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
Por:
Sancho, JM, Fernandez-Alvarez, R, Gual-Capllonch, F, Gonzalez-Garcia, E, Grande, C, Gutierrez, N, Penarrubia, MJ, Batlle-Lopez, A, Gonzalez-Barca, E, Guinea, JM, Gimeno, E, Penalver, FJ, Fuertes, M, Bastos, M, Hernandez-Rivas, JA, Moraleda, JM, Garcia, O, Sorigue, M and Martin, A
Publicada:
1 feb 2021
Ahead of Print:
1 ene 2021
Resumen:
The use of non-pegylated liposomal doxorubicin (Myocet(R)) 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(R) 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.
Filiaciones:
:
ICO IJC Hosp Germans Trias & Pujol, Hematol Dept, Badalona, Spain
Fernandez-Alvarez, R:
Hosp Cabuenes, Hematol Dept, Gijon, Spain
Gual-Capllonch, F:
Hosp Badalona Germans Trias & Pujol, Cardiol Dept, Badalona, Spain
Gonzalez-Garcia, E:
Hosp Cabuenes, Hematol Dept, Gijon, Spain
Grande, C:
Hosp Doce Octubre, Hematol Dept, Madrid, Spain
Gutierrez, N:
CIBERONC, IBSAL, Hosp Univ Salamanca, Hematol Dept, Salamanca, Spain
Penarrubia, MJ:
Hosp Clin Valladolid, Hematol Dept, Valladolid, Spain
Batlle-Lopez, A:
Hosp Marques Valdecilla, Hematol Dept, Santander, Spain
Gonzalez-Barca, E:
ICO Hosp Duran & Reynals, Hematol Dept, Barcelona, Spain
Guinea, JM:
Hosp Univ Araba, Hematol Dept, Vitoria, Spain
Gimeno, E:
Hosp Del Mar, Hematol Dept, Barcelona, Spain
Penalver, FJ:
Hosp Univ Fdn Alcorcon, Hematol Dept, Madrid, Spain
Fuertes, M:
Hosp Clin Lozano Blesa, Hematol Dept, Zaragoza, Spain
Bastos, M:
Hosp Gregorio Maranon, Hematol Dept, Madrid, Spain
Hernandez-Rivas, JA:
Hosp Univ Infanta Leonor, Hematol Dept, Madrid, Spain
Moraleda, JM:
Hosp Virgen Arrixaca, Hematol Dept, Murcia, Spain
Garcia, O:
ICO IJC Hosp Germans Trias & Pujol, Hematol Dept, Badalona, Spain
:
ICO IJC Hosp Germans Trias & Pujol, Hematol Dept, Badalona, Spain
Martin, A:
CIBERONC, IBSAL, Hosp Univ Salamanca, Hematol Dept, Salamanca, Spain
gold, Green Published
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