Treatment of patients with aortic atherosclerotic disease with paclitaxel-associated lipid nanoparticles
Identifieur interne : 000301 ( Ncbi/Merge ); précédent : 000300Treatment of patients with aortic atherosclerotic disease with paclitaxel-associated lipid nanoparticles
Auteurs : Afonso A. Shiozaki [Brésil] ; Tiago Senra [Brésil] ; Aleksandra T. Morikawa [Brésil] ; Débora F. Deus [Brésil] ; Antonio T. Paladino [Brésil] ; Ibraim M. F. Pinto [Brésil] ; Raul C. Maranhão [Brésil]Source :
- Clinics [ 1807-5932 ] ; 2016.
Abstract
The toxicity of anti-cancer chemotherapeutic agents can be reduced by associating these compounds, such as the anti-proliferative agent paclitaxel, with a cholesterol-rich nanoemulsion (LDE) that mimics the lipid composition of low-density lipoprotein (LDL). When injected into circulation, the LDE concentrates the carried drugs in neoplastic tissues and atherosclerotic lesions. In rabbits, atherosclerotic lesion size was reduced by 65% following LDE-paclitaxel treatment. The current study aimed to test the effectiveness of LDE-paclitaxel on inpatients with aortic atherosclerosis.
This study tested a 175 mg/m2 body surface area dose of LDE-paclitaxel (intravenous administration, 3/3 weeks for 6 cycles) in patients with aortic atherosclerosis who were aged between 69 and 86 yrs. A control group of 9 untreated patients with aortic atherosclerosis (72-83 yrs) was also observed.
The LDE-paclitaxel treatment elicited no important clinical or laboratory toxicities. Images were acquired via multiple detector computer tomography angiography (64-slice scanner) before treatment and at 1-2 months after treatment. The images showed that the mean plaque volume in the aortic artery wall was reduced in 4 of the 8 patients, while in 3 patients it remained unchanged and in one patient it increased. In the control group, images were acquired twice with an interval of 6-8 months. None of the patients in this group exhibited a reduction in plaque volume; in contrast, the plaque volume increased in three patients and remained stable in four patients. During the study period, one death unrelated to the treatment occurred in the LDE-paclitaxel group and one death occurred in the control group.
Treatment with LDE-paclitaxel was tolerated by patients with cardiovascular disease and showed the potential to reduce atherosclerotic lesion size.
Url:
DOI: 10.6061/clinics/2016(08)05
PubMed: NONE
PubMed Central: 4975788
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Shiozaki</name><affiliation wicri:level="2"><nlm:aff id="af1-cln_71p435">Instituto Dante Pazzanese de Cardiologia, São Paulo/SP, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Instituto Dante Pazzanese de Cardiologia, São Paulo/SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="af2-cln_71p435">Laboratório de Metabolismo e Lípides - Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Laboratório de Metabolismo e Lípides - Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation><affiliation wicri:level="1"><nlm:aff id="af3-cln_71p435">Hospital Maringá, Maringá/Paraná, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Hospital Maringá, Maringá/Paraná</wicri:regionArea><wicri:noRegion>Maringá/Paraná</wicri:noRegion></affiliation></author><author><name sortKey="Senra, Tiago" sort="Senra, Tiago" uniqKey="Senra T" first="Tiago" last="Senra">Tiago Senra</name><affiliation wicri:level="2"><nlm:aff id="af1-cln_71p435">Instituto Dante Pazzanese de Cardiologia, São Paulo/SP, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Instituto Dante Pazzanese de Cardiologia, São Paulo/SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Morikawa, Aleksandra T" sort="Morikawa, Aleksandra T" uniqKey="Morikawa A" first="Aleksandra T." last="Morikawa">Aleksandra T. Morikawa</name><affiliation wicri:level="4"><nlm:aff id="af2-cln_71p435">Laboratório de Metabolismo e Lípides - Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Laboratório de Metabolismo e Lípides - Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation></author><author><name sortKey="Deus, Debora F" sort="Deus, Debora F" uniqKey="Deus D" first="Débora F." last="Deus">Débora F. Deus</name><affiliation wicri:level="4"><nlm:aff id="af2-cln_71p435">Laboratório de Metabolismo e Lípides - Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Laboratório de Metabolismo e Lípides - Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation></author><author><name sortKey="Paladino, Antonio T" sort="Paladino, Antonio T" uniqKey="Paladino A" first="Antonio T" last="Paladino">Antonio T. Paladino</name><affiliation wicri:level="2"><nlm:aff id="af1-cln_71p435">Instituto Dante Pazzanese de Cardiologia, São Paulo/SP, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Instituto Dante Pazzanese de Cardiologia, São Paulo/SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Pinto, Ibraim M F" sort="Pinto, Ibraim M F" uniqKey="Pinto I" first="Ibraim M. F." last="Pinto">Ibraim M. F. Pinto</name><affiliation wicri:level="2"><nlm:aff id="af1-cln_71p435">Instituto Dante Pazzanese de Cardiologia, São Paulo/SP, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Instituto Dante Pazzanese de Cardiologia, São Paulo/SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Maranhao, Raul C" sort="Maranhao, Raul C" uniqKey="Maranhao R" first="Raul C." last="Maranhão">Raul C. Maranhão</name><affiliation wicri:level="4"><nlm:aff id="af2-cln_71p435">Laboratório de Metabolismo e Lípides - Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Laboratório de Metabolismo e Lípides - Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation><affiliation wicri:level="4"><nlm:aff id="af4-cln_71p435">Faculdade de Ciências Farmacêuticas da Universidade de São Paulo, São Paulo/SP, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Faculdade de Ciências Farmacêuticas da Universidade de São Paulo, São Paulo/SP</wicri:regionArea><placeName><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation></author></analytic><series><title level="j">Clinics</title><idno type="ISSN">1807-5932</idno><idno type="eISSN">1980-5322</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>OBJECTIVE:</title><p>The toxicity of anti-cancer chemotherapeutic agents can be reduced by associating these compounds, such as the anti-proliferative agent paclitaxel, with a cholesterol-rich nanoemulsion (LDE) that mimics the lipid composition of low-density lipoprotein (LDL). When injected into circulation, the LDE concentrates the carried drugs in neoplastic tissues and atherosclerotic lesions. In rabbits, atherosclerotic lesion size was reduced by 65% following LDE-paclitaxel treatment. The current study aimed to test the effectiveness of LDE-paclitaxel on inpatients with aortic atherosclerosis.</p></sec><sec><title>METHODS:</title><p>This study tested a 175 mg/m<sup>2</sup> body surface area dose of LDE-paclitaxel (intravenous administration, 3/3 weeks for 6 cycles) in patients with aortic atherosclerosis who were aged between 69 and 86 yrs. A control group of 9 untreated patients with aortic atherosclerosis (72-83 yrs) was also observed.</p></sec><sec><title>RESULTS:</title><p>The LDE-paclitaxel treatment elicited no important clinical or laboratory toxicities. Images were acquired via multiple detector computer tomography angiography (64-slice scanner) before treatment and at 1-2 months after treatment. The images showed that the mean plaque volume in the aortic artery wall was reduced in 4 of the 8 patients, while in 3 patients it remained unchanged and in one patient it increased. In the control group, images were acquired twice with an interval of 6-8 months. None of the patients in this group exhibited a reduction in plaque volume; in contrast, the plaque volume increased in three patients and remained stable in four patients. During the study period, one death unrelated to the treatment occurred in the LDE-paclitaxel group and one death occurred in the control group.</p></sec><sec><title>CONCLUSION:</title><p>Treatment with LDE-paclitaxel was tolerated by patients with cardiovascular disease and showed the potential to reduce atherosclerotic lesion size.