-vs-host disease (GVHD), which suggests that intentional induction of acute GVHD to facilitate the efficacy of GV-ATL effects might reduce the risk of relapse and contribute to improved survival after allogeneic hematopoietic stem cell transplantation. However, it is impractical to conduct a prospective study to assess the benefit of intentional induction of acute GVHD. In a simulation analysis using a Markov model, we assessed the impact on overall survival (OS) of changing the probability of overall acute GVHD and severe acute GVHD. When the probability of grade III-IV acute GVHD changed 5 | CLINIC AL IMPLIC ATION 1. Based on the simulation results, preventive management of grade III-IV acute GVHD is mandatory to achieve the clinical benefit associated with grade I-II GVHD in allogeneic HSCT for ATL. 2.A simulation analysis like Markov model is commonly used in the setting of cost-effective analysis, but not in other settings.However, as shown in this paper, such simulation analyses might be useful in the clinical situation where prospective RCTs are practically inappropriate. ACK N OWLED G M ENTS

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Outcomes of patients with relapsed aggressive adult T-cell leukemia-lymphoma: clinical effectiveness of anti-CCR4 antibody and allogeneic hematopoietic stem cell transplantation

Cited by 28 publications

References 13 publications

Safety and effectiveness of mogamulizumab in relapsed or refractory adult T‐cell leukemia‐lymphoma

Safety and effectiveness of mogamulizumab in relapsed or refractory adult T‐cell leukemia‐lymphoma

Hematopoietic stem cell transplantation for T-cell lymphoma

Does an increased probability of graft‐vs‐host disease improve the survival of patients with adult T‐cell leukemia‐lymphoma? A simulation analysis using a Markov model

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