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本妥昔单抗联合异环磷酰胺-卡铂-依托泊苷治疗初治难治性/复发性霍奇金淋巴瘤的最终结果:淋巴瘤研究协会I/II期研究

Final results of brentuximab vedotin combined with ifosfamide-carboplatin-etoposide in first refractory/relapsed Hodgkin lymphoma: a lymphoma study association phase I/II study.

作者信息

Stamatoullas Aspasia, Ghesquières Hervé, Feugier Pierre, André Marc, Le Bras Fabien, Gac Anne-Claire, Borel Cécile, Gastinne Thomas, Quittet Philippe, Morschhauser Franck, Ribrag Vincent, Guidez Stephanie, Nicolas-Virelizier Emmanuelle, Berriolo-Riedinger Alina, Vander Borght Thierry, Edeline Véronique, Brice Pauline

机构信息

Département d'Hématologie, Centre Henri Becquerel, Rouen, France.

Département d'Hématologie, Centre Hospitalier Lyon Sud, Lyon France.

出版信息

Leuk Lymphoma. 2022 Dec;63(13):3063-3071. doi: 10.1080/10428194.2022.2107204. Epub 2022 Aug 17.

Abstract

This phase I/II study assessed the combination of brentuximab vedotin (BV) with ifosfamide-carboplatin-etoposide (ICE) as a second-line therapy in refractory/relapsed (R/R) classical Hodgkin lymphoma (cHL) patients. Phase I study was designed to determine the maximum tolerated dose (MTD) of BV (10 patients) and phase II evaluated the rate of complete metabolic response (CMR) after 2 cycles of BV-ICE (42 patients). There were no dose-limiting toxicities (DLT) during phase I recommending BV 1.8 mg/kg for phase II. Twenty-six patients (61.9%) achieved CMR after 2 cycles of BV-ICE and 37 patients (88%) were transplanted. With a median follow-up of 38 months, the 3-year progression free survival (PFS) and overall survival (OS) rate were 64.3% and 100%, respectively. Hematological toxicities (81%) and infections (21%) were the most frequent adverse event encountered BV-ICE regimen is feasible with manageable toxicities and could be an alternative to other salvage treatments. : ClinicalTrials.gov identifier: NCT02686346.

摘要

这项I/II期研究评估了本妥昔单抗(BV)与异环磷酰胺-卡铂-依托泊苷(ICE)联合用于难治性/复发性(R/R)经典型霍奇金淋巴瘤(cHL)患者的二线治疗。I期研究旨在确定BV的最大耐受剂量(MTD)(10例患者),II期评估2个周期的BV-ICE治疗后的完全代谢缓解(CMR)率(42例患者)。I期期间未出现剂量限制性毒性(DLT),推荐II期使用BV 1.8 mg/kg。26例患者(61.9%)在2个周期的BV-ICE治疗后达到CMR,37例患者(88%)接受了移植。中位随访38个月,3年无进展生存期(PFS)和总生存期(OS)率分别为64.3%和100%。血液学毒性(81%)和感染(21%)是最常见的不良事件。BV-ICE方案可行,毒性可控,可作为其他挽救治疗的替代方案。:ClinicalTrials.gov标识符:NCT02686346。

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