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Capmany, Rp" uniqKey="Capmany R">RP Capmany</name></author><author><name sortKey="Iba Ez, Mo" uniqKey="Iba Ez M">MO Ibañez</name></author><author><name sortKey="Pesquer, Xj" uniqKey="Pesquer X">XJ Pesquer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Fujita, S" uniqKey="Fujita S">S Fujita</name></author><author><name sortKey="Sugioka, K" uniqKey="Sugioka K">K Sugioka</name></author><author><name sortKey="Matsumura, Y" uniqKey="Matsumura Y">Y Matsumura</name></author><author><name sortKey="Ito, A" uniqKey="Ito 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Clinics (Sao Paulo)</journal-id><journal-id journal-id-type="iso-abbrev">Clinics (Sao Paulo)</journal-id><journal-title-group><journal-title>Clinics</journal-title></journal-title-group><issn pub-type="ppub">1807-5932</issn><issn pub-type="epub">1980-5322</issn><publisher><publisher-name>Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmc">4975788</article-id><article-id pub-id-type="doi">10.6061/clinics/2016(08)05</article-id><article-id pub-id-type="publisher-id">cln_71p435</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical Science</subject></subj-group></article-categories><title-group><article-title>Treatment of patients with aortic atherosclerotic disease with paclitaxel-associated lipid nanoparticles</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Shiozaki</surname><given-names>Afonso A.</given-names></name><xref ref-type="aff" rid="af1-cln_71p435">I</xref><xref ref-type="aff" rid="af2-cln_71p435">II</xref><xref ref-type="aff" rid="af3-cln_71p435">III</xref></contrib><contrib contrib-type="author"><name><surname>Senra</surname><given-names>Tiago</given-names></name><xref ref-type="aff" rid="af1-cln_71p435">I</xref></contrib><contrib contrib-type="author"><name><surname>Morikawa</surname><given-names>Aleksandra T.</given-names></name><xref ref-type="aff" rid="af2-cln_71p435">II</xref></contrib><contrib contrib-type="author"><name><surname>Deus</surname><given-names>Débora F.</given-names></name><xref ref-type="aff" rid="af2-cln_71p435">II</xref></contrib><contrib contrib-type="author"><name><surname>Paladino</surname><given-names>Antonio T</given-names><suffix>Filho</suffix></name><xref ref-type="aff" rid="af1-cln_71p435">I</xref></contrib><contrib contrib-type="author"><name><surname>Pinto</surname><given-names>Ibraim M.F.</given-names></name><xref ref-type="aff" rid="af1-cln_71p435">I</xref></contrib><contrib contrib-type="author"><name><surname>Maranhão</surname><given-names>Raul C.</given-names></name><xref ref-type="aff" rid="af2-cln_71p435">II</xref><xref ref-type="aff" rid="af4-cln_71p435">IV</xref><xref ref-type="corresp" rid="c1-cln_71p435">*</xref></contrib><aff id="af1-cln_71p435"><label>I</label>Instituto Dante Pazzanese de Cardiologia, São Paulo/SP, Brazil</aff><aff id="af2-cln_71p435"><label>II</label>Laboratório de Metabolismo e Lípides - Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP, Brazil</aff><aff id="af3-cln_71p435"><label>III</label>Hospital Maringá, Maringá/Paraná, Brazil</aff><aff id="af4-cln_71p435"><label>IV</label>Faculdade de Ciências Farmacêuticas da Universidade de São Paulo, São Paulo/SP, Brazil</aff></contrib-group><author-notes><corresp id="c1-cln_71p435">E-mail: <email>ramarans@usp.br</email></corresp></author-notes><pub-date pub-type="epub"><month>8</month><year>2016</year></pub-date><pub-date pub-type="ppub"><month>8</month><year>2016</year></pub-date><volume>71</volume><issue>8</issue><fpage>435</fpage><lpage>439</lpage><history><date date-type="received"><day>1</day><month>3</month><year>2016</year></date><date date-type="rev-recd"><day>20</day><month>3</month><year>2016</year></date><date date-type="accepted"><day>20</day><month>4</month><year>2016</year></date></history><permissions><copyright-statement>Copyright © 2016 CLINICS</copyright-statement><copyright-year>2016</copyright-year><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an Open Access article distributed under the terms of the Creative Commons License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>) which permits unrestricted use, distribution, and reproduction in any medium or format, provided the original work is properly cited.</license-p></license></permissions><abstract><sec><title>OBJECTIVE:</title><p>The toxicity of anti-cancer chemotherapeutic agents can be reduced by associating these compounds, such as the anti-proliferative agent paclitaxel, with a cholesterol-rich nanoemulsion (LDE) that mimics the lipid composition of low-density lipoprotein (LDL). When injected into circulation, the LDE concentrates the carried drugs in neoplastic tissues and atherosclerotic lesions. In rabbits, atherosclerotic lesion size was reduced by 65% following LDE-paclitaxel treatment. The current study aimed to test the effectiveness of LDE-paclitaxel on inpatients with aortic atherosclerosis.