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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The authors would like to thank the patients who participated in this study and their families, as well as the staff at all clinical sites. We gratefully appreciate the commitment of data management staff (Beate Mann, Katja Rillich, Martina Kunert, Barbara Wicklein) at the IMISE, University of Leipzig. We are particularly grateful for the dedicated work of Elke Stitz at the T-NHL office at the UMG.
Bundesministerium für Bildung und Forschung (BMBF, FKZ 01KG0705); Genzyme-Sanofi (unrestricted grant).
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The authors declare that they have no conflict of interest.
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Members of the ACT-2 study investigators are listed in Supplementary information.
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Wulf, G.G., Altmann, B., Ziepert, M. et al. Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial. Leukemia 35, 143–155 (2021). https://doi.org/10.1038/s41375-020-0838-5
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