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

G.G. Wulf*, B. Altmann, M. Ziepert, F. D'Amore, G. Held, R. Greil, O. Tournilhac, T. Relander, A. Viardot, M. Wilhelm, C. Wilhelm, A. Pezzutto, J.M. Zijlstra, E. Van Den Neste, P.J. Lugtenburg, J.K. Doorduijn, M. van Gelder, G.W. van Imhoff, F. Zettl, F. BraulkeM. Nickelsen, B. Glass, A. Rosenwald, P. Gaulard, M. Loeffler, M. Pfreundschuh, N. Schmitz, L. Trumper, ACT-2 Study Investigators

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

29 Citations (Web of Science)

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.
Original languageEnglish
Pages (from-to)143-155
Number of pages13
JournalLeukemia
Volume35
Issue number1
DOIs
Publication statusPublished - 1 Jan 2021

Keywords

  • cd52 expression
  • chemotherapy
  • detude-des-lymphomes
  • epstein-barr-virus
  • lymphoproliferative disorders
  • non-hodgkin-lymphoma
  • phase-ii
  • prognostic-factors
  • prophylaxis
  • therapy
  • PROGNOSTIC-FACTORS
  • PHASE-II
  • CHEMOTHERAPY
  • PROPHYLAXIS
  • THERAPY
  • NON-HODGKIN-LYMPHOMA
  • DETUDE-DES-LYMPHOMES
  • LYMPHOPROLIFERATIVE DISORDERS
  • EPSTEIN-BARR-VIRUS
  • CD52 EXPRESSION

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