</p></sec><sec><title>METHODS:</title><p>This study tested a 175 mg/m<sup>2</sup> body surface area dose of LDE-paclitaxel (intravenous administration, 3/3 weeks for 6 cycles) in patients with aortic atherosclerosis who were aged between 69 and 86 yrs. A control group of 9 untreated patients with aortic atherosclerosis (72-83 yrs) was also observed.</p></sec><sec><title>RESULTS:</title><p>The LDE-paclitaxel treatment elicited no important clinical or laboratory toxicities. Images were acquired via multiple detector computer tomography angiography (64-slice scanner) before treatment and at 1-2 months after treatment. The images showed that the mean plaque volume in the aortic artery wall was reduced in 4 of the 8 patients, while in 3 patients it remained unchanged and in one patient it increased. In the control group, images were acquired twice with an interval of 6-8 months. None of the patients in this group exhibited a reduction in plaque volume; in contrast, the plaque volume increased in three patients and remained stable in four patients. During the study period, one death unrelated to the treatment occurred in the LDE-paclitaxel group and one death occurred in the control group.</p></sec><sec><title>CONCLUSION:</title><p>Treatment with LDE-paclitaxel was tolerated by patients with cardiovascular disease and showed the potential to reduce atherosclerotic lesion size.</p></sec></abstract><kwd-group><kwd>Nanoparticles</kwd><kwd>Solid Lipid Particles</kwd><kwd>Taxanes</kwd><kwd>Cardiovascular Disease Treatment</kwd><kwd>LDL Receptors</kwd><kwd>Drug Targeting</kwd></kwd-group></article-meta></front><floats-group><table-wrap id="t1-cln_71p435" position="float"><label>Table 1</label><caption><p>Toxicity of LDE-paclitaxel administered as an intravenous infusion over 2 h every 3 weeks to 10 patients with aortic atheroma at a dose of 175 mg/m<sup>2</sup>. Toxicity was classified from grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated) to grade 5 (death related to adverse event). The data represent the number of patients who presented grade 1 toxicity only because no grade 2-5 toxicities were observed.</p></caption><table frame="hsides" rules="groups"><thead><tr><th valign="middle" align="left" rowspan="1" colspan="1">Treatment cycles</th><th valign="middle" align="center" rowspan="1" colspan="1">1</th><th valign="middle" align="center" rowspan="1" colspan="1">2</th><th valign="middle" align="center" rowspan="1" colspan="1">3</th><th valign="middle" align="center" rowspan="1" colspan="1">4</th><th valign="middle" align="center" rowspan="1" colspan="1">5</th><th valign="middle" align="center" rowspan="1" colspan="1">6</th></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1">Grade 1 toxicity</td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Clinical</td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Nausea</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Vomiting</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Local pain</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Arrhythmia</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Fever</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Dyspnea</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Alopecia</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Hematologic</td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Anemia</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Leucopenia</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">1</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Thrombocytopenia</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Hepatic</td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> AST</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> ALT</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Bilirubin</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> AP</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> GGT</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">1</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Renal</td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Urea</td><td