| FRASER, GAM, A CHANAN-KHAN, F DEMIRKAN, Silva RS, S GROSICKI, A JANSSENS, Jiří MAYER, NL BARTLETT, MS DILHUYDY, J LOSCERTALES, A AVIGDOR, S RULE, O SAMOILOVA, MA PAVLOVSKY, A GOY, A MATO, M HALLEK, M SALMAN, M TAMEGNON, S SUN, A CONNOR, K NOTTAGE, N SCHUIER, S BALASUBRAMANIAN, A HOWES and P CRAMER. Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. LEUKEMIA & LYMPHOMA. LONDON: INFORMA HEALTHCARE, 2020, 10 pp. ISSN 1042-8194. Available from: https://dx.doi.org/10.1080/10428194.2020.1795159. |
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@article{1765760,
author = {Fraser, GAM and ChananandKhan, A and Demirkan, F and RS, Silva and Grosicki, S and Janssens, A and Mayer, Jiří and Bartlett, NL and Dilhuydy, MS and Loscertales, J and Avigdor, A and Rule, S and Samoilova, O and Pavlovsky, MA and Goy, A and Mato, A and Hallek, M and Salman, M and Tamegnon, M and Sun, S and Connor, A and Nottage, K and Schuier, N and Balasubramanian, S and Howes, A and Cramer, P},
article_location = {LONDON},
doi = {http://dx.doi.org/10.1080/10428194.2020.1795159},
keywords = {Ibrutinib; HELIOS phase 3 trial; 5-year follow-up; overall survival; relapsed chronic lymphocytic leukemia},
language = {eng},
issn = {1042-8194},
journal = {LEUKEMIA & LYMPHOMA},
note = {Bez afiliace k MU.},
title = {Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma},
year = {2020}
}
TY - JOUR
ID - 1765760
AU - Fraser, GAM - Chanan-Khan, A - Demirkan, F - RS, Silva - Grosicki, S - Janssens, A - Mayer, Jiří - Bartlett, NL - Dilhuydy, MS - Loscertales, J - Avigdor, A - Rule, S - Samoilova, O - Pavlovsky, MA - Goy, A - Mato, A - Hallek, M - Salman, M - Tamegnon, M - Sun, S - Connor, A - Nottage, K - Schuier, N - Balasubramanian, S - Howes, A - Cramer, P
PY - 2020
TI - Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
JF - LEUKEMIA & LYMPHOMA
PB - INFORMA HEALTHCARE
SN - 10428194
N1 - Bez afiliace k MU.
KW - Ibrutinib
KW - HELIOS phase 3 trial
KW - 5-year follow-up
KW - overall survival
KW - relapsed chronic lymphocytic leukemia
N2 - We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p (n = 578) were randomized 1:1 to 420 mg daily ibrutinib or placebo plus <= 6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone. Median follow-up was 63.7 months. Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229 [95% confidence interval (CI) 0.183-0.286];p < .0001). Despite crossover of 63.3% of patients from the placebo plus BR arm to ibrutinib treatment upon disease progression, ibrutinib plus BR versus placebo plus BR demonstrated an overall survival benefit (HR 0.611 [95% CI 0.455-0.822];p = .0010; median not reached in either arm). Long-term follow-up data confirm the survival benefit of ibrutinib plus BR over BR alone. Safety profiles were consistent with those known for ibrutinib and BR.
ER -
FRASER, GAM, A CHANAN-KHAN, F DEMIRKAN, Silva RS, S GROSICKI, A JANSSENS, Jiří MAYER, NL BARTLETT, MS DILHUYDY, J LOSCERTALES, A AVIGDOR, S RULE, O SAMOILOVA, MA PAVLOVSKY, A GOY, A MATO, M HALLEK, M SALMAN, M TAMEGNON, S SUN, A CONNOR, K NOTTAGE, N SCHUIER, S BALASUBRAMANIAN, A HOWES and P CRAMER. Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. \textit{LEUKEMIA \&{}amp; LYMPHOMA}. LONDON: INFORMA HEALTHCARE, 2020, 10 pp. ISSN~1042-8194. Available from: https://dx.doi.org/10.1080/10428194.2020.1795159.
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