Added text to state that a randomized, phase III, double-blind study has demonstrated noninferiority for the duration of severe neutropenia of biosimilar filgrastim compared with the U.S.-licensed product (cited Blackwell et al. as reference 98 and level of evidence 1iDiv).
Added text to state that similar results were noted in a larger, multicenter, randomized study led by the Hellenic Oncology Research Group (cited Mavroudis et al. as reference 122 and level of evidence 1iiA).
Revised text to state that palbociclib is an orally available CDK4/6 inhibitor that has been shown in two trials to enhance the efficacy of endocrine therapy and has been approved by the U.S. Food and Drug Administration (FDA).
Added text to state that PALOMA-2, a phase III, double-blind trial, confirmed the results of the PALOMA-1 trial by comparing placebo plus letrozole with palbociclib plus letrozole as initial therapy for estrogen receptor (ER)–positive postmenopausal patients with advanced disease. Added statistical information to show that progression-free survival (PFS), the primary endpoint, was met; no overall survival (OS) data are available; and adverse events in the two groups were included (cited Finn et al. as reference 33 and level of evidence 1iDiii).
Added text to state that ribociclib was also tested in the first-line setting for postmenopausal patients with ER–positive and HER2–negative recurrent or metastatic breast cancer in a phase III, placebo-controlled trial in which patients received ribociclib plus letrozole or placebo plus letrozole. Added statistical information to show that PFS, the primary endpoint, was met; the median PFS data were provided; no OS data are available; and graded data about specific adverse events in the two groups were included (cited Hortobagyi et al. as reference 36 and level of evidence 1iDiii).
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]//
weblog.maimonides.edu/farmacia/archives/UM_Informe_Autoevaluacion_FyB.pdf - //
weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - //
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