valign="top" align="center" rowspan="1" colspan="1">2</td><td valign="top" align="center" rowspan="1" colspan="1">2</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Creatinine</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">3</td><td valign="top" align="center" rowspan="1" colspan="1">2</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">0</td><td valign="top" align="center" rowspan="1" colspan="1">1</td></tr></tbody></table><table-wrap-foot><fn id="tfn1-cln_71p435"><p>AST: aspartate aminotransferase; ALT: alanine aminotransferase; AP: alkaline phosphatase; GGT: gamma-glutamyl transferase</p></fn></table-wrap-foot></table-wrap><table-wrap id="t2-cln_71p435" position="float"><label>Table 2</label><caption><p>Fasting serum lipids and apolipoproteins (in mg/dl) in the patients treated with LDE-paclitaxel, measured approximately 2 weeks after each treatment cycle (the results are shown as the mean±S.D.). Paclitaxel-LDE was administered via intravenous infusion every 3 weeks at a dose of 175 mg/m<sup>2</sup> body surface area.</p></caption><table frame="hsides" rules="groups"><thead><tr><th valign="top" align="left" rowspan="2" colspan="1">Parameters</th><th valign="top" colspan="7" align="center" rowspan="1">Treatment Cycles</th></tr><tr><th valign="top" align="center" rowspan="1" colspan="1">0</th><th valign="top" align="center" rowspan="1" colspan="1">1</th><th valign="top" align="center" rowspan="1" colspan="1">2</th><th valign="top" align="center" rowspan="1" colspan="1">3</th><th valign="top" align="center" rowspan="1" colspan="1">4</th><th valign="top" align="center" rowspan="1" colspan="1">5</th><th valign="top" align="center" rowspan="1" colspan="1">6</th></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1">Cholesterol (mg/dL)</td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> Total</td><td valign="top" align="center" rowspan="1" colspan="1">167±44</td><td valign="top" align="center" rowspan="1" colspan="1">169±32</td><td valign="top" align="center" rowspan="1" colspan="1">169±30</td><td valign="top" align="center" rowspan="1" colspan="1">168±24</td><td valign="top" align="center" rowspan="1" colspan="1">165±28</td><td valign="top" align="center" rowspan="1" colspan="1">173±34</td><td valign="top" align="center" rowspan="1" colspan="1">204±48</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> LDL</td><td valign="top" align="center" rowspan="1" colspan="1">90±34</td><td valign="top" align="center" rowspan="1" colspan="1">90±15</td><td valign="top" align="center" rowspan="1" colspan="1">86±14</td><td valign="top" align="center" rowspan="1" colspan="1">92±18</td><td valign="top" align="center" rowspan="1" colspan="1">87±18</td><td valign="top" align="center" rowspan="1" colspan="1">92±22</td><td valign="top" align="center" rowspan="1" colspan="1">109±34</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> HDL</td><td valign="top" align="center" rowspan="1" colspan="1">45±14</td><td valign="top" align="center" rowspan="1" colspan="1">46±13</td><td valign="top" align="center" rowspan="1" colspan="1">49±13</td><td valign="top" align="center" rowspan="1" colspan="1">48±14</td><td valign="top" align="center" rowspan="1" colspan="1">46±11</td><td valign="top" align="center" rowspan="1" colspan="1">47±13</td><td valign="top" align="center" rowspan="1" colspan="1">49±12</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Triglycerides (mg/dL)</td><td valign="top" align="center" rowspan="1" colspan="1">170±93</td><td valign="top" align="center" rowspan="1" colspan="1">161±105</td><td valign="top" align="center" rowspan="1" colspan="1">124±46</td><td valign="top" align="center" rowspan="1" colspan="1">147±56</td><td valign="top" align="center" rowspan="1" colspan="1">134±58</td><td valign="top" align="center" rowspan="1" colspan="1">156±72</td><td valign="top" align="center" rowspan="1" colspan="1">204±76</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Apolipoproteins (mg/dL)</td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td><td valign="top" align="left" rowspan="1" colspan="1"></td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> A1</td><td valign="top" align="center" rowspan="1" colspan="1">136±19</td><td