Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer
Identifieur interne : 002366 ( Main/Curation ); précédent : 002365; suivant : 002367Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer
Auteurs : Timothy M. Zagar ; Zeljko Vujaskovic ; Silvia Formenti ; Hope Rugo ; Franco Muggia ; Brigid O Onnor ; Robert Myerson ; Paul Stauffer ; I-Chow Hsu ; Chris Diederich ; William Straube ; Mary-Keara Boss ; Alina Boico ; Oana Craciunescu ; Paolo Maccarini ; David Needham ; Nicholas Borys ; Kimberly L. Blackwell [États-Unis] ; Mark W. DewhirstSource :
- International Journal of Hyperthermia [ 0265-6736 ] ; 2014.
Abstract
Unresectable chest wall recurrences of breast cancer (CWR) in heavily pretreated patients are especially difficult to treat. We hypothesised that thermally enhanced drug delivery using low temperature liposomal doxorubicin (LTLD), given with mild local hyperthermia (MLHT), will be safe and effective in this population.
This paper combines the results of two similarly designed phase I trials. Eligible CWR patients had progressed on the chest wall after prior hormone therapy, chemotherapy, and radiotherapy. Patients were to get six cycles of LTLD every 21–35 days, followed immediately by chest wall MLHT for 1 hour at 40–42 °C. In the first trial 18 subjects received LTLD at 20, 30, or 40 mg/m2; in the second trial, 11 subjects received LTLD at 40 or 50 mg/m2.
The median age of all 29 patients enrolled was 57 years. Thirteen patients (45%) had distant metastases on enrolment. Patients had received a median dose of 256 mg/m2 of prior anthracyclines and a median dose of 61 Gy of prior radiation. The median number of study treatments that subjects completed was four. The maximum tolerated dose was 50 mg/m2, with seven subjects (24%) developing reversible grade 3–4 neutropenia and four (14%) reversible grade 3–4 leucopenia. The rate of overall local response was 48% (14/29, 95% CI: 30–66%), with. five patients (17%) achieving complete local responses and nine patients (31%) having partial local responses.
LTLD at 50 mg/m2 and MLHT is safe. This combined therapy produces objective responses in heavily pretreated CWR patients. Future work should test thermally enhanced LTLD delivery in a less advanced patient population.
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DOI: 10.3109/02656736.2014.936049
PubMed: 25144817
PubMed Central: 4162656
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Timothy M. Zagar<affiliation><nlm:aff id="end-a1"><institution>Department of Radiation Oncology, University of North Carolina Hospital</institution><addr-line>Chapel Hill</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a2"><institution>Department of Radiation Oncology, University of Maryland Medical Center</institution><addr-line>Baltimore</addr-line><country>Maryland</country></nlm:aff><wicri:noCountry code="nlm country">Maryland</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a3"><institution>Department of Radiation Oncology, New York University Langone Medical Center</institution><country>New York</country></nlm:aff><wicri:noCountry code="nlm country">New York</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a4"><institution>Department of Medicine, University of California San Francisco Helen Diller Family Cancer Center</institution><addr-line>San Francisco</addr-line><country>California</country></nlm:aff><wicri:noCountry code="nlm country">California</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a5"><institution>Department of Medicine, New York University Langone Medical Center</institution><country>New York</country></nlm:aff><wicri:noCountry code="nlm country">New York</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a6"><institution>Department of Radiation Oncology, Rhode Island Hospital</institution><addr-line>Providence</addr-line><country>Rhode Island</country></nlm:aff><wicri:noCountry code="nlm country">Rhode Island</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a7"><institution>Department of Radiation Oncology, Washington University at St. Louis Siteman Cancer Center</institution><addr-line>St. Louis</addr-line><country>Missouri</country></nlm:aff><wicri:noCountry