Therapy of childhood acute lymphoblastic leukemia in resource-poor geospaces

The therapy of children with acute lymphoblastic leukemia (ALL) in limited resource geospaces is challenging and must balance safety, efficacy, availability, and affordability. We modified the control arm of the St. Jude Total XI protocol for outpatient delivery including once-weekly daunorubicin an...

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Main Authors: Moisés M. Gallardo-Pérez, Robert Peter Gale, Oscar A. Reyes-Cisneros, Daniela Sánchez-Bonilla, José A. Fernández-Gutiérrez, Wendy Stock, Iván Murrieta-Álvarez, Juan Carlos Olivares-Gazca, Guillermo J. Ruiz-Delgado, Rafael Fonseca, Guillermo J. Ruiz-Argüelles
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-06-01
Series:Frontiers in Oncology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fonc.2023.1187268/full
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author Moisés M. Gallardo-Pérez
Moisés M. Gallardo-Pérez
Robert Peter Gale
Oscar A. Reyes-Cisneros
Oscar A. Reyes-Cisneros
Daniela Sánchez-Bonilla
Daniela Sánchez-Bonilla
José A. Fernández-Gutiérrez
José A. Fernández-Gutiérrez
Wendy Stock
Iván Murrieta-Álvarez
Iván Murrieta-Álvarez
Juan Carlos Olivares-Gazca
Juan Carlos Olivares-Gazca
Guillermo J. Ruiz-Delgado
Guillermo J. Ruiz-Delgado
Guillermo J. Ruiz-Delgado
Rafael Fonseca
Guillermo J. Ruiz-Argüelles
Guillermo J. Ruiz-Argüelles
Guillermo J. Ruiz-Argüelles
author_facet Moisés M. Gallardo-Pérez
Moisés M. Gallardo-Pérez
Robert Peter Gale
Oscar A. Reyes-Cisneros
Oscar A. Reyes-Cisneros
Daniela Sánchez-Bonilla
Daniela Sánchez-Bonilla
José A. Fernández-Gutiérrez
José A. Fernández-Gutiérrez
Wendy Stock
Iván Murrieta-Álvarez
Iván Murrieta-Álvarez
Juan Carlos Olivares-Gazca
Juan Carlos Olivares-Gazca
Guillermo J. Ruiz-Delgado
Guillermo J. Ruiz-Delgado
Guillermo J. Ruiz-Delgado
Rafael Fonseca
Guillermo J. Ruiz-Argüelles
Guillermo J. Ruiz-Argüelles
Guillermo J. Ruiz-Argüelles
author_sort Moisés M. Gallardo-Pérez
collection DOAJ
description The therapy of children with acute lymphoblastic leukemia (ALL) in limited resource geospaces is challenging and must balance safety, efficacy, availability, and affordability. We modified the control arm of the St. Jude Total XI protocol for outpatient delivery including once-weekly daunorubicin and vincristine in initial therapy, postponing intrathecal chemotherapy until day 22, prophylactic oral antibiotics/antimycotics, use of generic drugs, and no central nervous system (CNS) radiation. Data were interrogated from 104 consecutive children ≤12 years (median, 6 years [interquartile range (IQR), 3, 9 years]. All therapies were given in an outpatient setting in 72 children. Median follow-up is 56 months (IQR 20, 126 months). A total of 88 children achieved a hematological complete remission. Median event-free survival (EFS) is 87 months [95% confidence interval (CI), 39, 60], 7.6 years in low-risk children (3.4, 8 years) whereas 2.5 years (1, 10 years) in high-risk children. The 5-year cumulative incidence of relapse (CIR) is 28% (18, 35%), 26% (14, 37%) in low-risk children and 35% (14, 52%) in high-risk children. Median survival for all subjects is not reached but must exceed 5 years. A total of 36 children relapsed at a median of 12 months (5, 23 months). Outcomes were comparable to those reported in the control arm of the Total Therapy XI study, but inferior to current treatment protocols in high-income countries. The average cost of the first 2 years of therapy was $28,500 USD compared with an average cost of approximately $150,000 USD in the US, an 80% saving. In conclusion, using an outpatient-based modification of the St. Jude Total XI protocol, we obtained good results with relatively few hospitalizations or adverse events and at a substantial saving. This model can be applied in other resource-poor geospaces.
