Бремя лечения, секвенирования и использования ресурсов здравоохранения в множестве миеломы в Латинской Америке: обзор целевой литературы.

Key Summary Points

Introduction

Multiple myeloma (MM) is a clonal B-cell malignancy characterized by proliferation of plasma cells in the bone marrow, resulting in symptoms such as hypercalcemia, renal insufficiency, anemia and bone lesions, known as CRAB symptoms [ 1 ]. Although it is generally considered a treatable disease, MM is not curable, and its incidence varies greatly across countries and regions [ 2 , 3 ]. Globally, MM accounts for 1–1.8% of all cancers and approximately 10% of hematologic malignancies; it is the cause of ~ 1% of all cancer deaths [ 2 , 4 , 5 ].

According to the most recent data from the International Agency for Research on Cancer (IARC), approximately 187,952 new cases of MM and 121,388 MM-related deaths were recorded worldwide in 2022 [ 2 ]. Of these, 15,194 new cases and 11,402 deaths were reported in Latin America (LATAM) [ 2 ]. The estimated 5-year prevalence of MM in LATAM is 6.4 per 100,000 people [ 2 ], with an underlying incidence that is increasing annually, attributed to a rapidly growing, aging population [ 6 ].

The management of MM has changed substantially in the last 2 decades following the approval of key drug classes, including immunomodulatory imide drugs, proteasome inhibitors (PI) and anti-CD38 monoclonal antibodies, which have improved survival for patients with MM and are recommended by global treatment guidelines [ 4 , 7 – 9 ]. Combinations of these agents have been used in triplet or quadruplet regimens to maximize depth of response as induction therapy prior to autologous stem cell transplantation (ASCT) in eligible patients or as first-line (1L) options in transplant-ineligible patients [ 4 , 10 ]. Single- or double-agent maintenance therapy may then be introduced [ 10 ]. Despite the increasing number of available treatment options, relapse eventually occurs in MM, and patients become refractory to treatment [ 10 ]. At first relapse, most patients are refractory to at least one of the drug classes in their initial treatment regimen, highlighting a need for new classes of agents and evidence-based guidance on appropriate sequencing of treatment for individual patients [ 10 – 13 ]. The choice of subsequent therapy depends on prior therapies received and refractoriness, as well as disease- and patient-related factors including frailty and presence of end organ damage [ 10 ]. Clinical trials in the newly diagnosed MM (NDMM) setting have demonstrated efficacy with quadruplet combination regimens in transplant-eligible and -ineligible patients [ 10 , 14 , 15 ], and overall survival of patients has doubled over the past 20 years where key drug classes are available [ 16 ]. However, in the relapsed/refractory MM (RRMM) setting, an unmet need at first relapse (second line; 2L) remains for novel combinations that are efficacious in a broad patient population to prevent re-treatment with the same agent or drug class, which is often associated with poor outcomes [ 17 – 19 ].

Access to common treatment regimens for MM varies widely across countries in LATAM. Although thalidomide- and bortezomib-based regimens are common frontline treatments in some LATAM countries, clinical outcomes are suboptimal [ 20 , 21 ]. In LATAM, most patients are treated in the public healthcare system, where access to newer treatments is restricted [ 16 ], and access to globally recognized standard of care therapies and interventions such as bortezomib and ASCT can also be limited [ 22 ]. In the relapsed setting, as patients become refractory to different drug classes and regimens, their treatment options and opportunities to switch to different, newer classes of agents or regimens (e.g., anti-CD38 monoclonal antibodies) depend upon the availability of these treatments in the public and private healthcare settings in different countries [ 16 ]. This differential access to effective treatments results in disparities in survival outcomes between patients treated in the public and private sectors and in different countries [ 23 ].

Approaches to treating MM continue to evolve, with the arrival of novel agents such as antibody–drug conjugates, bispecific T-cell engagers and chimeric antigen receptor (CAR) T-cell therapy expanding options for heavily pre-treated patients [ 11 ]. Some of these agents have been approved for the treatment of RRMM in select countries globally [ 11 , 12 ], but many are again either largely inaccessible or not approved in LATAM.

When patients become refractory to the different classes of therapies available, the treatment burden (i.e. treatment administration, adverse events [AEs] and symptom management) increases with each successive line of therapy (LOT), and clinical efficacy declines [ 24 , 25 ], with a subsequent impact on healthcare resource utilization (HCRU) [ 25 – 27 ]. Patients who have received multiple LOTs with three different agent classes are not only at higher risk of poor outcomes but also experience clinically significant HCRU to manage disease symptoms and treatment side effects, all of which can greatly impact their quality of life (QoL) [ 27 ]. As RRMM typically requires prolonged treatment, this can create a substantial clinical and economic burden on healthcare systems as well as individual patients [ 28 ].

The LATAM region often faces unique healthcare challenges, including limited resources and infrastructure. Improved understanding of HCRU for MM in this setting may aid in optimizing resource allocation [ 29 – 33 ]. Data on the availability and use of novel therapies in LATAM, as well as real-world effectiveness and safety, treatment sequencing and attrition, are limited. This information is crucial for identifying specific challenges in the management of MM in the region, as well as understanding the uptake and accessibility of standard of care and novel therapies. The aim of this literature review is to understand the epidemiology, burden of treatment and treatment sequencing and availability for MM in the LATAM countries of Argentina, Brazil, Chile, Colombia and Mexico. It also explores recent literature on patient and clinical outcomes and HCRU for MM in these countries.