code="nlm country">Missouri</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a9"><institution>Department of Radiation Oncology, University of California San Francisco Helen Diller Family Cancer Center</institution><addr-line>San Francisco</addr-line><country>California</country></nlm:aff><wicri:noCountry code="nlm country">California</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a9"><institution>Department of Radiation Oncology, University of California San Francisco Helen Diller Family Cancer Center</institution><addr-line>San Francisco</addr-line><country>California</country></nlm:aff><wicri:noCountry code="nlm country">California</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a7"><institution>Department of Radiation Oncology, Washington University at St. Louis Siteman Cancer Center</institution><addr-line>St. Louis</addr-line><country>Missouri</country></nlm:aff><wicri:noCountry code="nlm country">Missouri</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a10"><institution>Department of Molecular Biomedical Sciences, North Carolina State College of Veterinary Medicine</institution><addr-line>Raleigh</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a11"><institution>Department of Biomedical Engineering, Duke University</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a12"><institution>Department of Mechanical Engineering and Material Science, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a13"><institution>Celsion Corporation</institution><addr-line>Lawrenceville</addr-line><country>New Jersey</country></nlm:aff><wicri:noCountry code="nlm country">New Jersey</wicri:noCountry></affiliation><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation>Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer</title><author><name sortKey="Zagar, Timothy M" sort="Zagar, Timothy M" uniqKey="Zagar T" first="Timothy M." last="Zagar">Timothy M. Zagar</name><affiliation><nlm:aff id="end-a1"><institution>Department of Radiation Oncology, University of North Carolina Hospital</institution><addr-line>Chapel Hill</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Vujaskovic, Zeljko" sort="Vujaskovic, Zeljko" uniqKey="Vujaskovic Z" first="Zeljko" last="Vujaskovic">Zeljko Vujaskovic</name><affiliation><nlm:aff id="end-a2"><institution>Department of Radiation Oncology, University of Maryland Medical Center</institution><addr-line>Baltimore</addr-line><country>Maryland</country></nlm:aff><wicri:noCountry code="nlm country">Maryland</wicri:noCountry></affiliation></author><author><name sortKey="Formenti, Silvia" sort="Formenti, Silvia" uniqKey="Formenti S" first="Silvia" last="Formenti">Silvia Formenti</name><affiliation><nlm:aff id="end-a3"><institution>Department of Radiation Oncology, New York University Langone Medical Center</institution><country>New York</country></nlm:aff><wicri:noCountry code="nlm country">New York</wicri:noCountry></affiliation></author><author><name sortKey="Rugo, Hope" sort="Rugo, Hope" uniqKey="Rugo H" first="Hope" last="Rugo">Hope Rugo</name><affiliation><nlm:aff id="end-a4"><institution>Department of Medicine, University of California San Francisco Helen Diller Family Cancer Center</institution><addr-line>San Francisco</addr-line><country>California</country></nlm:aff><wicri:noCountry code="nlm country">California</wicri:noCountry></affiliation></author><author><name sortKey="Muggia, Franco" sort="Muggia, Franco" uniqKey="Muggia F" first="Franco" last="Muggia">Franco Muggia</name><affiliation><nlm:aff id="end-a5"><institution>Department of Medicine, New York University Langone Medical Center</institution><country>New York</country></nlm:aff><wicri:noCountry code="nlm country">New York</wicri:noCountry></affiliation></author><author><name sortKey="O Onnor, Brigid" sort="O Onnor, Brigid" uniqKey="O Onnor B" first="Brigid" last="O Onnor">Brigid O Onnor</name><affiliation><nlm:aff id="end-a6"><institution>Department of Radiation Oncology, Rhode Island Hospital</institution><addr-line>Providence</addr-line><country>Rhode Island</country></nlm:aff><wicri:noCountry code="nlm country">Rhode