valign="top" align="center" rowspan="1" colspan="1">127±24</td><td valign="top" align="center" rowspan="1" colspan="1">131±21</td><td valign="top" align="center" rowspan="1" colspan="1">131±9</td><td valign="top" align="center" rowspan="1" colspan="1">136±25</td><td valign="top" align="center" rowspan="1" colspan="1">136±20</td><td valign="top" align="center" rowspan="1" colspan="1">155±20</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1"> B</td><td valign="top" align="center" rowspan="1" colspan="1">92±30</td><td valign="top" align="center" rowspan="1" colspan="1">86±15</td><td valign="top" align="center" rowspan="1" colspan="1">86±19</td><td valign="top" align="center" rowspan="1" colspan="1">87±20</td><td valign="top" align="center" rowspan="1" colspan="1">84±18</td><td valign="top" align="center" rowspan="1" colspan="1">89±23</td><td valign="top" align="center" rowspan="1" colspan="1">99±38</td></tr></tbody></table></table-wrap><table-wrap id="t3-cln_71p435" position="float"><label>Table 3</label><caption><p>Aortic plaque volumes in 8 patients with aortic atherosclerotic disease before and after six cycles of treatment with LDE-paclitaxel administered via intravenous infusion over 2h every three weeks at a 175 mg/m<sup>2</sup> body surface area dose.</p></caption><table frame="hsides" rules="groups"><thead><tr><th valign="top" align="left" rowspan="2" colspan="1">Patient</th><th valign="top" colspan="2" align="center" rowspan="1">Plaque Volume (cm<sup>3</sup>)</th><th valign="top" align="center" rowspan="2" colspan="1">% Variation</th></tr><tr><th valign="top" align="center" rowspan="1" colspan="1">Pre-treatment</th><th valign="top" align="center" rowspan="1" colspan="1">Post-treatment</th></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1">1</td><td valign="top" align="center" rowspan="1" colspan="1">367</td><td valign="top" align="center" rowspan="1" colspan="1">288</td><td valign="top" align="center" rowspan="1" colspan="1">-22</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">2</td><td valign="top" align="center" rowspan="1" colspan="1">819</td><td valign="top" align="center" rowspan="1" colspan="1">851</td><td valign="top" align="center" rowspan="1" colspan="1">+4</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">3</td><td valign="top" align="center" rowspan="1" colspan="1">627</td><td valign="top" align="center" rowspan="1" colspan="1">641</td><td valign="top" align="center" rowspan="1" colspan="1">+2</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">4</td><td valign="top" align="center" rowspan="1" colspan="1">793</td><td valign="top" align="center" rowspan="1" colspan="1">572</td><td valign="top" align="center" rowspan="1" colspan="1">-28</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">5</td><td valign="top" align="center" rowspan="1" colspan="1">530</td><td valign="top" align="center" rowspan="1" colspan="1">477</td><td valign="top" align="center" rowspan="1" colspan="1">-10</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">6</td><td valign="top" align="center" rowspan="1" colspan="1">457</td><td valign="top" align="center" rowspan="1" colspan="1">530</td><td valign="top" align="center" rowspan="1" colspan="1">+16</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">7</td><td valign="top" align="center" rowspan="1" colspan="1">398</td><td valign="top" align="center" rowspan="1" colspan="1">377</td><td valign="top" align="center" rowspan="1" colspan="1">-5</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">8</td><td valign="top" align="center" rowspan="1" colspan="1">257</td><td valign="top" align="center" rowspan="1" colspan="1">256</td><td valign="top" align="center" rowspan="1" colspan="1">0</td></tr></tbody></table></table-wrap><table-wrap id="t4-cln_71p435" position="float"><label>Table 4</label><caption><p>Plaque volume (cm<sup>3</sup>) measured twice in the aorta with a 6-8 month interval between the two observations in 9 patients with aortic atherosclerotic disease who were not treated with LDE-paclitaxel (controls).