This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

Methods

A comprehensive bibliographic search strategy was developed utilizing the population, intervention, comparators and outcome (PICO) framework to construct the research topics and criteria. Broad search strings incorporating “Latin America or South America or LATAM,” individual countries (“Brazil,” “Argentina,” “Chile,” “Colombia” and “Mexico”) and “multiple myeloma [MeSH]” were applied to capture articles of relevance from four literature databases: PubMed, Embase, SciELO and LILACS. Literature searches were conducted from within the time frame of January 1, 2014, to November 1, 2024 (Supplementary Table 1). Research topics and criteria of interest in the predefined PICO framework included: patients with MM in the LATAM countries of interest; any 1L or 2L therapy for MM, any therapy for RRMM; epidemiology, treatment patterns, patient and clinical outcomes; policy and guideline development; and HCRU (Supplementary Table 2).

Article titles were initially screened for relevance by two unblinded data screeners on the basis of including key terms within the search strings used for each database, followed by abstract screening. Full text review and data extraction were conducted for included articles. Full article inclusion and exclusion criteria are listed in Supplementary Table 3. Where the data were available, disease epidemiology, patient characteristics, treatment patterns, clinical and patient-reported outcomes and healthcare resource utilization were summarized and analyzed by geography, LOT and intervention. Further details on the search strategy and methodology are available in the supplementary materials.

Results

In total, 878 articles were identified. Screening titles and abstracts excluded 591 articles, and the full text of the remaining 287 articles was screened for eligibility. Data were extracted from 230 articles. Reasons for exclusion are summarized in Fig. 1 .

Key clinical outcomes of interest were reported in 40 articles, most of which were retrospective observational studies ( n = 33), with four prospective studies, two physician surveys and one randomized controlled trial. Studies reporting data from Brazil were most common ( n = 14), followed by LATAM as a region ( n = 9) and Chile ( n = 6).

Epidemiology of Multiple Myeloma in Latin America

The incidence or prevalence of MM was described in only seven publications. Age-adjusted incidence rates were higher in men than women and increased with increasing age (Fig. 2 a) [ 34 , 35 ]. In an analysis of MM incidence and mortality utilizing IARC and WHO data collected over a 17-year period (1990–2007) from 17 LATAM countries, the highest incidence of MM was reported in Colombia, with age-standardized incidence rates of 2.6 per 100,000 men and 2.0 per 100,000 women. For those aged 40–59 years, the age-standardized incidence rates were 4.4 and 3.1 per 100,000 men and women, respectively, and for those aged > 60 years, the rates were 14.2 and 12.8 per 100,000 men and women, respectively [ 34 ]. Between the years 2003 and 2017, the age-standardized incidence rate was estimated to be 2.0 per 100,000 in São Paulo, Brazil, with the incidence being higher in men than in women (2.2 vs. 1.8 per 100,000 individuals, respectively) [ 35 ].

In a systematic review of global real world studies reporting on the epidemiologic burden of MM, the prevalence rate of MM in Brazil between 2009 and 2010 was reported to be 5.7 cases per 100,000 persons (Fig. 2 b) [ 36 ]. The prevalence rate of MM was estimated to be 2.96 and 1.82 cases per 100,000 persons in Argentina and Colombia, respectively, based on an analysis of national healthcare systems’ databases in 2015 [ 37 ]. However, a separate analysis of the individual registry of health service provision in Colombia from 2003 to 2012 estimated the prevalence rate of MM to be 4.5 per 100,000 women and 4.2 per 100,000 men [ 38 ]. The 5-year prevalence of MM in 2020 is presented in Fig. 2 c.

Seven publications described symptoms at presentation for patients with MM in Brazil, Chile, Colombia and Mexico. Commonly reported symptoms included bone pain, back pain and neuropathy, as well as anemia-related symptoms and pathologic fractures [ 39 – 44 ]. Among patients with central nervous system involvement, a Brazilian center reported headache to be the most common symptom, occurring in 50% of patients, as well as changes in visual acuity in 30% and vertigo in 20% [ 45 ]. No studies reported common symptoms experienced in the RRMM setting or enduring disease-related symptoms following the first LOT.

Although there are limited data detailing the severity of symptoms at presentation, in the Haemato-Oncology Latin America Observational (HOLA) study, conducted between 2008 and 2016 in seven countries across LATAM, a substantial proportion of patients presented with signs/symptoms of MM, including bone disease (78.5%) and anemia (72.7%), as well as renal disease (27.0%) [ 22 ], which occurred at similar rates in other studies in LATAM [ 46 , 47 ].

