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Yacoub, Abdulraheem; Mascarenhas, John; Kosiorek, Heidi; Prchal, Josef T.; Berenzon, Dmitry; Baer, Maria R.; Ritchie, Ellen; Silver, Richard T.; Kessler, Craig; Winton, Elliott; Finazzi, Maria Chiara; Rambaldi, Alessandro; Vannucchi, Alessandro M.; Leibowitz, David; Rondelli, Damiano; Arcasoy, Murat O.; Catchatourian, Rosalind; Vadakara, Joseph; Rosti, Vittorio; Hexner, Elizabeth; Kremyanskaya, Marina; Sandy, Lonette; Tripodi, Joseph; Najfeld, Vesna; Farnoud, Noushin; Papaemmanuil, Elli; Salama, Mohamed; Singer-Weinberg, Rona; Rampal, Raajit; Goldberg, Judith D.; Barbui, Tiziano; Mesa, Ruben; Dueck, Amylou C.; Hoffman, Ronald
Blood, 10/2019, Volume: 134, Issue: 18Journal Article
Prior studies have reported high response rates with recombinant interferon-α (rIFN-α) therapy in patients with essential thrombocythemia (ET) and polycythemia vera (PV). To further define the role of rIFN-α, we investigated the outcomes of pegylated-rIFN-α2a (PEG) therapy in ET and PV patients previously treated with hydroxyurea (HU). The Myeloproliferative Disorders Research Consortium (MPD-RC)-111 study was an investigator-initiated, international, multicenter, phase 2 trial evaluating the ability of PEG therapy to induce complete (CR) and partial (PR) hematologic responses in patients with high-risk ET or PV who were either refractory or intolerant to HU. The study included 65 patients with ET and 50 patients with PV. The overall response rates (ORRs; CR/PR) at 12 months were 69.2% (43.1% and 26.2%) in ET patients and 60% (22% and 38%) in PV patients. CR rates were higher in CALR-mutated ET patients (56.5% vs 28.0%; P = .01), compared with those in subjects lacking a CALR mutation. The median absolute reduction in JAK2V617F variant allele fraction was −6% (range, −84% to 47%) in patients achieving a CR vs +4% (range, −18% to 56%) in patients with PR or nonresponse (NR). Therapy was associated with a significant rate of adverse events (AEs); most were manageable, and PEG discontinuation related to AEs occurred in only 13.9% of subjects. We conclude that PEG is an effective therapy for patients with ET or PV who were previously refractory and/or intolerant of HU. This trial was registered at www.clinicaltrials.gov as #NCT01259856. •Pegylated-rIFN-α2a can achieve an ORR of 69% and 60% in ET and PV patients, respectively, previously treated with hydroxyurea.•The presence of a CALR mutation was associated with superior CR rates in ET patients treated with pegylated-rIFN-α2a. Display omitted
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