Island</wicri:noCountry></affiliation></author><author><name sortKey="Myerson, Robert" sort="Myerson, Robert" uniqKey="Myerson R" first="Robert" last="Myerson">Robert Myerson</name><affiliation><nlm:aff id="end-a7"><institution>Department of Radiation Oncology, Washington University at St. Louis Siteman Cancer Center</institution><addr-line>St. Louis</addr-line><country>Missouri</country></nlm:aff><wicri:noCountry code="nlm country">Missouri</wicri:noCountry></affiliation></author><author><name sortKey="Stauffer, Paul" sort="Stauffer, Paul" uniqKey="Stauffer P" first="Paul" last="Stauffer">Paul Stauffer</name><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Hsu, I Chow" sort="Hsu, I Chow" uniqKey="Hsu I" first="I-Chow" last="Hsu">I-Chow Hsu</name><affiliation><nlm:aff id="end-a9"><institution>Department of Radiation Oncology, University of California San Francisco Helen Diller Family Cancer Center</institution><addr-line>San Francisco</addr-line><country>California</country></nlm:aff><wicri:noCountry code="nlm country">California</wicri:noCountry></affiliation></author><author><name sortKey="Diederich, Chris" sort="Diederich, Chris" uniqKey="Diederich C" first="Chris" last="Diederich">Chris Diederich</name><affiliation><nlm:aff id="end-a9"><institution>Department of Radiation Oncology, University of California San Francisco Helen Diller Family Cancer Center</institution><addr-line>San Francisco</addr-line><country>California</country></nlm:aff><wicri:noCountry code="nlm country">California</wicri:noCountry></affiliation></author><author><name sortKey="Straube, William" sort="Straube, William" uniqKey="Straube W" first="William" last="Straube">William Straube</name><affiliation><nlm:aff id="end-a7"><institution>Department of Radiation Oncology, Washington University at St. Louis Siteman Cancer Center</institution><addr-line>St. Louis</addr-line><country>Missouri</country></nlm:aff><wicri:noCountry code="nlm country">Missouri</wicri:noCountry></affiliation></author><author><name sortKey="Boss, Mary Keara" sort="Boss, Mary Keara" uniqKey="Boss M" first="Mary-Keara" last="Boss">Mary-Keara Boss</name><affiliation><nlm:aff id="end-a10"><institution>Department of Molecular Biomedical Sciences, North Carolina State College of Veterinary Medicine</institution><addr-line>Raleigh</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Boico, Alina" sort="Boico, Alina" uniqKey="Boico A" first="Alina" last="Boico">Alina Boico</name><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Craciunescu, Oana" sort="Craciunescu, Oana" uniqKey="Craciunescu O" first="Oana" last="Craciunescu">Oana Craciunescu</name><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Maccarini, Paolo" sort="Maccarini, Paolo" uniqKey="Maccarini P" first="Paolo" last="Maccarini">Paolo Maccarini</name><affiliation><nlm:aff id="end-a11"><institution>Department of Biomedical Engineering, Duke University</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Needham, David" sort="Needham, David" uniqKey="Needham D" first="David" last="Needham">David Needham</name><affiliation><nlm:aff id="end-a12"><institution>Department of Mechanical Engineering and Material Science, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Borys, Nicholas" sort="Borys, Nicholas" uniqKey="Borys N" first="Nicholas" last="Borys">Nicholas Borys</name><affiliation><nlm:aff id="end-a13"><institution>Celsion Corporation</institution><addr-line>Lawrenceville</addr-line><country>New Jersey</country></nlm:aff><wicri:noCountry code="nlm country">New Jersey</wicri:noCountry></affiliation></author><author><name sortKey="Blackwell, Kimberly L" sort="Blackwell, Kimberly L" uniqKey="Blackwell K" first="Kimberly L." last="Blackwell">Kimberly L. Blackwell</name><affiliation wicri:level="1"><nlm:aff id="end-a14"><institution>Department of Medicine, Duke University Medical Center</institution><addr-line>Durham, North Carolina</addr-line><country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dewhirst, Mark W" sort="Dewhirst, Mark W" uniqKey="Dewhirst M" first="Mark W." last="Dewhirst">Mark W. Dewhirst</name><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25144817</idno><idno