Stoffel Tanja, Bacher Ulrike, Banz Yara, Daskalakis Michael, Novak Urban, Pabst Thomas
Department of Medical Oncology, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.
Department of Hematology, Central Hematology Laboratory, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.
J Clin Med. 2022 Jun 28;11(13):3748. doi: 10.3390/jcm11133748.
(1) Introduction: BEAM is a high-dose chemotherapy (HDCT) frequently administered before autologous stem cell transplantation (ASCT) in diffuse large B-cell lymphoma (DLBCL). Bendamustine replacing BCNU (BeEAM) is similarly effective at lower toxicities. However, relapse remains the major cause of death in DLBCL. (2) Methods: This is a 12-patient pilot study of the BeEAM preparative regimen with additional polatuzumab vedotin (PV, targeting CD79b) aiming to establish feasibility and to reduce toxicity without increasing the early progression rate. PV was given once at the standard dose of 1.8 mg/kg at day -6 together with BeEAM-HDCT (days -7 to -1) before ASCT. (3) Results: 8/12 patients (67%) received PV with BeEAM as a consolidation of first-line treatment, and 4/12 patients (33%) received PV with BeEAM after relapse treatment. All patients experienced complete engraftment (neutrophils: median 11 days; platelets: 13 days). Gastrointestinal toxicities occurred in 7/12 patients (58%, grade 3). All patients developed neutropenic infections with at least one identified pathogen (bacterial: 10/12 patients; viral: 2/12; and fungal: 1/12). The complete remission rate by PET-CT 100 days post-ASCT was 92%, with one mortality due to early progression. Eleven out of twelve patients (92%) were alive without progression after a median follow-up of 15 months. (4) Conclusions: Our study with 12 patients suggests that combining PV with BeEAM HDCT is feasible and safe, but the limited cohort prevents definite conclusions regarding efficacy. Larger cohorts must be evaluated.
(1) 引言：BEAM是一种高剂量化疗方案，常用于弥漫性大B细胞淋巴瘤（DLBCL）自体干细胞移植（ASCT）前。苯达莫司汀替代卡莫司汀（BeEAM）在毒性较低的情况下同样有效。然而，复发仍是DLBCL患者死亡的主要原因。(2) 方法：这是一项针对12名患者的先导性研究，采用含额外泊洛妥珠单抗（PV，靶向CD79b）的BeEAM预处理方案，旨在确定其可行性并降低毒性，同时不增加早期进展率。PV在ASCT前，于第-6天以1.8 mg/kg的标准剂量与BeEAM-HDCT（第-7天至-1天）联合给药一次。(3) 结果：8/12名患者（67%）接受PV联合BeEAM作为一线治疗的巩固治疗，4/12名患者（33%）在复发治疗后接受PV联合BeEAM治疗。所有患者均实现完全植入（中性粒细胞：中位时间11天；血小板：13天）。7/12名患者（58%，3级）出现胃肠道毒性。所有患者均发生中性粒细胞减少性感染，至少鉴定出一种病原体（细菌：10/12名患者；病毒：2/12；真菌：1/12）。ASCT后100天通过PET-CT检测的完全缓解率为92%，1例因早期进展死亡。12名患者中有11名（92%）在中位随访15个月后存活且无疾病进展。(4) 结论：我们对12名患者的研究表明，PV与BeEAM HDCT联合使用是可行且安全的，但由于队列有限，无法就疗效得出明确结论。必须评估更大的队列。