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spelling doaj.art-53721ee80d1d4a498117dfc902764eae2023-06-16T05:35:55ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2023-06-011310.3389/fonc.2023.11872681187268Therapy of childhood acute lymphoblastic leukemia in resource-poor geospacesMoisés M. Gallardo-Pérez0Moisés M. Gallardo-Pérez1Robert Peter Gale2Oscar A. Reyes-Cisneros3Oscar A. Reyes-Cisneros4Daniela Sánchez-Bonilla5Daniela Sánchez-Bonilla6José A. Fernández-Gutiérrez7José A. Fernández-Gutiérrez8Wendy Stock9Iván Murrieta-Álvarez10Iván Murrieta-Álvarez11Juan Carlos Olivares-Gazca12Juan Carlos Olivares-Gazca13Guillermo J. Ruiz-Delgado14Guillermo J. Ruiz-Delgado15Guillermo J. Ruiz-Delgado16Rafael Fonseca17Guillermo J. Ruiz-Argüelles18Guillermo J. Ruiz-Argüelles19Guillermo J. Ruiz-Argüelles20Centro de Hematología y Medicina Interna, Clínica Ruiz, Puebla, Puebla, MexicoUniversidad Popular Autónoma del Estado de Puebla, Facultad de Medicina, Puebla, Puebla, MexicoCentre for Haematology, Imperial College of Science, Technology and Medicine, London, United KingdomCentro de Hematología y Medicina Interna, Clínica Ruiz, Puebla, Puebla, MexicoUniversidad Anáhuac, Facultad de Medicina, Puebla, Puebla, MexicoCentro de Hematología y Medicina Interna, Clínica Ruiz, Puebla, Puebla, MexicoUniversidad Popular Autónoma del Estado de Puebla, Facultad de Medicina, Puebla, Puebla, MexicoCentro de Hematología y Medicina Interna, Clínica Ruiz, Puebla, Puebla, MexicoUniversidad Popular Autónoma del Estado de Puebla, Facultad de Medicina, Puebla, Puebla, MexicoDepartment of Medicine, University of Chicago, Chicago, IL, United StatesCentro de Hematología y Medicina Interna, Clínica Ruiz, Puebla, Puebla, MexicoUniversidad Popular Autónoma del Estado de Puebla, Facultad de Medicina, Puebla, Puebla, MexicoCentro de Hematología y Medicina Interna, Clínica Ruiz, Puebla, Puebla, MexicoUniversidad Popular Autónoma del Estado de Puebla, Facultad de Medicina, Puebla, Puebla, MexicoCentro de Hematología y Medicina Interna, Clínica Ruiz, Puebla, Puebla, MexicoUniversidad Popular Autónoma del Estado de Puebla, Facultad de Medicina, Puebla, Puebla, MexicoLaboratorios Ruiz, SYNLAB, Puebla, Puebla, MexicoMayo Clinic, Division of Hematology-Oncology, Scottsdale, AZ, United StatesCentro de Hematología y Medicina Interna, Clínica Ruiz, Puebla, Puebla, MexicoUniversidad Popular Autónoma del Estado de Puebla, Facultad de Medicina, Puebla, Puebla, MexicoLaboratorios Ruiz, SYNLAB, Puebla, Puebla, MexicoThe therapy of children with acute lymphoblastic leukemia (ALL) in limited resource geospaces is challenging and must balance safety, efficacy, availability, and affordability. We modified the control arm of the St. Jude Total XI protocol for outpatient delivery including once-weekly daunorubicin and vincristine in initial therapy, postponing intrathecal chemotherapy until day 22, prophylactic oral antibiotics/antimycotics, use of generic drugs, and no central nervous system (CNS) radiation. Data were interrogated from 104 consecutive children ≤12 years (median, 6 years [interquartile range (IQR), 3, 9 years]. All therapies were given in an outpatient setting in 72 children. Median follow-up is 56 months (IQR 20, 126 months). A total of 88 children achieved a hematological complete remission. Median event-free survival (EFS) is 87 months [95% confidence interval (CI), 39, 60], 7.6 years in low-risk children (3.4, 8 years) whereas 2.5 years (1, 10 years) in high-risk children. The 5-year cumulative incidence of relapse (CIR) is 28% (18, 35%), 26% (14, 37%) in low-risk children and 35% (14, 52%) in high-risk children. Median survival for all subjects is not reached but must exceed 5 years. A total of 36 children relapsed at a median of 12 months (5, 23 months). Outcomes were comparable to those reported in the control arm of the Total Therapy XI study, but inferior to current treatment protocols in high-income countries. The average cost of the first 2 years of therapy was $28,500 USD compared with an average cost of approximately $150,000 USD in the US, an 80% saving. In conclusion, using an outpatient-based modification of the St. Jude Total XI protocol, we obtained good results with relatively few hospitalizations or adverse events and at a substantial saving. This model can be applied in other resource-poor geospaces.https://www.frontiersin.org/articles/10.3389/fonc.2023.1187268/fullacute lymphoblastic leukaemiaresource poor countriesTotal XI St. Jude protocoloutpatientchildren
spellingShingle Moisés M. Gallardo-Pérez
Moisés M. Gallardo-Pérez
Robert Peter Gale
Oscar A. Reyes-Cisneros
Oscar A. Reyes-Cisneros
Daniela Sánchez-Bonilla
Daniela Sánchez-Bonilla
José A. Fernández-Gutiérrez
José A. Fernández-Gutiérrez
Wendy Stock
Iván Murrieta-Álvarez
Iván Murrieta-Álvarez
Juan Carlos Olivares-Gazca
Juan Carlos Olivares-Gazca
Guillermo J. Ruiz-Delgado
Guillermo J. Ruiz-Delgado
Guillermo J. Ruiz-Delgado
Rafael Fonseca
Guillermo J. Ruiz-Argüelles
Guillermo J. Ruiz-Argüelles
Guillermo J. Ruiz-Argüelles
Therapy of childhood acute lymphoblastic leukemia in resource-poor geospaces
Frontiers in Oncology
acute lymphoblastic leukaemia
resource poor countries
Total XI St. Jude protocol
outpatient
children
title Therapy of childhood acute lymphoblastic leukemia in resource-poor geospaces
title_full Therapy of childhood acute lymphoblastic leukemia in resource-poor geospaces
title_fullStr Therapy of childhood acute lymphoblastic leukemia in resource-poor geospaces
title_full_unstemmed Therapy of childhood acute lymphoblastic leukemia in resource-poor geospaces
title_short Therapy of childhood acute lymphoblastic leukemia in resource-poor geospaces
title_sort therapy of childhood acute lymphoblastic leukemia in resource poor geospaces
topic acute lymphoblastic leukaemia
resource poor countries
Total XI St. Jude protocol
outpatient
children
url https://www.frontiersin.org/articles/10.3389/fonc.2023.1187268/full
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