Patient Characteristics

Patient characteristics from studies reporting key clinical outcomes of interest in a NDMM or RRMM patient population (e.g., response rates, progression-free survival [PFS], overall survival [OS], AEs) are summarized in Table 1 . Of the 40 studies included, only four studies presented data specific to the RRMM population [ 48 – 51 ]. The average age of patients with MM reported in the studies identified ranged from 51–73 years. Most studies reported a slightly higher proportion of male patients (mean 51.5%, range 39–70%), as summarized by country in Fig. 3 a. Of the 26 studies reporting International Staging System (ISS) stage, 44.1% of patients with a known ISS stage reported in these studies had stage III disease (range 17.9–69.0%) (Fig. 3 b). The median number of prior LOTs in studies enrolling patients with RRMM ranged from one to seven [ 22 , 48 , 49 , 51 ]. In one study, the mean duration from first LOT to second relapse was 3.6 (standard deviation 2.1) years [ 50 ]. The HOLA study of 1103 patients diagnosed with NDMM reported 501 patients progressing to receive a second LOT and 129 progressing to a third LOT; patients included in the study had at least 1 year of follow-up, but median follow-up duration was not specified [ 22 ]. The presence of high-risk cytogenetics was reported in eight studies, of which only two reported the breakdown by cytogenetic abnormality; in these studies, high risk cytogenetic abnormalities were reported in 13–44% of patients [ 21 , 22 , 46 , 47 , 49 , 52 – 54 ].

Treatment Patterns

Treatment access varied across the LATAM region, and between public and private healthcare systems, which is reflected in real-world treatment patterns, summarized in Fig. 4 and Supplementary Table 4 [ 22 , 42 , 46 , 47 , 50 , 55 – 62 ]. Real-world treatment patterns were reported in these 16 observational studies from between 1992 and 2023 [ 22 , 42 , 46 , 47 , 50 , 55 – 62 ]. Patients were most often treated with bortezomib- (50.4%) or thalidomide-based regimens (31.4%). The most commonly used induction regimens in the studies identified included cyclophosphamide + thalidomide + dexamethasone (CTD; 12–64%), bortezomib + thalidomide + dexamethasone (VTD; 15–37%) and cyclophosphamide + bortezomib + dexamethasone (CyBorD; 7–47%). Bortezomib- and thalidomide-based regimens were more common in patients with NDMM (55% and 32%, respectively) than in those with RRMM (34% and 23%); patients with RRMM were more likely to be treated with newer therapies (such as lenalidomide, daratumumab, or carfilzomib) than patients with NDMM (11% vs 1%). HOLA was the only identified study that reported treatment patterns by specific LOT; it reported the increasing use of lenalidomide- and carfilzomib-based regimens from 1.3% in LOT 1 to 10.4% in LOT 2 and 20.9% in LOT 3 [ 22 ]. Bortezomib was more likely to be used in the private than the public healthcare setting (53% and 24%, respectively), where thalidomide was more commonly used (28% and 65%, respectively). Generally, use of newer treatments has been limited and more likely in the private than public healthcare setting (2% vs 0.3%) (Fig. 4 ).

In the HOLA study, most of the patient population sampled from Argentina and Colombia had received treatment in private clinics, whereas patients from Brazil and Mexico were primarily treated in public hospitals. Use of bortezomib in 1L was more common in Argentina and Colombia (39.9% and 56.8%, respectively) than in Brazil and Mexico (15.3% and 11.0%, respectively) [ 22 ]. Despite this, Mexico reported the highest use of newer agents (lenalidomide and carfilzomib) in this study (2.6%), followed by Colombia (1.2%), whereas Argentina and Brazil reported no use of newer agents in 1L [ 22 ].

Two physician surveys were identified in which hematologists in the LATAM region were asked what treatment regimens they chose for their patients with NDMM [ 63 , 64 ]. Generally, the responses from these surveys mirrored the treatment patterns reported in the observational studies (Supplementary Fig. 1). Nearly half of the physicians reported choosing a bortezomib-based regimen (41.8%), and 25.6% reported choosing a regimen with both bortezomib and thalidomide; the most commonly used treatment regimens were CyBorD (25.6%) and VTD (25.2%) [ 63 , 64 ]. One of the surveys—by the Grupo de Estudio Latino Americano de Mieloma Múltiple (GELAMM), which included physicians in both the private and public healthcare settings—took place between December 2017 and March 2018. In this survey, physicians in the private healthcare setting were more likely to choose bortezomib-based regimens than thalidomide-based regimens (47.0% and 7.8%, respectively), whereas the reverse was true in the public healthcare setting (32.3% and 38.1%, respectively) [ 63 ]. Newer agents, such as lenalidomide and carfilzomib, were more frequently chosen in the private than in the public healthcare setting (20.8% and 4.6%, respectively); no physicians reported choosing daratumumab-based treatments for patients with NDMM [ 63 ].

Few studies reported on retreatment in LATAM. The FREEDO MM study of 84 patients who had received ≥ 2 prior lines of therapy in five specialized cancer treatment centers in Colombia between 2013 and 2021 reported that the most frequent treatments received for second relapse included lenalidomide (14.7%), carfilzomib (12.9%), bortezomib (10.3%) and daratumumab (9.8%). Of the 33 (14.7%) patients treated with lenalidomide at second relapse, 18.2% had previously received lenalidomide as 1L therapy and 75.8% as 2L therapy, whereas 87.9% and 45.5% had received bortezomib as 1L and 2L therapy, respectively [ 50 ].

