Safety and efficacy of bexarotene for Japanese patients with cutaneous T-cell lymphoma: Real-world experience from post-marketing surveillance.
Safety and efficacy of bexarotene for Japanese patients with cutaneous T-cell lymphoma: Real-world experience from post-marketing surveillance.
复制标题
贝沙罗汀对日本皮肤 T 细胞淋巴瘤患者的安全性和有效性：上市后监测的真实经验。
DOI：
10.1111/1346-8138.16201
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发表时间：
2022
期刊：
影响因子：
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通讯作者：
Sugaya M.
中科院分区：
文献类型：
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作者：
Hamada T;Morita A;Suga H;Boki H;Fujimura T;Hirai Y;Shimauchi T;Tateishi C;Kiyohara E;Muto I;Nakajima H;Abe R;Fujii K;Nishigori C;Nakano E;Yonekura K;Funakoshi T;Amano M;Miyagaki T;Makita N;Manaka K;Shimoyama Y;Sugaya M.
为了建立有关贝沙罗汀治疗日本皮肤T细胞淋巴瘤患者的安全性和疗效的真实的证据，我们使用贝沙罗汀治疗上市后监测的数据进行了一项全国性队列研究。2016年6月至2018年6月期间，共确定了294例皮肤T细胞淋巴瘤患者。其中，267例患者被纳入安全性分析集。在267例患者中，175例被纳入疗效分析集。其中，139例患者患有蕈样肉芽肿，包括46例早期疾病和93例晚期疾病。139例蕈样肉芽肿患者中，客观缓解率为46.8%。在开始使用贝沙罗汀300 mg/m2的患者（61.6%）和开始使用贝沙罗汀小于300 mg/m2的患者（22.6%，p < 0.001）之间检测到客观缓解率的显著差异。在139例蕈样肉芽肿患者中，92例接受了贝沙罗汀加光（化疗）治疗。贝沙罗汀联合光（化）疗的客观缓解率（57.6%）与贝沙罗汀未联合光（化）疗的客观缓解率（25.5%，p < 0.001）有显著差异。贝沙罗汀300 mg/m2和联合光（化疗）治疗是影响疗效的独立因素。常见的治疗相关不良事件包括甲状腺功能减退症（85.8%）、高胆固醇血症（68.5%）、高胆固醇血症（43.8%）和中性粒细胞减少症（21.3%）。以300 mg/m2剂量开始接受贝沙罗汀治疗的患者中，高胆固醇血症、高胆固醇血症和中性粒细胞减少症的发生率高于以低于300 mg/m2剂量开始接受贝沙罗汀治疗的患者（高胆固醇血症，76.4%vs.57.0%，p = 0.001;高胆固醇血症，49.0%vs.36.4%，p = 0.045;中性粒细胞减少症，28.0%vs.12.1%，p = 0.002）。目前的研究表明，贝沙罗汀300 mg/m2开始与光（化疗）治疗相结合，为蕈样肉芽肿患者的治疗提供了一个有希望的疗效。未来应评估低剂量贝沙罗汀加光（化疗）治疗的疗效。
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/m2and 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/m2than 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/m2and 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.