吡柔比星、依托泊苷、苯达莫司汀、利妥昔单抗（P[R]EBEN）作为挽救治疗方案用于复发/难治侵袭性非霍奇金淋巴瘤-波兰淋巴瘤研究组真实世界分析。
Pixantrone, etoposide, bendamustine, rituximab (P[R]EBEN) as an effective salvage regimen for relapsed/refractory aggressive non-Hodgkin lymphoma-Polish Lymphoma Research Group real-life analysis.
机构信息
Department of Hematology, Jagiellonian University, Kraków, Poland.
Department of Clinical Transplantology, Medical University of Lublin, Lublin, Poland.
出版信息
Pharmacol Rep. 2019 Jun;71(3):473-477. doi: 10.1016/j.pharep.2019.02.001. Epub 2019 Feb 6.
BACKGROUND
Despite a significant improvement in treatment outcomes, 30-40% of aggressive non-Hodgkin lymphomas (NHL) patients are refractory or relapse after the first line therapy. Half of them are not eligible to autologous stem cell transplantation (ASCT) due to failure of platinum-based salvage regimens. Pixantrone is conditionally approved in Europe in patients with R/R aggressive NHL failing at least 2 previous lines of therapy. Polish Lymphoma Research Group (PLRG) evaluated the efficacy and tolerability of P[R]EBEN combining pixantrone, etoposide, bendamustine with or without rituximab), a new regimen developed recently by Francesco d'Amore, in real-life experience.
METHODS
In this retrospective audit, we analyzed the data of consecutive 25 R/R NHL cases, treated with P[R]EBEN regimen in 9 PLRG centers. Safety and efficacy data, including adverse reactions (AE), response rates, progression-free and overall survival (PFS and OS) were collected.
RESULTS
Overall response rate (ORR) to P[R]EBEN regimen was 68% (40% CR and 28% PR). Most patients responded, relatively early, by second cycle of therapy. P[R]EBEN was effective in 8 out of 15 patients (53%) refractory to previous platinum-based salvage regimens. In 4 patients (16%) stabilization of disease (SD) during therapy was observed and further 4 patients (16%) progressed during the treatment (PD). Response rates were higher in patients, chemosensitive to their prior regimen (ORR - 87.5%, including 50% CR). At the median follow-up of 7.5 months (range 1-16) the median PFS and OS were not reached. Projected PFS and OS at 12 months are 68% and 78% respectively. The P[R]EBEN regimen was well tolerated and most of patients received it as out-patients. AEs grade ≥3 occurred in 17 patients (68%). Most common grade 3-4 AEs were due to hematological toxicity with febrile neutropenia observed in 5 patients (20%). There were no episodes of septic deaths. Six patients (24%) died during treatment and follow-up period, all of them due to lymphoma progression.
CONCLUSION
Our data suggest good efficiency and tolerability of P[R]EBEN regimen as a rescue therapy in patients with R/R aggressive NHL.
背景
尽管治疗结果有了显著改善，但 30-40%的侵袭性非霍奇金淋巴瘤（NHL）患者在一线治疗后仍然存在耐药或复发。由于铂类挽救方案失败，其中一半患者不符合自体干细胞移植（ASCT）的条件。Pixantrone 在欧洲有条件批准用于至少接受过 2 线治疗失败的复发/难治性侵袭性 NHL 患者。波兰淋巴瘤研究组（PLRG）评估了 Francesco d'Amore 最近开发的新方案 P[R]EBEN（联合 pixantrone、依托泊苷、苯达莫司汀和/或利妥昔单抗）在真实世界中的疗效和耐受性。
方法
在这项回顾性审计中，我们分析了 9 个 PLRG 中心连续 25 例复发/难治性 NHL 患者接受 P[R]EBEN 方案治疗的数据。收集了安全性和疗效数据，包括不良反应（AE）、缓解率、无进展生存期（PFS）和总生存期（OS）。
结果
P[R]EBEN 方案的总缓解率（ORR）为 68%（40%CR 和 28%PR）。大多数患者在第 2 个周期治疗时相对较早地出现反应。P[R]EBEN 对 15 例先前接受过基于铂类的挽救方案治疗的患者中的 8 例（53%）有效。4 例（16%）在治疗期间出现疾病稳定（SD），4 例（16%）在治疗期间进展（PD）。对先前方案化疗敏感的患者缓解率更高（ORR-87.5%，包括 50%CR）。在中位随访 7.5 个月（范围 1-16）时，中位 PFS 和 OS 未达到。预计 12 个月时的 PFS 和 OS 分别为 68%和 78%。P[R]EBEN 方案耐受性良好，大多数患者作为门诊患者接受治疗。17 例（68%）患者出现≥3 级 AE。最常见的 3-4 级 AE 是血液学毒性，5 例（20%）患者出现发热性中性粒细胞减少症。没有脓毒症死亡的病例。6 例（24%）患者在治疗和随访期间死亡，均死于淋巴瘤进展。
结论
我们的数据表明，P[R]EBEN 方案作为复发/难治性侵袭性 NHL 患者的挽救治疗具有良好的疗效和耐受性。
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