Multiple Myeloma Multicenter Registry in Colombia: The Impact of Autologous Stem Transplantation on Overall and Disease-Free Survival

Aim: RENEHOC (Registro Epidemiológico de Neoplasias Hematológicas en Colombia) is a multicenter clinical quality database established in January 2018. The primary aim of the database is to provide local information on diagnosis and treatment of Multiple Myeloma (MM) and other hematologic neoplasms; this is key to show authorities the improvements that must be made to achieve better outcomes for Colombian patients and pose research questions relevant to our population. The aim of this report is to analyze variables related to event free survival (EFS) and overall survival (OS) in MM Colombian patients.

Study population: An ambispective registry of adult MM patients, treated in approved centers over the last 10 years in Colombia. As of July 2020, 890 patients have been registered. Descriptive statistics were used for patient's demographic and clinical characteristics. The Kaplan-Meier method was used to assess DFS and OS. Hazard Ratios (HR) using Cox proportional hazards regression modeling was estimated. <65 yrs. patients were considered transplant eligible (TE) and older than 65 yrs. transplant ineligible (TI).

Results: Data from 890 MM patients were reviewed. Median age at diagnosis was 66.8 (SD 11.17) years (TE 57 yrs., SD 6.71; TI 74.8 yrs., SD 6.87); 398 (57%) were TE; 52.9% were male. At diagnosis median hemoglobin was 10.1 (SD 2.5), 242 (27.2%) had renal failure, and 379 (42.6%) pathological fractures. IgG was the most common M component (n=328, 36.8%). Most patients were in an advanced stage by Durie Salmon at diagnosis (DS IIIA or IIIB: n=523, 77.4%), and had high risk ISS (ISS 1: n=128, 20.6%; ISS 2: n=180, 29.0%; ISS 3: n=312, 50.3%; NA n=270). Only 17,9% (n=160) had cytogenetic prognostic characterization. There were not significant differences in clinical characteristics at diagnosis between TE and TI patients.

The most common induction regimen for TE were Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) (n=190, 49%) and Bortezomib-Thalidomide-Dexamethasone (VTD) (n=103, 27%). For TI patients, most common regimens in first line were CyBorD (n=111, 245), VTD (n=90, 19%) and Bortezomib-Dexamethasone (Vd) (n=84, 18%). 69% TE and 59% TI patients had partial response or better after first line. 41% of TE patients actually received an Autologous Stem Cell Transplantation (ASCT) after 1 line. 19% of TI patients received an ASCT. Of note, in 78% of patients considered to have indication not taken to transplant, administrative barriers of access are reported.

Mean follow-up for the entire group was 28.35 months (SD 29.27, CI 26.41-30.29). The median DFS was 62 months being significantly longer in TE patients (74 vs 53 months for TI, p=0.0002), estimated 5 years DFS 52% (TE 56% vs 46% for TI). Median OS was 88 months (Not reached for TE vs 75 moths for TI, p=0.0001), estimated 5 years OS 62% (TE 70% vs 56% for TI). Univariate analysis showed ISS at diagnosis, age and ASCT were significantly related to OS. On multivariate analysis ISS 3 (HR 1.89; p=0.004; CI 1.22-2.93) at diagnosis and ASCT (HR 0.26, p=0.0001, CI (0.18-0.39) were the only factors significantly associated with OS. 5 yrs. OS for patients that received ASCT was 80% in comparison to 48% if not done.

Conclusion: At this timepoint data from RENEHOC is still limited, however, the potential of this growing registry is evident; until now little information about hematologic neoplasms in Colombia was available, this effort allows us to know the reality of our patients and plan relevant trials in our settings. We report here characteristic of a large cohort of MM patients in Colombia. OS and DFS are comparable with what have been published for similar patients in other latitudes. Consolidation with ASCT was the most important factor affecting prognosis in this cohort; the low transplant rate has to be addressed to improve outcomes for myeloma patients in Colombia.

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