Ruxolitinib for the treatment of inadequately controlled polycythemia vera without splenomegaly: 80-week follow-up from the RESPONSE-2 trial
| Autor: | Francesca Palandri, Martin Griesshammer, Caroline Bensasson, Jeannie Callum, Julian Perez Ronco, Güray Saydam, Serdar Sivgin, Paola Guglielmelli, Timothy Devos, Francesco Passamonti, Miklos Egyed, Giulia Benevolo, Mahmudul Khan |
|---|---|
| Přispěvatelé: | Ege Üniversitesi |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
Ruxolitinib HYDROXYUREA MPN Drug Resistance Phases of clinical research Hematocrit THERAPY 0302 clinical medicine Polycythemia vera Phlebotomy hemic and lymphatic diseases ESSENTIAL THROMBOCYTHEMIA Medicine CRITERIA health care economics and organizations Hematology Cross-Over Studies medicine.diagnostic_test General Medicine Middle Aged PROGNOSTIC VALUE Safety profile Treatment Outcome JAK inhibitor 030220 oncology & carcinogenesis SURVIVAL Original Article Female Chronic myeloproliferative disorders Life Sciences & Biomedicine geographic locations medicine.drug NEOPLASMS medicine.medical_specialty education 03 medical and health sciences Internal medicine parasitic diseases Nitriles Humans Aged Science & Technology business.industry social sciences medicine.disease Crossover study Drug Resistance Neoplasm Follow-Up Studies Polycythemia Vera Pyrazoles Splenomegaly Pyrimidines Neoplasm business 030215 immunology |
| Zdroj: | Annals of Hematology Web of Science |
| Popis: | WOS: 000440976800009 PubMed ID: 29804268 RESPONSE-2 is a phase 3 study comparing the efficacy and safety of ruxolitinib with the best available therapy (BAT) in hydroxyurea-resistant/hydroxyurea-intolerant polycythemia vera (PV) patients without palpable splenomegaly. This analysis evaluated the durability of the efficacy and safety of ruxolitinib after patients completed the visit at week 80 or discontinued the study. Endpoints included proportion of patients achieving hematocrit control (< 45%), proportion of patients achieving complete hematologic remission (CHR) at week 28, and the durability of hematocrit control and CHR. At the time of analysis, 93% (69/74) of patients randomized to ruxolitinib were receiving ruxolitinib; while in the BAT arm, 77% (58/75) of patients crossed over to ruxolitinib after week 28. No patient remained on BAT by week 80. Among patients who achieved a hematocrit response at week 28, the probability of maintaining response up to week 80 was 78% in the ruxolitinib arm. At week 80, durable CHR was achieved in 18 patients (24%) in the ruxolitinib arm versus 2 patients (3%) in the BAT arm. The safety profile of ruxolitinib was consistent with previous reports. These data support that ruxolitinib treatment should be considered also as a standard of care for hydroxyurea-resistant/hydroxyurea-intolerant PV patients without palpable splenomegaly. NovartisNovartis This study was funded by Novartis. |
| Databáze: | OpenAIRE |
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