Unit of Hematology and Stem Cell Transplantation, AOUC Policlinico, Ematologia Con Trapianto, Piazza G. Cesare 11, 70124, Bari, Italy.
Hematology Unit, Giovanni Paolo II IRCCS Cancer Institute Oncology Hospital, Bari, Italy.
Ann Hematol. 2023 Feb;102(2):385-392. doi: 10.1007/s00277-023-05100-0. Epub 2023 Jan 16.
Checkpoint inhibitors have significantly changed the prognosis of patients with relapsing refractory classical Hodgkin's lymphoma (cHL), demonstrating excellent results in heavily pretreated patients. However, there is still limited data on the real-world experience with PD-1 inhibitors in cHL. Within the context of the Apulian hematological network (Rete Ematologica Pugliese, REP), we performed a retrospective, multicenter analysis of 66 patients with relapsing refractory cHL who had received PD-1 inhibitors in the non-trial setting. Forty-three patients (65%) were treated with nivolumab and 23 (35%) with pembrolizumab. Thirty-one (47%) and 8 (12%) patients underwent autologous or allogeneic stem cell transplantation prior to checkpoint inhibitor therapy, respectively. The median number of lines of treatment attempted prior to PD-1 inhibitor therapy was 4 (range, 3 to 7). All patients had received brentuximab vedotin prior to checkpoint inhibitor therapy. The overall response rate to PD-1 inhibitors therapy was 70% (47% complete remission (CR) and 23% partial remission (PR)). Twenty-four immune-related adverse events (19 (80%) grades 1-2; 5 (20%) grades 3-4) were documented (4 gastrointestinal, 4 hepatic, 6 fever, 4 hematological, 3 dermatological, 3 allergic rhinitis). Toxicity resolved in all patients, and there were no deaths attributed to checkpoint inhibitor therapy. After a median follow-up of 26 months (range 3-72 months), 54 patients (82%) are alive, and 12 (18%) died. The cause of death was attributed to disease progression in 9 patients and sepsis in 3 patients. After PD-1 inhibitor therapy, 22 patients (33%) relapsed or progressed. The overall survival and progression-free survival at 5 years were 65% and 54%, respectively. This study confirms the efficacy and tolerability of PD-1 inhibitor therapy in relapsed refractory cHL in a real-world setting, demonstrating similar clinical outcomes and toxicity profiles compared to clinical studies.
检查点抑制剂显著改变了复发难治性经典霍奇金淋巴瘤（cHL）患者的预后，在经过大量预处理的患者中显示出了优异的疗效。然而，在 cHL 中，关于 PD-1 抑制剂的真实世界经验数据仍然有限。在普利亚血液学网络（Rete Ematologica Pugliese，REP）的框架内，我们对 66 例在非试验环境中接受 PD-1 抑制剂治疗的复发难治性 cHL 患者进行了回顾性、多中心分析。43 例（65%）患者接受纳武利尤单抗治疗，23 例（35%）患者接受帕博利珠单抗治疗。分别有 31 例（47%）和 8 例（12%）患者在接受检查点抑制剂治疗前接受了自体或异基因干细胞移植。在接受 PD-1 抑制剂治疗前，中位尝试的治疗线数为 4 条（范围 3-7 条）。所有患者在接受检查点抑制剂治疗前均接受了 Brentuximab vedotin 治疗。PD-1 抑制剂治疗的总体缓解率为 70%（47%完全缓解（CR）和 23%部分缓解（PR））。共记录了 24 例免疫相关不良事件（19 例（80%）为 1-2 级；5 例（20%）为 3-4 级）（4 例胃肠道，4 例肝脏，6 例发热，4 例血液学，3 例皮肤，3 例过敏性鼻炎）。所有毒性均得到缓解，无因检查点抑制剂治疗而导致的死亡。中位随访 26 个月（范围 3-72 个月）后，54 例（82%）患者存活，12 例（18%）死亡。9 例患者的死亡原因为疾病进展，3 例患者的死亡原因为脓毒症。PD-1 抑制剂治疗后，22 例（33%）患者复发或进展。5 年总生存率和无进展生存率分别为 65%和 54%。这项研究在真实环境中证实了 PD-1 抑制剂治疗复发难治性 cHL 的疗效和耐受性，与临床研究相比，显示出相似的临床结局和毒性特征。
