TY - JOUR
T1 - Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma
T2 - the DSHNHL2006-1B/ACT-2 trial
AU - for the ACT-2 study investigators
AU - Wulf, Gerald G.
AU - Altmann, Bettina
AU - Ziepert, Marita
AU - D’Amore, Francesco
AU - Held, Gerhard
AU - Greil, Richard
AU - Tournilhac, Olivier
AU - Relander, Thomas
AU - Viardot, Andreas
AU - Wilhelm, Martin
AU - Wilhelm, Christian
AU - Pezzutto, Antonio
AU - Zijlstra, Josee M.
AU - Neste, Eric Van Den
AU - Lugtenburg, Pieternella J.
AU - Doorduijn, Jeanette K.
AU - Gelder, Michel van
AU - van Imhoff, Gustaaf W.
AU - Zettl, Florian
AU - Braulke, Friederike
AU - Nickelsen, Maike
AU - Glass, Bertram
AU - Rosenwald, Andreas
AU - Gaulard, Philippe
AU - Loeffler, Markus
AU - Pfreundschuh, Michael
AU - Schmitz, Norbert
AU - Trümper, Lorenz
N1 - 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.
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85085082318&partnerID=8YFLogxK
U2 - https://doi.org/10.1038/s41375-020-0838-5
DO - https://doi.org/10.1038/s41375-020-0838-5
M3 - Article
C2 - 32382083
SN - 0887-6924
VL - 35
SP - 143
EP - 155
JO - Leukemia
JF - Leukemia
IS - 1
ER -