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

Sancho, J.M. ; Fernández-Alvarez, R. ; Gual-Capllonch, F. ; González-García, E. ; Grande, C. ; Gutiérrez, N. ; Peñarrubia, M.J. ; Batlle-López, A. ; González-Barca, E. ; Guinea, J.M. ; Gimeno, E. ; Peñalver, F.J. ; Fuertes, M. ; Bastos, M. ; Hernández-Rivas, J.Á. ; Moraleda, J.M. ; García, O. ; Sorigué, M. ; Martin, A.

Resumen: 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: ClinicalTrials.gov Identifier: NCT02012088.

Idioma: Inglés

DOI: 10.1002/cam4.3730

Año: 2021

Publicado en: Cancer medicine 10 (2021), 1314-1326
ISSN: 2045-7634

Factor impacto JCR: 4.711 (2021)

Categ. JCR: ONCOLOGY rank: 106 / 245 = 0.433 (2021) - Q2 - T2

Factor impacto CITESCORE: 6.7 - Medicine (Q1) - Biochemistry, Genetics and Molecular Biology (Q2)

Factor impacto SCIMAGO: 1.144 - Radiology, Nuclear Medicine and Imaging (Q1) - Cancer Research (Q1)

Tipo y forma: Artículo (Versión definitiva)