Clinical and Patient-Reported Outcomes

Survival outcomes were reported in 26 studies across various patient populations, including six studies that reported outcomes specifically in patients with NDMM and six in patients with RRMM, with the remaining studies reporting on patients with MM (Table 2 ). Median PFS in patients with NDMM ranged from 18.1 to 41 months; in patients with RRMM, PFS ranged from 7.2 to 23 months. Median OS was 21–99 months in patients with NDMM and 6–52 months in patients with RRMM. In the limited studies directly comparing outcomes in patients who did and did not receive ASCT, survival outcomes were shown to be better in patients who received ASCT (median PFS: 39 months with ASCT vs. 22 months without ASCT [ 58 ]; median OS: 65 months with ASCT vs. 41 months without ASCT [ 53 ]; 5-year OS: 93–100% with ASCT vs. 33–62% without ASCT [ 33 , 60 , 65 ], Table 2 ). Two studies compared clinical outcomes by healthcare setting [ 21 , 66 ], including one that focused on patients with NDMM [ 66 ]. Both studies reported better survival outcomes in patients treated in private healthcare settings than those treated in public healthcare settings, with improved median PFS (41 vs. 23 months), median OS (51 vs. 79 months) and 5-year OS rates (80% vs. 46%) [ 21 , 66 ]. Across the studies, no clear trends were seen in median PFS and OS with different treatments, likely due to differences in the patient populations and study designs.

Relatively high response rates were seen across the region in patients with MM (Table 2 ). Overall response rates (ORR) ranged from 50.9% to 94.4% in patients with NDMM and 40.0% to 91.7% in patients with RRMM. ORR by treatment setting was reported in one study of patients with NDMM, with a greater ORR reported in patients treated in private healthcare settings than in public healthcare settings (92–93% vs 62–81%, respectively) [ 66 ]. Patients who received ASCT had high ORRs of 87–94.4%, with 22–64.2% of patients achieving a complete response (CR); patients who did not receive ASCT had lower ORRs (67.9–89.7%), with 12.5–20.7% achieving a CR [ 46 , 52 , 53 , 60 , 65 , 67 , 68 ]. As with survival, no clear trends in response rates were seen for different treatment regimens across studies.

Two studies reported on outcomes of retreatment with lenalidomide in lenalidomide-treated patients. The FREEDO MM study analyzed the clinical outcomes of 84 patients with RRMM in Colombia experiencing a second relapse between January 2013 and June 2021 and who had received at least two prior lines of therapy, including lenalidomide [ 50 ]. Lenalidomide was the most frequently used treatment at second relapse (14.7%); 50% of these patients achieved an objective response, with a median PFS and OS of 16.0 and 26.8 months, respectively, while the median PFS and OS of the overall study population were 12.7 and 17.5 months, respectively [ 50 ]. Regardless of treatment at second relapse, 50% of patients in the study had a third relapse and 25% had died by the study cut-off date [ 50 ]. A study by the Grupo Argentino de Mieloma Múltiple (GAMM) analyzed the clinical outcomes in patients with RRMM who were treated with lenalidomide-based triplet regimens between May 2013 and June 2019. Patients with lenalidomide-refractory disease ( n = 41) had a significantly shorter median PFS than those who were not refractory (14 vs. 25 months; hazard ratio 2.55, 95% confidence interval [CI] 1.45–4.51, P = 0.001) and a lower ORR (64% vs. 77%, P = 0.05) [ 49 ].

Among MM-related symptoms, insomnia, pain and fatigue showed the greatest impact on QoL as assessed by EORTC QLQ-MY20 [ 69 ]. One study investigated QoL using the SF-36 questionnaire; physical functioning, physical role functioning and emotional role functioning were the variables with the lowest scores, indicating a greater disability [ 70 ]. When using the Oswestry scale for evaluating patient disability, 45.8% of patients were reported to have poor functionality (score 31–50); patients with spinal fractures who were treated with vertebroplasty were three times more likely to have good functionality on the Oswestry scale (odds ratio [OR] 3.11, 95% CI 0.42–25.22) and good performance of daily tasks per the Karnofsky scale (OR 3, 95% CI 0.35–30.52) than those who received conservative treatment, although these were not statistically significant [ 71 ].

