Yazarlar : Vij R, Wang M, Kaufman JL et al

Yayın : Blood

Yayın Yılı : 2012

Pubmed Linki : http://www.ncbi.nlm.nih.gov/pubmed/22555973

Konu : Myelom

Literatür İçeriği :  

Abstract

Carfilzomib is a selective proteasome inhibitor that binds irreversibly to its target. In phase 1 studies, carfilzomib elicited promising responses and an acceptable toxicity profile in patients with relapsed and/or refractory multiple myeloma (R/R MM). In this phase 2 multicenter, open-label study, 129 bortezomib-naïve patients with R/R MM (median of 2 prior therapies) were separated into Cohort 1, scheduled to receive intravenous (IV) carfilzomib 20 mg/m(2) for all treatment cycles, and Cohort 2, scheduled to receive 20 mg/m(2) for Cycle 1 and then 27 mg/m(2) for all subsequent cycles. The primary endpoint was overall response rate (ORR, ≥ partial response): 42.4% in Cohort 1 and 52.2% in Cohort 2. Clinical benefit response (ORR + minimal response) was 59.3% and 64.2% in Cohorts 1 and 2, respectively. Median duration of response was 13.1 months and not reached, and median time to progression was 8.3 months and not reached, respectively. The most common treatment-emergent adverse events were fatigue (62.0%) and nausea (48.8%). Single-agent carfilzomib elicited a low incidence of peripheral neuropathy- 17.1% overall (1 Grade 3; no Grade 4)-in these pretreated bortezomib-naïve patients. Collectively, these results support its potential use in this patient population. Trial registered at www.clinicaltrials.gov as #NCT00530816.

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