Effectiveness and Safety of Pixantrone for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Every-Day Clinical Practice: The Italian Cohort of the PIXA Registry.

Abstract

INTRODUCTION:

Treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) represents a challenge for clinicians due to the lack of therapeutic options. DLBCL is not a rare disease in Italy. Pixantrone is an aza-anthracenedione, which, when compared to anthracyclines and anthracenediones, has a significantly reduced cardiotoxicity while maintaining good anti-tumor activity. However, the evidence on the use of pixantrone in the context of daily clinical practice is scarce.

METHODS:

We focused on the Italian patient subset of a larger European retrospective study (the PIXA Registry) to assess the efficacy and safety of pixantrone in a real-life DLBCL population. The molecular profile of the disease and its impact on drug efficacy were also assessed.

RESULTS:

Fifteen heavily pretreated DLBCL patients (13 males and 2 females) underwent treatment with pixantrone for a median of 2 cycles (range 1-6). Eight patients were bcl2 positive, 7 bcl6 positive, and 4 myc positive; 4 patients were diagnosed as double-hit, and 2 as triple-hit DLBCL. The overall response rate was 26.7% with a best response rate of 46.7%. Three patients had grade IV adverse events, which caused drug discontinuation. Four patients had 5 cases of grade III toxicities (1 thrombocytopenia, 1 stomatitis, and 3 neutropenia). One mild cardiac toxicity (sinus tachycardia for which no action was required) was possibly related to the study drug.

CONCLUSION:

Our data documented drug efficacy that is satisfactory for this high-risk subset of patients with an acceptable toxicity profile. Results indicate that pixantrone could be a significant treatment option in patients with R/R aggressive DLBCL treated in everyday clinical practice.

• Authors: Pier Luigi Zinzani, Marco Bregni, Mario Spione, Manfred Mitterer, Gerardo Musuraca, Annamaria Bugli, Francesco Piazza, Antonello Pinto
• Journal: Acta haematologica (Acta Haematol) Vol. 144 Issue 3 Pg. 259-263 ( 2021) ISSN: 1421-9662 [Electronic] Switzerland
• PMID: 33040061 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 S. Karger AG, Basel.

Chemical References

• Isoquinolines
• Topoisomerase II Inhibitors
• pixantrone

Topics

• Adult
• Aged
• Aged, 80 and over
• Cohort Studies
• Drug Administration Schedule
• Female
• Genetic Diseases, X-Linked (etiology)
• Humans
• Isoquinolines (adverse effects, therapeutic use)
• Italy
• Lymphoma, Large B-Cell, Diffuse (drug therapy)
• Male
• Middle Aged
• Neutropenia (etiology)
• Registries
• Retrospective Studies
• Thrombocytopenia (etiology)
• Topoisomerase II Inhibitors (adverse effects, therapeutic use)
• Treatment Outcome