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皮沙酮治疗复发性或难治性侵袭性非霍奇金 B 细胞淋巴瘤的疗效和安全性。

Efficacy and safety of pixantrone for the treatment of multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas.

机构信息

Clinical Haematology Department, ICO-IJC-Hospital Germans Trias i Pujol, Badalona, Spain.

Hospital Universitario Puerta de Hierro, Madrid, Spain.

出版信息

Eur J Haematol. 2020 May;104(5):499-508. doi: 10.1111/ejh.13392. Epub 2020 Feb 11.

DOI:10.1111/ejh.13392
PMID:31997425
Abstract

BACKGROUND AND OBJECTIVE

Few treatment options exist for patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) who fail first- and second-line therapies. Pixantrone is a novel aza-anthracenedione agent with reduced potential for cardiotoxicity but maintained anti-tumour activity relative to anthracyclines. The current retrospective, observational, real-life study was undertaken in 79 patients who received pixantrone monotherapy for multiply R/R aggressive B-cell NHL in Spain and Italy.

RESULTS

Before pixantrone, patients had received a median of 3 prior therapies and 84.6% of them were refractory to the last regimen. Median progression-free survival (mPFS) was 2.8 months (95% confidence interval [CI] 2.1-3.6) and median overall survival (mOS) was 4.0 months (95%CI 5.6-7.9), with an objective response rate (ORR) of 29% (complete remission [CR]: 13.2%, partial remission [PR]: 15.2%). Patients receiving ≥2 cycles of pixantrone showed mPFS and mOS of 3.1 and 6.0 months, respectively, and an ORR of 36.8% (CR: 17.5%, PR: 19.3%). Overall, 63.3% of patients reported ≥1 adverse event (AE), most commonly haematological AEs. One patient developed grade 2 sinus tachycardia.

CONCLUSION

Pixantrone was effective and well tolerated in a real-world population of multiply R/R patients with aggressive B-cell NHL, many of whom had very poor prognostic factors.

摘要

背景与目的

对于一线和二线治疗失败的复发/难治性(R/R)B 细胞非霍奇金淋巴瘤(NHL)患者,治疗选择有限。比柔比星是一种新型的氮杂蒽二酮药物,其心脏毒性降低,但与蒽环类药物相比,抗肿瘤活性保持不变。本研究是在西班牙和意大利开展的一项回顾性、观察性、真实世界研究,共纳入 79 例接受比柔比星单药治疗的复发性/难治性侵袭性 B 细胞 NHL 患者。

结果

在接受比柔比星治疗之前,患者的中位治疗线数为 3 线,84.6%的患者对末次治疗方案耐药。中位无进展生存期(mPFS)为 2.8 个月(95%CI 2.1-3.6),中位总生存期(mOS)为 4.0 个月(95%CI 5.6-7.9),客观缓解率(ORR)为 29%(完全缓解[CR]:13.2%,部分缓解[PR]:15.2%)。接受≥2 个周期比柔比星治疗的患者 mPFS 和 mOS 分别为 3.1 个月和 6.0 个月,ORR 为 36.8%(CR:17.5%,PR:19.3%)。总体而言,63.3%的患者报告≥1 种不良事件(AE),最常见的是血液学 AE。1 例患者发生 2 级窦性心动过速。

结论

比柔比星在复发/难治性侵袭性 B 细胞 NHL 患者中具有疗效且耐受性良好,这些患者大多预后不良。

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