Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial

Zimmermann H, Koenecke C, Dreyling MH, Pott C, Duehrsen U, Hahn D, Meidenbauer N, Hauser IA, Rummel MJ, Wolf D, Heuser M, Schmidt C, Schlattmann P, Ritgen M, Siebert R, Oschlies I, Anagnostopoulos I, Trappe RU (2022)

Publication Type: Journal article

Publication year: 2022

Journal

Leukemia Springer Nature

DOI: 10.1038/s41375-022-01667-1

Abstract

The prospective multicentre Phase II PTLD-2 trial (NCT02042391) tested modified risk-stratification in adult SOT recipients with CD20-positive PTLD based on principles established in the PTLD-1 trials: sequential treatment and risk-stratification. After rituximab monotherapy induction, patients in complete remission as well as those in partial remission with IPI < 3 at diagnosis (low-risk) continued with rituximab monotherapy and thus chemotherapy free. Most others (high-risk) received R-CHOP-21. Thoracic SOT recipients who progressed (very-high-risk) received alternating R-CHOP-21 and modified R-DHAOx. The primary endpoint was event-free survival (EFS) in the low-risk group. The PTLD-1 trials provided historical controls. Rituximab was applied subcutaneously. Of 60 patients enrolled, 21 were low-risk, 28 high-risk and 9 very-high-risk. Overall response was 45/48 (94%, 95% CI 83-98). 2-year Kaplan-Meier estimates of time to progression and overall survival were 78% (95% CI 65-90) and 68% (95% CI 55-80) - similar to the PTLD-1 trials. Treatment-related mortality was 4/59 (7%, 95% CI 2-17). In the low-risk group, 2-year EFS was 66% (95% CI 45-86) versus 52% in the historical comparator that received CHOP (p = 0.432). 2-year OS in the low-risk group was 100%. Results with R-CHOP-21 in high-risk patients confirmed previous results. Immunochemotherapy intensification in very-high-risk patients was disappointing.

Authors with CRIS profile

Norbert Meidenbauer Department of Medicine 5 – Haematology and Oncology

Involved external institutions

Universitätsklinikum Schleswig-Holstein (UKSH) DE Germany (DE) Universitätsklinikum Bonn DE Germany (DE) Katharinenhospital Stuttgart DE Germany (DE) Julius-Maximilians-Universität Würzburg DE Germany (DE) Universität Ulm DE Germany (DE) Medizinische Hochschule Hannover (MHH) / Hannover Medical School DE Germany (DE) Goethe-Universität Frankfurt am Main DE Germany (DE) Universität Duisburg-Essen (UDE) DE Germany (DE) Universitätsklinikum Gießen und Marburg (UKGM) DE Germany (DE) Universitätsklinikum der Ludwig-Maximilians-Universität München DE Germany (DE) DIAKO Evangelisches Diakonie-Krankenhaus gGmbH DE Germany (DE) Universitätsklinikum Jena DE Germany (DE)

How to cite

APA:

Zimmermann, H., Koenecke, C., Dreyling, M.H., Pott, C., Duehrsen, U., Hahn, D.,... Trappe, R.U. (2022). Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial. Leukemia. https://doi.org/10.1038/s41375-022-01667-1

MLA:

Zimmermann, Heiner, et al. "Modified risk-stratified sequential treatment (subcutaneous rituximab with or without chemotherapy) in B-cell Post-transplant lymphoproliferative disorder (PTLD) after Solid organ transplantation (SOT): the prospective multicentre phase II PTLD-2 trial." Leukemia (2022).

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