</p></caption><table frame="hsides" rules="groups"><thead><tr><th valign="top" align="left" rowspan="2" colspan="1">Patient</th><th valign="top" colspan="2" align="center" rowspan="1">Plaque Volume (cm<sup>3</sup>)</th><th valign="top" align="left" rowspan="2" colspan="1">% Variation</th></tr><tr><th valign="top" align="center" rowspan="1" colspan="1">1<sup>st</sup> Observation</th><th valign="top" align="center" rowspan="1" colspan="1">2<sup>nd</sup> Observation</th></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1">9</td><td valign="top" align="center" rowspan="1" colspan="1">202</td><td valign="top" align="center" rowspan="1" colspan="1">204</td><td valign="top" align="center" rowspan="1" colspan="1">+2</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">10</td><td valign="top" align="center" rowspan="1" colspan="1">358</td><td valign="top" align="center" rowspan="1" colspan="1">363</td><td valign="top" align="center" rowspan="1" colspan="1">+2</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">11</td><td valign="top" align="center" rowspan="1" colspan="1">133</td><td valign="top" align="center" rowspan="1" colspan="1">136</td><td valign="top" align="center" rowspan="1" colspan="1">+2</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">12</td><td valign="top" align="center" rowspan="1" colspan="1">272</td><td valign="top" align="center" rowspan="1" colspan="1">280</td><td valign="top" align="center" rowspan="1" colspan="1">+3</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">13</td><td valign="top" align="center" rowspan="1" colspan="1">382</td><td valign="top" align="center" rowspan="1" colspan="1">398</td><td valign="top" align="center" rowspan="1" colspan="1">+4</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">14</td><td valign="top" align="center" rowspan="1" colspan="1">538</td><td valign="top" align="center" rowspan="1" colspan="1">552</td><td valign="top" align="center" rowspan="1" colspan="1">+3</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">15</td><td valign="top" align="center" rowspan="1" colspan="1">138</td><td valign="top" align="center" rowspan="1" colspan="1">142</td><td valign="top" align="center" rowspan="1" colspan="1">+3</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">16</td><td valign="top" align="center" rowspan="1" colspan="1">190</td><td valign="top" align="center" rowspan="1" colspan="1">201</td><td valign="top" align="center" rowspan="1" colspan="1">+6</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">17</td><td valign="top" align="center" rowspan="1" colspan="1">392</td><td valign="top" align="center" rowspan="1" colspan="1">406</td><td valign="top" align="center" rowspan="1" colspan="1">+4</td></tr></tbody></table></table-wrap></floats-group></pmc><affiliations><list><country><li>Brésil</li></country><region><li>État de São Paulo</li></region><settlement><li>São Paulo</li></settlement><orgName><li>Université de São Paulo</li></orgName></list><tree><country name="Brésil"><region name="État de São Paulo"><name sortKey="Shiozaki, Afonso A" sort="Shiozaki, Afonso A" uniqKey="Shiozaki A" first="Afonso A." last="Shiozaki">Afonso A. Shiozaki</name></region><name sortKey="Deus, Debora F" sort="Deus, Debora F" uniqKey="Deus D" first="Débora F." last="Deus">Débora F. Deus</name><name sortKey="Maranhao, Raul C" sort="Maranhao, Raul C" uniqKey="Maranhao R" first="Raul C." last="Maranhão">Raul C. Maranhão</name><name sortKey="Maranhao, Raul C" sort="Maranhao, Raul C" uniqKey="Maranhao R" first="Raul C." last="Maranhão">Raul C. Maranhão</name><name sortKey="Morikawa, Aleksandra T" sort="Morikawa, Aleksandra T" uniqKey="Morikawa A" first="Aleksandra T." last="Morikawa">Aleksandra T. Morikawa</name><name sortKey="Paladino, Antonio T" sort="Paladino, Antonio T" uniqKey="Paladino A" first="Antonio T" last="Paladino">Antonio T. Paladino</name><name sortKey="Pinto, Ibraim M F" sort="Pinto, Ibraim M F" uniqKey="Pinto I" first="Ibraim M. F." last="Pinto">Ibraim M. F. Pinto</name><name sortKey="Senra, Tiago" sort="Senra, Tiago" uniqKey="Senra T" first="Tiago" last="Senra">Tiago Senra</name><name sortKey="Shiozaki, Afonso A" sort="Shiozaki, Afonso A" uniqKey="Shiozaki A" first="Afonso A." last="Shiozaki">Afonso A. Shiozaki</name><name sortKey="Shiozaki, Afonso A" sort="Shiozaki, Afonso A" uniqKey="Shiozaki A" first="Afonso A." last="Shiozaki">Afonso A. Shiozaki</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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