Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial
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 leuka...
Gespeichert in:
| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
[2-8 October 2010]
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| In: |
The lancet
Year: 2010, Jahrgang: 376, Heft: 9747, Pages: 1164-1174 |
| ISSN: | 1474-547X |
| DOI: | 10.1016/S0140-6736(10)61381-5 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/S0140-6736(10)61381-5 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0140673610613815 
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| Verfasserangaben: | M. Hallek, K. Fischer, G. Fingerle-Rowson, A.M. Fink, R. Busch, J. Mayer, M. Hensel, G. Hopfinger, G. Hess, U. von Grünhagen, M. Bergmann, J. Catalano, P.L. Zinzani, F. Caligaris-Cappio, J.F. Seymour, A. Berrebi, U. Jäger, B. Cazin, M. Trneny, A. Westermann, C.M. Wendtner, B.F. Eichhorst, P. Staib, A. Bühler, D. Winkler, T. Zenz, S. Böttcher, M. Ritgen, M. Mendila, M. Kneba, H. Döhner, S. Stilgenbauer, on behalf of an international group of investigators and the German Chronic Lymphotic Leukaemia Study Group |
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| 245 | 1 | 0 | |a Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia |b a randomised, open-label, phase 3 trial |c M. Hallek, K. Fischer, G. Fingerle-Rowson, A.M. Fink, R. Busch, J. Mayer, M. Hensel, G. Hopfinger, G. Hess, U. von Grünhagen, M. Bergmann, J. Catalano, P.L. Zinzani, F. Caligaris-Cappio, J.F. Seymour, A. Berrebi, U. Jäger, B. Cazin, M. Trneny, A. Westermann, C.M. Wendtner, B.F. Eichhorst, P. Staib, A. Bühler, D. Winkler, T. Zenz, S. Böttcher, M. Ritgen, M. Mendila, M. Kneba, H. Döhner, S. Stilgenbauer, on behalf of an international group of investigators and the German Chronic Lymphotic Leukaemia Study Group |
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| 520 | |a 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/m2 per day) and cyclophosphamide (250 mg/m2 per day) for the first 3 days of each 28-day treatment course with or without rituximab (375 mg/m2 on day 0 of first course, and 500 mg/m2 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. | ||
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