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<title xml:lang="en">Liposomal Nystatin in Patients with Invasive Aspergillosis Refractory to or Intolerant of Amphotericin B</title>
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<name sortKey="Offner, Fritz" sort="Offner, Fritz" uniqKey="Offner F" first="Fritz" last="Offner">Fritz Offner</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
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<author>
<name sortKey="Krcmery, Vladimir" sort="Krcmery, Vladimir" uniqKey="Krcmery V" first="Vladimir" last="Krcmery">Vladimir Krcmery</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
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<author>
<name sortKey="Boogaerts, Marc" sort="Boogaerts, Marc" uniqKey="Boogaerts M" first="Marc" last="Boogaerts">Marc Boogaerts</name>
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<nlm:aff id="aff1"></nlm:aff>
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<author>
<name sortKey="Doyen, Chantal" sort="Doyen, Chantal" uniqKey="Doyen C" first="Chantal" last="Doyen">Chantal Doyen</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
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<author>
<name sortKey="Engelhard, Dan" sort="Engelhard, Dan" uniqKey="Engelhard D" first="Dan" last="Engelhard">Dan Engelhard</name>
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<nlm:aff id="aff1"></nlm:aff>
</affiliation>
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<author>
<name sortKey="Ribaud, Patricia" sort="Ribaud, Patricia" uniqKey="Ribaud P" first="Patricia" last="Ribaud">Patricia Ribaud</name>
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</affiliation>
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<author>
<name sortKey="Cordonnier, Catherine" sort="Cordonnier, Catherine" uniqKey="Cordonnier C" first="Catherine" last="Cordonnier">Catherine Cordonnier</name>
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<name sortKey="De Pauw, Ben" sort="De Pauw, Ben" uniqKey="De Pauw B" first="Ben" last="De Pauw">Ben De Pauw</name>
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<name sortKey="Durrant, Simon" sort="Durrant, Simon" uniqKey="Durrant S" first="Simon" last="Durrant">Simon Durrant</name>
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<name sortKey="Marie, Jean Pierre" sort="Marie, Jean Pierre" uniqKey="Marie J" first="Jean-Pierre" last="Marie">Jean-Pierre Marie</name>
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<name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name>
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<name sortKey="Guiot, Harry" sort="Guiot, Harry" uniqKey="Guiot H" first="Harry" last="Guiot">Harry Guiot</name>
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<name sortKey="Samonis, George" sort="Samonis, George" uniqKey="Samonis G" first="George" last="Samonis">George Samonis</name>
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<nlm:aff id="aff1"></nlm:aff>
</affiliation>
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<author>
<name sortKey="Sylvester, Richard" sort="Sylvester, Richard" uniqKey="Sylvester R" first="Richard" last="Sylvester">Richard Sylvester</name>
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</affiliation>
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<name sortKey="Herbrecht, Raoul" sort="Herbrecht, Raoul" uniqKey="Herbrecht R" first="Raoul" last="Herbrecht">Raoul Herbrecht</name>
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<idno type="RBID">PMC:529246</idno>
<idno type="doi">10.1128/AAC.48.12.4808-4812.2004</idno>
<date when="2004">2004</date>
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<title xml:lang="en" level="a" type="main">Liposomal Nystatin in Patients with Invasive Aspergillosis Refractory to or Intolerant of Amphotericin B</title>
<author>
<name sortKey="Offner, Fritz" sort="Offner, Fritz" uniqKey="Offner F" first="Fritz" last="Offner">Fritz Offner</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Krcmery, Vladimir" sort="Krcmery, Vladimir" uniqKey="Krcmery V" first="Vladimir" last="Krcmery">Vladimir Krcmery</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Boogaerts, Marc" sort="Boogaerts, Marc" uniqKey="Boogaerts M" first="Marc" last="Boogaerts">Marc Boogaerts</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Doyen, Chantal" sort="Doyen, Chantal" uniqKey="Doyen C" first="Chantal" last="Doyen">Chantal Doyen</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Engelhard, Dan" sort="Engelhard, Dan" uniqKey="Engelhard D" first="Dan" last="Engelhard">Dan Engelhard</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Ribaud, Patricia" sort="Ribaud, Patricia" uniqKey="Ribaud P" first="Patricia" last="Ribaud">Patricia Ribaud</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Cordonnier, Catherine" sort="Cordonnier, Catherine" uniqKey="Cordonnier C" first="Catherine" last="Cordonnier">Catherine Cordonnier</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="De Pauw, Ben" sort="De