Autologous stem cell transplantation as a first-line treatment strategy for chronic lymphocytic leukemia: a multicenter, randomized, controlled trial from the SFGM-TC and GFLLC.

Abstract

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 < 66 years of age with Binet stage B or C CLL. They received 3 courses of mini-CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, and prednisone/prednisolone) and then 3 courses of fludarabine. Patients in complete response (CR) were then randomized to ASCT or observation, whereas the other patients were randomized to dexamethasone, high-dose aracytin, cisplatin (DHAP) salvage followed by either ASCT or 3 courses of fludarabine plus cyclophosphamide (FC). The primary end point 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 EFS rates were 79.8% and 35.5%; the adjusted hazard ratio was 0.3 (95% CI: 0.1-0.7; P = .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%, respectively; the adjusted hazard ratio was 1.7 (95% CI: 0.9-3.2; P = .13). No difference in overall survival was found between the 2 response subgroups. In young CLL patients in CR, ASCT consolidation markedly delayed disease progression. No difference was observed between ASCT and FC in patients requiring DHAP salvage.

• Authors: Laurent Sutton, Sylvie Chevret, Olivier Tournilhac, Marine Diviné, Véronique Leblond, Bernadette Corront, Stéphane Leprêtre, Houchingue Eghbali, Eric Van Den Neste, Mauricette Michallet, Frédéric Maloisel, Krimo Bouabdallah, Didier Decaudin, Christian Berthou, Pauline Brice, Hugo Gonzalez, Elise Chapiro, Isabelle Radford-Weiss, Nathalie Leporrier, Karim Maloum, Florence Nguyen-Khac, Frédéric Davi, Julie Lejeune, Hélène Merle-Béral, Michel Leporrier, Société Française de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) and Groupe Français d'étude de la Leucémie Lymphoïde Chronique (GFLLC)
• Journal: Blood (Blood) Vol. 117 Issue 23 Pg. 6109-19 (Jun 09 2011) ISSN: 1528-0020 [Electronic] United States
• PMID: 21406717 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cytarabine
• Vincristine
• Dexamethasone
• Doxorubicin
• Cyclophosphamide
• Cisplatin
• Prednisone

Topics

• Adolescent
• Adult
• Age Factors
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Cisplatin (administration & dosage)
• Cyclophosphamide (administration & dosage)
• Cytarabine (administration & dosage)
• Dexamethasone (administration & dosage)
• Disease-Free Survival
• Doxorubicin (administration & dosage)
• Female
• Humans
• Leukemia, Lymphocytic, Chronic, B-Cell (mortality, therapy)
• Male
• Middle Aged
• Neoplasm Staging
• Prednisone (administration & dosage)
• Stem Cell Transplantation
• Survival Rate
• Time Factors
• Transplantation, Autologous
• Vincristine (administration & dosage)