Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL : 5 years of follow-up from the phase 3 RESONATE-2 study
- Burger, Jan A.
- Barr, Paul M.
- Robak, Tadeusz
- Owen, Carolyn
- Ghia, Paolo
- Tedeschi, Alessandra
- Bairey, Osnat
- Hillmen, Peter
- Coutre, Steven E.
- Devereux, Stephen
- Grosicki, Sebastian
- McCarthy, Helen
- Simpson, David
- Offner, Fritz
- Moreno, Carol
- Dai, Sandra
- Lal, Indu
- Dean, James P.
- Kipps, Thomas J.
DOIAbstract
RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged >= 65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for = 3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time
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