Kürzel Sabine, Blaudszun André-René, Stahl Lilly, Herbst Regina, Kroschinsky Frank, Birkmann Josef, Hänel Annette, Schaefer-Eckart Kerstin, Ehninger Gerhard, Fiedler Friedrich, Bornhäuser Martin, Fricke Stephan, Hänel Mathias
Medical Clinic 5, Klinikum Dresden-Neustadt, Dresden, Germany.
Department of GMP Process Development/ATMP Design, Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.
J Cancer Res Clin Oncol. 2022 May;148(5):1171-1181. doi: 10.1007/s00432-021-03702-7. Epub 2021 Jun 26.
The aim of this study was to prospectively compare the MIFAP protocol, which had been shown to be effective in patients with relapsed and refractory Hodgkin's lymphoma (HL) or aggressive non-Hodgkin's lymphoma (NHL), to an established regimen like Dexa-BEAM.
Seventy-three adult patients with HL (N = 25) or aggressive NHL (N = 48) suffering from relapse or refractory disease were randomly allocated to receive two cycles of Dexa-BEAM (dexamethasone, carmustine, etoposide, cytarabine, melphalan; N = 37) or MIFAP (mitoxantrone, fludarabine, cytarabine, cisplatin; N = 36) prior to a consolidating high-dose therapy and hematopoietic cell transplantation (HCT). Primary endpoint was the overall response rate (ORR) [complete response (CR) and partial response (PR)] after two courses of salvage chemotherapy.
The ORR was 51% (CR 38%) and 53% (CR 36%) in the Dexa-BEAM arm and in the MIFAP arm (both not significant), respectively. There was a significantly higher grade 3-4 toxicity after MIFAP compared to Dexa-BEAM. Thirty-five patients were consolidated by autologous (N = 29), allogeneic (N = 1) or sequential autologous/allogeneic (N = 5) HCT. No significant differences were found in progression-free survival (PFS) and overall survival (OS) between the Dexa-BEAM and the MIFAP arms.
Compared to Dexa-BEAM, MIFAP is associated with a higher toxicity and does not improve the outcome of patients with recurrent HL or aggressive NHL. For those patients, innovative treatment concepts like recently developed immunotherapies are necessary.
EudraCT number 2021-001937-38.
7 April 2021, retrospectively registered.
本研究旨在前瞻性地比较已被证明对复发难治性霍奇金淋巴瘤（HL）或侵袭性非霍奇金淋巴瘤（NHL）患者有效的MIFAP方案与既定方案如地塞米松-卡莫司汀-依托泊苷-阿糖胞苷-美法仑（Dexa-BEAM）。
73例复发或难治性HL（N = 25）或侵袭性NHL（N = 48）成年患者被随机分配在巩固性大剂量治疗和造血细胞移植（HCT）之前接受两个周期的Dexa-BEAM（地塞米松、卡莫司汀、依托泊苷、阿糖胞苷、美法仑；N = 37）或MIFAP（米托蒽醌、氟达拉滨、阿糖胞苷、顺铂；N = 36）。主要终点是两个疗程挽救性化疗后的总缓解率（ORR）[完全缓解（CR）和部分缓解（PR）]。
Dexa-BEAM组和MIFAP组的ORR分别为51%（CR 38%）和53%（CR 36%）（均无显著性差异）。与Dexa-BEAM相比，MIFAP后的3-4级毒性显著更高。35例患者通过自体（N = 29）、异体（N = 1）或序贯自体/异体（N = 5）HCT进行巩固治疗。Dexa-BEAM组和MIFAP组在无进展生存期（PFS）和总生存期（OS）方面未发现显著差异。
与Dexa-BEAM相比，MIFAP毒性更高，且不能改善复发HL或侵袭性NHL患者的预后。对于这些患者，需要如最近开发的免疫疗法等创新治疗理念。
欧洲临床试验数据库编号2021-001937-38。
2021年4月7日，追溯注册。
