| Literature DB >> 32382083 |
Gerald G Wulf1, Bettina Altmann2, Marita Ziepert2, Francesco D'Amore3, Gerhard Held4, Richard Greil5,6, Olivier Tournilhac7, Thomas Relander8, Andreas Viardot9, Martin Wilhelm10, Christian Wilhelm11, Antonio Pezzutto12, Josee M Zijlstra13, Eric Van Den Neste14, Pieternella J Lugtenburg15, Jeanette K Doorduijn15, Michel van Gelder16, Gustaaf W van Imhoff17, Florian Zettl18, Friederike Braulke19, Maike Nickelsen20, Bertram Glass21, Andreas Rosenwald22, Philippe Gaulard23, Markus Loeffler2, Michael Pfreundschuh24, Norbert Schmitz25, Lorenz Trümper19.
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 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.Entities:
Year: 2020 PMID： 32382083 DOI： 10.1038/s41375-020-0838-5
Source DB: PubMed Journal: Leukemia ISSN： 0887-6924 Impact factor: 11.528