title: 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.affiliation: Department of Clinical Hematology, Victor Dupouy Hospital, Argenteuil, France. laurent.sutton@ch-argenteuil.fr
authors.forename: Laurent
authors.initials: L
authors.lastname: Sutton
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Olivier
authors.initials: O
authors.lastname: Tournilhac
authors.forename: Marine
authors.initials: M
authors.lastname: Diviné
authors.forename: Véronique
authors.initials: V
authors.lastname: Leblond
authors.forename: Bernadette
authors.initials: B
authors.lastname: Corront
authors.forename: Stéphane
authors.initials: S
authors.lastname: Leprêtre
authors.forename: Houchingue
authors.initials: H
authors.lastname: Eghbali
authors.forename: Eric
authors.initials: E
authors.lastname: Van Den Neste
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.forename: Frédéric
authors.initials: F
authors.lastname: Maloisel
authors.forename: Krimo
authors.initials: K
authors.lastname: Bouabdallah
authors.forename: Didier
authors.initials: D
authors.lastname: Decaudin
authors.forename: Christian
authors.initials: C
authors.lastname: Berthou
authors.forename: Pauline
authors.initials: P
authors.lastname: Brice
authors.forename: Hugo
authors.initials: H
authors.lastname: Gonzalez
authors.forename: Elise
authors.initials: E
authors.lastname: Chapiro
authors.forename: Isabelle
authors.initials: I
authors.lastname: Radford-Weiss
authors.forename: Nathalie
authors.initials: N
authors.lastname: Leporrier
authors.forename: Karim
authors.initials: K
authors.lastname: Maloum
authors.forename: Florence
authors.initials: F
authors.lastname: Nguyen-Khac
authors.forename: Frédéric
authors.initials: F
authors.lastname: Davi
authors.forename: Julie
authors.initials: J
authors.lastname: Lejeune
authors.forename: Hélène
authors.initials: H
authors.lastname: Merle-Béral
authors.forename: Michel
authors.initials: M
authors.lastname: Leporrier
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002945:Cisplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000401:mortality* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage; D033581:Stem Cell Transplantation; D015996:Survival Rate; D013997:Time Factors; D014182:Transplantation, Autologous; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D003561:Cytarabine; D014750:Vincristine; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide; D002945:Cisplatin; D011241:Prednisone