A phase 2 study of ruxolitinib in combination with azacitidine in patients with myelofibrosis
Year: 2018
Type: article
Study design: Clinical Trial
Abstract: (days 1-5). Forty-six patients were enrolled with a median follow-up of 28 months (range, 4-50+ months). An International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) response was achieved in 33 patients (72%), with a median time to response of 1.8 months (range, 0.7-19.0 months). One-fourth (7 of 33) of the IWG-MRT responses occurred after the addition of AZA. A reduction of >50% in palpable spleen length at 24 weeks and at any time on the study was achieved in 62% and 71% of the evaluable patients, respectively. Among patients who achieved a >50% reduction in spleen length at 24 weeks, 95% had maintained it at 48 weeks. Notably, improvements in bone marrow reticulin fibrosis grade occurred in 57% of the patients at 24 months. Treatment discontinuations as a result of drug-related toxicities occurred in 4 patients (9%), all as a result of cytopenias. New onset grade 3 to 4 anemia and thrombocytopenia occurred in 35% and 26% of patients, respectively. RUX and AZA were safe, with encouraging spleen response rates and improvement in bone marrow fibrosis in patients with MF. This trial was registered at www.clinicaltrials.gov as #NCT01787487.
Source: Blood
Authors: Lucia Masarova, Srdan Verstovsek, Juliana E. Hidalgo-Lopez, Naveen Pemmaraju, Prithviraj Bose, Zeev Estrov, Elias J. Jabbour, Farhad Ravandi-Kashani, Koichi Takahashi, Jorge E. Cortes, Jing Ning, Maro Ohanian, Yesid Alvarado, Lingsha Zhou, Sherry Pierce, Romany Gergis, Keyur P. Patel, Rajyalakshmi Luthra, Tapan M. Kadia, Courtney D. DiNardo, Gautam Borthakur, Kapil Bhalla, Guillermo Garcia-Manero, Carlos E. Bueso-Ramos, Hagop M. Kantarjian, Naval Daver
Institution: The University of Texas MD Anderson Cancer Center
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,500
OpenAlex ID: W2891891723