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
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% random...
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| Published in: | Cancer medicine (Malden, MA) Vol. 10; no. 4; pp. 1314 - 1326 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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01-02-2021
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| 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.
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 prospective randomized phase 2 trial of RCOMP versus RCHOP in DLBCL patients ≥60 years and normal cardiac function demonstrated that 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. |
|---|---|
| AbstractList | 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.
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 prospective randomized phase 2 trial of RCOMP versus RCHOP in DLBCL patients ≥60 years and normal cardiac function demonstrated that 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. 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. 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. 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. 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. 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. 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 prospective randomized phase 2 trial of RCOMP versus RCHOP in DLBCL patients ≥60 years and normal cardiac function demonstrated that 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. |
| Author | García, Olga Peñalver, Francisco‐Javier Gutiérrez, Norma Peñarrubia, María‐Jesús González‐García, Esther Fuertes, Miguel Moraleda, José‐María Bastos, Mariana Hernández‐Rivas, José‐Ángel Sorigué, Marc Martin, Alejandro Sancho, Juan‐Manuel Grande, Carlos Batlle‐López, Ana Gimeno, Eva Fernández‐Alvarez, Rubén Gual‐Capllonch, Francisco Guinea, José‐María González‐Barca, Eva |
| AuthorAffiliation | 1 Hematology Department ICO‐IJC‐Hospital Germans Trias i Pujol Badalona Spain 6 Hematology Department Hospital Clínico de Valladolid Valladolid Spain 5 Hematology Department Hospital Universitario de Salamanca IBSAL, CIBERONC Salamanca Spain 7 Hematology Department Hospital Marqués de Valdecilla Santander Spain 2 Hematology Department Hospital de Cabueñes Gijón Spain 3 Cardiology Department of Hospital Germans Trias i Pujol Badalona Spain 13 Hematology Department Hospital Gregorio Marañón Madrid Spain 4 Hematology Department Hospital Doce de Octubre Madrid Spain 9 Hematology Department Hospital Universitario de Araba Vitoria Spain 12 Hematology Department Hospital Clínico Lozano Blesa Zaragoza Spain 15 Hematology Department Hospital Virgen de la Arrixaca Murcia Spain 11 Hematology Department Hospital Universitario Fundación de Alcorcón Madrid Spain 10 Hematology Department Hospital del Mar Barcelona Spain 14 Hematology Department Hospital Universitario Infanta Leonor Madrid Spain 8 Hematology Depart |
| AuthorAffiliation_xml | – name: 11 Hematology Department Hospital Universitario Fundación de Alcorcón Madrid Spain – name: 1 Hematology Department ICO‐IJC‐Hospital Germans Trias i Pujol Badalona Spain – name: 15 Hematology Department Hospital Virgen de la Arrixaca Murcia Spain – name: 14 Hematology Department Hospital Universitario Infanta Leonor Madrid Spain – name: 12 Hematology Department Hospital Clínico Lozano Blesa Zaragoza Spain – name: 5 Hematology Department Hospital Universitario de Salamanca IBSAL, CIBERONC Salamanca Spain – name: 2 Hematology Department Hospital de Cabueñes Gijón Spain – name: 6 Hematology Department Hospital Clínico de Valladolid Valladolid Spain – name: 13 Hematology Department Hospital Gregorio Marañón Madrid Spain – name: 3 Cardiology Department of Hospital Germans Trias i Pujol Badalona Spain – name: 4 Hematology Department Hospital Doce de Octubre Madrid Spain – name: 8 Hematology Department ICO‐Hospital Durán i Reynals (Hospitalet de Llobregat Barcelona Spain – name: 9 Hematology Department Hospital Universitario de Araba Vitoria Spain – name: 10 Hematology Department Hospital del Mar Barcelona Spain – name: 7 Hematology Department Hospital Marqués de Valdecilla Santander Spain |
