Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Duvic, M; Dummer, R; Becker, JC; Poulalhon, N; Romero, PO; Bernengo, MG; Lebbe, C; Assaf, C; Squier, M; Williams, D; Marshood, M; Tai, F; Prince, HM; .
Panobinostat activity in both bexarotene-exposed and -naive patients with refractory cutaneous T-cell lymphoma: Results of a phase II trial.
EUR J CANCER. 2013; 49(2): 386-394.
Doi: 10.1016/j.ejca.2012.08.017
Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
- Becker Jürgen Christian
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- Abstract:
- Background: Panobinostat is a potent, oral pan-deacetylase inhibitor (pan-DACi) that increases the acetylation of proteins involved in multiple oncogenic pathways. Here, panobinostat is studied in bexarotene-exposed and -naive patients with refractory cutaneous T-cell lymphoma (CTCL). Patients and methods: Patients with CTCL subtypes mycosis fungoides and Sezary syndrome who received >= 2 prior systemic therapy regimens received panobinostat (20 mg) three times every week. The primary objective was overall response rate (ORR) as determined by a combined evaluation of skin disease and involvement of lymph node and viscera. Disease progression was defined as an unconfirmed, >= 25% increase in modified Severity Weighted Assessment Tool (mSWAT) compared with nadir. Results: Seventy-nine bexarotene-exposed and 60 bexarotene-naive patients were enrolled. Reductions in baseline mSWAT scores were observed in 103 patients (74.1%). The ORR was 17.3% in all patients in the primary analysis (15.2% and 20.0% in the bexarotene-exposed and -naive groups, respectively). The median progression-free survival was 4.2 and 3.7 months in the bexarotene-exposed and -naive groups, respectively. The median duration of response was 5.6 months in the bexarotene-exposed patients and was not reached at data cutoff in the bexarotene-naive patients. Additional responses were observed when less-stringent progression criteria were used. The most common adverse events were thrombocytopenia, diarrhoea, fatigue and nausea. Thrombocytopenia and neutropenia were the only grade 3/4 adverse events in > 5% of patients and were manageable. Conclusion: Despite a very conservative definition of disease progression, panobinostat demonstrated activity with a manageable safety profile in bexarotene-exposed and -naive CTCL patients. ClinicalTrials.gov Identifier: NCT00425555. (C) 2012 Elsevier Ltd. All rights reserved.
- Find related publications in this database (using NLM MeSH Indexing)
- Anticarcinogenic Agents - administration & dosage
- Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use
- Disease Progression -
- Disease-Free Survival -
- Female -
- Histone Deacetylase Inhibitors - adverse effects Histone Deacetylase Inhibitors - therapeutic use
- Humans -
- Hydroxamic Acids - adverse effects Hydroxamic Acids - therapeutic use
- Indoles - adverse effects Indoles - therapeutic use
- Male -
- Middle Aged -
- Mycosis Fungoides - drug therapy Mycosis Fungoides - pathology
- Sezary Syndrome - drug therapy Sezary Syndrome - pathology
- Skin Neoplasms - drug therapy Skin Neoplasms - pathology
- Tetrahydronaphthalenes - administration & dosage
- Find related publications in this database (Keywords)
- Cutaneous T-cell lymphoma
- Panobinostat
- Pan-deacetylase inhibitor
- Mycosisfungoides
- Sezary syndrome
- Bexarotene