Yagi Yu, Kanemasa Yusuke, Sasaki Yuki, Hayashi Yudai, Mino Mano, Kato Chika, Sakai Satoshi, Ohigashi An, Kanbara Yasuhiro, Morita Yuka, Tamura Taichi, Atsuta Yuya, Konuma Ryosuke, Nakamura Shohei, Wada Atsushi, Okuya Toshihiro, Kageyama Akihiko, Murakami Daisuke, Nakashima Shiori, Uchibori Yusuke, Onai Daishi, Hamamura Atsushi, Nishijima Akihiko, Omuro Yasushi, Shingai Naoki, Shimizuguchi Takuya, Toya Takashi, Shimizu Hiroaki, Najima Yuho, Kobayashi Takeshi, Haraguchi Kyoko, Ohashi Kazuteru, Doki Noriko, Okuyama Yoshiki, Shimoyama Tatsu
Department of Medical Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital.
Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital.
Rinsho Ketsueki. 2022;63(10):1363-1372. doi: 10.11406/rinketsu.63.1363.
Chimeric antigen receptor (CAR) T-cell therapy has revolutionized the approach to patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). This study retrospectively analyzed patients treated with commercially available tisagenlecleucel at our hospital and evaluated its safety and effectiveness. Of the 21 patients evaluated, any grade and grade ≥3 cytokine release syndrome (CRS) occurred in 85.7% and 9.5% of the patients, respectively. A total of 66.7% received tocilizumab and 28.6% received glucocorticoids for the treatment of CRS. The complete response (CR) rate at 3 months was 61.9% (95% confidence interval [CI] 38.4-81.9). After a median follow-up of 6.3 months following CAR-T infusion, the progression-free survival (PFS) and overall survival rates at 6 months were 53.1% (95%CI 28.3-72.7) and 69.2% (95%CI 43.7-84.9), respectively. Severe cytopenia and hypogammaglobulinemia occurred frequently following CAR-T infusion. Eight patients (38.1%) had comorbidities that would have made them ineligible for leukapheresis in the JULIET trial. However, the presence of comorbidities at the time of leukapheresis had no significant effect on the rates of CR, PFS, and adverse events. Tisagenlecleucel for r/r DLBCL in the real-world setting showed high efficacy and manageable safety profile comparable with the pivotal trial.
嵌合抗原受体（CAR）T细胞疗法彻底改变了复发或难治性弥漫性大B细胞淋巴瘤（r/r DLBCL）患者的治疗方法。本研究回顾性分析了我院接受市售替沙格宁（tisagenlecleucel）治疗的患者，并评估了其安全性和有效性。在评估的21例患者中，任何级别和≥3级细胞因子释放综合征（CRS）分别发生在85.7%和9.5%的患者中。共有66.7%的患者接受托珠单抗治疗，28.6%的患者接受糖皮质激素治疗CRS。3个月时的完全缓解（CR）率为61.9%（95%置信区间[CI]38.4-81.9）。在CAR-T输注后中位随访6.3个月时，6个月时的无进展生存期（PFS）和总生存率分别为53.1%（95%CI 28.3-72.7）和69.2%（95%CI 43.7-84.9）。CAR-T输注后严重血细胞减少和低丙种球蛋白血症频繁发生。8例患者（38.1%）存在合并症，这使他们在JULIET试验中不符合白细胞分离术的条件。然而，白细胞分离术时合并症的存在对CR、PFS和不良事件的发生率没有显著影响。在现实世界中，替沙格宁用于r/r DLBCL显示出高疗效和可控的安全性，与关键试验相当。
