High-Dose Methotrexate Usage Without Drug-Level Monitoring in Advanced Pediatric Mature B-Cell Non-Hodgkin Lymphoma in a Resource-Limited Setting in Malawi

PURPOSEExcellent survival for advanced (stages II with high lactate dehydrogenase, III, and IV) pediatric mature B-cell non-Hodgkin lymphoma (MB-NHL) has been achieved with intensive regimens, but adoption in sub-Saharan Africa is limited by inadequate supportive care. We provide real-world data on...

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Main Authors: Rizine R. Mzikamanda, Loviisa Mulanje, Casey L. McAtee, Apatsa Matatiyo, Zoe Mwale, Grace Chirwa, Watipaso Wanda, Atupele Miranda Mpasa, Stella Wachepa, Minke H.W. Huibers, Steve Martin, Tamiwe Tomoka, Maurice Mulenga, Yuri Fedoriw, Gugulethu Mapurisa, Julie M. Gastier Foster, Nader El-Mallawany, Katherine D. Westmoreland, Peter Wasswa, Carl E. Allen, Nmazuo Ozuah
Format: Article
Language:English
Published: American Society of Clinical Oncology 2025-04-01
Series:JCO Global Oncology
Online Access:https://ascopubs.org/doi/10.1200/GO-24-00591
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author Rizine R. Mzikamanda
Loviisa Mulanje
Casey L. McAtee
Apatsa Matatiyo
Zoe Mwale
Grace Chirwa
Watipaso Wanda
Atupele Miranda Mpasa
Stella Wachepa
Minke H.W. Huibers
Steve Martin
Tamiwe Tomoka
Maurice Mulenga
Yuri Fedoriw
Gugulethu Mapurisa
Julie M. Gastier Foster
Nader El-Mallawany
Katherine D. Westmoreland
Peter Wasswa
Carl E. Allen
Nmazuo Ozuah
author_facet Rizine R. Mzikamanda
Loviisa Mulanje
Casey L. McAtee
Apatsa Matatiyo
Zoe Mwale
Grace Chirwa
Watipaso Wanda
Atupele Miranda Mpasa
Stella Wachepa
Minke H.W. Huibers
Steve Martin
Tamiwe Tomoka
Maurice Mulenga
Yuri Fedoriw
Gugulethu Mapurisa
Julie M. Gastier Foster
Nader El-Mallawany
Katherine D. Westmoreland
Peter Wasswa
Carl E. Allen
Nmazuo Ozuah
author_sort Rizine R. Mzikamanda
collection DOAJ
description PURPOSEExcellent survival for advanced (stages II with high lactate dehydrogenase, III, and IV) pediatric mature B-cell non-Hodgkin lymphoma (MB-NHL) has been achieved with intensive regimens, but adoption in sub-Saharan Africa is limited by inadequate supportive care. We provide real-world data on treating advanced MB-NHL with high-dose methotrexate (HD-MTX; ≥1,000 mg/m2/cycle) where real-time serum MTX monitoring is unavailable.METHODSWe identified two cohorts—a retrospective (January 2017-December 2020) cohort treated with 1,000 or 3,000 mg/m2/cycle of HD-MTX and a prospective (July 2022-July 2023) cohort—with a modified LMB96 protocol containing 3,000 mg/m2/cycle of HD-MTX. All doses of HD-MTX were given over 3 hours. Estimates of 12-month event-free survival (EFS) and overall survival (OS) were calculated with abandonment as an event. Clinical toxicity data were available for the prospective cohort.RESULTSThe retrospective cohort had 108 patients who received HD-MTX 1,000 mg/m2 (n = 98, 91%) or 3,000 mg/m2 per cycle. The 12-month EFS and OS were 39% (95% CI, 30 to 50) and 54% (95% CI, 44 to 64), respectively. HD-MTX at 3,000 mg/m2 had superior EFS: 69% (95% CI, 49 to 96) versus 33% (95% CI, 24 to 46), P = .004. The prospective cohort had 38 patients. Two ≥grade 3 mucositis, one acute kidney injury, and three treatment-related deaths (8%) occurred. Seven (18%) abandoned treatment. With a median follow-up of 14.5 months, 12-month EFS and OS were 45% (95% CI, 32 to 65) and 59% (95% CI, 45 to 79), respectively. Most relapses were stage IV: EFS 20% versus 51% (non–stage IV; P = .057). Severe malnutrition was associated with OS of 33% versus 58% (normal) or 76% (moderate; P = .055).CONCLUSIONHD-MTX dosed at 3,000 mg/m2/cycle is feasible in low-resource settings where routine MTX monitoring is unavailable. Stage IV disease and severe malnutrition may contribute to poorer outcomes.
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spelling doaj-art-d92a81218229461bb6f235f4e327b0192025-08-20T03:06:09ZengAmerican Society of Clinical OncologyJCO Global Oncology2687-89412025-04-011110.1200/GO-24-00591High-Dose Methotrexate Usage Without Drug-Level Monitoring in Advanced Pediatric Mature B-Cell Non-Hodgkin Lymphoma in a Resource-Limited Setting in MalawiRizine R. Mzikamanda0Loviisa Mulanje1Casey L. McAtee2Apatsa Matatiyo3Zoe Mwale4Grace Chirwa5Watipaso Wanda6Atupele Miranda Mpasa7Stella Wachepa8Minke H.W. Huibers9Steve Martin10Tamiwe Tomoka11Maurice Mulenga12Yuri Fedoriw13Gugulethu Mapurisa14Julie M. Gastier Foster15Nader El-Mallawany16Katherine D. Westmoreland17Peter Wasswa18Carl E. Allen19Nmazuo Ozuah20Pediatric Hematology-Oncology, Kamuzu Central Hospital, Lilongwe, MalawiDepartment of Epidemiological Methods and Etiological Research, Leibniz Institute of Prevention Research and Epidemiology, Bremen, GermanyDepartment of Pediatrics, Baylor College of Medicine, Houston, TXUniversity of North Carolina Project Malawi, Lilongwe, MalawiBaylor College of Medicine Children's Foundation—Malawi, Lilongwe, MalawiPediatric Hematology-Oncology, Kamuzu Central Hospital, Lilongwe, MalawiPediatric Hematology-Oncology, Kamuzu Central Hospital, Lilongwe, MalawiPediatric Hematology-Oncology, Kamuzu Central Hospital, Lilongwe, MalawiPediatric Hematology-Oncology, Kamuzu Central Hospital, Lilongwe, MalawiPrinces' Maxima Center Pediatric Oncology, Utrecht, the NetherlandsDepartment of Pediatrics, University of South Carolina School of Medicine, Greenville, SCUniversity of North Carolina Project Malawi, Lilongwe, MalawiUniversity of North Carolina Project Malawi, Lilongwe, MalawiUniversity of North Carolina Project Malawi, Lilongwe, MalawiUniversity of North Carolina Project Malawi, Lilongwe, MalawiDepartment of Pediatrics, Baylor College of Medicine, Houston, TXDepartment of Pediatrics, Baylor College of Medicine, Houston, TXUniversity of North Carolina Project Malawi, Lilongwe, MalawiDepartment of Pediatrics, Baylor College of Medicine, Houston, TXDepartment of Pediatrics, Baylor College of Medicine, Houston, TXDepartment of Pediatrics, Baylor College of Medicine, Houston, TXPURPOSEExcellent survival for advanced (stages II with high lactate dehydrogenase, III, and IV) pediatric mature B-cell non-Hodgkin lymphoma (MB-NHL) has been achieved with intensive regimens, but adoption in sub-Saharan Africa is limited by inadequate supportive care. We provide real-world data on treating advanced MB-NHL with high-dose methotrexate (HD-MTX; ≥1,000 mg/m2/cycle) where real-time serum MTX monitoring is unavailable.METHODSWe identified two cohorts—a retrospective (January 2017-December 2020) cohort treated with 1,000 or 3,000 mg/m2/cycle of HD-MTX and a prospective (July 2022-July 2023) cohort—with a modified LMB96 protocol containing 3,000 mg/m2/cycle of HD-MTX. All doses