Identifying and addressing unmet clinical needs on the use of zanubrutinib in chronic lymphocytic leukemia: A consensus‐based position paper from an ad hoc expert panel

Author:

Mauro Francesca Romana1,Tedeschi Alessandra2ORCID,Varettoni Marzia3ORCID,Zaja Francesco45ORCID,Barosi Giovanni6,Zinzani Pier Luigi78ORCID

Affiliation:

1. Hematology Department of Translational and Precision Medicine ‘Sapienza’ University Roma Italy

2. Department of Hematology Niguarda Cancer Center ASST Grande Ospedale Metropolitano Niguarda Milano Italy

3. Division of Hematology Fondazione IRCCS Policlinico San Matteo Pavia Italy

4. Dipartimento Clinico di Scienze Mediche Chirurgiche e della Salute Università degli Studi di Trieste Trieste Italy

5. Unità Complessa Operativa (UCO) Ematologia Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy

6. Center for the Study of Myelofibrosis IRCCS Policlinico S. Matteo Foundation Pavia Italy

7. IRCCS Azienda Ospedaliero‐Universitaria di Bologna Istituto di Ematologia ‘Seràgnoli' Bologna Italy

8. Dipartimento di Scienze Mediche e Chirurgiche Università di Bologna Bologna Italy

Abstract

AbstractZanubrutinib has been approved for treating patients with different lymphoproliferative disorders and now represents a significant breakthrough in treating relapsed/refractory and previously untreated patients with chronic lymphocytic leukemia (CLL). Because few systematic studies or comparative randomized clinical trials have been conducted, optimal use of zanubrutinib in approved indications may be challenging. This article presents the results of a group discussion among an ad hoc constituted panel of experts to identify and address unmet clinical needs (UCNs) in using zanubrutinib in patients with CLL. Key UCNs were selected according to the criterion of clinical relevance using the Delphi process. Panel members reviewed the results of first‐line and upstream controlled trials in which the efficacy and toxicity profile of zanubrutinib and other BTK inhibitors were investigated in patients with CLL. Based on a critical discussion of data, the panel produced recommendations for using zanubrutinib and proposals for new studies to increase the evidence for the optimal treatment of patients with CLL. The recommendations given by the panel are intended for use not only by expert centers but, above all, by less experienced hematologists as well as general practitioners.

Publisher

Wiley

Reference61 articles.

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2. The SEER database the surveillance E and end results (SEER) program of the national cancer institute. Cancer Stat Facts: Leukemia—Chronic Lymphocytic Leukemia (CLL).https://seer.cancer.gov/statfacts/html/clyl; access2022.

3. Chemotherapeutic Options in Chronic Lymphocytic Leukemia: a Meta-analysis of the Randomized Trials

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