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Phase I/II study of the oral retinoid X receptor agonist bexarotene in Japanese patients with cutaneous T-cell lymphomas.
Hamada, Toshihisa; Sugaya, Makoto; Tokura, Yoshiki; Ohtsuka, Mikio; Tsuboi, Ryoji; Nagatani, Tetsuo; Tani, Mamori; Setoyama, Mitsuru; Matsushita, Shigeto; Kawai, Kazuhiro; Yonekura, Kentaro; Yoshida, Tsuyoshi; Saida, Toshiaki; Iwatsuki, Keiji.
Afiliación
  • Hamada T; Department of Dermatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
  • Sugaya M; Department of Dermatology, Faculty of Medicine, University of Tokyo, Tokyo, Japan.
  • Tokura Y; Department of Dermatology, Hamamatsu University School of Medicine, Shizuoka, Japan.
  • Ohtsuka M; Department of Dermatology, Fukushima Medical University, Fukushima, Japan.
  • Tsuboi R; Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
  • Nagatani T; Department of Dermatology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan.
  • Tani M; Department of Dermatology, Osaka University Graduate School of Medicine, Osaka, Japan.
  • Setoyama M; Department of Dermatology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
  • Matsushita S; Department of Dermatology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
  • Kawai K; Department of Dermatology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
  • Yonekura K; Department of Dermatology, Imamura Bun-in Hospital, Kagoshima, Japan.
  • Yoshida T; Minophagen Pharmaceutical, Tokyo, Japan.
  • Saida T; Department of Dermatology, Shinshu University, Nagano, Japan.
  • Iwatsuki K; Department of Dermatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
J Dermatol ; 44(2): 135-142, 2017 Feb.
Article en En | MEDLINE | ID: mdl-27543197
Safety, tolerability, pharmacokinetics and efficacy of bexarotene, a novel retinoid X receptor (RXR)-selective retinoid, were evaluated in Japanese patients with stage IIB-IVB and relapsed/refractory stage IB-IIA cutaneous T-cell lymphomas (CTCL). This study was conducted as a multicenter, open-label, historically controlled, single-arm phase I/II study. Bexarotene was p.o. administrated once daily at a dose of 300 mg/m2 for 24 weeks in 13 patients, following an evaluation of safety and tolerability for 4 weeks at a dose of 150 mg/m2 in three patients. Eight of 13 patients (61.5%) with an initial dose of 300 mg/m2 met the response criteria using the modified severity-weighted assessment tool (mSWAT) at 24 weeks or discontinuation. Dose-limiting toxic effects (DLT) were present in four of 13 patients (31%) at a dose of 300 mg/m2 : two neutropenia, one abnormal hepatic function and one hypertriglyceridemia. No DLT was observed in patients received 150 mg/m2 bexarotene. In the 13 patients at 300 mg/m2 , common drug-related adverse events (AE) included hypothyroidism (92%), hypercholesterolemia (77%), leukopenia or neutropenia (39%), nasopharyngitis or anemia (31%). The treatment-related grade 3 AE included hypertriglyceridemia (4/16 patients, 25%), increased alanine aminotransferase, increased aspartate aminotransferase, dyslipidaemia, leukopenia and neutropenia (1/16 patients, 6%), and one of 16 patients experienced grade 4 hypertriglyceridemia. No patients discontinued bexarotene due to the AE during the study, but dose reduction or suspension was required. Bexarotene was shown to be well tolerated at 300 mg/m2 once daily and effective in Japanese patients with CTCL.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tetrahidronaftalenos / Linfoma Cutáneo de Células T / Anticarcinógenos / Receptores X Retinoide Tipo de estudio: Clinical_trials Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Dermatol Año: 2017 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tetrahidronaftalenos / Linfoma Cutáneo de Células T / Anticarcinógenos / Receptores X Retinoide Tipo de estudio: Clinical_trials Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Dermatol Año: 2017 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido