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Multicenter Study
. 2025 Jul;122(1):83-92.
doi: 10.1007/s12185-025-03963-9. Epub 2025 Mar 11.

Effects of tucidinostat in adult T-cell leukemia/lymphoma in clinical practice

Ayako Kamiunten  1 , Takuro Kameda  2 , Masaaki Sekine  3 , Hiroshi Kawano  3 , Takanori Toyama  4 , Keiichi Akizuki  1 , Noriaki Kawano  5 , Kouichi Maeda  6 , Seiichi Sato  6 , Masanori Takeuchi  7 , Junzo Ishizaki  7 , Koshiro Nagamine  1 , Ayuka Kuroki  1 , Ryoma Ikeda  1 , Kengo Matsumoto  1 , Masayoshi Karasawa  1 , Yuki Tahira  1 , Taisuke Uchida  1 , Haruko Shimoda  1 , Tomonori Hidaka  1 , Kiyoshi Yamashita  5 , Hideki Yamaguchi  1 , Yoko Kubuki  1 , Kazuya Shimoda  1 , Kotaro Shide  1
Affiliations
Multicenter Study

Effects of tucidinostat in adult T-cell leukemia/lymphoma in clinical practice

Ayako Kamiunten et al. Int J Hematol. 2025 Jul.

Abstract

Adult T-cell leukemia/lymphoma (ATL) is a peripheral T-cell malignancy with a poor prognosis. We conducted a retrospective study across six institutions in Miyazaki Prefecture, Japan, to assess the efficacy of tucidinostat in patients with relapsed/refractory ATL who had not undergone transplantation. Between October 2021 and July 2023, 24 patients aged 41 to 88 years (median, 73.4 years) who had undergone prior therapies, including intensive chemotherapy (79.2%) and mogamulizumab immunotherapy (79.2%), received tucidinostat. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated as key outcomes. ORR and DCR reached 54.2% and 91.7%, respectively. The median PFS was 3.95 months, and OS was 8.04 months, which were not inferior to the results of a phase IIb study. The influential factors for PFS were age ≥ 75 years and high soluble IL-2 receptor (sIL-2R) levels above 5000 U/mL at the start of treatment. Favorable patients without these factors achieved a PFS of 11.4 months. Treatment-related adverse events were mainly hematologic but were managed over the course of treatment. Our findings indicate that tucidinostat provides survival benefits in patients with relapsed/refractory ATL in clinical practice and highlight key clinical factors for better outcomes.

Keywords: Adult T-cell leukemia/lymphoma; HDAC inhibitor; Tucidinostat.

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Conflict of interest statement

Declarations. Conflict of interest: K. Shimoda received consulting fees from Novartis Pharma, Takeda Pharmaceutical, and Bristol-Myers, all outside the submitted work, and received research grants from Perseus Proteomics, Pharma Essentia Japan KK, AbbVie GK, Astellas Pharma, MSD, Chugai Pharmaceutical, Kyowa Kirin, Pfizer, Novartis Pharma, Otsuka Pharmaceutical, Meiji Seika Pharma, and Asahi Kasei Medical, all outside the submitted work.

Figures

Fig. 1
Fig. 1
Treatment details and clinical courses of patients who received tucidinostat therapy. Swimmer plots showing treatment doses, treatment discontinuation, salvage therapy, and clinical outcomes. Horizontal bars indicate different doses of tucidinostat: 20, 30, and 40 mg BIW (twice weekly). Blue bars indicate salvage therapy. Circles and triangles represent patient responses, including complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). Blue lines indicate the duration of response. X indicates an adverse event. + indicates patient death. Arrows indicate the continuation of tucidinostat therapy. The table on the left shows the clinical information at the start of tucidinostat treatment and the best response achieved for each patient
Fig. 2
Fig. 2
Survival outcomes following tucidinostat therapy. A Progression-free survival (PFS) after initiation of tucidinostat therapy determined using the Kaplan–Meier method. Number at risk and median survival time (MST) with 95% CI are shown. B Overall survival (OS) from the start of tucidinostat treatment to death or last follow-up. C Duration of response (DOR), defined as the time from the initial documented response (CR or PR) to disease progression or death from any cause, among patients who achieved CR or PR. D PFS stratified by a prognostic model based on the total number of adverse factors (older age (≥ 75 years) and higher sIL-2R level (≥ 5000 U/mL) at the start of tucidinostat. E OS stratified according to this prognostic model
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References

    1. Uchiyama T, Yodoi J, Sagawa K, Takatsuki K, Uchino H. Adult T-cell leukemia: clinical and hematologic features of 16 cases. Blood. 1977;50(3):481–92. - PubMed
    1. Shimoyama M. Diagnostic criteria and classification of clinical subtypes of adult T-cell leukaemia-lymphoma. A report from the Lymphoma Study Group (1984–87). Br J Haematol. 1991;79(3):428–37. - PubMed
    1. Shimoyama M. Chemotherapy of ATL. K Takatsuki (Ed), Adult T-Cell Leukemia, Oxford University Press, Oxford. 1994:221–227.
    1. Tsukasaki K, Utsunomiya A, Fukuda H, Shibata T, Fukushima T, Takatsuka Y, et al. VCAP-AMP-VECP compared with biweekly CHOP for adult T-cell leukemia-lymphoma: Japan Clinical Oncology Group Study JCOG9801. J Clin Oncol. 2007;25(34):5458–64. 10.1200/JCO.2007.11.9958. - PubMed
    1. Sekine M, Kameda T, Shide K, Maeda K, Toyama T, Kawano N, et al. Higher average chemotherapy dose intensity improves prognosis in patients with aggressive adult T-cell leukemia/lymphoma. Eur J Haematol. 2021;106(3):398–407. 10.1111/ejh.13565. - PubMed

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