Response to rituximab induction is a predictive marker in B-cell post-transplant lymphoproliferative disorder and allows successful stratification into rituximab or r-chop consolidation in an international, prospective, multicenter Phase II trial

Trappe, Ralf U., Dierickx, Daan, Zimmermann, Heiner, Morschhauser, Franck, Mollee, Peter, Zaucha, Jan M., Dreyling, Martin H., Duhrsen, Ulrich, Reinke, Petra, Verhoef, Gregor, Subklewe, Marion, Huttmann, Andreas, Tousseyn, Thomas, Salles, Gilles, Kliem, Volker, Hauser, Ingeborg A., Tarella, Corrado, Neste, Eric Van Den, Gheysens, Olivier, Anagnostopoulos, Ioannis, Leblond, Veronique, Riess, Hanno and Choquet, Sylvain (2017) Response to rituximab induction is a predictive marker in B-cell post-transplant lymphoproliferative disorder and allows successful stratification into rituximab or r-chop consolidation in an international, prospective, multicenter Phase II trial. Journal of Clinical Oncology, 35 5: 536-543. doi:10.1200/JCO.2016.69.3564

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Author Trappe, Ralf U.
Dierickx, Daan
Zimmermann, Heiner
Morschhauser, Franck
Mollee, Peter
Zaucha, Jan M.
Dreyling, Martin H.
Duhrsen, Ulrich
Reinke, Petra
Verhoef, Gregor
Subklewe, Marion
Huttmann, Andreas
Tousseyn, Thomas
Salles, Gilles
Kliem, Volker
Hauser, Ingeborg A.
Tarella, Corrado
Neste, Eric Van Den
Gheysens, Olivier
Anagnostopoulos, Ioannis
Leblond, Veronique
Riess, Hanno
Choquet, Sylvain
Title Response to rituximab induction is a predictive marker in B-cell post-transplant lymphoproliferative disorder and allows successful stratification into rituximab or r-chop consolidation in an international, prospective, multicenter Phase II trial
Journal name Journal of Clinical Oncology   Check publisher's open access policy
ISSN 1527-7755
0732-183X
Publication date 2017-02-10
Sub-type Article (original research)
DOI 10.1200/JCO.2016.69.3564
Open Access Status File (Publisher version)
Volume 35
Issue 5
Start page 536
End page 543
Total pages 8
Place of publication Alexandria, VA, United States
Publisher American Society of Clinical Oncology
Language eng
Formatted abstract
Purpose: The Sequential Treatment of CD20-Positive Posttransplant Lymphoproliferative Disorder (PTLD-1) trial (ClinicalTrials.gov identifier, NCT01458548) established sequential treatment with four cycles of rituximab followed by four cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy as a standard in the management of post-transplant lymphoproliferative disorder (PTLD) and identified response to rituximab induction as a prognostic factor for overall survival. We hypothesized that rituximab consolidation might be sufficient treatment for patients with a complete response after rituximab induction.

Patients and Methods: In this prospective, international, multicenter phase II trial, 152 treatment-naive adult solid organ transplant recipients, with CD20+ PTLD unresponsive to immunosuppression reduction, were treated with four weekly doses of rituximab induction. After restaging, complete responders continued with four courses of rituximab consolidation every 21 days; all others received four courses of rituximab plus CHOP chemotherapy every 21 days. The primary end point was treatment efficacy measured as the response rate in patients who completed therapy and the response duration in those who completed therapy and responded. Secondary end points were frequency of infections, treatment-related mortality, and overall survival in the intention-to-treat population.

Results: One hundred eleven of 126 patients had a complete or partial response (88%; 95% CI, 81% to 93%), of whom 88 had a complete response (70%; 95% CI, 61% to 77%). Median response duration was not reached. The 3-year estimate was 82% (95% CI, 74% to 90%). Median overall survival was 6.6 years (95% CI, 5.5 to 7.6 years). The frequency of grade 3 or 4 infections and of treatment-related mortality was 34% (95% CI, 27% to 42%) and 8% (95% CI, 5% to 14%), respectively. Response to rituximab induction remained a prognostic factor for overall survival despite treatment stratification.

Conclusion: In B-cell PTLD, treatment stratification into rituximab or rituximab plus CHOP consolidation on the basis of response to rituximab induction is feasible, safe, and effective.
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Document type: Journal Article
Sub-type: Article (original research)
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