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Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia.
J Clin Oncol. 2010 Apr 01; 28(10):1756-65.JC

Abstract

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 (1%), 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.

Authors+Show Affiliations

Department of Hematology, Medical University of Lodz, Ciolkowskiego 2, Lodz, Poland 93-510. robaktad@csk.umed.lodz.plNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20194844

Citation

Robak, Tadeusz, et al. "Rituximab Plus Fludarabine and Cyclophosphamide Prolongs Progression-free Survival Compared With Fludarabine and Cyclophosphamide Alone in Previously Treated Chronic Lymphocytic Leukemia." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 28, no. 10, 2010, pp. 1756-65.
Robak T, Dmoszynska A, Solal-Céligny P, et al. Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol. 2010;28(10):1756-65.
Robak, T., Dmoszynska, A., Solal-Céligny, P., Warzocha, K., Loscertales, J., Catalano, J., Afanasiev, B. V., Larratt, L., Geisler, C. H., Montillo, M., Zyuzgin, I., Ganly, P. S., Dartigeas, C., Rosta, A., Maurer, J., Mendila, M., Saville, M. W., Valente, N., Wenger, M. K., & Moiseev, S. I. (2010). Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 28(10), 1756-65. https://doi.org/10.1200/JCO.2009.26.4556
Robak T, et al. Rituximab Plus Fludarabine and Cyclophosphamide Prolongs Progression-free Survival Compared With Fludarabine and Cyclophosphamide Alone in Previously Treated Chronic Lymphocytic Leukemia. J Clin Oncol. 2010 Apr 1;28(10):1756-65. PubMed PMID: 20194844.
* Article titles in AMA citation format should be in sentence-case
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, 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, Y1 - 2010/03/01/ PY - 2010/3/3/entrez PY - 2010/3/3/pubmed PY - 2010/4/10/medline SP - 1756 EP - 65 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J. Clin. Oncol. VL - 28 IS - 10 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 (1%), 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. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/20194844/Rituximab_plus_fludarabine_and_cyclophosphamide_prolongs_progression_free_survival_compared_with_fludarabine_and_cyclophosphamide_alone_in_previously_treated_chronic_lymphocytic_leukemia_ L2 - http://ascopubs.org/doi/full/10.1200/JCO.2009.26.4556?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -