目的:在本文中,我们通过由意大利血液学学会和附属学会任命的专家小组的小组讨论,对关键概念和研究观点进行了回顾,并就非霍奇金淋巴瘤(NHL)中pixantrone的最佳使用提出了建议。SocietàItalianadiEmatologiaSperimentaleandGruppoItalianoTrapiantodiMidolloOseo.
方法:使用Delphi方法产生建议。使用推荐等级分析了pixantroone疗效的科学证据,评估,发展,和评估(GRADE)方法在至少一项随机试验发表的地区。针对以下关键问题提出了实际建议:pixantron单药治疗侵袭性复发性或难治性非霍奇金B细胞淋巴瘤,以及pixantron候选患者的毒性风险管理。
结论:经过平衡和以价值为导向的讨论,专家小组一致认为,获益/风险概况支持pixantrone治疗患有多重复发或难治性侵袭性NHLB细胞淋巴瘤的成年患者.Pixantrone被认为是患有不受控制的心血管疾病的患者的禁忌。尽管临床试验中报道的pixantrone的心脏毒性较低,专家组建议所有接受pixantrone的患者都应接受定期心脏监测.
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.