Safety and Tolerability of Treatments Received

Of the 26 studies reporting clinical outcomes, only 11 reported on the toxicity of the investigated treatments. Overall, there was a relatively low incidence of serious AEs or severe complications with the treatment regimens investigated in the studies retrieved. Commonly reported AEs included peripheral neuropathy, hematologic AEs (including neutropenia, leukopenia and thrombocytopenia) and infections (Fig. 5 ). Peripheral neuropathy tended to be reported with bortezomib and thalidomide treatment, occurring in up to 71.4% and 67.9% of patients, respectively; peripheral neuropathy has also been reported in 20% of patients with MM prior to MM treatment [ 42 ]. Of grade ≥ 3 AEs, neutropenia was most common, occurring in up to 34.4% and 25% of patients treated with thalidomide- and daratumumab-based therapy, respectively [ 22 ]. Infusion-related reactions were reported in 34–51.0% of patients treated with daratumumab, including dyspnea, cough, pyrexia, throat irritation and chills, which mostly occurred during the first infusion and were generally grade 1 or 2 in severity [ 48 , 54 ]. Hematologic events were collectively reported in a study by Duarte et al. and occurred in significantly fewer patients treated with isatuximab + lenalidomide + dexamethasone (IRd) than with carfilzomib + lenalidomide + dexamethasone (KRd), bortezomib + lenalidomide + dexamethasone (VRd) or daratumumab + lenalidomide + dexamethasone (DRd) (50% vs. 90%, 86% and 80%, respectively; P = 0.045) [ 49 ]. Hematologic events collectively were also more prevalent with CyBorD than with VTD (16.39% vs. 5.95%; P = 0.017), whereas thrombosis events were significantly less frequent with CyBorD than with VTD (3.36% vs. 13.10%; P = 0.0001) [ 52 ].

Healthcare Resource Utilization

Studies reporting on the healthcare costs associated with MM in LATAM are summarized in Table 3 . No studies reported on costs in Argentina and no studies were identified detailing the impact of MM on indirect costs. Specific costs associated with hospitalization, ASCT and outpatient care were reported in one study of the Brazilian private healthcare system, utilizing data from the Orizon database of patients treated for MM between January 2013 and June 2015 [ 72 ]. This study reported an average cost of 23,151 BRL (approximately US $4000 as of March 2025) per hospitalization, including an average of 7474 BRL (approximately US $1300) related to bone marrow transplant, and 2109 BRL (approximately US $365) per day of hospitalization [ 72 ]. Average outpatient care costs were 11,913 BRL (approximately US $2060) per patient-year [ 72 ]. A separate study published in 2020 analyzed the costs of managing skeletal-related events and found an annual cost of 25,442 BRL (approximately US $4400), with costs differing across the various events [ 73 ]. The use of denosumab was found to decrease costs through the prevention and management of these events, including vertebral and non-vertebral fractures [ 73 , 74 ].

Other studies reporting on healthcare costs associated with MM in LATAM compared costs between different treatment regimens. In the Brazilian private healthcare system, DRd incurred the greatest total treatment costs (1,383,596–1,507,544 BRL [approximately US $240,000–260,500]) compared with KRd, elotuzumab + lenalidomide + dexamethasone or IRd [ 75 , 76 ]. DRd was also associated with the greatest average cost per achieved ORR (1,487,737–1,528,986 BRL [approximately US $256,400–264,500]), and KRd was the most cost-effective in this setting (cost per ORR: 1,063,660–1,119,770 BRL [approximately US $184,000–193,000]) [ 75 , 76 ].

Discussion

Our review of the recent literature published on MM in LATAM has revealed the high variability in treatment patterns, limited availability of globally accepted standard of care treatments and disparate clinical and patient outcomes across countries in the region. These findings reflect a substantial treatment burden not only on individual patients with MM but also in terms of HCRU in managing MM in LATAM.

Epidemiology and Disease Burden

The incidence and prevalence rates reported in the studies retrieved in this analysis are higher than in global figures reported by the IARC, which estimated an age-standardized incidence in 2022 of 1.8 per 100,000 both globally and in the region of Latin America and the Caribbean [ 2 ]. However, the incidence and prevalence rates reported in the studies identified here may be skewed by the study populations; many of the studies are focused on subpopulations within a country, such as a specific municipality or province, and may not be representative of the country as a whole.

In alignment with global literature, studies of patients with MM in LATAM reported a greater incidence in older individuals, especially men [ 34 ]. As with overall incidence, these rates are higher than those reported by the IARC, with global age-standardized incidence rates of 2.5 and 2.0 per 100,000 men and women, respectively, among those aged 40–59 years and 14.1 and 9.7 per 100,000 men and women aged > 60 years [ 2 ].

Risk factors for MM include increasing age, male sex, Black race and family history [ 34 ]. Differences in the incidence of MM between countries in LATAM may reflect varying exposures to environmental risk factors and demographic differences [ 34 ], although there are limited studies in LATAM to elucidate the reasons for the heterogeneity in disease patterns across the region. The existing heterogeneity in disease patterns may also be influenced by healthcare access and data availability in individual countries [ 34 ]. Age > 65 years is a significant risk factor for MM, as reflected by the higher incidence reported in this age group in the studies retrieved.

A high proportion of patients with MM in LATAM present with advanced disease, with 43.8% presenting with ISS stage III at diagnosis or study entry. This contrasts with global studies; for example, the proportion of patients classified as ISS stage III at enrollment was 27.0% for those with RRMM in the CharisMMa observational study in Spain and only 19.0% of all patients with MM in the Flatiron MM Core Registry in the US [ 77 , 78 ]. However, these LATAM results are similar to observations from a retrospective analysis of patients with MM in Asia and LATAM, in which 40.8% of patients from Asia presented with ISS stage III at diagnosis [ 30 ]. Together with the higher incidence of MM in the older age groups, and the associated comorbidities that contribute to the disease burden, these findings suggest a considerable unmet need for early identification and appropriate management of these patients. These observations may also reflect the lack of early access to appropriate diagnostic and prognostic tools that can inform the best treatment selection. It is crucial to assess whether delays in diagnosis or treatment within public versus private healthcare settings are linked to the clinical presentations of MM seen in LATAM, which are likely influenced by the substantial proportion of patients presenting with advanced disease.