type="pmc">4162656</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4162656</idno><idno type="RBID">PMC:4162656</idno><idno type="doi">10.3109/02656736.2014.936049</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">003F60</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">003F60</idno><idno type="wicri:Area/Pmc/Curation">003F59</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">003F59</idno><idno type="wicri:Area/Pmc/Checkpoint">001653</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001653</idno><idno type="wicri:Area/Ncbi/Merge">006A14</idno><idno type="wicri:Area/Ncbi/Curation">006A14</idno><idno type="wicri:Area/Ncbi/Checkpoint">006A14</idno><idno type="wicri:doubleKey">0265-6736:2014:Zagar T:two:phase:i</idno><idno type="wicri:Area/Main/Merge">002369</idno><idno type="wicri:Area/Main/Curation">002366</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer</title><author><name sortKey="Zagar, Timothy M" sort="Zagar, Timothy M" uniqKey="Zagar T" first="Timothy M." last="Zagar">Timothy M. Zagar</name><affiliation><nlm:aff id="end-a1"><institution>Department of Radiation Oncology, University of North Carolina Hospital</institution><addr-line>Chapel Hill</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Vujaskovic, Zeljko" sort="Vujaskovic, Zeljko" uniqKey="Vujaskovic Z" first="Zeljko" last="Vujaskovic">Zeljko Vujaskovic</name><affiliation><nlm:aff id="end-a2"><institution>Department of Radiation Oncology, University of Maryland Medical Center</institution><addr-line>Baltimore</addr-line><country>Maryland</country></nlm:aff><wicri:noCountry code="nlm country">Maryland</wicri:noCountry></affiliation></author><author><name sortKey="Formenti, Silvia" sort="Formenti, Silvia" uniqKey="Formenti S" first="Silvia" last="Formenti">Silvia Formenti</name><affiliation><nlm:aff id="end-a3"><institution>Department of Radiation Oncology, New York University Langone Medical Center</institution><country>New York</country></nlm:aff><wicri:noCountry code="nlm country">New York</wicri:noCountry></affiliation></author><author><name sortKey="Rugo, Hope" sort="Rugo, Hope" uniqKey="Rugo H" first="Hope" last="Rugo">Hope Rugo</name><affiliation><nlm:aff id="end-a4"><institution>Department of Medicine, University of California San Francisco Helen Diller Family Cancer Center</institution><addr-line>San Francisco</addr-line><country>California</country></nlm:aff><wicri:noCountry code="nlm country">California</wicri:noCountry></affiliation></author><author><name sortKey="Muggia, Franco" sort="Muggia, Franco" uniqKey="Muggia F" first="Franco" last="Muggia">Franco Muggia</name><affiliation><nlm:aff id="end-a5"><institution>Department of Medicine, New York University Langone Medical Center</institution><country>New York</country></nlm:aff><wicri:noCountry code="nlm country">New York</wicri:noCountry></affiliation></author><author><name sortKey="O Onnor, Brigid" sort="O Onnor, Brigid" uniqKey="O Onnor B" first="Brigid" last="O Onnor">Brigid O Onnor</name><affiliation><nlm:aff id="end-a6"><institution>Department of Radiation Oncology, Rhode Island Hospital</institution><addr-line>Providence</addr-line><country>Rhode Island</country></nlm:aff><wicri:noCountry code="nlm country">Rhode Island</wicri:noCountry></affiliation></author><author><name sortKey="Myerson, Robert" sort="Myerson, Robert" uniqKey="Myerson R" first="Robert" last="Myerson">Robert Myerson</name><affiliation><nlm:aff id="end-a7"><institution>Department of Radiation Oncology, Washington University at St. Louis Siteman Cancer Center</institution><addr-line>St. Louis</addr-line><country>Missouri</country></nlm:aff><wicri:noCountry code="nlm country">Missouri</wicri:noCountry></affiliation></author><author><name sortKey="Stauffer, Paul" sort="Stauffer, Paul" uniqKey="Stauffer P" first="Paul" last="Stauffer">Paul Stauffer</name><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Hsu, I Chow" sort="Hsu, I Chow" uniqKey="Hsu I" first="I-Chow" last="Hsu">I-Chow Hsu</name><affiliation><nlm:aff id="end-a9"><institution>Department of Radiation Oncology, University of California San Francisco Helen Diller Family