J 2019

Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma

FRASER, G., P. CRAMER, F. DEMIRKAN, R.S. SILVA, S. GROSICKI et. al.

Basic information

Original name

Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma

Authors

FRASER, G. (124 Canada), P. CRAMER (276 Germany), F. DEMIRKAN (792 Turkey), R.S. SILVA (76 Brazil), S. GROSICKI (616 Poland), A. PRISTUPA (643 Russian Federation), A. JANSSENS (56 Belgium), Jiří MAYER (203 Czech Republic, belonging to the institution), N.L. BARTLETT (840 United States of America), M.S. DILHUYDY (250 France), H. PYLYPENKO (804 Ukraine), J. LOSCERTALES (724 Spain), A. AVIGDOR (376 Israel), S. RULE (826 United Kingdom of Great Britain and Northern Ireland), D. VILLA (124 Canada), O. SAMOILOVA (643 Russian Federation), P. PANAGIOTIDIS (300 Greece), A. GOY (840 United States of America), M.A. PAVLOVSKY (32 Argentina), C. KARLSSON (752 Sweden), M. HALLEK (276 Germany), M. MAHLER (840 United States of America), M. SALMAN (840 United States of America), S. SUN (840 United States of America), C. PHELPS (840 United States of America), S. BALASUBRAMANIAN (840 United States of America), A. HOWES (826 United Kingdom of Great Britain and Northern Ireland) and A. CHANAN-KHAN (826 United Kingdom of Great Britain and Northern Ireland)

Edition

Leukemia, London, Nature Publishing Group, 2019, 0887-6924

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 8.665

RIV identification code

RIV/00216224:14110/19:00109488

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1038/s41375-018-0276-9

UT WoS

000463162400012

Keywords in English

ibrutinib; bendamustine; rituximab

Tags

14110212, rivok

Tags

International impact, Reviewed
Změněno: 18/4/2019 11:29, Soňa Böhmová

Abstract

V originále

We report follow-up results from the randomized, placebo-controlled, phase 3 HELIOS trial of ibrutinib+bendamustine and rituximab (BR) for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) without deletion 17p. Overall, 578 patients were randomized 1: 1 to either ibrutinib (420 mg daily) or placebo, in combination with 6 cycles of BR, followed by ibrutinib or placebo alone. Median follow-up was 34.8 months (range: 0.1-45.8). Investigator-assessed median progression-free survival (PFS) was not reached for ibrutinib+BR, versus 14.3 months for placebo+BR (hazard ratio [HR] [95% CI], 0.206 [0.159-0.265]; P < 0.0001); 36-month PFS rates were 68.0% versus 13.9%, respectively. The results are consistent with the primary analysis findings (HR = 0.203, as assessed by independent review committee, with 17-month median follow-up). Median overall survival was not reached in either arm; HR (95% CI) for ibrutinib+BR versus placebo: 0.652 (0.454-0.935; P = 0.019). Minimal residual disease (MRD)-negative response rates were 26.3% for ibrutinib+BR and 6.2% for placebo+BR (P < 0.0001). Incidence of treatment-emergent adverse events (including grades 34) were generally consistent with the initial HELIOS report. These long-term data support improved survival outcomes and deepening responses with ibrutinib+BR compared with BR in relapsed CLL/SLL.
Displayed: 9/11/2024 19:50