Long Term Significance of Response in Multiple Myeloma After Stem Cell Transplantation.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1811-1811
Author(s):  
Joaquin Martínez-López ◽  
Joan Blade ◽  
M. Carmen Gomez del Castillo ◽  
Maria Victoria Mateos ◽  
Adrian Alegre ◽  
...  

Abstract Abstract 1811 Poster Board I-837 The prognostic significance of achieving complete remission (CR) in Multiple Myeloma (MM) has finally been accepted. However, available studies have been based on series with a median follow-up around 5 years. This time period is insufficient according to the current life expectation of MM. Aim To establish the real effect of prognosis of the different response categories in a cohort of MM patients treated with autologous stem cell transplantation (ASCT) after long term follow up. Patients and methods Follow-up from diagnosis of 344 MM patients transplanted between 1989 and 1998 has been updated. These patients were previously included in a study aimed at establishing the post-ASCT response significance in MM and to validate the EBMT classification (Br J Haemat 2000;109:438-46). It was possible to update the follow up of 322 patients as at April 2009. At this date 99 patients were alive with a median follow-up form diagnosis of 12.5 years. Response categories and evaluated cases were: i) Complete Response (IF-) (CR), n= 84 ii) near Complete Response (EF-/IF+) (nCR), n= 66 iii) Very good partial response (VGPR) (<90% reduction of M component), n= 66 iv) Partial response PR (reduction of M component between 90-50%), n= 113 v) Stable Disease (SD), n= 12, y vi) Progression (PD), n=14 Survival analyses were performed by Kaplan-Meier curves (log-rank test). Cox logistic regression was employed to establish variables associated with a higher survival. Results Significant differences in overall survival (OS) and event free survival (EFS) were found between CR and nCR groups (p 0.01 and 0.0022, respectively); or between CR and VGPR (p 0.0001 and 0.0035); no differences were detected between nRC and VGPR groups (p 0.21 and 0.99) and between these groups and PR group (p 0.1 y p 0.8). OS and EFS of patients with ED o PD were lower than the rest of the groups. Overall survival at 12 years was 43% in CR patients, 21% in nCR, 20% in VGPR, 30% in PR, 8% in SD and 0% in PD groups. Median survival (OS, EFS respectively) of each group was 91 months and 36 m, 26 m and 21 m, 20 m and 15 m, 31 m and 12 m, 8 m and 5 m, and 6 and 1 month. Land-mark study (10 years) found a plateau phase in OS and EFS after 11 years. Twenty two percent of patients are still alive with stable status between 11 and 15.54 years and only two cases had relapsed in the non CR group. In a regression study for OS, response was only one variable with statistical significance (CR P <0.0000, OR 0.044, IC-95%: 0.020-0.30). Conclusions In MM achieving CR after ASCT is the most important prognostic factor even after long-term follow-up. Relapse rate is very low in patients with >11 years of follow-up, this could mean a cure for patients in CR. Disclosures No relevant conflicts of interest to declare.

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1019-1019
Author(s):  
Nicolaus Kroeger ◽  
Simona Iacobelli ◽  
Linda Koster ◽  
Dietger Niederwieser ◽  
Uwe Platzbecker ◽  
...  

