Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Gerald G. Wulf, University of Göttingen
  • ,
  • Bettina Altmann, Leipzig University
  • ,
  • Marita Ziepert, Leipzig University
  • ,
  • Francesco D’Amore
  • Gerhard Held, Westpfalz-Klinikum GmbH
  • ,
  • Richard Greil, Cancer Research Institute, Paracelsus Private Medical University
  • ,
  • Olivier Tournilhac, Centre Hospitalier Universitaire de Clermont-Ferrand
  • ,
  • Thomas Relander, Lund University
  • ,
  • Andreas Viardot, Ulm University
  • ,
  • Martin Wilhelm, Klinikum Nurnberg
  • ,
  • Christian Wilhelm, Universitätsklinikum Giessen und Marburg, Standort Marburg
  • ,
  • Antonio Pezzutto, Charité-Universitätsmedizin Berlin
  • ,
  • Josee M. Zijlstra, Vrije Universiteit Amsterdam
  • ,
  • Eric Van Den Neste, Université catholique de Louvain
  • ,
  • Pieternella J. Lugtenburg, Erasmus University Rotterdam
  • ,
  • Jeanette K. Doorduijn, Erasmus University Rotterdam
  • ,
  • Michel van Gelder, Maastricht University
  • ,
  • Gustaaf W. van Imhoff, University of Groningen
  • ,
  • Florian Zettl, Klinikum Traunstein
  • ,
  • Friederike Braulke, University of Göttingen
  • ,
  • Maike Nickelsen, Onkologie Lerchenfeld
  • ,
  • Bertram Glass, HELIOS Klinikum Berlin-Buch
  • ,
  • Andreas Rosenwald, University of Würzburg
  • ,
  • Philippe Gaulard, Hopital Henri Mondor
  • ,
  • Markus Loeffler, Leipzig University
  • ,
  • Michael Pfreundschuh, Saarland University
  • ,
  • Norbert Schmitz
  • Lorenz Trümper, University of Göttingen
  • ,
  • ACT-2 study investigators

PTCL patients exhibit poor survival with existing treatments. We investigated the efficacy of CHOP combined with alemtuzumab in 116 PTCL patients age 61–80 in an open-label, randomized phase 3 trial. Alemtuzumab was given on day 1, to a total of 360 mg in 21 patients, or 120 mg in 37. Hematotoxicity was increased with A-CHOP resulting in more grade ≥3 infections (40% versus 21%) and 4 versus 1 death due to infections, respectively. CR/CRu rate was 60% for A-CHOP and 43% for CHOP, and OR rate was 72% and 66%, respectively. Three-year-EFS, PFS and OS were 27% [15%–39%], 28% [15%–40%], and 37% ([23%–50%] for A-CHOP, and 24% [12%–35%], 29% [17%–41%], and 56% [44%–69%] for CHOP, respectively, showing no significant differences. Multivariate analyses, adjusted for strata and sex confirmed these results (hazard ratio HREFS: 0.7 ([95% CI: 0.5–1.1]; p = 0.094), HRPFS: 0.8 ([95% CI: 0.5–1.2]; p = 0.271), HROS: 1.4 ([95% CI: 0.9–2.4]; p = 0.154). The IPI score was validated, and male sex (HREFS 2.5) and bulky disease (HREFS 2.2) were significant risk factors for EFS, PFS, and OS. Alemtuzumab added to CHOP increased response rates, but did not improve survival due to treatment-related toxicity.

OriginalsprogEngelsk
TidsskriftLeukemia
Vol/bind35
Nummer1
Sider (fra-til)143-155
Antal sider13
ISSN0887-6924
DOI
StatusUdgivet - jan. 2021

Bibliografisk note

Funding Information:
Funding Bundesministerium für Bildung und Forschung (BMBF, FKZ 01KG0705); Genzyme-Sanofi (unrestricted grant).

Publisher Copyright:
© 2020, The Author(s), under exclusive licence to Springer Nature Limited.

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

Se relationer på Aarhus Universitet Citationsformater

ID: 213526915