Nonpegylated liposomal doxorubicin combination regimen in patients with diffuse large B-cell lymphoma and cardiac comorbidity. Results of the HEART01 phase II trial conducted by the Fondazione Italiana Linfomi

Stefano Luminari, Elda Viel, Andrés José Maria Ferreri, Francesco Zaja, Emanuela Chimienti, Gerardo Musuraca, Alessandra Tucci, Monica Balzarotti, Monica Tani, Francesca Salvi, Emanuela A Pesce, Angela Ferrari, Anna M Liberati, Antonio Spadea, Dario Marino, Maria Bruno-Ventre, Stefano Volpetti, Chiara Bottelli, Elena Ravaioli, Francesco MerliMichele Spina

Research output: Contribution to journalArticle

Abstract

The purpose of this phase 2, multicenter study was to determine the activity and safety of nonpegylated liposomal doxorubicin as part of "R-COMP" combination in patients with diffuse large B-cell lymphoma and coexisting cardiac disorders. The study was conducted using a Bayesian continuing assessment method using complete remission rate and rate of cardiac events as study endpoints. Between November 2009 and October 2011, 50 evaluable patients were enrolled (median age, 76 years). Median baseline left ventricular ejection fraction (LVEF) was 60%. Ischemic cardiopathy was the most frequent preexisting cardiac disorder (35%), followed by atrial fibrillation (15%), left ventricular hypertrophy (13%), and baseline LVEF <50% (12%). Based on the intent to treat analysis, overall response rate was 72%, including 28 patients in complete remission (complete remission rate, 56%), and 8 in partial remission (16%). At the end of treatment, grades 3 to 4 cardiac events were observed in 6 patients. No significant modifications from baseline values of LVEF were observed during treatment and follow-up. Nonpegylated liposomal doxorubicin instead of doxorubicin in the R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen is a feasible option for patients with diffuse large B-cell lymphoma presenting with concomitant cardiac disorders.

Original languageEnglish
Pages (from-to)68-75
Number of pages8
JournalHematological Oncology
Volume36
Issue number1
DOIs
Publication statusPublished - Feb 2018

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Lymphoma, Large B-Cell, Diffuse
Comorbidity
Stroke Volume
Doxorubicin
Preexisting Condition Coverage
Left Ventricular Hypertrophy
Vincristine
Prednisone
Cyclophosphamide
Atrial Fibrillation
Multicenter Studies
liposomal doxorubicin
Safety
Therapeutics

Keywords

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols/pharmacology
  • Comorbidity
  • Doxorubicin/administration & dosage
  • Female
  • Heart Diseases/drug therapy
  • Humans
  • Italy
  • Lymphoma, Large B-Cell, Diffuse/drug therapy
  • Male
  • Polyethylene Glycols/administration & dosage
  • Treatment Outcome

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Nonpegylated liposomal doxorubicin combination regimen in patients with diffuse large B-cell lymphoma and cardiac comorbidity. Results of the HEART01 phase II trial conducted by the Fondazione Italiana Linfomi. / Luminari, Stefano; Viel, Elda; Ferreri, Andrés José Maria; Zaja, Francesco; Chimienti, Emanuela; Musuraca, Gerardo; Tucci, Alessandra; Balzarotti, Monica; Tani, Monica; Salvi, Francesca; Pesce, Emanuela A; Ferrari, Angela; Liberati, Anna M; Spadea, Antonio; Marino, Dario; Bruno-Ventre, Maria; Volpetti, Stefano; Bottelli, Chiara; Ravaioli, Elena; Merli, Francesco; Spina, Michele.

In: Hematological Oncology, Vol. 36, No. 1, 02.2018, p. 68-75.

Research output: Contribution to journalArticle

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abstract = "The purpose of this phase 2, multicenter study was to determine the activity and safety of nonpegylated liposomal doxorubicin as part of {"}R-COMP{"} combination in patients with diffuse large B-cell lymphoma and coexisting cardiac disorders. The study was conducted using a Bayesian continuing assessment method using complete remission rate and rate of cardiac events as study endpoints. Between November 2009 and October 2011, 50 evaluable patients were enrolled (median age, 76 years). Median baseline left ventricular ejection fraction (LVEF) was 60{\%}. Ischemic cardiopathy was the most frequent preexisting cardiac disorder (35{\%}), followed by atrial fibrillation (15{\%}), left ventricular hypertrophy (13{\%}), and baseline LVEF <50{\%} (12{\%}). Based on the intent to treat analysis, overall response rate was 72{\%}, including 28 patients in complete remission (complete remission rate, 56{\%}), and 8 in partial remission (16{\%}). At the end of treatment, grades 3 to 4 cardiac events were observed in 6 patients. No significant modifications from baseline values of LVEF were observed during treatment and follow-up. Nonpegylated liposomal doxorubicin instead of doxorubicin in the R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen is a feasible option for patients with diffuse large B-cell lymphoma presenting with concomitant cardiac disorders.",
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T1 - Nonpegylated liposomal doxorubicin combination regimen in patients with diffuse large B-cell lymphoma and cardiac comorbidity. Results of the HEART01 phase II trial conducted by the Fondazione Italiana Linfomi

AU - Luminari, Stefano

AU - Viel, Elda

AU - Ferreri, Andrés José Maria

AU - Zaja, Francesco

AU - Chimienti, Emanuela

AU - Musuraca, Gerardo

AU - Tucci, Alessandra

AU - Balzarotti, Monica

AU - Tani, Monica

AU - Salvi, Francesca

AU - Pesce, Emanuela A

AU - Ferrari, Angela

AU - Liberati, Anna M

AU - Spadea, Antonio

AU - Marino, Dario

AU - Bruno-Ventre, Maria

AU - Volpetti, Stefano

AU - Bottelli, Chiara

AU - Ravaioli, Elena

AU - Merli, Francesco

AU - Spina, Michele

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KW - Humans

KW - Italy

KW - Lymphoma, Large B-Cell, Diffuse/drug therapy

KW - Male

KW - Polyethylene Glycols/administration & dosage

KW - Treatment Outcome

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JO - Hematological Oncology

JF - Hematological Oncology

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