Pauw, Ben" uniqKey="De Pauw B" first="Ben" last="De Pauw">Ben De Pauw</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Durrant, Simon" sort="Durrant, Simon" uniqKey="Durrant S" first="Simon" last="Durrant">Simon Durrant</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Marie, Jean Pierre" sort="Marie, Jean Pierre" uniqKey="Marie J" first="Jean-Pierre" last="Marie">Jean-Pierre Marie</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Guiot, Harry" sort="Guiot, Harry" uniqKey="Guiot H" first="Harry" last="Guiot">Harry Guiot</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Samonis, George" sort="Samonis, George" uniqKey="Samonis G" first="George" last="Samonis">George Samonis</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Sylvester, Richard" sort="Sylvester, Richard" uniqKey="Sylvester R" first="Richard" last="Sylvester">Richard Sylvester</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Herbrecht, Raoul" sort="Herbrecht, Raoul" uniqKey="Herbrecht R" first="Raoul" last="Herbrecht">Raoul Herbrecht</name>
<affiliation>
<nlm:aff id="aff1"></nlm:aff>
</affiliation>
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</analytic>
<series>
<title level="j">Antimicrobial Agents and Chemotherapy</title>
<idno type="ISSN">0066-4804</idno>
<idno type="eISSN">1098-6596</idno>
<imprint>
<date when="2004">2004</date>
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<front>
<div type="abstract" xml:lang="en">
<p>We assessed the activity and safety of liposomal nystatin, a broad-spectrum antifungal agent, for invasive aspergillosis in patients refractory to or intolerant of amphotericin B. Thirty-three patients were enrolled, received at least one dose of the study drug, and were evaluable for safety. Twenty-six patients had confirmed probable or definite aspergillosis and were fully eligible. Most patients had a hematological malignancy (53.8%) or hematopoietic stem cell transplantation (23.0%), were neutropenic (61.5%), and were refractory to previous amphotericin B (92.3%). The median duration of previous amphotericin B treatment was 16.5 days (range, 5 to 64 days). Aspergillosis was definite in 3 cases and probable in 23 cases. Liposomal nystatin was initiated at a dose of 4 mg/kg of body weight/day. Twenty-five patients were evaluable for response: a complete response was achieved for one patient, and a partial response was achieved for six. Thus, the overall response rate is 7 of 25 (28%; 95% confidence interval, 12 to 49%). Seventeen (68.0%) of the 25 evaluable patients died during therapy or within 1 month after the end of therapy. The primary cause of death was invasive aspergillosis for nine patients and underlying malignancy for eight patients. The most frequent side effects included chills, shivering, and fever, leading to discontinuation of therapy for two patients. Grade 1 decline in renal function was seen for 10 (30.3%) patients, and hypokalemia was seen for 13 (39.4%). We conclude that liposomal nystatin can be effective for salvage therapy of invasive aspergillosis. Infusion-related adverse events have been observed frequently.</p>
</div>
</front>
</TEI>
<pmc article-type="research-article">
<pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Antimicrob Agents Chemother</journal-id>
<journal-id journal-id-type="publisher-id">aac</journal-id>
<journal-title>Antimicrobial Agents and Chemotherapy</journal-title>
<issn pub-type="ppub">0066-4804</issn>
<issn pub-type="epub">1098-6596</issn>
<publisher>
<publisher-name>American Society for Microbiology</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">15561860</article-id>
<article-id pub-id-type="pmc">529246</article-id>
<article-id pub-id-type="publisher-id">1411-03</article-id>
<article-id pub-id-type="doi">10.1128/AAC.48.12.4808-4812.2004</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Clinical Therapeutics</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Liposomal Nystatin in Patients with Invasive Aspergillosis Refractory to or Intolerant of Amphotericin B</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Offner</surname>
<given-names>Fritz</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Krcmery</surname>
<given-names>Vladimir</given-names>
</name>
<xref ref-type="aff" rid="aff1">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Boogaerts</surname>
<given-names>Marc</given-names>
</name>
<xref ref-type="aff" rid="aff1">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Doyen</surname>
<given-names>Chantal</given-names>
</name>
<xref ref-type="aff" rid="aff1">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Engelhard</surname>
<given-names>Dan</given-names>
</name>
<xref ref-type="aff" rid="aff1">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Ribaud</surname>
<given-names>Patricia</given-names>
</name>
<xref ref-type="aff" rid="aff1">6</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Cordonnier</surname>
<given-names>Catherine</given-names>
</name>
<xref ref-type="aff" rid="aff1">7</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>de Pauw</surname>
