Hayashino Kenta, Terao Toshiki, Nishimori Hisakazu, Kitamura Wataru, Kobayashi Hiroki, Kamoi Chihiro, Seike Keisuke, Fujiwara Hideaki, Asada Noboru, Ennishi Daisuke, Fujii Keiko, Fujii Nobuharu, Matsuoka Ken-Ichi, Maeda Yoshinobu
Department of Hematology and Oncology, Okayama University Hospital, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, 700-8558, Japan.
Department of Hematology, Oncology and Respiratory Medicine, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.
Int J Hematol. 2025 Feb;121(2):232-243. doi: 10.1007/s12185-024-03888-9. Epub 2024 Dec 16.
This study investigated the efficacy of tisagenlecleucel (tisa-cel) and allogeneic hematopoietic stem cell transplantation (allo-SCT) for patients with relapsed and/or refractory (r/r) large B-cell lymphoma (LBCL) with poor prognostic factors, defined as performance status (PS) ≥ 2, multiple extranodal lesions (EN), chemorefractory disease, or higher lactate dehydrogenase (LDH). Overall, the allo-SCT group demonstrated worse progression-free survival (PFS), higher non-relapse mortality, and a similar relapse/progression rate. Notably, the tisa-cel group showed better PFS than the allo-SCT group among patients with chemorefractory disease (3.2 vs. 2.0 months, p = 0.092) or higher LDH (4.0 vs. 2.0 months, p = 0.018), whereas PFS in the two cellular therapy groups was similar among those with PS ≥ 2 or multiple EN. Survival time after relapse post-cellular therapy in patients with poor prognostic factors was 1.6 with allo-SCT and 4.6 months with tisa-cel. These findings were confirmed in a propensity score matching cohort. In conclusion, tisa-cel resulted in better survival than allo-SCT in patients with poor prognostic factors. However, patients who relapsed post-cellular therapy had dismal outcomes regardless of therapy. Further strategies are warranted to improve outcomes in these patients.
本研究调查了替沙格宁乐克（tisagenlecleucel，tisa-cel）和异基因造血干细胞移植（allo-SCT）对复发和/或难治性（r/r）大B细胞淋巴瘤（LBCL）且具有不良预后因素患者的疗效，不良预后因素定义为体能状态（PS）≥2、多个结外病变（EN）、化疗难治性疾病或较高的乳酸脱氢酶（LDH）水平。总体而言，allo-SCT组的无进展生存期（PFS）更差，非复发死亡率更高，复发/进展率相似。值得注意的是，在化疗难治性疾病患者（3.2个月对2.0个月，p = 0.092）或LDH水平较高的患者中（4.0个月对2.0个月，p = 0.018），tisa-cel组的PFS优于allo-SCT组，而在PS≥2或多个EN的患者中，两种细胞治疗组的PFS相似。具有不良预后因素的患者在细胞治疗后复发后的生存时间，allo-SCT组为1.6个月，tisa-cel组为4.6个月。这些发现在倾向评分匹配队列中得到了证实。总之，对于具有不良预后因素的患者，tisa-cel比allo-SCT的生存效果更好。然而，无论接受何种治疗，细胞治疗后复发的患者预后都很差。需要进一步的策略来改善这些患者的预后。
