Pegylated interferon as a first line treatment in polycythemia vera and essential thrombocythemia patients: a quasi-experimental study

Abstract

BACKGROUND: Polycythemia vera (PV) and essential thrombocythemia (ET) are myeloproliferative disorders that are characterized by a proliferation of the erythroid and platelet series, respectively. These patients' survival is long and therefore drugs that are safe and effective in the long term are needed. In this respect, pegylated interferon (peg-IFNα-2a) is proposed as an optimal drug for first-line treatment. With the new formulations of the molecule, the tolerability profile has improved considerably and there is evidence of clinicohematologic and molecular responses that are not only comparable to classical treatment (hydroxyurea), but also more sustained over time. In some cases, it is even becoming possible to discontinue treatment without disease progression. OBJECTIVE: The aim of this study is to evaluate the effect of peg-IFNα-2a on clinicohematologic and molecular response, incidence of thrombotic/bleeding events and toxicity after 24 months of treatment. DESIGN: A multicenter ambispective quasi-experimental study has been designed. PARTICIPANTS: Patients with PV or ET diagnosis that are candidates to receive peg-IFNα-2a as a first line treatment in Catalan hospitals. METHODS: Data will be obtained both retrospectively and prospectively from the medical history of the patients and their regular visits on the Hematological departments. Statistical representation of the variables results will also be performed through a univariate, bivariate and multivariate analysis