Autologous stem cell transplantation as a first-line treatment strategy for chronic lymphocytic leukemia: a multicenter randomized controlled trial

March 25, 2011

BlankAutologous stem cell transplantation as a first-line treatment strategy for

chronic lymphocytic leukemia: a multicenter randomized controlled trial.

L Sutton, S Chevret, O Tournilhac, M Divine, V Leblond, B Corront, S Lepretre, H

Eghbali, E Van Den Neste, M Michallet, F Maloisel, K Bouabdallah, D Decaudin, C

Berthou, P Brice, H , E Chapiro, I Radford-Weiss, N Leporrier, K Maloum,

F Nguyen-Khac, F Davi, J Lejeune, H Merle-Beral, and M Leporrier

Blood, March 15, 2011

Department of clinical hematology, Victor Dupouy Hospital, Argenteuil, France;

Long-term responses have been reported after autologous stem cell

transplantation (ASCT) for chronic lymphocytic leukemia (CLL). We conducted a

prospective randomized trial of ASCT in previously untreated CLL patients. We

enrolled 241 patients under 66 years of age with Binet stage B or C CLL. They

first received 3 courses of mini-CHOP, then 3 courses of fludarabine. Patients

in complete response (CR) were then randomized to ASCT or observation, while the

other patients were randomized to DHAP salvage followed by either ASCT or 3

courses of fludarabine+cyclophosphamide. The primary endpoint was event-free

survival (EFS). After up-front treatment 105 patients entered CR and were

randomized between ASCT (n=52) and observation (n=53); their respective 3-year

event-free survival (EFS) rates were 79.8% and 35.5%; the adjusted hazard ratio

was 0.3 (95%CI: 0.1-0.7; p=0.003). Ninety-four patients who did not enter CR

were randomized between ASCT (n=46) and FC (n=48); their respective 3-year EFS

rates were 48.9% and 44.4%; the adjusted hazard ratio was 1.7 (95%CI: 0.9-3.2;

p=0.13). No difference in OS was found between the two response subgroups. In

young CLL patients in CR, ASCT consolidation markedly delayed disease

progression. No difference was observed between ASCT and

fludarabine+cyclophosphamide in patients requiring DHAP salvage. This study is

registered at www.ClinicalTrials.gov as NCT00931645.

PMID: 21406717

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