| Autor: |
Fraser, G. Cramer, P. Demirkan, F. Silva, R.S. 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. Chanan-Khan, A. |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Popis: |
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 3–4) 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. © 2018, The Author(s). |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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