Abstract Introduction Retrospective studies in MDS/sAML suggest that reducing the intensity of the conditioning regimen prior to allogeneic stem cell transplantation reduces the risk of non-relapse mortality but is associated with a higher risk of relapse. A higher risk of relapse after RIC was confirmed in a prospective BMT CTN study but the prospective randomized studies from the EBMT for MDS and sAML did not show a difference in outcome after 2 years (J Clin Oncol. 2017 Jul 1;35(19):2157-2164). Here we present a long term follow-up of the study after a median follow-up of 75 months (range 4-150 months). Methods Within the European Society of Blood and Marrow Transplantation (EBMT) we conducted a prospective, multicenter, open label, randomized phase III trial comparing comparing a busulfan based (Busulfan 8mg/kg orally or equivalent dosis intravenously (iv) plus fludarabin 180mg/m²) reduced intensity conditioning regimen (RIC) and a standard myeloablative busulfan (Busulfan 16mg/kg orally or equivalent dosis iv plus cyclophosphamide 120mg/kg) based regimen (MAC) in patients with MDS or sAML (<20 % blasts). Between May 2004 and December 2012, a total of 129 patients were enrolled from 18 centers. Patients were randomly assigned in a 1 : 1 ratio and stratified according to donor, age and blast count. Results In the first report (JCO 2017) the CI of NRM after 1 year was 17% (95% CI 8-26%) after RIC and 25% (95% CI 15-36%) after MAC (p = 0.29). The CI of relapse at 2 years was 17% (95% CI 8-26%) after RIC and 15% (95% CI 6-24%) after MAC (p = 0.6), resulting in a 2 year relapse-free and overall survival of 62% (95% CI 50-74%) and 76% (95% CI 66-87%) after RIC and 58% (95% CI 46-71%) and 63% (95% CI 51-75%) after MAC (p = 0.58 and p = 0.08, respectively). In the current follow-up study, all cases but one who were alive at last report could be updated. The median follow-up is now 75 months in the MAC and 72 months in the RIC arm. Since last follow-up =18 death occurred in both arm (MAC n=8, RIC n=10) 8 relapses (MAC n=4; RIC n=4) and 6 NRM (MAC n=2; RIC n=4). Second allogeneic stem cell transplantation was performed in 18 patients (n=10 in RIC and n=8 in MAC) due to graft failure (n=4) relapse (n=11) and others (n=3). The CI of chronic GvHD at 5 years was 65% (95% CI: 53-78) after RIC and 68% after MAC ((95% CI: 55-81; p = 0.70). At 5 years there was no difference in CI of NRM (22%, 95%CI: 12-32 vs 30% , 95%CI : 19-42, p=0.5) in CI of Relapse (22% , 95% CI: 12-32 vs18%, 95% CI: 8-28, p= 0.7), Relapse free- (57%, 95% CI: 44-69 vs51%, 95% CI: 39-64, p=0.8) and Overall survival (69%, 95% CI: 58-80 vs 53%, 95% CI: 40-65, p=0.15) between RIC and MAC, respectively. Conclusion This long term follow-up of the prospective randomized EBMT trial confirmed early results that RIC resulted in at least similar long term relapse-free and overall survival as MAC in patients with MDS or sAML. The trial was registered under ClinicalTrials.gov Identifier: NCT01203228. Disclosures Niederwieser: Miltenyi: Speakers Bureau; Novartis: Research Funding. Platzbecker:Celgene: Research Funding. Scheid:Celgene: Honoraria; Janssen: Honoraria; Novartis: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; BMS: Honoraria; Amgen: Honoraria. Stelljes:MSD: Consultancy; Amgen: Honoraria; JAZZ: Honoraria; Pfizer: Consultancy, Honoraria, Research Funding; Novartis: Honoraria. Heim:Novartis: Research Funding. Bethge:Miltenyi Biotec GmbH: Consultancy, Honoraria, Research Funding; Neovii GmbH: Honoraria, Research Funding. Kobbe:Roche: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Celgene: Honoraria, Other: Travel Support, Research Funding.


Blood ◽  
2011 ◽  
Vol 118 (3) ◽  
pp. 529-534 ◽  
Author(s):  
Joaquin Martinez-Lopez ◽  
Joan Blade ◽  
María-Victoria Mateos ◽  
Carlos Grande ◽  
Adrián Alegre ◽  
...  

AbstractFor establishing the true effect of different response categories in patients with multiple myeloma (MM) treated with autologous stem cell transplantation, we evaluated, after a median follow-up of 153 months, 344 patients with MM who received a transplant between 1989 and 1998. Overall survival (OS) at 12 years was 35% in complete response (CR) patients, 22% in near complete response (nCR), 16% in very good partial response (VGPR), and 16% in partial response (PR) groups. Significant differences in OS and progression-free survival were found between CR and nCR groups (P = .01 and P = .002, respectively), between CR and VGPR groups (P = .0001 and P = .003), or between CR and PR groups (P = .003 and P = < 10−5); no differences were observed between the nCR and VGPR groups (P = .2 and P = .9) or between these groups and the PR group (P = .1 and P = .8). A landmark study found a plateau phase in OS after 11 years; 35% patients in the CR group and 11% in the nCR+VGPR+PR group are alive at 17 years; 2 cases had relapsed in the nCR+VGPR+PR group. In conclusion, MM achieving CR after autologous stem cell transplantation is a central prognostic factor. The relapse rate is low in patients with > 11 years of follow-up, possibly signifying a cure for patients in CR.


2010 ◽  
Vol 28 (35) ◽  
pp. e741-e743 ◽  
Author(s):  
Josien C. Regelink ◽  
Cinthy H.M. van Roessel ◽  
Karin P.M. van Galen ◽  
Gert J. Ossenkoppele ◽  
Peter C. Huijgens ◽  
...  

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