Differences Between Public and Private Healthcare Settings

Most patients in the studies reported here received treatment in the public healthcare setting [ 20 , 22 , 56 , 59 , 66 ]. Of note, several studies have suggested that patients treated in a public healthcare setting face worse outcomes than those in a private setting, with shorter median PFS and OS and fewer patients achieving objective response [ 21 , 63 , 66 ]. Many factors may contribute to this observation. Compared with private healthcare institutions, patients treated at public institutions were more likely to be symptomatic at diagnosis, with a greater incidence of anemia, renal failure, hypercalcemia and bone disease, and to present with more advanced disease [ 21 , 66 ]. This is likely associated with the lack of access to testing in the public setting, where over half of patients so not have access to adequate imaging and rely on x-ray for screening, leading to inaccurate and delayed diagnoses [ 63 ]. Furthermore, access to prognostic testing is also limited, with less than one third of patients in LATAM having fluorescence in situ hybridization performed for cytogenetic testing, including only 17% of patients in the public setting compared with 44% of patients in the private setting [ 21 ]. This may result in patients with high-risk disease missing out on intensive treatment. Owing to the lack of adequate testing, including access to serum immunofixation and serum free light chains, remission evaluation may also be inaccurate, impacting treatment decisions [ 63 ]. Understanding these disparities can provide valuable insights into optimizing diagnostic pathways and improving outcomes across different healthcare settings in LATAM. Importantly, treatment regimens available in public and private healthcare settings were also shown to be substantially different, as discussed below [ 21 , 66 ].

Availability of Treatments

Although treatment options for MM have evolved significantly, access to these novel treatments varies widely within the LATAM region, particularly between public and private healthcare systems. Access to PIs and ASCT is inconsistent, and public healthcare systems often struggle to provide these treatments, leading to disparities in patient outcomes [ 66 , 79 ]. Economic factors play a critical role in treatment accessibility, and patients in resource-constrained settings often rely on older, less effective therapies, such as thalidomide, because of the high costs associated with newer agents such as bortezomib and lenalidomide [ 21 , 53 , 63 , 66 ]. Although access to lenalidomide was limited across the region, more patients treated in the private setting were prescribed lenalidomide-containing regimens than those in the public setting [ 63 ]. Further impacting patient outcomes is the need for time-consuming approval processes for access to many novel agents through the public healthcare system, leading to delays in patients receiving treatment [ 63 ]. Importantly, patients treated in private institutions had greater median PFS, median OS, 5-year OS and ORR [ 21 , 66 ], likely because of a combination of treatment access disparities and the differences in diagnostic and prognostic testing between private and public healthcare systems. The paucity of clinical trials in LATAM is a further hindrance to patients receiving optimal treatments [ 53 , 79 ]. While this is changing with increasing involvement of private healthcare centers in international trials, access for patients in the public healthcare system remains limited. In Brazil, the limited access to novel MM treatments within the public healthcare system is only marginally mitigated by the inclusion of patients in international clinical trials. These trials are most applicable when investigating 1L therapies, as patients with relapsed or refractory disease often face exclusion because of prerequisites involving prior exposure to drugs that are unavailable in the public system. This is a barrier that frequently disqualifies Brazilian institutions, and others from across LATAM, from participating in such studies.

There are few localized or regional guidelines for the management of MM across LATAM, although comprehensive guidelines have been developed in the past 5 years in Mexico, Brazil and Argentina [ 80 – 82 ]. Many countries refer to the US National Comprehensive Cancer Network guidelines, but treatment regimens vary, with considerable reliance on thalidomide- and bortezomib-based regimens in the frontline for transplant-eligible patients, in contrast to regimens favored in the US (e.g., VRd) [ 6 ]. CTD, VTD and CyBorD were the most common front-line treatment regimens reported, which aligns with the recommendations of the Mexican consensus of MM management [ 80 ]. This difference could again be explained by the limited access to or lack of availability of novel agents in LATAM that are approved and more readily accessible for patients elsewhere [ 6 ]; an unmet need for improved access to newer therapies in LATAM remains. Treatment approval and access are often delayed because of cost concerns and resource limitations [ 22 , 83 ]. The 2022 guidelines on the diagnosis and management of MM by the Brazilian Medical Association recommended four to six induction cycles using triplet or quadruplet regimens from distinct therapeutic classes for patients eligible for ASCT and advised using daratumumab + VTD or VRd, with VTD and CyBorD as suitable alternatives [ 81 ]. Despite this recommendation, no real-world studies have reported the use of daratumumab + VTD, which could be at least partially explained by a lag in reporting due to the publication process, while the use of VRd varied greatly (0–26%), with patients with high-risk disease more frequently receiving treatment with VRd than those with standard risk, who were mainly treated with thalidomide-based regimens [ 63 ]. Although newer agents, such as bispecific T-cell engagers and CAR T-cell therapies, are approved in some countries in the region, access remains limited [ 84 ]. Furthermore, these new treatment modalities are associated with serious, potentially life-threatening AEs that require extra monitoring and management, such as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, which can add further strain to a resource-limited setting [ 85 ]. Physicians therefore rely on older therapies such as thalidomide and bortezomib, particularly in 1L, regardless of transplant eligibility.

