Long-Term Follow-Up of the Prospective Randomized AATT Study (Autologous or Allogeneic Transplantation in Patients With Peripheral T-Cell Lymphoma).

IF 42.1 1区 医学 Q1 ONCOLOGY Journal of Clinical Oncology Pub Date : 2024-11-10 Epub Date: 2024-09-13 DOI:10.1200/JCO.24.00554
Olivier Tournilhac, Bettina Altmann, Birte Friedrichs, Kamal Bouabdallah, Mathieu Leclerc, Guillaume Cartron, Pascal Turlure, Peter Reimer, Eva Wagner-Drouet, Laurence Sanhes, Roch Houot, Murielle Roussel, Frank Kroschinsky, Peter Dreger, Andreas Viardot, Laurence de Leval, Andreas Rosenwald, Philippe Gaulard, Gerald Wulf, Alban Villate, Christelle Latiere, Ahmet Elmaagacli, Bertram Glass, Viola Poeschel, Gandhi Damaj, David Sibon, Eric Durot, Karin Bilger, Anne Banos, Mathias Haenel, Martin Dreyling, Ulrich Keller, Mourad Tiab, Bernard Drenou, Jérome Cornillon, Stéphanie Nguyen, Marie Robin, Maike Nickelsen, Lorenz Trümper, Georg Lenz, Marita Ziepert, Norbert Schmitz
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引用次数: 0

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Primary analysis of the phase III randomized AATT study showed that younger patients with peripheral T-cell lymphoma (PTCL) consolidated with autologous or allogeneic transplantation (alloSCT) had similar event-free survival (EFS) and overall survival (OS). Seven-year EFS of patients randomly assigned to alloSCT was 38% (95% CI, 25 to 52) compared with 34% (95% CI, 22 to 47) for patients randomly assigned to autologous transplantation of hematopoietic stem cells (autoSCT); OS was 55% (95% CI, 41 to 69) and 61% (95% CI, 47 to 74). Among patients undergoing alloSCT (n = 26) or autoSCT (n = 41) on study, the cumulative progression/relapse rate was 8% (95% CI, 0 to 19) and 55% (95% CI, 35 to 74). Nonrelapse mortality (NRM) was 31% (95% CI, 13 to 49) and 3% (95% CI, 0 to 8) after alloSCT and autoSCT, respectively. Fifteen of 30 patients with early progression and 11 of 20 patients with progression/relapse after autoSCT received alloSCT. Seven-year OS after salvage alloSCT was 61% (95% CI, 47 to 74); NRM was 23% (95% CI, 6 to 40). Long-term follow-up documents the strong graft versus lymphoma effect of alloSCT independent of the timing of transplantation. Survival of patients unable to undergo transplantation was dismal. AlloSCT is the treatment of choice for younger, transplant-eligible patients with relapsed/refractory PTCL. AlloSCT is currently not recommended as part of first-line consolidation.

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前瞻性随机 AATT 研究(外周 T 细胞淋巴瘤患者的自体或异体移植)的长期随访。
临床试验经常包括多个终点,这些终点在不同时间成熟。最初的报告通常以主要终点为基础,可能会在关键的计划共同主要分析或次级分析尚未完成时发布。III期随机AATT研究的初步分析显示,外周T细胞淋巴瘤(PTCL)年轻患者接受自体或异体移植(alloSCT)治疗后,无事件生存期(EFS)和总生存期(OS)相似。随机分配接受异体干细胞移植的患者七年无事件生存率为38%(95% CI,25至52),而随机分配接受自体造血干细胞移植(autoSCT)的患者七年无事件生存率为34%(95% CI,22至47);OS为55%(95% CI,41至69)和61%(95% CI,47至74)。在接受alloSCT(26人)或autoSCT(41人)治疗的患者中,累积进展/复发率分别为8%(95% CI,0至19)和55%(95% CI,35至74)。alloSCT和autoSCT后的非复发死亡率(NRM)分别为31%(95% CI,13-49)和3%(95% CI,0-8)。30例早期进展患者中有15例接受了异体干细胞移植,20例自体干细胞移植后进展/复发患者中有11例接受了异体干细胞移植。挽救性异体移植后的7年OS为61%(95% CI,47-74);NRM为23%(95% CI,6-40)。长期随访结果表明,异体干细胞移植对淋巴瘤有很强的移植物抗淋巴瘤效应,与移植时机无关。无法接受移植的患者生存率很低。对于年龄较小、符合移植条件的复发/难治性 PTCL 患者,异体干细胞移植是首选治疗方法。目前不推荐将异体干细胞移植作为一线巩固治疗的一部分。
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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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