<given-names>Ben</given-names>
</name>
<xref ref-type="aff" rid="aff1">8</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Durrant</surname>
<given-names>Simon</given-names>
</name>
<xref ref-type="aff" rid="aff1">9</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Marie</surname>
<given-names>Jean-Pierre</given-names>
</name>
<xref ref-type="aff" rid="aff1">10</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Moreau</surname>
<given-names>Philippe</given-names>
</name>
<xref ref-type="aff" rid="aff1">11</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Guiot</surname>
<given-names>Harry</given-names>
</name>
<xref ref-type="aff" rid="aff1">12</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Samonis</surname>
<given-names>George</given-names>
</name>
<xref ref-type="aff" rid="aff1">13</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Sylvester</surname>
<given-names>Richard</given-names>
</name>
<xref ref-type="aff" rid="aff1">14</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Herbrecht</surname>
<given-names>Raoul</given-names>
</name>
<xref ref-type="aff" rid="aff1">15</xref>
<xref ref-type="corresp" rid="cor1">*</xref>
</contrib>
<contrib contrib-type="author">
<collab>the EORTC Invasive Fungal Infections Group
<xref ref-type="fn" rid="fn1"></xref>
</collab>
</contrib>
</contrib-group>
<aff id="aff1">UZ Gent, Ghent,
<label>1</label>
UZ Gasthuisberg, Leuven,
<label>3</label>
Clinique Universitaire Mont Godinne, Yvoir,
<label>4</label>
EORTC Data Center, Brussels, Belgium,
<label>14</label>
St. Elisabeth Cancer Institute, Bratislava, Slovakia,
<label>2</label>
Hadassah University Hospital, Jerusalem, Israel,
<label>5</label>
Hôpital Saint Louis,
<label>6</label>
Hotel-Dieu, Paris,
<label>10</label>
Hôpital Henri Mondor, Créteil,
<label>7</label>
CHR Hotel-Dieu, Nantes,
<label>11</label>
Hôpital de Hautepierre, Strasbourg, France,
<label>15</label>
University Medical Centre, Nijmegen,
<label>8</label>
Leiden University Medical Center, Leiden, The Netherlands,
<label>12</label>
Royal Brisbane Hospital, Brisbane, Australia,
<label>9</label>
University General Hospital, Heraklion, Greece
<label>13</label>
</aff>
<author-notes>
<fn id="cor1">
<label>*</label>
<p>Corresponding author. Mailing address: Département d'Hématologie et d'Oncologie, Hôpital de Hautepierre, 67098 Strasbourg, France. Phone: 33 388 12 76 88. Fax: 33 388 12 76 81. E-mail:
<email>raoul.herbrecht@chru-strasbourg.fr</email>
.</p>
</fn>
<fn id="fn1">
<label></label>
<p>Participants in the EORTC Invasive Fungal Infections Group are listed in Acknowledgments.</p>
</fn>
</author-notes>
<pub-date pub-type="ppub">
<month>12</month>
<year>2004</year>
</pub-date>
<volume>48</volume>
<issue>12</issue>
<fpage>4808</fpage>
<lpage>4812</lpage>
<history>
<date date-type="received">
<day>31</day>
<month>12</month>
<year>2003</year>
</date>
<date date-type="rev-recd">
<day>12</day>
<month>2</month>
<year>2004</year>
</date>
<date date-type="accepted">
<day>25</day>
<month>6</month>
<year>2004</year>
</date>
</history>
<copyright-statement>Copyright © 2004, American Society for Microbiology</copyright-statement>
<copyright-year>2004</copyright-year>
<abstract>
<p>We assessed the activity and safety of liposomal nystatin, a broad-spectrum antifungal agent, for invasive aspergillosis in patients refractory to or intolerant of amphotericin B. Thirty-three patients were enrolled, received at least one dose of the study drug, and were evaluable for safety. Twenty-six patients had confirmed probable or definite aspergillosis and were fully eligible. Most patients had a hematological malignancy (53.8%) or hematopoietic stem cell transplantation (23.0%), were neutropenic (61.5%), and were refractory to previous amphotericin B (92.3%). The median duration of previous amphotericin B treatment was 16.5 days (range, 5 to 64 days). Aspergillosis was definite in 3 cases and probable in 23 cases. Liposomal nystatin was initiated at a dose of 4 mg/kg of body weight/day. Twenty-five patients were evaluable for response: a complete response was achieved for one patient, and a partial response was achieved for six. Thus, the overall response rate is 7 of 25 (28%; 95% confidence interval, 12 to 49%). Seventeen (68.0%) of the 25 evaluable patients died during therapy or within 1 month after the end of therapy. The primary cause of death was invasive aspergillosis for nine patients and underlying malignancy for eight patients. The most frequent side effects included chills, shivering, and fever, leading to discontinuation of therapy for two patients. Grade 1 decline in renal function was seen for 10 (30.3%) patients, and hypokalemia was seen for 13 (39.4%). We conclude that liposomal nystatin can be effective for salvage therapy of invasive aspergillosis. Infusion-related adverse events have been observed frequently.</p>
</abstract>
</article-meta>
</front>
</pmc>
</record>

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