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Title: R‐COMP versus R‐CHOP as first‐line therapy for diffuse large B‐cell lymphoma in patients ≥60 years: Results of a randomized phase 2 study from the Spanish GELTAMO group
Author: Sancho, Juan Manuel
Fernández Alvarez, Rubén
Gual Capllonch, Francisco
González García, Esther
Grande, Carlos
Gutiérrez, Norma
Peñarrubia, María Jesús
Batlle López, Ana
González Barca, Eva
Guinea, José María
Gimeno, Eva
Peñalver, Francisco Javier
Fuertes, Miguel
Bastos, Mariana
Hernández Rivas, José Ángel
Moraleda, José María
García, Olga
Sorigué, Marc
Martin, Alejandro
Keywords: Limfomes
Cèl·lules B
B cells
Issue Date: 25-Jan-2021
Publisher: Wiley
Abstract: The use of non-pegylated liposomal doxorubicin (Myocet®) in diffuse large B-cell lymphoma (DLBCL) has been investigated in retrospective and single-arm prospective studies. This was a prospective phase 2 trial of DLBCL patients ≥60 years old with left ventricular ejection fraction (LVEF) ≥55% randomized to standard R-CHOP or investigational R-COMP (with Myocet® instead of conventional doxorubicin). The primary end point was to evaluate the differences in subclinical cardiotoxicity, defined as decrease in LVEF to <55% at the end of treatment. Secondary objectives were efficacy, safety, and variations of troponin and N-terminal pro-B-type natriuretic peptide (NT-proBNP) and LVEF along follow-up. Ninety patients were included, 45 in each group. No differences were observed in the percentage of patients with LVEF <55% at end of treatment (11% in R-CHOP arm vs. 7% in R-COMP arm, p = 0.697) or at 4 months (10% vs. 6%, respectively, p = 0.667) and 12 months (8% vs. 7%, respectively, p = 1). However, a higher percentage of R-CHOP compared with R-COMP patients showed increased troponin levels in cycle 6 (100% vs. 63%, p = 0.001) and at 1 month after treatment (88% vs. 56%, respectively, p = 0.015). Cardiovascular adverse events were seen in five R-CHOP patients (nine episodes, four grade ≥3) and in four R-COMP patients (five episodes, all grade 1–2). No significant differences in efficacy were observed. In conclusion, R-COMP is a feasible immunochemotherapy schedule for DLBCL patients ≥60 years, with similar efficacy to R-CHOP. However, the use of non-pegylated doxorubicin instead of conventional doxorubicin was not associated with less early cardiotoxicity, although some reduced cardiac safety signals were observed. Trial registration: Identifier: NCT02012088.
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It is part of: Cancer Medicine, 2021
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Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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