不适合移植的大 B 细胞淋巴瘤二线使用 axicabtagene ciloleucel：ALYCANTE 最终分析
Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
Dexa-BEAM 对比 MIFAP 作为复发性淋巴瘤挽救方案：中位随访 14.4 年的前瞻性随机多中心 II 期试验
英文原题：Dexa-BEAM versus MIFAP as salvage regimen for recurrent lymphoma: a prospective randomized multicenter phase II trial with a median follow-up of 14.4 years.
查看英文原题
Dexa-BEAM versus MIFAP as salvage regimen for recurrent lymphoma: a prospective randomized multicenter phase II trial with a median follow-up of 14.4 years.
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研究概要
与 Dexa-BEAM 相比，MIFAP 毒性更高，且未能改善复发性 HL 或侵袭性 NHL 患者的结局。
中文摘要
目的
前期研究显示 MIFAP 方案对复发/难治性霍奇金淋巴瘤（HL）或侵袭性非霍奇金淋巴瘤（NHL）有效。本研究拟前瞻性比较 MIFAP 与成熟方案 Dexa-BEAM。
方法
73 例复发/难治性成人患者（HL 25 例、侵袭性 NHL 48 例）随机接受两个疗程 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），随后接受巩固性大剂量治疗和造血细胞移植（HCT）。主要终点为两疗程挽救化疗后的总缓解率（ORR；完全缓解 [CR] 和部分缓解 [PR]）。
结果
Dexa-BEAM 组 ORR 为 51%（CR 38%），MIFAP 组为 53%（CR 36%），组间均无显著差异。MIFAP 组 3–4 级毒性显著高于 Dexa-BEAM 组。35 例患者接受巩固移植：自体 29 例、异体 1 例、序贯自体/异体 5 例。Dexa-BEAM 与 MIFAP 组的无进展生存期（PFS）和总生存期（OS）均无显著差异。
结论
与 Dexa-BEAM 相比，MIFAP 毒性更高，且未改善复发性 HL 或侵袭性 NHL 患者结局。此类患者需要近期开发的免疫疗法等创新治疗策略。试验注册号：EudraCT 2021-001937-38。注册日期：2021 年 4 月 7 日，回顾性注册。
展开英文摘要原文
PURPOSE
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.
METHODS
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.
RESULTS
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.
CONCLUSION
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. TRIAL REGISTRATION NUMBER: EudraCT number 2021-001937-38. DATE OF REGISTRATION: 7 April 2021, retrospectively registered.
论文信息
- 作者
- Kürzel S、Blaudszun AR、Stahl L、Herbst R、Kroschinsky F、Birkmann J、Hänel A、Schaefer-Eckart K
- 第一作者单位
- Medical Clinic 5, Klinikum Dresden-Neustadt, Dresden, Germany.Germany
- 通讯作者单位
- Department of Internal Medicine III, Klinikum Chemnitz gGmbH, Flemmingstrasse 1, 09116, Chemnitz, Germany. m.haenel@skc.de.Germany
- 文献类型
- II 期临床试验 · 多中心研究 · 随机对照试验
- 期刊
- Journal of cancer research and clinical oncology2022 May
- 原文标识
- PubMed 34176014 · DOI 10.1007/s00432-021-03702-7
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