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Hematol Oncol. 2018 Feb;36(1):68-75. doi: 10.1002/hon.2425. Epub 2017 May 19.

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.

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Hematology, Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.
Department of Diagnostic, Clinic and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
Cardiology Unit, National Cancer Center, Istituto di Ricovero e Cura a Carattere Scientifico, Aviano, Pordenone, Italy.
Unit of Lymphoid Malignancies, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Haematology Section, DISM, Azienda Sanitaria Universitaria Integrata S. M. Misericordia, Udine, Italy.
Division of Medical Oncology A, National Cancer Center, Istituto di Ricovero e Cura a Carattere Scientifico, Aviano, Pordenone, Italy.
Department of Hematology, Istituto Scientifico Romagnolo per Studio e Cura dei Tumori, Meldola, Forlì-Cesena, Italy.
Division of Hematology, Spedali Civili, Brescia, Italy.
Hematology Unit, Humanitas Cancer Center, Rozzano, Milan, Italy.
Hematology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy.
Department of Hematology, SS Antonio E Biagio E Cesare Arrigo Hospital, Alessandria, Italy.
Fondazione Italiana Linfomi Onlus, Italy.
Oncohematology, AO S. Maria di Terni, Terni, Italy.
Hematology and Stem Cell Transplant Unit, Regina Elena National Cancer Institute, Rome, Italy.
Division of Medical Oncology 1, Istituto Oncologico Veneto-IRCCS, Padova, Italy.


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.


cardiotoxicity; diffuse large B-cell lymphoma; non-pegylated liposomal doxorubicin

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