Universität zu Köln

Fraser, G., Cramer, P., Demirkan, F., Silva, R. Santucci, Grosicki, S., Pristupa, A., Janssens, A., Mayer, J., Bartlett, N. L., Dilhuydy, M-S, Pylypenko, H., Loscertales, J., Avigdor, A., Rule, S., Villa, D., Samoilova, O., Panagiotidis, P., Goy, A., Pavlovsky, M. A., Karlsson, C., Hallek, M., Mahler, M., Salman, M., Sun, S., Phelps, C., Balasubramanian, S., Howes, A. and Chanan-Khan, A. (2019). Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. Leukemia, 33 (4). S. 969 - 981. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

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Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Fraser, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cramer, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Demirkan, F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Silva, R. Santucci UNSPECIFIED UNSPECIFIED UNSPECIFIED Grosicki, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pristupa, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Janssens, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mayer, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bartlett, N. L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dilhuydy, M-S UNSPECIFIED UNSPECIFIED UNSPECIFIED Pylypenko, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Loscertales, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Avigdor, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rule, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Villa, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Samoilova, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Panagiotidis, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Goy, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pavlovsky, M. A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Karlsson, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mahler, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Salman, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sun, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Phelps, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Balasubramanian, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Howes, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chanan-Khan, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-152378
DOI:	10.1038/s41375-018-0276-9
Journal or Publication Title:	Leukemia
Volume:	33
Number:	4
Page Range:	S. 969 - 981
Date:	2019
Publisher:	NATURE PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1476-5551
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language KINASE INHIBITOR IBRUTINIB; ATRIAL-FIBRILLATION; RESIDUAL DISEASE; CHEMOIMMUNOTHERAPY; WORKING; CLL Multiple languages Oncology; Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/15237