Back to Search Start Over

Safety and efficacy of bexarotene for Japanese patients with cutaneous T‐cell lymphoma: Real‐world experience from post‐marketing surveillance.

Authors :
Hamada, Toshihisa
Morita, Akimichi
Suga, Hiraku
Boki, Hikari
Fujimura, Taku
Hirai, Yoji
Shimauchi, Takatoshi
Tateishi, Chiharu
Kiyohara, Eiji
Muto, Ikko
Nakajima, Hideki
Abe, Riichiro
Fujii, Kazuyasu
Nishigori, Chikako
Nakano, Eiji
Yonekura, Kentaro
Funakoshi, Takeru
Amano, Masahiro
Miyagaki, Tomomitsu
Makita, Noriko
Source :
Journal of Dermatology; Feb2022, Vol. 49 Issue 2, p253-262, 10p
Publication Year :
2022

Abstract

To establish real‐world evidence about the safety and efficacy of bexarotene for Japanese patients with cutaneous T‐cell lymphoma, we conducted a nationwide cohort study using data from post‐marketing surveillance for bexarotene treatment. In total, 294 patients with cutaneous T‐cell lymphoma were identified between June 2016 and June 2018. Of these, 267 patients were included as the safety analysis set. Of the 267 patients, 175 were included in the efficacy analysis set. Of these, 139 patients had mycosis fungoides, including 46 with early stage disease and 93 with advanced stage disease. Among the 139 patients with mycosis fungoides, the objective response rate was 46.8%. A significant difference in objective response rate was detected between patients who started with bexarotene at 300 mg/m2 (61.6%) and patients who started with bexarotene at less than 300 mg/m2 (22.6%, p < 0.001). Of the 139 patients with mycosis fungoides, 92 were treated with a combination of bexarotene plus photo(chemo)therapy. A significant difference in objective response rate was seen between bexarotene with a combination of photo(chemo)therapy (57.6%) and bexarotene without a combination of photo(chemo)therapy (25.5%, p < 0.001). Starting bexarotene at 300 mg/m2 and combination with photo(chemo)therapy were detected as independent factors influencing response. Common treatment‐related adverse events included hypothyroidism (85.8%), hypertriglyceridemia (68.5%), hypercholesterolemia (43.8%), and neutropenia (21.3%). Hypertriglyceridemia, hypercholesterolemia, and neutropenia occurred more frequently in patients who started with bexarotene at 300 mg/m2 than patients who started with bexarotene at less than 300 mg/m2 (hypertriglyceridemia, 76.4% vs. 57.0%, p = 0.001; hypercholesterolemia, 49.0% vs. 36.4%, p = 0.045; neutropenia, 28.0% vs. 12.1%, p = 0.002; respectively). The present study indicates that starting bexarotene at 300 mg/m2 and combination of photo(chemo)therapy offer a promising efficacy for the treatment of patients with mycosis fungoides. Efficacy of low‐dose bexarotene plus photo(chemo)therapy should be evaluated in future. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
03852407
Volume :
49
Issue :
2
Database :
Complementary Index
Journal :
Journal of Dermatology
Publication Type :
Academic Journal
Accession number :
155028885
Full Text :
https://doi.org/10.1111/1346-8138.16201