A dose‐dense short‐term therapy for human immunodeficiency virus/acquired immunodeficiency syndrome patients with high‐risk Burkitt lymphoma or high‐grade B‐cell lymphoma: safety and efficacy results of the “CARMEN” phase II trial
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Le résumé fourni par la source
A few prospective trials in HIV-positive patients with Burkitt lymphoma (BL) or high-grade B-cell lymphoma (HGBL) have been reported. Investigated therapies have shown good efficacy but relevant safety problems, with high rates of interruptions, severe mucositis, septic complications, and fungal infections. Here, we report the results of a multicentre phase II trial addressing a new dose-dense, short-term therapy aimed at maintaining efficacy and improving tolerability. The experimental programme included a 36-day polychemotherapy induction followed by high-dose cytarabine-based consolidation and response-tailored BEAM (carmustine, etoposide, cyatarabine, and melphalan)- conditioned autologous stem cell transplantation (ASCT). This therapy would be considered active if ≥11 complete remissions (CR) after induction (primary endpoint) were recorded among 20 assessable patients. HIV-positive adults (median age 42, range 26-58; 16 males) with untreated BL (n = 16), HGBL (n = 3) or double-hit lymphoma (n = 1) were enrolled. All patients had high-risk features, with meningeal and bone marrow infiltration in five and nine patients respectively. The experimental programme was safe and active in a multicentre setting, with only two episodes of grade 4 non-haematological toxicity (hepatotoxicity and mucositis), and no cases of systemic fungal infections; two patients died of toxicity (bacterial infections). Response after induction (median duration: 47 days; interquartile range 41-54), was complete in 13 patients and partial in five [overall response rate = 90%; 95% confidence interval (CI) = 77-100]. All responders received consolidation, and five required autologous stem cell transplant. At a median follow-up of 55 (41-89) months, 14 patients are relapse-free and 15 are alive, with a five-year progression-free survival and an overall survival of 70% (95% CI = 60-80%) and 75% (95% CI = 66-84) respectively. No patient with cerebrospinal fluid (CSF)/meningeal lymphoma experienced central nervous system recurrence. With respect to previously reported regimens, this programme was delivered in a shorter period, and achieved the main goal of maintaining efficacy and improving tolerability.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- A dose‐dense short‐term therapy for human immunodeficiency virus/acquired immunodeficiency syndrome patients with high‐risk Burkitt lymphoma or high‐grade B‐cell lymphoma: safety and efficacy results of the “CARMEN” phase II trial
- Date Crossref
- 21/10/2020
- Éditeur
- Wiley
- 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.
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Istituti di Ricovero e Cura a Carattere Scientifico pays non établi dans la noticeÉtablissement de santé
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Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele pays non établi dans la noticeÉtablissement de santé
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia pays non établi dans la noticeÉtablissement de santé
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Centro di Riferimento Oncologico pays non établi dans la noticeÉtablissement de santé
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Azienda Ospedaliera San Gerardo pays non établi dans la noticeÉtablissement de santé
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Fondazione Ricerca Molinette pays non établi dans la noticeOrganisation à but non lucratif
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Vita-Salute San Raffaele University pays non établi dans la noticeUniversité ou école supérieure
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Ospedale San Paolo pays non établi dans la noticeÉtablissement de santé
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Azienda Ospedaliero-Universitaria Careggi pays non établi dans la noticeÉtablissement de santé
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Lymphoma Unit Department of Onco‐Hematology IRCCS San Raffaele Scientific Institute Milan Italy Department of Onco-Hematology pays non établi dans la noticeStructure de recherche
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Division of Hematology Ospedali Civili di Brescia Brescia Italy pays non établi dans la noticeInstitution
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Istituti di Ricovero e Cura a Carattere Scientifico, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele et Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.