TY - JOUR
T1 - Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia
AU - Robak, Tadeusz
AU - Dmoszynska, Anna
AU - Solal-Céligny, Philippe
AU - Warzocha, Krzysztof
AU - Loscertales, Javier
AU - Catalano, John
AU - Afanasiev, Boris V.
AU - Larratt, Loree
AU - Geisler, Christian H.
AU - Montillo, Marco
AU - Zyuzgin, Ilya S.
AU - Ganly, Peter S.
AU - Dartigeas, Caroline
AU - Rosta, András
AU - Maurer, Jörg
AU - Mendila, Myriam
AU - Saville, M. Wayne
AU - Valente, Nancy
AU - Wenger, Michael K.
AU - Moiseev, Sergey I.
PY - 2010/4/1
Y1 - 2010/4/1
N2 - Purpose: Rituximab, a monoclonal antibody that targets the CD20 cell surface antigen, has clinical activity in patients with non-Hodgkin's lymphoma and other B-lymphocyte disorders when administered alone or in combination with chemotherapy. Promising results have previously been reported in nonrandomized studies in patients with chronic lymphocytic leukemia (CLL). This trial was designed to compare chemoimmunotherapy with chemotherapy alone in patients with previously treated CLL. Patients and Methods: This international, multicenter, randomized trial compared six cycles of rituximab plus fludarabine and cyclophosphamide (R-FC) with six cycles of fludarabine and cyclophosphamide alone (FC) in patients with previously treated CLL. A total of 552 patients with Binet stage A (10%), B (59%), or C (31%) disease entered the study and were randomly assigned to receive R-FC (n = 276) or FC (n = 276). Results: After a median follow-up time of 25 months, rituximab significantly improved progression-free survival in patients with previously treated CLL (hazard ratio = 0.65; P < .001; median, 30.6 months for R-FC v 20.6 months for FC). Event-free survival, response rate, complete response rate, duration of response, and time to new CLL treatment or death were also significantly improved. Although the rates of adverse events, grade 3 or 4 events, and serious adverse events were slightly higher in the R-FC arm, R-FC was generally well tolerated, with no new safety findings and no detrimental effect on quality of life. Conclusion: R-FC significantly improved the outcome of patients with previously treated CLL.
AB - Purpose: Rituximab, a monoclonal antibody that targets the CD20 cell surface antigen, has clinical activity in patients with non-Hodgkin's lymphoma and other B-lymphocyte disorders when administered alone or in combination with chemotherapy. Promising results have previously been reported in nonrandomized studies in patients with chronic lymphocytic leukemia (CLL). This trial was designed to compare chemoimmunotherapy with chemotherapy alone in patients with previously treated CLL. Patients and Methods: This international, multicenter, randomized trial compared six cycles of rituximab plus fludarabine and cyclophosphamide (R-FC) with six cycles of fludarabine and cyclophosphamide alone (FC) in patients with previously treated CLL. A total of 552 patients with Binet stage A (10%), B (59%), or C (31%) disease entered the study and were randomly assigned to receive R-FC (n = 276) or FC (n = 276). Results: After a median follow-up time of 25 months, rituximab significantly improved progression-free survival in patients with previously treated CLL (hazard ratio = 0.65; P < .001; median, 30.6 months for R-FC v 20.6 months for FC). Event-free survival, response rate, complete response rate, duration of response, and time to new CLL treatment or death were also significantly improved. Although the rates of adverse events, grade 3 or 4 events, and serious adverse events were slightly higher in the R-FC arm, R-FC was generally well tolerated, with no new safety findings and no detrimental effect on quality of life. Conclusion: R-FC significantly improved the outcome of patients with previously treated CLL.
UR - http://www.scopus.com/inward/record.url?scp=77950478885&partnerID=8YFLogxK
U2 - 10.1200/JCO.2009.26.4556
DO - 10.1200/JCO.2009.26.4556
M3 - Article
C2 - 20194844
AN - SCOPUS:77950478885
SN - 0732-183X
VL - 28
SP - 1756
EP - 1765
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 10
ER -