Citations 2
Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial
Dueck, Amylou C. , Scher, Howard I. , Mazza, Gina L. , Thanarajasingam, Gita , Schwab, Gisela, Weitzman, Aaron, Rogak, Lauren J. , Basch, Ethan , Dueck, A. C. , Mazza, Gina L , Bennett, Antonia V , Basch, Ethan
JAMA Oncology | September 26, 2019 | Volume: 6 | Issue: 2 | Pages: e193332
Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome–positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance
Kantarjian, Hagop M. , Gattermann, Norbert , Bhalla, Kapil N. , Alimena, Giuliana, Palandri, Francesca , Ossenkoppele, Gert J., Nicolini, Franck-Emmanuel, O’Brien, Stephen G., Litzow, Mark R. , Cervantes, Francisco , Shou, Yaping, Resta, Debra, Weitzman, Aaron, Hochhaus, Andreas , Coutre, Philipp le , Giles, Francis Joseph , Bhatia, Ravi , Haque, Md Ariful , Palandri, Francesca , Kantarjian, Hagop
Blood | August 22, 2007 | Volume: 110 | Issue: 10 | Pages: 3540-3546
Abstract Nilotinib, an orally bioavailable, selective Bcr-Abl tyrosine kinase inhibitor, is 30-fold more potent than imatinib in pre-clinical models, and overcomes most imatinib resistant BCR-ABL mutations. In this phase 2 open-label study, 400 mg nilotinib was administered orally twice daily to 280 patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) after imatinib failure or intolerance. Patients had at least 6 months of follow-up and were evaluated for hematologic and cytogenetic responses, as well as for safety and overall survival. At 6 months, the rate of major cytogenetic response (Ph ≤ 35%) was 48%: complete (Ph = 0%) in 31%, and partial (Ph = 1%-35%) in 16%. The estimated survival at 12 months was 95%. Nilotinib was effective in patients harboring BCR-ABL mutations associated with imatinib resistance (except T315I), and also in patients with a resistance mechanism independent of BCR-ABL mutations. Adverse events were mostly mild to moderate, and there was minimal cross-intolerance with imatinib. Grades 3 to 4 neutropenia and thrombocytopenia were observed in 29% of patients; pleural or pericardial effusions were observed in 1% (none were severe). In summary, nilotinib is highly active and safe in patients with CML-CP after imatinib failure or intolerance. This clinical trial is registered at http://clinicaltrials.gov as ID no. NCT00109707.