Patients with multiple myeloma (MM) often have cardiac comorbidities because of several factors, including the history of cardiac events, myeloma and treatment-related factors. Age is an important risk factor, given that the median age at the diagnosis of MM in Russia is 64 years. Additionally, the MM-related cardiac risk factors include underlying and undiagnosed cardiac amyloidosis, hyperviscosity, high-output failure, anemia and renal failure. Therefore, there are poorly understanding of real efficiency anti-myeloma treatment for this category of patients. In the presented work we have analyzed the efficiency of the most commonly used bortezomib-containing regimens in anti-myeloma treatment for patients with MM with concomitant cardiac diseases.
One hundred and forty-eight (males – 69, females – 79) patients were enrolled in this trial during March 2008 – May 2010. They divided on groups with (1) newly diagnosed and (2) relapsed and refractory MM. The median ages for patients of all groups was 64.7 years (ranges, 36.3 – 82.7). An obligatory condition was the presence in all patients of significant cardiac pathology. The bortezomib-containing regimens VCD (n = 95), VMP (n = 36) or VD (n = 15) were used as anti-myeloma treatment. IMWG (2006) criteria were used for anti-myeloma response assessment. Comparisons for categorical variables among different groups were wade with chi-square test. Overall survival (OS) was measured from the date of treatment initiation until the date of death or the date of last follow up. For multivariant analysis, factors associated with time to event were introduced into a Cox proportional model.
ECOG performance status of ≤ 2 have 81 (54.7%) patients. The verified diagnosis of ischemic heart disease was in 109 (73.6%) patients and symptoms of chronic heart failure was in 86 (58.1%) patients. The overall response rate (ORR) documented in 65.7% cases with newly diagnosed and 59.5% cases with relapsed and refractory MM including complete and strong complete remission (CR/sCR) in 22.9% and 20.3% cases respectively. With a median follow-up of 4.9 years for the comparison groups, the 5-year overall survival (OS) was 22.8 ± 5.3% and 17.3 ± 4.4% (p = 0.295). The median OS was 40.0 and 31.8 months respectively.
In multivariate analysis only ECOG scores ≥ 2 were demonstrated an independent negative prognostic value both for the event-free survival (Hazard ratio 1.69; p = 0.006) and OS (Hazard ratio 1.76; p = 0.003). Overall, the bortezomib-based treatment in myeloma patients with concomitant cardiac pathology accompanied by no significant increase in the incidence of cardiovascular adverse events.
Clinical trial identification
Legal entity responsible for the study
Pirogov Russian National Research Medical University (RNRMU) Research Medical University (RNRMU)
All authors have declared no conflicts of interest.