TY - JOUR
T1 - Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial
AU - Wulf, G.G.
AU - Altmann, B.
AU - Ziepert, M.
AU - D'Amore, F.
AU - Held, G.
AU - Greil, R.
AU - Tournilhac, O.
AU - Relander, T.
AU - Viardot, A.
AU - Wilhelm, M.
AU - Wilhelm, C.
AU - Pezzutto, A.
AU - Zijlstra, J.M.
AU - Van Den Neste, E.
AU - Lugtenburg, P.J.
AU - Doorduijn, J.K.
AU - van Gelder, M.
AU - van Imhoff, G.W.
AU - Zettl, F.
AU - Braulke, F.
AU - Nickelsen, M.
AU - Glass, B.
AU - Rosenwald, A.
AU - Gaulard, P.
AU - Loeffler, M.
AU - Pfreundschuh, M.
AU - Schmitz, N.
AU - Trumper, L.
AU - ACT-2 Study Investigators
PY - 2021/1/1
Y1 - 2021/1/1
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.
KW - cd52 expression
KW - chemotherapy
KW - detude-des-lymphomes
KW - epstein-barr-virus
KW - lymphoproliferative disorders
KW - non-hodgkin-lymphoma
KW - phase-ii
KW - prognostic-factors
KW - prophylaxis
KW - therapy
KW - PROGNOSTIC-FACTORS
KW - PHASE-II
KW - CHEMOTHERAPY
KW - PROPHYLAXIS
KW - THERAPY
KW - NON-HODGKIN-LYMPHOMA
KW - DETUDE-DES-LYMPHOMES
KW - LYMPHOPROLIFERATIVE DISORDERS
KW - EPSTEIN-BARR-VIRUS
KW - CD52 EXPRESSION
U2 - 10.1038/s41375-020-0838-5
DO - 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 -