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, 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 de Castro, José María; Gimeno Vázquez, Eva; Peñalver, Francisco-Javier; Fuertes, Miguel; Bastos Oreiro, Mariana; Hernández Rivas, José Ángel; Moraleda, José María; García, Olga; Sorigué, Marc; Martin, Alejandro

doi:http://dx.doi.org/10.1002/cam4.3730

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

Citation

Sancho JM, Fernández-Alvarez R, Gual-Capllonch F, González-García E, Grande C, Gutiérrez N, Peñarrubia MJ, Batlle-López A, González-Barca E, Guinea JM, Gimeno E, Peñalver FJ, Fuertes M, Bastos M, Hernández-Rivas JÁ, Moraleda JM, García O, Sorigué M, Martin A. 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. Cancer Med. 2021;10(4):1314-26. DOI: 10.1002/cam4.3730

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: ClinicalTrials.gov Identifier: NCT02012088.