1. Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial.
- Author
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Wulf GG, Altmann B, Ziepert M, D'Amore F, Held G, Greil R, Tournilhac O, Relander T, Viardot A, Wilhelm M, Wilhelm C, Pezzutto A, Zijlstra JM, Neste EVD, Lugtenburg PJ, Doorduijn JK, Gelder MV, van Imhoff GW, Zettl F, Braulke F, Nickelsen M, Glass B, Rosenwald A, Gaulard P, Loeffler M, Pfreundschuh M, Schmitz N, and Trümper L
- Subjects
- Aged, Aged, 80 and over, Alemtuzumab administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cause of Death, Cyclophosphamide adverse effects, Cyclophosphamide therapeutic use, Doxorubicin adverse effects, Doxorubicin therapeutic use, Female, Humans, Lymphoma, T-Cell, Peripheral diagnosis, Lymphoma, T-Cell, Peripheral mortality, Male, Medication Adherence, Middle Aged, Prednisone adverse effects, Prednisone therapeutic use, Prognosis, Survival Analysis, Treatment Outcome, Vincristine adverse effects, Vincristine therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Lymphoma, T-Cell, Peripheral drug therapy
- 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 HR
EFS : 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.- Published
- 2021
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