With patients in private clinics more likely to receive ASCT and lenalidomide or bortezomib-based therapies [ 21 , 22 , 66 ], a significant proportion of the patient population receives more cost-effective treatments (e.g., thalidomide + dexamethasone, followed by ASCT and thalidomide maintenance). These regimens remain important in LATAM to improve accessibility for patients with MM in countries or regions with limited resources [ 86 ]. In a small retrospective study ( N = 44) conducted in Mexico, patients receiving VTD followed by ASCT and thalidomide maintenance were shown to have comparable OS and PFS to those receiving more expensive treatment regimens such as KRd, VRd and daratumumab + VTD, and their treatment was more cost-effective in a resource-limited setting [ 86 ]. However, larger prospective studies with head-to-head comparative designs, incorporating patient-reported QoL assessments, are needed to strengthen these findings and provide a more comprehensive cost-effectiveness evaluation.

Clinical and Patient Outcomes

MM treatments have significantly improved with the introduction of novel immunomodulatory drugs and PIs over the past 2 decades, leading to improved patient outcomes. Survival and response rates varied widely in the studies identified, in line with the global literature [ 22 , 87 ]. Response rates in real-world studies were generally high, despite limited access to newer drugs, such as lenalidomide and daratumumab, meaning that most patients were treated with a bortezomib- or thalidomide-based regimen.

Globally, re-treatment with lenalidomide is common in patients with RRMM [ 24 , 88 ]; however, only two studies identified in our search reported clinical outcomes in such patients, which may be a result of lenalidomide’s limited use in the region. The FREEDO MM study investigated lenalidomide retreatment in Colombia; of the 33 (14.7%) patients who were treated with lenalidomide as their third LOT, 18.2% and 75.8% had previously received lenalidomide as their first and second LOT, respectively [ 50 ]. Despite this, 50% of patients treated with lenalidomide as 3L therapy achieved an objective response, and median OS was longer than with carfilzomib, bortezomib, or daratumumab (26.8 months vs. 16.9, 11.5 and 18.2 months) [ 50 ]. Of note, the FREEDO MM study did not report on the refractoriness of the patients, nor did it report the time between LOTs, both of which might have impacted the likelihood of response to lenalidomide as 3L therapy. These findings contrasted the results from the GAMM study in Argentina, which reported reduced PFS and OS in patients with lenalidomide-refractory disease compared with those who were not refractory [ 49 ]. A recent systematic review of patients with lenalidomide-refractory disease also aligned with the GAMM study, finding that these patients reported shorter median PFS (8.8 months) and median OS (21.7 months) than the intent-to-treat population (13.8 months and 35.9 months, respectively) in clinical trials [ 17 ].

Patients with MM often report a significant reduction in health-related QoL, impacted by symptoms of the disease and AEs associated with treatment, with many patients reporting difficulties in performing daily activities and participating in social interactions [ 69 , 89 ]. In particular, most patients reported moderate or severe pain, with an impact on daily life, even when their disease was stabilized [ 69 ]. Patients with bone metastases, particularly those with spinal involvement, report significant pain, and although surgery carries significant risk, most patients were satisfied with their decision to proceed with surgical decompression, and many reported improved function that was associated with pain relief, as well as improved ability to perform daily tasks [ 71 , 90 ].

Of the studies reporting clinical outcomes, fewer than half reported on the toxicity of the related treatments, many of which reported on specific AEs only and not the toxicity profile of treatment regimens in a real-world setting. This is likely due to the retrospective nature of the studies, which relied on information captured in databases and clinical practice, and not prospectively collected. Overall, few serious AEs were reported, but most patients experienced at least one AE while receiving treatment for MM. In particular, peripheral neuropathy was frequently reported in patients treated with thalidomide or bortezomib (up to 71.4% [ 91 ]), which were the most frequently used therapies in the LATAM region. Chemotherapy-induced peripheral neuropathy has been associated with anxiety, depression and reduced health-related QoL in patients with MM [ 92 , 93 ]. Importantly, advanced chemotherapy-induced peripheral neuropathy is reversible in only approximately 25% of patients, highlighting the need for close monitoring and immediate dose reduction or discontinuation in patients experiencing significant peripheral neuropathy [ 93 ].

