000100714 001__ 100714 000100714 005__ 20230519145418.0 000100714 0247_ $$2doi$$a10.1002/cam4.3730 000100714 0248_ $$2sideral$$a123394 000100714 037__ $$aART-2021-123394 000100714 041__ $$aeng 000100714 100__ $$aSancho, J.M. 000100714 245__ $$aR-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 000100714 260__ $$c2021 000100714 5060_ $$aAccess copy available to the general public$$fUnrestricted 000100714 5203_ $$aThe 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. 000100714 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000100714 590__ $$a4.711$$b2021 000100714 592__ $$a1.144$$b2021 000100714 594__ $$a6.7$$b2021 000100714 591__ $$aONCOLOGY$$b106 / 245 = 0.433$$c2021$$dQ2$$eT2 000100714 593__ $$aRadiology, Nuclear Medicine and Imaging$$c2021$$dQ1 000100714 593__ $$aCancer Research$$c2021$$dQ1 000100714 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000100714 700__ $$aFernández-Alvarez, R. 000100714 700__ $$aGual-Capllonch, F. 000100714 700__ $$aGonzález-García, E. 000100714 700__ $$aGrande, C. 000100714 700__ $$aGutiérrez, N. 000100714 700__ $$aPeñarrubia, M.J. 000100714 700__ $$aBatlle-López, A. 000100714 700__ $$aGonzález-Barca, E. 000100714 700__ $$aGuinea, J.M. 000100714 700__ $$aGimeno, E. 000100714 700__ $$aPeñalver, F.J. 000100714 700__ $$0(orcid)0000-0001-8076-4227$$aFuertes, M. 000100714 700__ $$aBastos, M. 000100714 700__ $$aHernández-Rivas, J.Á. 000100714 700__ $$aMoraleda, J.M. 000100714 700__ $$aGarcía, O. 000100714 700__ $$aSorigué, M. 000100714 700__ $$aMartin, A. 000100714 773__ $$g10 (2021), 1314-1326$$pCancer med.$$tCancer medicine$$x2045-7634 000100714 8564_ $$s337663$$uhttps://zaguan.unizar.es/record/100714/files/texto_completo.pdf$$yVersión publicada 000100714 8564_ $$s1968376$$uhttps://zaguan.unizar.es/record/100714/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000100714 909CO $$ooai:zaguan.unizar.es:100714$$particulos$$pdriver 000100714 951__ $$a2023-05-18-14:03:49 000100714 980__ $$aARTICLE