Panobinostat activity in both bexarotene-exposed and -naïve patients with refractory cutaneous T-cell lymphoma: Results of a phase II trial
Identifieur interne : 005244 ( PascalFrancis/Curation ); précédent : 005243; suivant : 005245Panobinostat activity in both bexarotene-exposed and -naïve patients with refractory cutaneous T-cell lymphoma: Results of a phase II trial
Auteurs : Madeleine Duvic [États-Unis] ; Reinhard Dummer [Suisse] ; Jürgen C. Becker [Autriche] ; Nicolas Poulalhon [France] ; Pablo Ortiz Romero [Espagne] ; Maria Grazia Bernengo [Italie] ; Celeste Lebbe [France] ; Chalid Assaf [Allemagne] ; Margaret Squier [États-Unis] ; Denise Williams [États-Unis] ; Miriam Marshood [États-Unis] ; FENG TAI [États-Unis] ; H. Miles Prince [Australie]Source :
- European journal of cancer : (1990) [ 0959-8049 ] ; 2013.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
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 Sézary 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-naïve 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 -naïve CTCL patients. ClinicalTrials.gov Identifier: NCT00425555.
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<author><name sortKey="Becker, Jurgen C" sort="Becker, Jurgen C" uniqKey="Becker J" first="Jürgen C." last="Becker">Jürgen C. Becker</name>
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<author><name sortKey="Grazia Bernengo, Maria" sort="Grazia Bernengo, Maria" uniqKey="Grazia Bernengo M" first="Maria" last="Grazia Bernengo">Maria Grazia Bernengo</name>
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<author><name sortKey="Assaf, Chalid" sort="Assaf, Chalid" uniqKey="Assaf C" first="Chalid" last="Assaf">Chalid Assaf</name>
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<author><name sortKey="Squier, Margaret" sort="Squier, Margaret" uniqKey="Squier M" first="Margaret" last="Squier">Margaret Squier</name>
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<author><name sortKey="Feng Tai" sort="Feng Tai" uniqKey="Feng Tai" last="Feng Tai">FENG TAI</name>
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<s2>East Hanover, NJ</s2>
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<sZ>9 aut.</sZ>
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<author><name sortKey="Prince, H Miles" sort="Prince, H Miles" uniqKey="Prince H" first="H. Miles" last="Prince">H. Miles Prince</name>
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<series><title level="j" type="main">European journal of cancer : (1990)</title>
<title level="j" type="abbreviated">Eur. j. cancer : (1990)</title>
<idno type="ISSN">0959-8049</idno>
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<seriesStmt><title level="j" type="main">European journal of cancer : (1990)</title>
<title level="j" type="abbreviated">Eur. j. cancer : (1990)</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term>
<term>Bexarotene</term>
<term>Biological activity</term>
<term>Cancerology</term>
<term>Chronic</term>
<term>Cutaneous T cell lymphoma</term>
<term>Human</term>
<term>Lymphoid neoplasm</term>
<term>Mycosis fungoides</term>
<term>Panobinostat</term>
<term>Phase II trial</term>
<term>Sezary syndrome</term>
<term>T cell neoplasm</term>
<term>Treatment resistance</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Panobinostat</term>
<term>Activité biologique</term>
<term>Bexarotène</term>
<term>Mycosis fongoïde</term>
<term>Homme</term>
<term>Résistance traitement</term>
<term>Essai clinique phase II</term>
<term>Cancérologie</term>
<term>Syndrome de Sezary</term>
<term>Anticancéreux</term>
<term>Chronique</term>
<term>Lymphome T cutané</term>
<term>Hémopathie maligne lymphoïde</term>
<term>Hémopathie lymphoïde T</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
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<front><div type="abstract" xml:lang="en">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 Sézary 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-naïve 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 -naïve CTCL patients. ClinicalTrials.gov Identifier: NCT00425555.</div>
</front>
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<sZ>1 aut.</sZ>
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<s3>CHE</s3>
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<fA14 i1="03"><s1>Medical University of Graz</s1>
<s2>Graz</s2>
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<sZ>3 aut.</sZ>
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<sZ>5 aut.</sZ>
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<fA14 i1="06"><s1>University of Turin, Department of Biomedical Science and Human Oncology</s1>
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<s3>ITA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>AP-HP Hôpital Saint-Louis, Department of Dermatology and Center of Clinical Investigation, Université Paris Diderot</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>HELIOS Klinikum Krefeld, Department of Dermatology</s1>
<s2>Krefeld</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Skin Cancer Center Charité, Department of Dermatology and Allergology, Charité-Universitätsmedizin Berlin</s1>
<s2>Berlin</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Novartis Pharmaceuticals Corporation</s1>
<s2>East Hanover, NJ</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Peter MacCallum Cancer Centre and University of Melbourne</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA20><s1>386-394</s1>
</fA20>
<fA21><s1>2013</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>12648</s2>
<s5>354000182501500140</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2013 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>33 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>13-0084490</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>European journal of cancer : (1990)</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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 Sézary 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-naïve 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 -naïve CTCL patients. ClinicalTrials.gov Identifier: NCT00425555.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B02</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B04</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Panobinostat</s0>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Panobinostat</s0>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Panobinostat</s0>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Activité biologique</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Biological activity</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Actividad biológica</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Bexarotène</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Bexarotene</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Bexaroteno</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Mycosis fongoïde</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Mycosis fungoides</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Micosis fungoides</s0>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Homme</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Human</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Hombre</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Résistance traitement</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Treatment resistance</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Resistencia tratamiento</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Essai clinique phase II</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Phase II trial</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Ensayo clínico fase II</s0>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Cancérologie</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Cancerology</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Cancerología</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Syndrome de Sezary</s0>
<s5>10</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Sezary syndrome</s0>
<s5>10</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Sezary síndrome</s0>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Anticancéreux</s0>
<s5>25</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Antineoplastic agent</s0>
<s5>25</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Anticanceroso</s0>
<s5>25</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Chronique</s0>
<s5>26</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Chronic</s0>
<s5>26</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Crónico</s0>
<s5>26</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Lymphome T cutané</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Cutaneous T cell lymphoma</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Linfoma T cutáneo</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Hémopathie maligne lymphoïde</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Lymphoid neoplasm</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE"><s0>Hémopathie lymphoïde T</s0>
<s4>CD</s4>
<s5>98</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG"><s0>T cell neoplasm</s0>
<s4>CD</s4>
<s5>98</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Inhibiteur histone deacetylase</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Histone deacetylase inhibitor</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Inhibidor histone deacetylase</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Hémopathie maligne</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Malignant hemopathy</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Hemopatía maligna</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Lymphome non hodgkinien</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Non Hodgkin lymphoma</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Linfoma no Hodgkin</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Syndrome lymphoprolifératif</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Lymphoproliferative syndrome</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Linfoproliferativo síndrome</s0>
<s2>NM</s2>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Pathologie de la peau</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Skin disease</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Piel patología</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Hématodermie</s0>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG"><s0>Cutaneous hematologic disease</s0>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA"><s0>Hematodermia</s0>
<s5>42</s5>
</fC07>
<fC07 i1="08" i2="X" l="FRE"><s0>Lymphome périphérique à cellules T</s0>
<s5>43</s5>
</fC07>
<fC07 i1="08" i2="X" l="ENG"><s0>Peripheral T cell lymphoma</s0>
<s5>43</s5>
</fC07>
<fC07 i1="08" i2="X" l="SPA"><s0>Linfoma célula T periférica</s0>
<s5>43</s5>
</fC07>
<fN21><s1>056</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>
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