title: Critical concepts, practice recommendations, and research perspectives of pixantrone therapy in non-Hodgkin lymphoma: a SIE, SIES, and GITMO consensus paper.
abstract: OBJECTIVE
  In this paper, we present a review of critical concepts and research perspectives and produce recommendations on the optimal use of pixantrone in non-Hodgkin lymphoma (NHL) by group discussion from an expert panel appointed by the Italian Society of Hematology and the affiliate societies, Società Italiana di Ematologia Sperimentale and Gruppo Italiano Trapianto di Midollo Osseo.
  
  
  METHODS
  Recommendations were produced using the Delphi process. Scientific evidence on pixantrone efficacy was analyzed using Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology in the areas where at least one randomized trial was published. The following key issues were addressed for practical recommendations: pixantrone monotherapy in aggressive relapsed or refractory non-Hodgkin B-cell lymphomas and toxicity risk management in patients candidates to pixantrone.
  
  
  CONCLUSIONS
  After a balanced and value-oriented discussion, the panel agreed that the benefit/risk profile was in favor of pixantrone in the treatment of adult patients with multiply relapsed or refractory aggressive NHL B-cell lymphomas. Pixantrone was deemed to be contraindicated in patients with uncontrolled cardiovascular disease. Despite a low rate of cardiotoxicity of pixantrone reported in clinical trials, the panel recommended that all patients receiving pixantrone should undergo periodical cardiac monitoring.
authors.affiliation: Institute of Hematology "Seràgnoli", University of Bologna, Bologna, Italy.
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Zinzani
authors.affiliation: Division of Hematology and Bone Marrow Transplantation, Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milano, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Corradini
authors.affiliation: Dipartimento Biotecnologie Cellulari ed Ematologia, Universitá La Sapienza, Rome, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Martelli
authors.affiliation: Department of Medicine and Units of Drug Sciences and Clinical Pharmacology, University Campus Bio-Medico, Rome, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Minotti
authors.affiliation: Cardiology Unit, National Cancer Institute IRCCS "Giovanni Paolo II", Bari, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Oliva
authors.affiliation: Division of Medical Oncology A, National Cancer Institute, Aviano, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Spina
authors.affiliation: Center of the Study of Myelofibrosis, Biotechnology Research Area, IRCCS Policlinico S. Matteo Foundation, Pavia, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Barosi
authors.affiliation: University of Bologna, Bologna, Italy.
authors.forename: Sante
authors.initials: S
authors.lastname: Tura
mesh_terms: D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D003131:Combined Modality Therapy; D019468:Disease Management; D004353:Drug Evaluation, Preclinical; D019008:Drug Resistance, Neoplasm; D006801:Humans; D007546:Isoquinolines / Q000494:pharmacology / Q000627:therapeutic use*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000473:pathology; D017410:Practice Guidelines as Topic; D012008:Recurrence; D059005:Topoisomerase II Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D007546:Isoquinolines; D059005:Topoisomerase II Inhibitors; C086548:pixantrone
keywords: GRADE methodology; guidelines; non-Hodgkin lymphoma; pixantrone