Citation

Magni M, Nicola MD, Patti C, Scimè R, Mulè A, Rambaldi A, Intermesoli T, Viero P, Tarella C, Gueli A, Bergui L, Trentin L, Barzan A, Benedetti F, Ambrosetti A, Di Raimondo F, Chiarenza A, Parvis G, Billio A, Attolico I, Olivieri A, Montanari M, Carlo-Stella C, Matteucci P, Devizzi L, Guidetti A, Viviani S, Valagussa P, Gianni AM. Bone Marrow Transplant. 2014; 49(4): 485-491.

Copyright

(Copyright © 2014, Nature Publishing Group)

DOI

10.1038/bmt.2013.214

PMID

unavailable

Abstract

The importance of early therapy intensification in B-cell CLL (B-CLL) patients remains to be defined. Even though several studies have been published, no randomized trials comparing directly autologous stem cell transplant (ASCT) and the accepted conventional therapy (that is, rituximab, fludarabine and CY; R-FC) have been reported so far. To assess the benefit of a first-line aggressive therapy, we designed a multicenter, randomized, phase 3 trial comparing R-FC and high-dose chemotherapy supported by ASCT in patients under 65 years of age, with stage B(II) or C B-CLL. Primary end point was CR: 96 patients were enrolled (48 in each arm). On an intent-to-treat basis, the CR rates in the ASCT and R-FC arms were 62.5% and 58%, respectively. After 5 years of follow-up, PFS was 60.4% in the ASCT arm and 65.1% in the R-FC arm, time to progression 65.8 and 70.5%, and overall survival 88% vs 88.1%, respectively. Our trial demonstrates, for the first time in a randomized manner, that frontline ASCT does not translate into a survival advantage when compared with benchmark chemoimmunotherapy in B-CLL patients; the possibility of its clinical benefit in certain subgroups remains uncertain. © 2014 Macmillan Publishers Limited.

Language: en

Keywords

Humans; Adult; Aged; Female; Male; Middle Aged; adult; human; suicide; female; male; Prospective Studies; aged; randomized controlled trial; clinical trial; article; major clinical study; mental disease; controlled study; virus infection; neutropenia; priority journal; thrombocytopenia; vincristine; phase 3 clinical trial; age distribution; middle aged; bleeding; cardiotoxicity; sepsis; follow up; drug fatality; drug withdrawal; multicenter study; drug megadose; fever; prospective study; dexamethasone; allergic reaction; antineoplastic agent; cisplatin; hemolytic anemia; bone marrow suppression; cancer staging; pancytopenia; blood toxicity; treatment response; thrombosis; brain ischemia; bacterial infection; immune deficiency; cyclophosphamide; Cyclophosphamide; continuous infusion; progression free survival; septic shock; overall survival; Antineoplastic Combined Chemotherapy Protocols; doxorubicin; Doxorubicin; mucosa inflammation; procedures; acute granulocytic leukemia; myelodysplastic syndrome; autologous stem cell transplantation; Transplantation, Autologous; parallel design; prednisone; cytarabine; autotransplantation; monoclonal antibody; multiple cycle treatment; chronic lymphatic leukemia; rituximab; brain abscess; hematopoietic stem cell transplantation; Prednisone; Hematopoietic Stem Cell Transplantation; vidarabine; analogs and derivatives; mantle cell lymphoma; intention to treat analysis; fludarabine; melphalan; Pseudomonas infection; Antibodies, Monoclonal, Murine-Derived; Autologous transplantation; B-CLL; Cytarabine; Hematopoietic Stem Cell Mobilization; High-dose chemotherapy; Leukemia, Lymphocytic, Chronic, B-Cell; Melphalan; parvovirus infection; pyrexia idiopathica; stem cell mobilization; Vidarabine; Vincristine