Multiple myeloma (MM) treatment and monitoring with MRD-Next Generation Flow (NGF) has evolved fast in the last decade. Nevertheless, its incorporation by low-middle income countries remains challenging. Despite Lenalidomide maintenance (M-Len) after ASCT improves PFS and OS of MM, and MRD-NGF monitoring can discriminate patients with better outcomes, there is no data about these approaches in real-world patients in Brazil (BR) and Latin America. Here we evaluated in two cohorts of patients guided by drug access, the benefit in outcomes of M-Len and MRD-NGF monitoring after ASCT. The study enrolled patients from public and private healthcare systems (HS). A total of 53 patients with symptomatic MM receiving up-front CTD n = 27 or VCD n = 26. All pts had a BM sample at D+100 for MRD-NGF following the EuroFlow SOPs with a limit of detection of 10−6 and a complete protein profile to meet the IMWG response and MRD criteria. Median patient age was 58 (40-70) years, 51% were females. At D+100 the conventional responses were: PR, 5 (9%); VGPR, 21 (40%); CR, 6 (11%); sCR, 21 (40%). Residual plasma-cells were detected by MRD-NGF in 60% of all studied patients and in 44% of those in CR/sCR. MRD+ patients showed a significantly inferior outcome in this setting with median PFS of 26 months vs NR (p = 0.05). Since Len was recently approved in BR and restricted to private HS, we evaluated the impact of this practice in a subset of 18 patients (30%), with a median treatment time of 20.5 months. In this group only, 2/18 (11%) cases progressed whereas in those without maintenance, progression occurred in 19/35 (54%) cases with median PFS NR vs. 21 months (p = 0.001). This benefit also extended to OS, since in the M-len group had no deaths, in contrast to 11/35 (31%) (p = 0.01) deaths in the absence of this drug. Combining the M-Len and MRD-NGF monitoring post ASCT allowed the recognition of groups of patients with different outcomes: M-Len /MRD− (n = 7) vs. no M-Len/MRD+ (n = 21) with medianPFS NR vs 16 months (p = 0.003). Interestingly, the benefit of maintenance was particularly clear among MRD+ these patients had an improved disease control (n = 11) vs MRD+ patients with no M-Len(n = 21): medianPFS NR vs 16 months (p = 0.002) and median OS of NR vs NR (p = 0.02). In our cohort, the majority of patients admitted to the public HS had access to CTD induction without M-Len (n = 24; 45%), while in the private HS they were covered for Bortezomib induction and M-Len post-transplant (n = 15; 28%) with some patients having other mixed situations with VCD induction without M-Len (n = 11; 22%) or CTD+M-Len (n = 3; 5%). Firstly, the comparison between the strategies available by drug access CTD/no-M-len in public vs VCD/M-len in private had an impact on both PFS (median of 16 months vs NR; p = 0.003) and OS (median NR vs NR; p = 0.02). Similarly, patients that had access to PI in induction without M-len also had different outcomes: median PFS NR vs. 21 months for VCD/M-Len vs VCD/no M-Len, respectively (p = 0.01), with a trend in OS (p = 0.06). Finally, different induction regimens (CTD vs VCD without M-Len) showed no impact on PFS (median: 16 vs.21 months; p = 0.6). In real-life, the use of M-Len post-ASCT is associated with better survival outcomes, MRD-NGF was a reproductible and powerful tool to discriminate patients at higher and earlier relapse risk. Inequity of drug access remains a hurdle in countries with constraints, particularly in public HS with a negative impact on survival of MM.
Journal Information
Vol. 43. Issue S1.
Pages S216-S217 (October 2021)
Vol. 43. Issue S1.
Pages S216-S217 (October 2021)
Open Access
THE ROLE OF LENALIDOMIDE MAINTENANCE AND MEASURABLE RESIDUAL DISEASE IN A REAL LIFE MULTIPLE MYELOMA TRANSPLANTED POPULATION RECEIVING DIFFERENT STRATEGIES GUIDED BY ACCESSIBLE TREATMENTS IN BRAZIL
Visits
1320
ABDS Salgadoa,b, RJP Magalhãesb, RM Pontesa,c, E Barbosaa, GS Pimentab, J Flores-Monterod,e, LDCS Florese,f, A Orfaod,e, ES Costaa,g, A Maiolinoa,b
a Internal Medicine Postgraduate Program, Faculty of Medicine, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil
b Department of Clinical Haematology, Hospital Universitário Clementino Fraga Filho (HUCFF), Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil
c Hospital da Criança de Brasília, Brasília, DF, Brazil
d Translational and Clinical Research Program, Cancer Research Center, Cytometry Service and Department of Medicine, University of Salamanca (USAL), Salamanca, Spain
e Centro de Investigación Biomédica en Red de Cáncer, Instituto Carlos III, Madrid, Spain
f Institute of Biomedicine of Seville, Department of Hematology, University of Seville, Seville, Spain
g Cytometry Service, Instituto de Puericultura e Pediatria Martagão Gesteira (IPPMG), Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil
This item has received
Article information
Special issue
Full text is only aviable in PDF