The Prognostic Impact of Complete Remission (CR) Plus Very Good Partial Remission (VGPR) in a Double-Transplantation Program for Newly Diagnosed Multiple Myeloma (MM). Combined Results of the IFM 99 Trials.
The Prognostic Impact of Complete Remission (CR) Plus Very Good Partial Remission (VGPR) in a Double-Transplantation Program for Newly Diagnosed Multiple Myeloma (MM). Combined Results of the IFM 99 Trials.
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新诊断多发性骨髓瘤 (MM) 双移植计划中完全缓解 (CR) 加上良好部分缓解 (VGPR) 的预后影响。
DOI：
10.1182/blood.v108.11.3077.3077
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发表时间：
2006
期刊：
影响因子：
20.3
通讯作者：
H. Avet
中科院分区：
文献类型：
--
作者：
J. Harousseau;M. Attal;P. Moreau;F. Garban;T. Facon;H. Avet
介绍。在 MM 中，CR 成就的影响仍然是一个有争议的问题。在 IFM 90 和 IFM 94 试验中，达到 CR（阴性电泳，有或没有阴性免疫固定）加上非常好的部分缓解（M 成分减少 90%）与较长的总生存期 (OS) 显着相关（M. Attal 等人：NEJM1996；348：1875–83 和 M. Attal 等人；NEJM2003；349： 2495–502）。我们想要检查这种简单的反应评估方法对旨在提高 CR 率的双移植计划的影响。方法。在风险适应 IFM 99 试验中，治疗策略基于对两种不良预后因素的评估（β2 微球蛋白 > 3 mg/L；FISH 分析 del (13)）。所有 65 岁以下的患者均在 3-4 个疗程的 VAD 诱导治疗后接受双移植。在标准风险 MM（0 或 1 个不良预后因素）中，患者接受双自体干细胞移植 (ASCT)（美法仑 140 mg/m 2 /美法仑 200 mg/m 2 ），并随机分为不进一步治疗、帕米膦酸钠或沙利度胺加帕米膦酸钠 (IFM 99/02)。在高风险 MM（2 个不良预后因素）中，患者接受第一次 ASCT（美法仑 200 mg/m 2 之后），如果有 HLA 相同的同胞，则接受强度降低的同种异体 SCT（IFM 99/03）或第二次 ASCT（美法仑 220 mg/m 2 ± 抗 IL-6 抗体后）（IFM 99/04）。结果。中位随访时间为 47 个月，中位无事件生存期 (EFS) 为 39 个月，5 年 OS 概率为 62%。对 849 名患者的最佳治疗反应进行了评估：274 名患者 (32%) 达到 CR，191 名患者 (22.5%) 达到 VGPR，311 名患者 (37%) 仅部分缓解 (PR)，73 名患者 (8.5%) 病情稳定或进展。达到 CR 的患者的中位 EFS 和 5 年 OS 分别为 42 个月和 77%，VGPR 患者的中位 EFS 和 5 年 OS 分别为 38 个月和 63%，PR 患者的中位 EFS 和 5 年 OS 分别为 30 个月和 55%。 465 名 M 成分减少至少 90% (CR+VGPR) 的患者的结果明显好于 384 名有结论的患者。在双移植计划中，54.5% 的患者获得 CR + VGPR。我们确认，反应质量与结果显着相关，并且可以通过非常简单的方法评估的 CR + VGPR 的实现具有很强的预后影响。我们无法证明在 VAD 诱导治疗后实现 CR+ VGPR 的益处，但 353/465 (76%) 仅在双移植计划后才达到此状态。
Introduction. In MM, the impact of CR achievement is still a matter of debate. In the IFM 90 and IFM 94 trials the achievement of CR (negative electrophoresis with or without negative immunofixation) plus very good partial remission (90% reduction of the M-component) was significantly associated with longer overall survival (OS) (M. Attal et al: NEJM1996;348:1875–83 and M. Attal et al; NEJM2003; 349: 2495–502). We wanted to check the impact of this simple way of response assessment in a program of double transplantation designed with the objective of increasing the CR rate. Methods. In the risk-adapted IFM 99 trials, therapeutic strategy was based on the assessement of two adverse prognostic factors (β2 microglobulin > 3 mg/L; del (13) by FISH analysis). All patients up to 65 years of age were to receive a double transplantation after an induction treatment with 3–4 courses of VAD. In standard risk MM (0 or 1 adverse prognostic factors), patients received a double autologous stem-cell transplantation (ASCT) (Melphalan 140 mg/m 2 /Melphalan 200 mg/m 2 ) and were there randomized between no further treatment, pamidronate, or Thalidomide plus pamidronate (IFM 99/02). In high risk MM (2 adverse prognostic factors), patients received a first ASCT (after Melphalan 200 mg/m 2 ) followed by either a reduced-intensity allogeneic SCT if an HLA-identical sibling was available (IFM 99/03) or a second ASCT (after Melphalan 220 mg/m 2 ± anti IL-6 antibody) (IFM 99/04). Results. With a median follow-up time of 47 months, the median event-free survival (EFS) was 39 months and the probability of 5-year OS was 62%. Best response to treatment was assessed in 849 patients: CR was achieved in 274 patients (32%) and VGPR in 191 patients (22.5%), while 311 patients (37%) had only a partial remission (PR) and 73 pts (8.5%) had a stable or progressive disease. Median EFS and 5-year OS were respectively 42 months and 77% for patients who achieved CR, 38 months and 63% for patients with VGPR, 30 months and 55% for patients with PR. The outcome was significantly better for the 465 patients with at least 90% reduction of their M-component (CR+VGPR) than for the 384 patients with Conclusion. In the context of a double transplantation program, CR + VGPR is obtained in 54.5 % of patients. We confirm that the quality of response is significantly correlated to the outcome and that achievement of CR + VGPR which can be assessed by very simple means, has a strong prognostic impact. We were not able to show a benefit of achieving CR+ VGPR after the induction treatment with VAD but 353/465 (76%) achieved this status only after the double transplant program.