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

Mostra el registre complet Registre parcial de l'ítem

  • dc.contributor.author Sancho, Juan Manuel
  • dc.contributor.author Fernández Alvarez, Rubén
  • dc.contributor.author Gual Capllonch, Francisco
  • dc.contributor.author González García, Esther
  • dc.contributor.author Grande, Carlos
  • dc.contributor.author Gutiérrez, Norma
  • dc.contributor.author Peñarrubia, María Jesús
  • dc.contributor.author Batlle López, Ana
  • dc.contributor.author González Barca, Eva
  • dc.contributor.author Guinea de Castro, José María
  • dc.contributor.author Gimeno Vázquez, Eva
  • dc.contributor.author Peñalver, Francisco-Javier
  • dc.contributor.author Fuertes, Miguel
  • dc.contributor.author Bastos Oreiro, Mariana
  • dc.contributor.author Hernández Rivas, José Ángel
  • dc.contributor.author Moraleda, José María
  • dc.contributor.author García, Olga
  • dc.contributor.author Sorigué, Marc
  • dc.contributor.author Martin, Alejandro
  • dc.date.accessioned 2021-04-22T06:55:17Z
  • dc.date.available 2021-04-22T06:55:17Z
  • dc.date.issued 2021
  • dc.description.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.
  • dc.format.mimetype application/pdf
  • dc.identifier.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
  • dc.identifier.doi http://dx.doi.org/10.1002/cam4.3730
  • dc.identifier.issn 2045-7634
  • dc.identifier.uri http://hdl.handle.net/10230/47184
  • dc.language.iso eng
  • dc.publisher Wiley
  • dc.relation.ispartof Cancer Med. 2021;10(4):1314-26
  • dc.rights © 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by/4.0/
  • dc.subject.keyword N-terminal pro-B-type natriuretic peptide
  • dc.subject.keyword Cardiotoxicity
  • dc.subject.keyword Diffuse large B-cell lymphoma
  • dc.subject.keyword Liposomal doxorubicin
  • dc.subject.keyword Troponin
  • dc.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
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

Col·leccions

Articles (Hospital del Mar Research Institute)