Added text to state that a prospective, randomized trial of 447 patients who were previously untreated compared ofatumumab plus chlorambucil with chlorambucil alone (cited Hillmen et al. as reference 18 and level of evidence 1iiDiii).
Added text to state that a prospective trial of 474 previously treated patients who attained partial or complete remission to second- or third-line chemotherapy were randomly assigned to 2 years of maintenance therapy with ofatumumab versus observation (cited van Oers et al. as reference 19 and level of evidence 1iiDiii).
Added text to state that a prospective, randomized trial of 269 previously untreated patients who were aged 65 years or older compared ibrutinib with chlorambucil. (cited Burger et al. as reference 25 and level of evidence 1iiA).
Added text to state that a prospective, randomized trial of 578 previously treated patients compared ibrutinib plus bendamustine plus rituximab with bendamustine plus rituximab (cited Chanan-Khan et al. as reference 26 and level of evidence 1iDiii).
Added text to state that these randomized trials established the rationale for first-line use of ibrutinib in patients with CLL, especially for high-risk patients with 17p- disease. These trials also established the use of ibrutinib for patients with relapsed disease.
Added option to list of standard treatments to include venetoclax, a highly selective inhibitor of B-cell lymphoma 2.
Added text to state that in a phase I dose escalation study, 56 previously treated patients received venetoclax, resulting in a 79% response rate, including patients with adverse prognosis resistant to fludarabine or with 17p deletion (cited Roberts et al. as reference 27 and level of evidence 3iiiDiv). Also added that these data led to U.S. Food and Drug Administration approval for use in relapsed disease.
Added text to state that in 64 previously untreated patients, the combination of idelalisib plus rituximab resulted in a progression-free survival (PFS) rate of 83% at 3 years (cited O'Brien et al. as reference 28 and level of evidence 3iiiDiii).
Added text to state that with a 36-month median follow-up, the median PFS was better for fludarabine, cyclophosphamide, and rituximab (FCR), but there was no difference in OS at 3 years (cited Eichhorst et al. as reference 48 and level of evidence 1iiDiii).
Revised text to state that a combination chemotherapy was used in a trial of 817 patients that compared FCR with fludarabine and cyclophosphamide and at a median follow-up of 5.9 years showed improved OS at 6 years for the rituximab combination.
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weblog.maimonides.edu/farmacia/archives/UM_Informe_Autoevaluacion_FyB.pdf - //
weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - //
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