| HALLEK, M., K. FISCHER, G. FINGERLE-ROWSON, A.M. FINK, R. BUSCH, Jiří MAYER, M. HENSEL, G. HOPFINGER, G. HESS, U. VON GRÜNHAGEN, N. BERGMANN, J. CATALANO, P.L. ZINZANI, F. CALIGARIS-CAPPIO, J.F. SEYMOUR, A. BERREBI, U. JAEGER, B. CAZIN, M. TRNENY, A. WESTERMANN, C.M. WENDTNER, B.F. EICHHORST, P. STAIB, A. BUEHLER, D. WINKLER, T. ZENZ, S. BOETTCHER, M. RITGEN, M. MENDILA, M. KNEBA, H. DOEHNER and S. STILGENBAUER. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010, vol. 376, No 9747, p. 1164-1174. ISSN 0140-6736. Available from: https://dx.doi.org/10.1016/S0140-6736(10)61381-5. |
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@article{905581,
author = {Hallek, M. and Fischer, K. and FingerleandRowson, G. and Fink, A.M. and Busch, R. and Mayer, Jiří and Hensel, M. and Hopfinger, G. and Hess, G. and von Grünhagen, U. and Bergmann, N. and Catalano, J. and Zinzani, P.L. and CaligarisandCappio, F. and Seymour, J.F. and Berrebi, A. and Jaeger, U. and Cazin, B. and Trneny, M. and Westermann, A. and Wendtner, C.M. and Eichhorst, B.F. and Staib, P. and Buehler, A. and Winkler, D. and Zenz, T. and Boettcher, S. and Ritgen, M. and Mendila, M. and Kneba, M. and Doehner, H. and Stilgenbauer, S.},
article_number = {9747},
doi = {http://dx.doi.org/10.1016/S0140-6736(10)61381-5},
keywords = {STEM-CELL TRANSPLANTATION; PROGRESSION-FREE SURVIVAL; PLUS CYCLOPHOSPHAMIDE; CYTOKINE-RELEASE; INITIAL THERAPY; III TRIAL; CHEMOIMMUNOTHERAPY; EXPRESSION; LYMPHOMA; DELETION},
language = {eng},
issn = {0140-6736},
journal = {Lancet},
title = {Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial.},
volume = {376},
year = {2010}
}
TY - JOUR
ID - 905581
AU - Hallek, M. - Fischer, K. - Fingerle-Rowson, G. - Fink, A.M. - Busch, R. - Mayer, Jiří - Hensel, M. - Hopfinger, G. - Hess, G. - von Grünhagen, U. - Bergmann, N. - Catalano, J. - Zinzani, P.L. - Caligaris-Cappio, F. - Seymour, J.F. - Berrebi, A. - Jaeger, U. - Cazin, B. - Trneny, M. - Westermann, A. - Wendtner, C.M. - Eichhorst, B.F. - Staib, P. - Buehler, A. - Winkler, D. - Zenz, T. - Boettcher, S. - Ritgen, M. - Mendila, M. - Kneba, M. - Doehner, H. - Stilgenbauer, S.
PY - 2010
TI - Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial.
JF - Lancet
VL - 376
IS - 9747
SP - 1164-1174
EP - 1164-1174
SN - 01406736
KW - STEM-CELL TRANSPLANTATION
KW - PROGRESSION-FREE SURVIVAL
KW - PLUS CYCLOPHOSPHAMIDE
KW - CYTOKINE-RELEASE
KW - INITIAL THERAPY
KW - III TRIAL
KW - CHEMOIMMUNOTHERAPY
KW - EXPRESSION
KW - LYMPHOMA
KW - DELETION
N2 - 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. 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. 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. 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.
ER -
HALLEK, M., K. FISCHER, G. FINGERLE-ROWSON, A.M. FINK, R. BUSCH, Jiří MAYER, M. HENSEL, G. HOPFINGER, G. HESS, U. VON GRÜNHAGEN, N. BERGMANN, J. CATALANO, P.L. ZINZANI, F. CALIGARIS-CAPPIO, J.F. SEYMOUR, A. BERREBI, U. JAEGER, B. CAZIN, M. TRNENY, A. WESTERMANN, C.M. WENDTNER, B.F. EICHHORST, P. STAIB, A. BUEHLER, D. WINKLER, T. ZENZ, S. BOETTCHER, M. RITGEN, M. MENDILA, M. KNEBA, H. DOEHNER and S. STILGENBAUER. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. \textit{Lancet}. 2010, vol.~376, No~9747, p.~1164-1174. ISSN~0140-6736. Available from: https://dx.doi.org/10.1016/S0140-6736(10)61381-5.
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