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

J 2020

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

FRASER, GAM, A CHANAN-KHAN, F DEMIRKAN, Silva RS, S GROSICKI et. al.

Základní údaje

Originální název

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

Autoři

Vydání

LEUKEMIA & LYMPHOMA, LONDON, INFORMA HEALTHCARE, 2020, 1042-8194

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 3.280

DOI

http://dx.doi.org/10.1080/10428194.2020.1795159

UT WoS

000556471600001

Klíčová slova anglicky

Ibrutinib; HELIOS phase 3 trial; 5-year follow-up; overall survival; relapsed chronic lymphocytic leukemia

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 5. 5. 2021 09:45, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

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 a 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 s. ISSN 1042-8194. Dostupné z: https://dx.doi.org/10.1080/10428194.2020.1795159.

@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 a 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 s. ISSN~1042-8194. Dostupné z: https://dx.doi.org/10.1080/10428194.2020.1795159.

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