| Author_xml | – sequence: 1 givenname: Juan‐Manuel orcidid: 0000-0001-7168-6538 surname: Sancho fullname: Sancho, Juan‐Manuel email: jsancho@iconcologia.net organization: ICO‐IJC‐Hospital Germans Trias i Pujol – sequence: 2 givenname: Rubén surname: Fernández‐Alvarez fullname: Fernández‐Alvarez, Rubén organization: Hospital de Cabueñes – sequence: 3 givenname: Francisco surname: Gual‐Capllonch fullname: Gual‐Capllonch, Francisco organization: Cardiology Department of Hospital Germans Trias i Pujol – sequence: 4 givenname: Esther surname: González‐García fullname: González‐García, Esther organization: Hospital de Cabueñes – sequence: 5 givenname: Carlos surname: Grande fullname: Grande, Carlos organization: Hospital Doce de Octubre – sequence: 6 givenname: Norma surname: Gutiérrez fullname: Gutiérrez, Norma organization: IBSAL, CIBERONC – sequence: 7 givenname: María‐Jesús surname: Peñarrubia fullname: Peñarrubia, María‐Jesús organization: Hospital Clínico de Valladolid – sequence: 8 givenname: Ana surname: Batlle‐López fullname: Batlle‐López, Ana organization: Hospital Marqués de Valdecilla – sequence: 9 givenname: Eva orcidid: 0000-0002-1323-1508 surname: González‐Barca fullname: González‐Barca, Eva organization: ICO‐Hospital Durán i Reynals (Hospitalet de Llobregat – sequence: 10 givenname: José‐María surname: Guinea fullname: Guinea, José‐María organization: Hospital Universitario de Araba – sequence: 11 givenname: Eva surname: Gimeno fullname: Gimeno, Eva organization: Hospital del Mar – sequence: 12 givenname: Francisco‐Javier surname: Peñalver fullname: Peñalver, Francisco‐Javier organization: Hospital Universitario Fundación de Alcorcón – sequence: 13 givenname: Miguel surname: Fuertes fullname: Fuertes, Miguel organization: Hospital Clínico Lozano Blesa – sequence: 14 givenname: Mariana orcidid: 0000-0002-9431-4646 surname: Bastos fullname: Bastos, Mariana organization: Hospital Gregorio Marañón – sequence: 15 givenname: José‐Ángel surname: Hernández‐Rivas fullname: Hernández‐Rivas, José‐Ángel organization: Hospital Universitario Infanta Leonor – sequence: 16 givenname: José‐María surname: Moraleda fullname: Moraleda, José‐María organization: Hospital Virgen de la Arrixaca – sequence: 17 givenname: Olga surname: García fullname: García, Olga organization: ICO‐IJC‐Hospital Germans Trias i Pujol – sequence: 18 givenname: Marc surname: Sorigué fullname: Sorigué, Marc organization: ICO‐IJC‐Hospital Germans Trias i Pujol – sequence: 19 givenname: Alejandro surname: Martin fullname: Martin, Alejandro organization: IBSAL, CIBERONC |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33492774$$D View this record in MEDLINE/PubMed |
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| Copyright | 2021 The Authors. published by John Wiley & Sons Ltd. 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| Keywords | cardiotoxicity diffuse large B-cell lymphoma troponin N-terminal pro-B-type natriuretic peptide liposomal doxorubicin |
| Language | English |
| License | Attribution 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
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| References | 2002; 16 2004; 22 2010; 53 2015; 16 2011; 118 1958; 53 2008; 9 2003; 14 2014; 26 2011; 12 2004; 109 2016; 58 2011; 7 2018; 9 2010; 21 2004; 31 2002; 86 2008; 49 2010; 134 2017; 12 2001; 19 2005; 51 1973; 29 2002; 346 2011; 49 1998; 56 2007; 25 e_1_2_8_28_1 e_1_2_8_29_1 e_1_2_8_24_1 e_1_2_8_25_1 e_1_2_8_26_1 e_1_2_8_27_1 e_1_2_8_3_1 e_1_2_8_2_1 e_1_2_8_5_1 e_1_2_8_4_1 e_1_2_8_7_1 e_1_2_8_6_1 e_1_2_8_9_1 e_1_2_8_8_1 e_1_2_8_20_1 e_1_2_8_21_1 e_1_2_8_22_1 e_1_2_8_23_1 e_1_2_8_17_1 e_1_2_8_18_1 e_1_2_8_19_1 e_1_2_8_13_1 e_1_2_8_15_1 e_1_2_8_16_1 e_1_2_8_10_1 e_1_2_8_11_1 e_1_2_8_12_1 Armitage JO (e_1_2_8_14_1) 2002; 16 |
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| Snippet | The use of non‐pegylated liposomal doxorubicin (Myocet®) in diffuse large B‐cell lymphoma (DLBCL) has been investigated in retrospective and single‐arm... The use of non-pegylated liposomal doxorubicin (Myocet ) in diffuse large B-cell lymphoma (DLBCL) has been investigated in retrospective and single-arm... The use of non‐pegylated liposomal doxorubicin (Myocet ® ) in diffuse large B‐cell lymphoma (DLBCL) has been investigated in retrospective and single‐arm... The use of non-pegylated liposomal doxorubicin (Myocet®) in diffuse large B-cell lymphoma (DLBCL) has been investigated in retrospective and single-arm... Abstract The use of non‐pegylated liposomal doxorubicin (Myocet®) in diffuse large B‐cell lymphoma (DLBCL) has been investigated in retrospective and... |
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