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Post-marketing surveillance of the safety and effectiveness of nivolumab for classic Hodgkin lymphoma in Japan.
Kawasaki, Akira; Hatake, Kiyohiko; Matsumura, Itaru; Izutsu, Koji; Hoshino, Tomohiro; Akamatsu, Ayumi; Kakuuchi, Akito; Tobinai, Kensei.
Afiliación
  • Kawasaki A; Ono Pharmaceutical Co., Ltd, 1-5, Dosho-machi 2-chome, Chuo-ku, Osaka, 541-8526, Japan. ak.kawasaki@ono-pharma.com.
  • Hatake K; Department of Hematology, International University of Health and Welfare, Tokyo, Japan.
  • Matsumura I; Department of Hematology and Rheumatology, Faculty of Medicine, Kindai University, Osaka, Japan.
  • Izutsu K; Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
  • Hoshino T; Ono Pharmaceutical Co., Ltd, 1-5, Dosho-machi 2-chome, Chuo-ku, Osaka, 541-8526, Japan.
  • Akamatsu A; Ono Pharmaceutical Co., Ltd, 1-5, Dosho-machi 2-chome, Chuo-ku, Osaka, 541-8526, Japan.
  • Kakuuchi A; Ono Pharmaceutical Co., Ltd, 1-5, Dosho-machi 2-chome, Chuo-ku, Osaka, 541-8526, Japan.
  • Tobinai K; Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Int J Hematol ; 119(6): 667-676, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38521840
ABSTRACT
Nivolumab was approved for relapsed/refractory classic Hodgkin lymphoma (cHL) in Japan in 2016. After its approval, a prospective, non-interventional, observational post-marketing surveillance was initiated to evaluate the safety and effectiveness of nivolumab treatment for up to 12 months in patients with relapsed/refractory cHL. Of 304 registered patients, 288 were included in safety analyses and 282 in effectiveness analyses. There were 191 (66.3%) male patients, median age was 64.0 years, and 54 patients (18.8%) had performance status ≥ 2. Treatment-related adverse events (TRAEs) were reported in 183 (63.5%) patients, with grade 3-5 TRAEs in 86 (29.9%). The most common TRAEs were infusion reaction (14.6%), hepatic function abnormal (5.9%), interstitial lung disease (ILD) (5.6%), and hypothyroidism (5.2%). TRAEs of special interest in ≥ 5% of patients were infusion reaction (15.6%), hepatic failure/hepatic dysfunction/hepatitis/cholangitis sclerosing (13.2%), thyroid dysfunction (9.7%), and ILD (7.3%). In multivariable analyses, prior allogeneic hematopoietic stem cell transplantation was a risk factor for hepatic failure/hepatic dysfunction/hepatitis/cholangitis sclerosing, and prior thyroid gland disorders was a risk factor for thyroid dysfunction. The overall response rate was 61.7%. In conclusion, nivolumab showed a similar safety profile and comparable effectiveness to that reported in clinical trials for relapsed/refractory cHL (CheckMate 205, ONO-4538-15).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / Enfermedad de Hodgkin / Nivolumab Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Int J Hematol Asunto de la revista: HEMATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vigilancia de Productos Comercializados / Enfermedad de Hodgkin / Nivolumab Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Int J Hematol Asunto de la revista: HEMATOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón