Epidemiological Study of Mutiple Myeloma In Spain: Efectiveness and Survival Analysis

Epidemiological studies are the base to evaluate the efficiency of medical interventions in the interest of the public health. Updated epidemiological data and effectivenes in the daily clinical practice are needed in Multiple Myeloma (MM).

Epidemiological retrospective, longitudinal, multicenter nation wide Spanish study of an historical cohort of patients with MM. Data from patients aged ≥ 18 years, with a MM Stage II or III, who received a treatment on a daily clinical practice (not in clinical trials) for MM in the September'03-August'05 time frame were collected. The study protocol was approved by an Ethics Committee in 2009. Data were collected in 37 Spanish Centres during a 6 months period. Stratified effectiveness and survival analysis were performed (age <65, ≥65; gender; ECOG 0–1 vs 2–3; stage; heavy chain IgA vs IgG; light chain kappa vs lambda, bone lesions or not, plasmacytoma or not, Hb level <10 vs ≥ 10 gr/dL, LDH <130 vs ≥130 U/L, beta2 microglobuline <3.5 vs >3.5, calcium <11 vs ≥ 11 mg/dL, creatinine <1.5 vs ≥ 1.5 mg/dL, plasma cells <10 vs >10%, myelomatous cells <10 vs >10%, induction treatment, dose delayed, full dose).

Data from 338 patients' files who fulfill all the study selection criteria were reviewed. Median age at diagnosed was 66 years. A 45% were aged less than 65 years, 34% 65–74 years and 21% ≥ 75. Male/female ratio: 50/50. ECOG performance status were available in 314 patients (93%) in whom the score was 0/1/2/3/4 in a proportion (%) of 25/25/25/20/5 respectively. Secretor MM was present in 95% of the patients. Bone lesions were present in 244 patients (73%). Plasmacytoma was evidenced in 51 (15%). Half of the patients were transplant candidates and it was performed in 128 (38%). Overall response rate were statistically different when using VBAD/VBMCP vs VAD and MP as induction regimens (86% vs 62% vs 50%, p=0,002). It must be noted that most novel treatments were not widely used by the time of the study. Median survival was 56.1 months. Survival rate at 3 years was 60.8%. Variables statistical significant at the discriminant analysis are showed at table 1. A stepwise Cox Model determine Hb level <10 g/dL, LDH <500 and transplant are prognostic factors for survival (table 2). Toxicity was manageable and no differences with those data already published were reported.

These epidemiological data suggest the effectivemens of the treatment depends on its individualization based on patients' characteristics and in treatment adherence. LDH is a survival prognostic parameter in MM. No new safety issues appears, despite those already published.

De La Rubia:Celgene: Research Funding. Castillo:Celgene: Research Funding. López:Celgene: Employment. Ramirez:Celgene: Research Funding.