Addition of rituximab to fludarabine and cyclophosphamide in
patients with chronic lymphocytic leukaemia: a randomised,
open-label, phase 3 trial.

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 a S. STILGENBAUER. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010, roč. 376, č. 9747, s. 1164-1174. ISSN 0140-6736. Dostupné z: https://dx.doi.org/10.1016/S0140-6736(10)61381-5.

Další formáty: BibTeX LaTeX RIS

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  -

Základní údaje
Originální název	Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial.
Autoři	HALLEK, M. (276 Německo, garant), K. FISCHER (276 Německo), G. FINGERLE-ROWSON (276 Německo), A.M. FINK (276 Německo), R. BUSCH (276 Německo), Jiří MAYER (203 Česká republika, domácí), M. HENSEL (276 Německo), G. HOPFINGER (40 Rakousko), G. HESS (276 Německo), U. VON GRÜNHAGEN (276 Německo), N. BERGMANN (276 Německo), J. CATALANO (36 Austrálie), P.L. ZINZANI (380 Itálie), F. CALIGARIS-CAPPIO (380 Itálie), J.F. SEYMOUR (36 Austrálie), A. BERREBI (376 Izrael), U. JAEGER (40 Rakousko), B. CAZIN (250 Francie), M. TRNENY (203 Česká republika), A. WESTERMANN (276 Německo), C.M. WENDTNER (276 Německo), B.F. EICHHORST (276 Německo), P. STAIB (276 Německo), A. BUEHLER (276 Německo), D. WINKLER (276 Německo), T. ZENZ (276 Německo), S. BOETTCHER (276 Německo), M. RITGEN (276 Německo), M. MENDILA (756 Švýcarsko), M. KNEBA (276 Německo), H. DOEHNER (276 Německo) a S. STILGENBAUER (276 Německo).
Vydání	Lancet, 2010, 0140-6736.

Další údaje
Originální jazyk	angličtina
Typ výsledku	Článek v odborném periodiku
Obor	30200 3.2 Clinical medicine
Stát vydavatele	Spojené státy
Utajení	není předmětem státního či obchodního tajemství
Impakt faktor	Impact factor: 33.633
Kód RIV	RIV/00216224:14110/10:00051497
Organizační jednotka	Lékařská fakulta
Doi	http://dx.doi.org/10.1016/S0140-6736(10)61381-5
UT WoS	000282915700033
Klíčová slova anglicky	STEM-CELL TRANSPLANTATION; PROGRESSION-FREE SURVIVAL; PLUS CYCLOPHOSPHAMIDE; CYTOKINE-RELEASE; INITIAL THERAPY; III TRIAL; CHEMOIMMUNOTHERAPY; EXPRESSION; LYMPHOMA; DELETION
Příznaky	Mezinárodní význam
Změnil	Změnil: Mgr. Michal Petr, učo 65024. Změněno: 20. 4. 2012 12:38.

Anotace

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.

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