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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Seymour, J. F. Cazin, B. Catalano, J. Hensel, M. Jäger, U. Fischer, K. Trneny, M. Ritgen, M. Hopfinger, G. Bergmann, M. Fingerle-rowson, G. Zenz, T. Winkler, D. Böttcher, S. Döhner, H. Mendila, M. Caligaris-cappio, F. Fink, A. M. Zinzani, P. L. Mayer, J. Eichhorst, B. F. Hess, G. Stilgenbauer, S. Busch, R. Staib, P. Bühler, A. Berrebi, A. Von Grünhagen, U. Hallek, M. Westermann, A. Wendtner, C. M. Kneba, M. |
| Description | Author Affiliation: Hallek M ( Department I of Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany. michael.hallek@uni-koeln.de) |
| Abstract | BACKGROUND: On the basis of promising results that were reported in several phase 2 trials, we investigated whether the addition of the monoclonal antibody rituximab to first-line chemotherapy with fludarabine and cyclophosphamide would improve the outcome of patients with chronic lymphocytic leukaemia. METHODS: Treatment-naive, physically fit patients (aged 30-81 years) with CD20-positive chronic lymphocytic leukaemia were randomly assigned in a one-to-one ratio to receive six courses of intravenous fludarabine (25 mg/m(2) per day) and cyclophosphamide (250 mg/m(2) per day) for the first 3 days of each 28-day treatment course with or without rituximab (375 mg/m(2) on day 0 of first course, and 500 mg/m(2) on day 1 of second to sixth courses) in 190 centres in 11 countries. Investigators and patients were not masked to the computer-generated treatment assignment. The primary endpoint was progression-free survival (PFS). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00281918. FINDINGS: 408 patients were assigned to fludarabine, cyclophosphamide, and rituximab (chemoimmunotherapy group) and 409 to fludarabine and cyclophosphamide (chemotherapy group); all patients were analysed. At 3 years after randomisation, 65% of patients in the chemoimmunotherapy group were free of progression compared with 45% in the chemotherapy group (hazard ratio 0·56 [95% CI 0·46-0·69], p<0·0001); 87% were alive versus 83%, respectively (0·67 [0·48-0·92]; p=0·01). Chemoimmunotherapy was more frequently associated with grade 3 and 4 neutropenia (136 [34%] of 404 vs 83 [21%] of 396; p<0·0001) and leucocytopenia (97 [24%] vs 48 [12%]; p<0·0001). Other side-effects, including severe infections, were not increased. There were eight (2%) treatment-related deaths in the chemoimmunotherapy group compared with ten (3%) in the chemotherapy group. INTERPRETATION: Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab improves progression-free survival and overall survival in patients with chronic lymphocytic leukaemia. Moreover, the results suggest that the choice of a specific first-line treatment changes the natural course of chronic lymphocytic leukaemia. FUNDING: F Hoffmann-La Roche. |
| ISSN | 01406736 |
| e-ISSN | 1474547X |
| Journal | The Lancet |
| Issue Number | 9747 |
| Volume Number | 376 |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2010-10-02 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | Open |
| Subject Keyword | Antibodies, Monoclonal Administration & Dosage Antineoplastic Combined Chemotherapy Protocols Therapeutic Use Leukemia, Lymphocytic, Chronic, B-Cell Drug Therapy Adverse Effects Antibodies, Monoclonal, Murine-Derived Cyclophosphamide Disease Progression Disease-Free Survival Drug Administration Schedule Immunologic Factors Kaplan-Meier Estimate Mortality Leukopenia Chemically Induced Neutropenia Rituximab Severity Of Illness Index Vidarabine Analogs & Derivatives Clinical Trial, Phase III Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
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