Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda
Rattachement africain : us, Ouganda. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
PURPOSE: Patients with diffuse large B-cell lymphoma (DLBCL) who are treated in low-resource settings have inferior outcomes compared with those in high-resource settings. Rituximab, an anti-CD20 monoclonal antibody, when combined with chemotherapy, improves overall survival (OS) for DLBCL. However, in part due to the limited availability of infusion centers in low-resource countries, rituximab is rarely used. Subcutaneous rituximab (sqR) is a potential solution; however, its safety and efficacy have not been tested in low-income countries. METHODS: This open-label phase I study enrolled patients 18 years or older with newly diagnosed DLBCL. The first cohort (n = 6) received intravenous rituximab plus CHOP. This cohort received sqR for subsequent cycles. The second cohort (n = 12) received sqR plus CHOP for all cycles. Safety and tolerability were evaluated; secondary outcomes included response rates and treatment completion. RESULTS: Between October 25, 2019, and October 7, 2022, 18 patients, with a median age of 36.5 years, were enrolled; 10 were male, and 10 presented with advanced-stage disease. The most common hematologic toxicity was neutropenia (n = 9, 50%). Fifteen of the 18 participants completed treatment; 14 (93.3%) patients achieved a complete response, and one patient (6.7%) had a partial response. The OS and progression-free survival (PFS) at 12 months were 83% (95% CI, 68 to 100) and 67% (95% CI, 48 to 92), respectively. The OS and PFS at 24 months were 66% (95% CI, 47 to 92) and 67% (95% CI, 48 to 92), respectively. CONCLUSION: As demonstrated in other parts of the world, sqR together with CHOP was safe, well-tolerated, and efficacious among Ugandan patients with DLBCL. The very high OS rates are nearly double those of historical controls and comparable with outcomes expected in resource-rich settings. This study demonstrated the feasibility, safety, and efficacy of sqR-CHOP, increased the research infrastructure in Uganda, and will improve care in other resource-limited settings.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda
- Date Crossref
- 01/04/2025
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Washington Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Fred Hutch Cancer Center pays non établi dans la noticeOrganisation à but non lucratif
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Uganda Cancer Institute Kampala, Ouganda (code pays fourni par la source)Structure de recherche
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Hutchinson Centre Research Institute in Uganda Ouganda (code pays fourni par la source)Établissement de santé
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Vaccine and Infectious Disease Division pays non établi dans la noticeInstitution
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Hutchinson Centre Research Institute—Uganda Kampala, Ouganda (pays nommé en fin d’affiliation)Structure de recherche
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Translational Science and Therapeutics Division pays non établi dans la noticeInstitution
Department of Medicine — University of Washington, Fred Hutch Cancer Center et Uganda Cancer Institute (Kampala, Ouganda), avec 4 autres affiliations. Pays d’affiliation : Ouganda.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.