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

Wulf, Gerald G. ; Altmann, Bettina ; Ziepert, Marita ; D’Amore, Francesco ; Held, Gerhard ; Greil, Richard ; Tournilhac, Olivier ; Relander, Thomas LU ; Viardot, Andreas and Wilhelm, Martin , et al. (2021) In Leukemia 35(1). p.143-155
Abstract

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... (More)

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.

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author collaboration
publishing date
type
Contribution to journal
publication status
published
subject
in
Leukemia
volume
35
issue
1
pages
143 - 155
publisher
Nature Publishing Group
external identifiers
  • pmid:32382083
  • scopus:85085082318
ISSN
0887-6924
DOI
10.1038/s41375-020-0838-5
language
English
LU publication?
no
id
0d3f9446-88f8-4892-8cf2-970e817257b2
date added to LUP
2020-06-22 14:02:14
date last changed
2024-04-17 10:43:35
@article{0d3f9446-88f8-4892-8cf2-970e817257b2,
  abstract     = {{<p>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 HR<sub>EFS</sub>: 0.7 ([95% CI: 0.5–1.1]; p = 0.094), HR<sub>PFS</sub>: 0.8 ([95% CI: 0.5–1.2]; p = 0.271), HR<sub>OS</sub>: 1.4 ([95% CI: 0.9–2.4]; p = 0.154). The IPI score was validated, and male sex (HR<sub>EFS</sub> 2.5) and bulky disease (HR<sub>EFS</sub> 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.</p>}},
  author       = {{Wulf, Gerald G. and Altmann, Bettina and Ziepert, Marita and D’Amore, Francesco and Held, Gerhard and Greil, Richard and Tournilhac, Olivier and Relander, Thomas and Viardot, Andreas and Wilhelm, Martin and Wilhelm, Christian and Pezzutto, Antonio and Zijlstra, Josee M. and Neste, Eric Van Den and Lugtenburg, Pieternella J. and Doorduijn, Jeanette K. and Gelder, Michel van and van Imhoff, Gustaaf W. and Zettl, Florian and Braulke, Friederike and Nickelsen, Maike and Glass, Bertram and Rosenwald, Andreas and Gaulard, Philippe and Loeffler, Markus and Pfreundschuh, Michael and Schmitz, Norbert and Trümper, Lorenz}},
  issn         = {{0887-6924}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{143--155}},
  publisher    = {{Nature Publishing Group}},
  series       = {{Leukemia}},
  title        = {{Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma : the DSHNHL2006-1B/ACT-2 trial}},
  url          = {{http://dx.doi.org/10.1038/s41375-020-0838-5}},
  doi          = {{10.1038/s41375-020-0838-5}},
  volume       = {{35}},
  year         = {{2021}},
}