Analysis of Availability and Access of Anti-myeloma Drugs and Impact on the Management of Multiple Myeloma in Latin American Countries

Filho, Roberto Jose Pessoa de Magalhaes; Crusoé, Edvan; Riva, Eloísa; Bujan, Willen; Conte, Guillermo; Cabrera, Juan Ramon Navarro; García, D; Vega, Guilhermo Quintero; Macías, José Luis Salcini; Alvear, Jose Willian Oliveros; Royg, Mercedes; Neves, Lidiane Andino; Dopico, Jose Luis Lopez; Espino, German; Ortiz, Douglas Rosales; Socarra, Zurelis; Fantl, Dorotea; Ruíz‐Argüelles, Guillermo J.; Maiolino, Ângelo; Hungria, Vânia; Harousseau, Jean‐Luc; Durie, Brian G.M.

doi:10.1016/j.clml.2018.08.005

Cited by 20 publications

(16 citation statements)

References 36 publications

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“…The more striking decline in both MM and other causes of death among the SEER population could be explained in part by improvements in MM treatment options. 21 However, this may differ in Puerto Rico where the decrease in the proportion of deaths from MM was lower than in the SEER population. Puerto Ricans are known to be vulnerable to cancer disparities and may have less access to new 1 Alive as of December 2013 or lost to follow-up.…”

Section: Discussionmentioning

confidence: 95%

“…Similarly, in the SEER population, we observed a decrease in the proportion of deaths from both MM and other causes over the study period, although the decrease in deaths from MM was greater in magnitude than the decrease in deaths from non‐MM causes. The more striking decline in both MM and other causes of death among the SEER population could be explained in part by improvements in MM treatment options . However, this may differ in Puerto Rico where the decrease in the proportion of deaths from MM was lower than in the SEER population.…”

Section: Discussionmentioning

confidence: 96%

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Trends in cause of death among patients with multiple myeloma in Puerto Rico and the United States SEER population, 1987–2013

Castañeda‐Avila

Ortiz‐Ortiz

Torres‐Cintrón

et al. 2019

Intl Journal of Cancer

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Multiple myeloma (MM) survival has improved due to recent developments in MM treatment. As a result, other co‐morbid conditions may be of increasing importance to MM patients’ long‐term survival. This study examines trends in common causes of death among patients with MM in Puerto Rico, and in the US Surveillance, Epidemiology, and End Results (SEER) population. We analyzed the primary cause of death among incident MM cases recorded in the Puerto Rico Central Cancer Registry (n = 3,018) and the US SEER Program (n = 67,733) between 1987 and 2013. We calculated the cumulative incidence of death due to the eight most common causes and analyzed temporal trends in mortality rates using joinpoint regression. Analyses of SEER were also stratified by Hispanic ethnicity. MM accounted for approximately 72% of all reported deaths among persons diagnosed with MM in Puerto Rico and in SEER. In both populations, the proportion of patients who died from MM decreased with increasing time since diagnosis. Age‐standardized temporal trends showed a decreased MM‐specific mortality rate among US SEER (annual percent change [APC] = −5.0) and Puerto Rican (APC = −1.8) patients during the study period, and particularly after 2003 in non‐Hispanic SEER patients. Temporal decline in non‐MM causes of death was also observed among US SEER (APC = −2.1) and Puerto Rican (APC = −0.1) populations. MM‐specific mortality decreased, yet remained the predominant cause of death for individuals diagnosed with MM over a 26‐year period. The most pronounced decreases in MM‐specific death occurred after 2003, which suggests a possible influence of more recently developed MM therapies.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 96%

Trends in cause of death among patients with multiple myeloma in Puerto Rico and the United States SEER population, 1987–2013

Castañeda‐Avila

Ortiz‐Ortiz

Torres‐Cintrón

et al. 2019

Intl Journal of Cancer

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“…Because the sample was not population‐based, our results may not be representative of practice patterns within the individual countries or in Latin America as a whole. Practice patterns and access to ASCT and newer therapeutic agents are likely to differ by country, health insurance status and practice setting (public vs. private) (Pessoa de Magalhaes Filho et al , ).…”

Section: Discussionmentioning

confidence: 99%

“…With the introduction of novel immunomodulatory therapies (e.g., thalidomide, lenalidomide) and proteasome inhibitors (e.g., bortezomib), 5‐year relative survival in MM patients improved from 30–35% to 50–55% in the United States and Europe (Kumar et al , ; Sant et al , ; National Cancer Institute Surveillance Epidemiology & End Results Program, ). However, in many Latin American countries, the approval of, and access to, new treatments may be delayed due to cost concerns and resource limitations (Strasser‐Weippl et al , ; Pessoa de Magalhaes Filho et al , ; Tarin‐Arzaga et al , ).…”

