作者: Hagop M. Kantarjian , Richard A. Larson , Francois Guilhot , Stephen G. O'Brien , Manisha Mone
DOI: 10.1002/CNCR.24066
关键词: Tyrosine-kinase inhibitor 、 Imatinib mesylate 、 Oncology 、 Randomized controlled trial 、 Internal medicine 、 Medicine 、 Imatinib 、 Cytarabine 、 Population 、 Tolerability 、 Pharmacology 、 Phases of clinical research
摘要: Imatinib mesylate (Glivec, Gleevec; Novartis Pharmaceuticals Corporation, Basel, Switzerland; East Hanover, NJ) is a selective BCR-ABL tyrosine kinase inhibitor. An imatinib dose of 400 mg daily the standard care for patients with newly diagnosed chronic myeloid leukemia (CML) in phase (CML-CP). Treatment first-line setting associated an overall survival rate 88% after 6 years therapy.1,2 Dose escalation to 600 or 800 has demonstrated benefit who have slow inadequate response and disease progression.3 To our knowledge, experimental arm International Randomized Study Interferon (IFN) STI571 (IRIS) trial largest controlled population CML-CP which its durability and/or treatment can be estimated.1,4 The IRIS trial, was initiated 2000, multicenter, international, open-label, 3 study eligible were randomized receive therapy either IFN-α plus cytarabine. It allowed step-wise escalation, first then mg, when certain criteria not met while patient receiving imatinib, major cytogenetic (MCyR) lost, progression occurred. Stepwise recommended because tolerability higher doses well known during initial portion study. The success changed practices CML based on expectations improved rates. Recommendations been published by European LeukemiaNet (ELN).5 ELN recommends at times clinical assessments response; these correlate similar lower burden compared protocol criteria. recommend case failure suboptimal (Table 1). In current report, we describe outcome enrolled IRIS, began daily, subsequently underwent escalation. Table 1 Response Criteria From Recommendations*