| FRASER, G., P. CRAMER, F. DEMIRKAN, R.S. SILVA, S. GROSICKI, A. PRISTUPA, A. JANSSENS, Jiří MAYER, N.L. BARTLETT, M.S. DILHUYDY, H. PYLYPENKO, J. LOSCERTALES, A. AVIGDOR, S. RULE, D. VILLA, O. SAMOILOVA, P. PANAGIOTIDIS, A. GOY, M.A. PAVLOVSKY, C. KARLSSON, M. HALLEK, M. MAHLER, M. SALMAN, S. SUN, C. PHELPS, S. BALASUBRAMANIAN, A. HOWES and A. CHANAN-KHAN. Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. Leukemia. London: Nature Publishing Group, 2019, vol. 33, No 4, p. 969-980. ISSN 0887-6924. Available from: https://dx.doi.org/10.1038/s41375-018-0276-9. |
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@article{1522776,
author = {Fraser, G. and Cramer, P. and Demirkan, F. and Silva, R.S. and Grosicki, S. and Pristupa, A. and Janssens, A. and Mayer, Jiří and Bartlett, N.L. and Dilhuydy, M.S. and Pylypenko, H. and Loscertales, J. and Avigdor, A. and Rule, S. and Villa, D. and Samoilova, O. and Panagiotidis, P. and Goy, A. and Pavlovsky, M.A. and Karlsson, C. and Hallek, M. and Mahler, M. and Salman, M. and Sun, S. and Phelps, C. and Balasubramanian, S. and Howes, A. and ChananandKhan, A.},
article_location = {London},
article_number = {4},
doi = {http://dx.doi.org/10.1038/s41375-018-0276-9},
keywords = {ibrutinib; bendamustine; rituximab},
language = {eng},
issn = {0887-6924},
journal = {Leukemia},
title = {Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma},
url = {http://dx.doi.org/10.1038/s41375-018-0276-9},
volume = {33},
year = {2019}
}
TY - JOUR
ID - 1522776
AU - Fraser, G. - Cramer, P. - Demirkan, F. - Silva, R.S. - Grosicki, S. - Pristupa, A. - Janssens, A. - Mayer, Jiří - 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. - Chanan-Khan, A.
PY - 2019
TI - Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma
JF - Leukemia
VL - 33
IS - 4
SP - 969-980
EP - 969-980
PB - Nature Publishing Group
SN - 08876924
KW - ibrutinib
KW - bendamustine
KW - rituximab
UR - http://dx.doi.org/10.1038/s41375-018-0276-9
L2 - http://dx.doi.org/10.1038/s41375-018-0276-9
N2 - 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.
ER -
FRASER, G., P. CRAMER, F. DEMIRKAN, R.S. SILVA, S. GROSICKI, A. PRISTUPA, A. JANSSENS, Jiří MAYER, N.L. BARTLETT, M.S. DILHUYDY, H. PYLYPENKO, J. LOSCERTALES, A. AVIGDOR, S. RULE, D. VILLA, O. SAMOILOVA, P. PANAGIOTIDIS, A. GOY, M.A. PAVLOVSKY, C. KARLSSON, M. HALLEK, M. MAHLER, M. SALMAN, S. SUN, C. PHELPS, S. BALASUBRAMANIAN, A. HOWES and A. CHANAN-KHAN. Updated results from the phase 3 HELIOS study of ibrutinib, bendamustine, and rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. \textit{Leukemia}. London: Nature Publishing Group, 2019, vol.~33, No~4, p.~969-980. ISSN~0887-6924. Available from: https://dx.doi.org/10.1038/s41375-018-0276-9.
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