Incidence of thromboembolism and associated factors in multiple myeloma patients treated with immunomodulatory drugs: a retrospective analysis in Belo Horizonte, Brazil.

PURPOSE: The use of immunomodulators in the treatment of multiple myeloma (MM) patients has been associated with venous thromboembolism (VTE). Due to the increase in mortality of cancer patients, venous thromboembolism is an important concern for newly diagnosed multiple myeloma (NDMM) patients. The aim of this study was to determine the incidence of thromboembolic events and evaluate associated risk factors among Brazilian NDMM patients using immunomodulators. METHODS: Real-life retrospective cohort study in two Brazilian institutions with newly diagnosed multiple myeloma (NDMM) patients treated with immunomodulators from January 2009 to December 2019. Data was collected from patients' medical records for the period of 1 year, and Cox regression was performed to identify risk factors on the development of VTE. RESULTS: We included 131 patients of which there was a mean age of 61.5 years (SD 11.3), 51.9% female, and predominantly using thalidomide (97.7%) as immunomodulator. We found 9 VTE episodes among our patients, with a 12-month cumulative incidence of 6.97% (95% CI 3.41-12.24). Associated factors after multivariate analysis were recent sepsis, recent traumatic injury, previous VTE, and thromboprophylaxis. CONCLUSION: Our real-life retrospective cohort presented a low incidence of VTE among Brazilian NDMM patients treated with immunomodulators.

Chemotherapy-Induced Peripheral Neuropathy Impacts Quality Of Life And Activities Of Daily Living Of Brazilian Multiple Myeloma Patients.

BACKGROUND: Survival in multiple myeloma (MM) has improved in the past years with the introduction of immunomodulators and proteasome inhibitors. However, chemotherapy-induced peripheral neuropathy (CIPN) is associated with both drug classes affecting Health-Related Quality of Life (HRQoL) and activities of daily living (ADL). OBJECTIVE: We evaluated CIPN in MM patients to identify associated factors and impacts on HRQoL and ADL. METHODS: This is a cross-sectional study with Brazilian patients from public and private health services. Patients were interviewed using validated tools to measure CIPN and HRQoL, along with sociodemographic and clinical questions. Logistic regression was used to assess the association of CIPN with sociodemographic, clinical, and HRQoL variables. RESULTS: In total, 217 patients were eligible for the study. The median age was 67, 50.9% were women, 51.6% had low income, 47.5% had low education, and 55.3% attended private health services. The chemotherapy regimen most used was the combination of cyclophosphamide, thalidomide, and dexamethasone (17.5%) among the 24 types of regimens found. Most patients (90.3%) had at least one CIPN symptom: 62.7% were severe, and 51.62% were extremely bothered ADL. Numbness was the most common symptom (40.6%). CIPN was independently associated with education, hospitalization, chemotherapy, side effects, disease symptoms, and global health status in HRQoL. CONCLUSION: MM patients showed a high frequency of CIPN, which affected ADL and impaired HRQoL. Early and accurate detection of CIPN and dose management in patients with thalidomide and bortezomib-based regimens should be performed to provide better treatment outcomes and avoid permanent disabilities.

Health-related quality of life and use of medication with anticholinergic activity in patients with multiple myeloma.

PURPOSE: Verify the association between anticholinergic burden and health-related quality of life of patients with multiple myeloma. METHODS: Cross-sectional study with multiple myeloma outpatient from a state capital city in southeastern Brazil. Sociodemographic, clinical, and pharmacotherapeutic variables were collected by interview. Clinical data were complemented by medical records. Drugs with anticholinergic activity were identified with Brazilian Anticholinergic Activity Drug Scale. Health-related quality of life scores were obtained using QLQ-C30 and QLQ-MY20 instruments. Mann-Whitney was used to compare the median of the health-related quality of life scale scores and the independent variables. Multivariate linear regression was performed to verify the association between independent variables and health-related quality of life scores. RESULTS: Two hundred thirteen patients were included, 56.3% had multi-morbidities, and 71.8% used polypharmacy. In all health-related quality of life domains, there were differences between the medians of the polypharmacy variable. A significant difference was identified between the ACh burden and QLQ-C30 and QLQ-MY20 scores. Linear regression identified an association between the use of drugs with anticholinergic activity and the reduction of global status scores (QLQ-C30), functional scale (QLQ-C30), body image (QLQ-MY20), and future perspective (QLQ-MY20). Drugs with anticholinergic activity were associated with increased symptom scores (QLQ-C30 and QLQ-MY20). Polypharmacy was associated with reduction of functioning score and increase of symptom score (QLQ-C30). CONCLUSION: Anticholinergic burden in MM patients is associated with lower scores in quality of life domains: global health and symptoms (QLQ-C30) and functional (QLQ-C30 and QLQ-MY20). The presence of polypharmacy is also associated with lower scores for functional scales and symptom scales (QLQ-C30).

Comparison of three risk assessment models for thromboembolism in multiple myeloma patients receiving immunomodulators: a Brazilian historical cohort.

Venous thromboembolism (VTE) is among the complications of Multiple Myeloma (MM) and may occur in up to 10% of this patient population. However, medications used in MM therapy such as immunomodulators (IMID) may raise these rates. Thus, risk prediction models have been developed to quantify the risk of VTE in MM patients. The aim of this study is to compare the performance of three risk assessment models for VTE in newly diagnosed MM (NDMM) patients using immunomodulatory agents. A historical cohort study during a 10-year period in a Brazilian metropolis with NDMM treated with IMID. Data were collected from patient's medical charts for the period of one year to calculate the scores using IMPEDE VTE, SAVED, and International Myeloma Working Group (IMWG) guidelines. The area under the curve (AUC) of the Receiver Operating Characteristic curve analysis was calculated to assess the discriminative power of three risk assessment models. We included 131 patients (9 in the VTE group versus 122 in the non VTE group). According to IMPEDE, 19.1, 62.6, and 18.3% of patients were considered low, intermediate, and high risk, respectively. SAVED classified 32.1% as high risk and 64.9% had ≥2 risk factors based on IMWG guidelines. The AUC of the IMPEDE VTE score was 0.80 (95% CI 0.66-0.95, p = 0.002), of the SAVED score was 0.69 (95% CI 0.49-0.89, p = 0.057), and of the IMWG risk score was 0.68 (95% CI 0.48-0.88, p = 0.075). IMPEDE VTE was the most accurate in predicting the development of VTE in Brazilian patients on IMID therapy. The SAVED score and the IMWG guidelines did not show discriminative ability in predicting VTE based on the population involved in this study.