Zinzani Pier Luigi, Mauro Francesca Romana, Tedeschi Alessandra, Varettoni Marzia, Zaja Francesco, Barosi Giovanni
IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia 'Seràgnoli', Bologna, Italy.
Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
Hematol Oncol. 2023 Dec;41(5):795-808. doi: 10.1002/hon.3172. Epub 2023 May 11.
Zanubrutinib has been approved for the treatment of patients with different lymphoproliferative disorders, and now represents a major breakthrough in the treatment of patients resistant or relapsing after the recommended therapies. Because few systematic studies or comparative randomized clinical trials have been conducted, optimal use of the drug in approved indications is challenging, and questions are emerging on its use in earlier stages of the disorders. This article presents the results of group discussion among an ad hoc constituted panel of experts aimed at identifying and addressing unmet clinical needs (UCNs) in the use of zanubrutinib in the lymphomas which have received the approval of use, specifically Waldenström macroglubulinemia, marginal zone lymphoma and mantle cell lymphoma. Key UCNs were selected according to the criterion of clinical relevance using the Delphi process. The panel produced recommendations and proposals for new studies for the management of the identified UCNs. These recommendations are intended for use not only by expert centers but above all by not experienced hematologists as well as general practitioners.
泽布替尼已被批准用于治疗不同的淋巴增殖性疾病患者,目前在推荐治疗后耐药或复发患者的治疗方面取得了重大突破。由于很少进行系统研究或比较随机临床试验,在已批准适应症中优化使用该药物具有挑战性,并且在疾病早期阶段使用该药物的相关问题也不断涌现。本文介绍了一个特别组建的专家小组进行小组讨论的结果,旨在识别和解决泽布替尼在已获批使用的淋巴瘤(特别是华氏巨球蛋白血症、边缘区淋巴瘤和套细胞淋巴瘤)使用中尚未满足的临床需求(UCN)。使用德尔菲法根据临床相关性标准选择关键的UCN。该小组针对已识别的UCN的管理提出了建议和新研究提案。这些建议不仅供专家中心使用,最重要的是供经验不足的血液科医生以及全科医生使用。