Healthcare Resource Utilization

Globally, MM is associated with substantial economic impact, with direct costs associated with treatments, hospitalization and management of AEs, as well as indirect costs from loss of productivity and caregiver burden [ 94 – 97 ]. For patients with RRMM receiving treatment with a PI-based regimen, up to 90% of the monthly total direct costs can be attributed to the anti-myeloma drug [ 28 ]. Additional indirect costs associated with routine management and disease progression also impact HCRU [ 98 ]. Our research showed that there was a significant data gap in understanding HCRU in LATAM, with no studies from the past 10 years reporting on the indirect costs associated with MM, and no studies reporting on HCRU in Argentina. Most studies focused on comparing specific treatment regimens, and there is a lack of data on the broader economic impact of MM in the region. A recent analysis of real-world treatment patterns and HCRU among patients with MM across five European countries revealed that patients who had previously received treatment with three therapy classes (i.e., at least one immunomodulatory imide, one PI and one CD38 monoclonal antibody; tri-exposed) experienced higher HCRU than patients who were not tri-exposed in terms of the number of inpatient hospitalizations and the number of times they had been seen by a healthcare professional in the previous 12 months [ 27 ]. However, most patients overall (66%) experienced at least one inpatient hospitalization in the 12 months prior to study data collection [ 27 ]. Similar findings were reported by the Prospective REsearch Assessment in multiple Myeloma: an oBservationaL Evaluation (PREAMBLE) study in the US. Of the healthcare provider visits reported by 764 patients with RRMM over a median follow-up period of 15.1 months, 44% were hospital outpatients, 41% clinic/physician visits and 6% hospitalizations; the primary reason for visit was management of MM and its sequelae [ 98 ]. Although the data from LATAM are limited and inconsistent, trends toward increasing costs and HCRU with successive LOTs for tri-exposed patients can be seen. Selecting treatment regimens that prolong time to disease progression may improve clinical outcomes and HCRU [ 27 ]. Larger studies with standardized designs and outcomes are therefore warranted across LATAM countries to elucidate the scale of the impact of MM on HCRU and to inform appropriate strategies to alleviate this impact for patients and healthcare systems.

Limitations

We highlight some limitations to our analysis that warrant specific mention here. Much of the data retrieved were retrospective in nature and prone to potential bias. There is also inconsistent and limited reporting on AEs, treatment response and HCRU in MM in LATAM. The lack of prospective, randomized controlled studies in MM in LATAM also limits the extent to which conclusions can be drawn on patient outcomes in the region.

Conclusion

Our analysis of the published literature reveals a lack of comprehensive data on the epidemiology and management of MM in LATAM, hindering fully informed clinical and health policy decisions. There are clear variations in patient characteristics and treatment patterns between countries, highlighting a need for further investigation into the factors contributing to these disparities and the adoption of standardized management approaches regionally. The burden of disease and treatment for patients with RRMM in particular is high, with limited treatment options in a heavily pre-treated population. However, there are considerable gaps in our understanding of the treatments received, patient outcomes and associated HCRU in these patients across LATAM. Better understanding of treatment patterns and sequencing in different countries across the region may provide pathways to improving access for newer therapies that can alleviate the substantial disease and treatment burden of MM.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 275 kb)

Acknowledgements

Medical Writing, Editorial, and Other Assistance

Medical writing support was provided by Joyce Lee, PhD, CMPP, and Tim Stentiford, CMPP, of Nucleus Global, an Inizio company, and was funded by GSK. Publication management support was provided by OPEN Health Communications, in accordance with Good Publication Practice guidelines ( http://www.ismpp.org/gpp-2022 ), and was funded by GSK.

Author Contributions

All authors (Cristian Maximiliano Seehaus, Guillermina Remaggi, Jayr Schmidt Filho, Paola Ochoa, Ricardo Bigni, Roberto José Pessoa de Magalhães, Ruddy Dalfeor, Bhumika Aggarwal, Claudia Soares and Jacopo Bitetti) made substantial contributions to the conception and design, acquisition of data or analysis and interpretation of data. All authors took part in drafting, revising or critically reviewing the manuscript; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. All authors meet the International Committee of Medical Journal Editors criteria for authorship for this article, take responsibility for the integrity of the work and have given their approval for this version to be published.

Funding

This review was funded by GSK (study ID: 300632). The journal’s Rapid Service Fee was funded by GSK.

Data Availability

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Declarations

Conflict of Interest

Guillermina Remaggi declares receiving honoraria as a speaker from Janssen, Sanofi and Pfizer; advisory board for Janssen, Sanofi, Pfizer and GSK. Roberto José Pessoa de Magalhães declares receiving honoraria as a speaker and on advisory boards from Bristol Myers Squibb, GSK, Janssen, Pfizer and Sanofi. Cristian Maximiliano Seehaus, Jayr Schmidt Filho, Ricardo Bigni and Ruddy Dalfeor have no conflicts of interest to disclose. Paola Ochoa declares receiving honoraria as a speaker from Bristol Myers Squibb, GSK, Johnson and Johnson and Sanofi; advisory board for Bristol Myers Squibb, GSK, Johnson and Johnson, Pfizer and Sanofi; travel support from Johnson and Johnson and Sanofi. Bhumika Aggarwal and Jacopo Bitetti are employed by GSK and hold financial equities in GSK. Claudia Soares was an employee of GSK and held financial equities in GSK at the time of manuscript initiation.

Ethical Approval

This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

Footnotes

Claudia Soares’s affiliation at the time of manuscript initiation.

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Associated Data

Supplementary Materials

Supplementary file1 (PDF 275 kb)

Data Availability Statement

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.