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confidence: 99%

Multiple myeloma treatment patterns and clinical outcomes in the Latin America Haemato‐Oncology (HOLA) Observational Study, 2008–2016

Hungria¹,

Martínez-Baños

Peñafiel

et al. 2019

Br J Haematol

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Limited data are available regarding contemporary multiple myeloma (MM) treatment practices in Latin America. In this retrospective cohort study, medical records were reviewed for a multinational cohort of 1103 Latin American MM patients (median age, 61 years) diagnosed in 2008-2015 who initiated first-line therapy (LOT1). Of these patients, 33Á9% underwent autologous stem cell transplantation (ASCT). During follow-up, 501 (45Á4%) and 129 (11Á7%) patients initiated second-(LOT2) and thirdline therapy (LOT3), respectively. In the LOT1 setting, from 2008 to 2015, there was a decrease in the use of thalidomide-based therapy, from 66Á7% to 42Á6%, and chemotherapy from, 20Á2% to 5Á9%, whereas use of bortezomib-based therapy or bortezomib + thalidomide increased from 10Á7% to 45Á5%. Bortezomib-based therapy and bortezomib + thalidomide were more commonly used in ASCT patients and in private clinics. In non-ASCT and ASCT patients, median progression-free survival (PFS) was 15Á0 and 31Á1 months following LOT1 and 10Á9 and 9Á5 months following LOT2, respectively. PFS was generally longer in patients treated with bortezomib-based or thalidomide-based therapy versus chemotherapy. These data shed light on recent trends in the management of MM in Latin America. Slower uptake of newer therapies in public clinics and poor PFS among patients with relapsed MM point to areas of unmet therapeutic need in Latin America.

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“…In Latin America, the uptake of novel treatments for MM has been slow, in part due to economic constraints and the existence of separate regulatory agencies for each nation in the region [ 7 , 8 ]. Although there is variability between, and sometimes within, countries, bortezomib- or thalidomide-based regimens are generally considered SoC for transplant-ineligible patients with NDMM in Latin America [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Standard of Care in Latin America for Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Propensity Score Matching Analysis

Hungria¹,

Martínez-Baños

Mateos

et al. 2020

Adv Ther

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Introduction The phase 3 ALCYONE study demonstrated significantly longer progression-free and overall survival (PFS/OS) and higher overall response rates (ORR) with daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) versus VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). In Latin America, bortezomib- or thalidomide-based regimens remain standard of care (SoC) for this population. No head-to-head trials have compared D-VMP with SoC regimens used in Latin America. Methods Propensity score matching (PSM) was used to control for baseline differences between patient populations and compare outcomes for D-VMP versus SoC regimens used in Latin America. Data for the D-VMP cohort were from the D-VMP arm of the ALCYONE trial ( n = 350). Data for the SoC cohort were from the retrospective, observational Hemato-Oncology Latin America (HOLA) study, which included patients with NDMM who did not receive a transplant ( n = 729). Propensity scores were estimated using logistic regression. Exact, optimal, and nearest-neighbor PSM were applied to pick the best-performing method. Doubly robust estimation was the base case, since some baseline imbalances persisted. Results All 350 patients from the D-VMP arm of ALCYONE were included in OS/PFS analyses and 338 in ORR analysis; 478 and 324 patients, respectively, from HOLA were included in these analyses. Naïve comparison revealed important differences in baseline characteristics (age, chronic kidney disease, hypercalcemia, and International Staging System [ISS] stage). After nearest-neighbor matching, baseline characteristics, except ISS stage, were well balanced; comparisons favored D-VMP over SoC for OS (hazard ratio = 0.41; 95% confidence interval [CI] 0.25–0.66; P = 0.002) and PFS (hazard ratio = 0.48; 95% CI 0.35–0.67; P < 0.001). After exact matching, imbalances remained in age and ISS stage; comparisons favored D-VMP over SoC for ORR (odds ratio = 5.44; 95% CI 2.65–11.82; P < 0.001). Conclusion In transplant-ineligible patients with NDMM, D-VMP showed superior effectiveness versus bortezomib- and thalidomide-based regimens, supporting adoption of daratumumab-containing regimens in Latin America.

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Analysis of Availability and Access of Anti-myeloma Drugs and Impact on the Management of Multiple Myeloma in Latin American Countries

Cited by 20 publications

References 36 publications

Trends in cause of death among patients with multiple myeloma in Puerto Rico and the United States SEER population, 1987–2013

Trends in cause of death among patients with multiple myeloma in Puerto Rico and the United States SEER population, 1987–2013

Multiple myeloma treatment patterns and clinical outcomes in the Latin America Haemato‐Oncology (HOLA) Observational Study, 2008–2016

Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Standard of Care in Latin America for Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Propensity Score Matching Analysis

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