Hematology Department, IDIBAPS, Hospital Clínic, Barcelona, Spain.
Hematology Department, Hospital Vall de Hebrón, Department of Medicine, Universtat Autònoma de Barcelona (UAB), Vall d'Hebron Institut of Oncology (VHIO), Barcelona, Spain.
Biol Blood Marrow Transplant. 2020 Aug;26(8):1534-1542. doi: 10.1016/j.bbmt.2020.02.003. Epub 2020 Feb 14.
Clinical trials have shown that nivolumab has remarkable activity against relapsed/refractory classical Hodgkin lymphoma (cHL). However, the role of allogeneic hematopoietic stem cell transplantation (allo-HSCT) as consolidation therapy in these patients remains controversial. We performed a retrospective analysis of data from 74 patients treated with nivolumab. The overall response rate was 58% (including 30.6% with complete responses). Treatment-related adverse events were reported in 56.8% of patients (grade ≥3 in 9.4%). The main reasons for nivolumab discontinuation were referral for transplantation (41.7% patients) and disease progression (37.5%). The 2-year overall survival (OS) rate was 52% for the entire series. Ultimately, 39 patients underwent allo-HSCT. The cumulative incidence of grade II-IV acute graft-versus-host disease was 33.3% (grade III-IV in 2 patients). The cumulative incidence of nonrelapse mortality was 13.2%. Among the patients who responded to nivolumab, the 2-year OS and progression-free survival (PFS) were higher in patients who underwent consolidation with allo-HSCT (77.5% versus 42.6% [P = .126] and 73.9% versus 27.2% [P = .025], respectively). Thus, the efficacy and safety of nivolumab were comparable to values reported in previous clinical trials. The percentage of patients who bridged to transplantation was high, indicating a preference for Spanish physicians. These results suggest that consolidation allo-HSCT increases OS and PFS.
临床试验表明,纳武利尤单抗对复发/难治性经典霍奇金淋巴瘤(cHL)具有显著疗效。然而,异基因造血干细胞移植(allo-HSCT)作为这些患者的巩固治疗的作用仍存在争议。我们对 74 例接受纳武利尤单抗治疗的患者的数据进行了回顾性分析。总缓解率为 58%(包括 30.6%的完全缓解率)。56.8%的患者出现治疗相关不良事件(≥3 级 9.4%)。纳武利尤单抗停药的主要原因是转诊进行移植(41.7%的患者)和疾病进展(37.5%)。整个系列的 2 年总生存率(OS)为 52%。最终,39 例患者接受了 allo-HSCT。Ⅱ-Ⅳ级急性移植物抗宿主病的累积发生率为 33.3%(2 例为Ⅲ-Ⅳ级)。非复发死亡率的累积发生率为 13.2%。在对纳武利尤单抗有反应的患者中,接受 allo-HSCT 巩固治疗的患者 2 年 OS 和无进展生存(PFS)更高(77.5%比 42.6%[P=0.126]和 73.9%比 27.2%[P=0.025])。因此,纳武利尤单抗的疗效和安全性与之前临床试验报道的值相当。桥接至移植的患者比例较高,表明西班牙医生对此类治疗方案的偏好。这些结果表明,allo-HSCT 巩固治疗可提高 OS 和 PFS。