of HD-MTX were given over 3 hours. Estimates of 12-month event-free survival (EFS) and overall survival (OS) were calculated with abandonment as an event. Clinical toxicity data were available for the prospective cohort.RESULTSThe retrospective cohort had 108 patients who received HD-MTX 1,000 mg/m2 (n = 98, 91%) or 3,000 mg/m2 per cycle. The 12-month EFS and OS were 39% (95% CI, 30 to 50) and 54% (95% CI, 44 to 64), respectively. HD-MTX at 3,000 mg/m2 had superior EFS: 69% (95% CI, 49 to 96) versus 33% (95% CI, 24 to 46), P = .004. The prospective cohort had 38 patients. Two ≥grade 3 mucositis, one acute kidney injury, and three treatment-related deaths (8%) occurred. Seven (18%) abandoned treatment. With a median follow-up of 14.5 months, 12-month EFS and OS were 45% (95% CI, 32 to 65) and 59% (95% CI, 45 to 79), respectively. Most relapses were stage IV: EFS 20% versus 51% (non–stage IV; P = .057). Severe malnutrition was associated with OS of 33% versus 58% (normal) or 76% (moderate; P = .055).CONCLUSIONHD-MTX dosed at 3,000 mg/m2/cycle is feasible in low-resource settings where routine MTX monitoring is unavailable. Stage IV disease and severe malnutrition may contribute to poorer outcomes.https://ascopubs.org/doi/10.1200/GO-24-00591
spellingShingle Rizine R. Mzikamanda
Loviisa Mulanje
Casey L. McAtee
Apatsa Matatiyo
Zoe Mwale
Grace Chirwa
Watipaso Wanda
Atupele Miranda Mpasa
Stella Wachepa
Minke H.W. Huibers
Steve Martin
Tamiwe Tomoka
Maurice Mulenga
Yuri Fedoriw
Gugulethu Mapurisa
Julie M. Gastier Foster
Nader El-Mallawany
Katherine D. Westmoreland
Peter Wasswa
Carl E. Allen
Nmazuo Ozuah
High-Dose Methotrexate Usage Without Drug-Level Monitoring in Advanced Pediatric Mature B-Cell Non-Hodgkin Lymphoma in a Resource-Limited Setting in Malawi
JCO Global Oncology
title High-Dose Methotrexate Usage Without Drug-Level Monitoring in Advanced Pediatric Mature B-Cell Non-Hodgkin Lymphoma in a Resource-Limited Setting in Malawi
title_full High-Dose Methotrexate Usage Without Drug-Level Monitoring in Advanced Pediatric Mature B-Cell Non-Hodgkin Lymphoma in a Resource-Limited Setting in Malawi
title_fullStr High-Dose Methotrexate Usage Without Drug-Level Monitoring in Advanced Pediatric Mature B-Cell Non-Hodgkin Lymphoma in a Resource-Limited Setting in Malawi
title_full_unstemmed High-Dose Methotrexate Usage Without Drug-Level Monitoring in Advanced Pediatric Mature B-Cell Non-Hodgkin Lymphoma in a Resource-Limited Setting in Malawi
title_short High-Dose Methotrexate Usage Without Drug-Level Monitoring in Advanced Pediatric Mature B-Cell Non-Hodgkin Lymphoma in a Resource-Limited Setting in Malawi
title_sort high dose methotrexate usage without drug level monitoring in advanced pediatric mature b cell non hodgkin lymphoma in a resource limited setting in malawi
url https://ascopubs.org/doi/10.1200/GO-24-00591
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