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Sequential chemoimmunotherapy of fludarabine, mitoxantrone, and cyclophosphamide induction followed by alemtuzumab consolidation is effective in T‐cell prolymphocytic leukemia
Author(s) -
Hopfinger Georg,
Busch Raymonde,
Pflug Natali,
Weit Nicole,
Westermann Anne,
Fink AnnaMaria,
Cramer Paula,
Reinart Nina,
Winkler Dirk,
FingerleRowson Günter,
Stilgenbauer Stephan,
Döhner Hartmut,
Kandler Gabriele,
Eichhorst Barbara,
Hallek Michael,
Herling Marco
Publication year - 2013
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.27972
Subject(s) - alemtuzumab , medicine , chemoimmunotherapy , mitoxantrone , fludarabine , cyclophosphamide , vidarabine , oncology , prolymphocytic leukemia , leukemia , chemotherapy , chronic lymphocytic leukemia , transplantation
BACKGROUND Scarce systematic trial data have prevented uniform therapeutic guidelines for T‐cell prolymphocytic leukemia (T‐PLL). A central need in this historically refractory tumor is the controlled evaluation of multiagent chemotherapy and its combination with the currently most active single agent, alemtuzumab. METHODS This prospective multicenter phase 2 trial assessed response, survival, and toxicity of a novel regimen in previously treated (n = 9) and treatment‐naive (n = 16) patients with T‐PLL. Induction by fludarabine, mitoxantrone, and cyclophosphamide (FMC), for up to 4 cycles, was followed by alemtuzumab (A) consolidation, up to 12 weeks. RESULTS Of the 25 patients treated with FMC, 21 subsequently received alemtuzumab. Overall response rate to FMC was 68%, comprising 6 complete remissions (all bone‐marrow confirmed) and 11 partial remissions. Alemtuzumab consolidation increased the intent‐to‐treat overall response rate to 92% (12 complete remissions; 11 partial remissions). Median overall survival after FMC‐A was 17.1 months and median progression‐free survival was 11.9 months. Progression‐free survival tended to be shorter for patients with high‐level T‐cell leukemia 1 oncoprotein expression. Hematologic toxicities were the most frequent grade 3/4 side effects under FMC‐A. Exclusively in the 21 alemtuzumab‐consolidated patients, 13 cytomegalovirus reactivations were observed; 9 of these 13 represented a clinically relevant infection. CONCLUSIONS FMC‐A is a safe and efficient protocol in T‐PLL, which compares favorably to published data. Cancer 2013;119:2258–2267. © 2013 American Cancer Society.