Cancer Center</institution><addr-line>San Francisco</addr-line><country>California</country></nlm:aff><wicri:noCountry code="nlm country">California</wicri:noCountry></affiliation></author><author><name sortKey="Diederich, Chris" sort="Diederich, Chris" uniqKey="Diederich C" first="Chris" last="Diederich">Chris Diederich</name><affiliation><nlm:aff id="end-a9"><institution>Department of Radiation Oncology, University of California San Francisco Helen Diller Family Cancer Center</institution><addr-line>San Francisco</addr-line><country>California</country></nlm:aff><wicri:noCountry code="nlm country">California</wicri:noCountry></affiliation></author><author><name sortKey="Straube, William" sort="Straube, William" uniqKey="Straube W" first="William" last="Straube">William Straube</name><affiliation><nlm:aff id="end-a7"><institution>Department of Radiation Oncology, Washington University at St. Louis Siteman Cancer Center</institution><addr-line>St. Louis</addr-line><country>Missouri</country></nlm:aff><wicri:noCountry code="nlm country">Missouri</wicri:noCountry></affiliation></author><author><name sortKey="Boss, Mary Keara" sort="Boss, Mary Keara" uniqKey="Boss M" first="Mary-Keara" last="Boss">Mary-Keara Boss</name><affiliation><nlm:aff id="end-a10"><institution>Department of Molecular Biomedical Sciences, North Carolina State College of Veterinary Medicine</institution><addr-line>Raleigh</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Boico, Alina" sort="Boico, Alina" uniqKey="Boico A" first="Alina" last="Boico">Alina Boico</name><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Craciunescu, Oana" sort="Craciunescu, Oana" uniqKey="Craciunescu O" first="Oana" last="Craciunescu">Oana Craciunescu</name><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Maccarini, Paolo" sort="Maccarini, Paolo" uniqKey="Maccarini P" first="Paolo" last="Maccarini">Paolo Maccarini</name><affiliation><nlm:aff id="end-a11"><institution>Department of Biomedical Engineering, Duke University</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Needham, David" sort="Needham, David" uniqKey="Needham D" first="David" last="Needham">David Needham</name><affiliation><nlm:aff id="end-a12"><institution>Department of Mechanical Engineering and Material Science, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author><author><name sortKey="Borys, Nicholas" sort="Borys, Nicholas" uniqKey="Borys N" first="Nicholas" last="Borys">Nicholas Borys</name><affiliation><nlm:aff id="end-a13"><institution>Celsion Corporation</institution><addr-line>Lawrenceville</addr-line><country>New Jersey</country></nlm:aff><wicri:noCountry code="nlm country">New Jersey</wicri:noCountry></affiliation></author><author><name sortKey="Blackwell, Kimberly L" sort="Blackwell, Kimberly L" uniqKey="Blackwell K" first="Kimberly L." last="Blackwell">Kimberly L. Blackwell</name><affiliation wicri:level="1"><nlm:aff id="end-a14"><institution>Department of Medicine, Duke University Medical Center</institution><addr-line>Durham, North Carolina</addr-line><country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dewhirst, Mark W" sort="Dewhirst, Mark W" uniqKey="Dewhirst M" first="Mark W." last="Dewhirst">Mark W. Dewhirst</name><affiliation><nlm:aff id="end-a8"><institution>Department of Radiation Oncology, Duke University Medical Center</institution><addr-line>Durham</addr-line><country>North Carolina</country></nlm:aff><wicri:noCountry code="nlm country">North Carolina</wicri:noCountry></affiliation></author></analytic><series><title level="j">International Journal of Hyperthermia</title><idno type="ISSN">0265-6736</idno><idno type="eISSN">1464-5157</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>Unresectable chest wall recurrences of breast cancer (CWR) in heavily pretreated patients are especially difficult to treat. We hypothesised that thermally enhanced drug delivery using low temperature liposomal doxorubicin (LTLD), given with mild local hyperthermia (MLHT), will be safe and effective in this population.</p></sec><sec><title>Patients and methods</title><p>This paper combines the results of two similarly designed phase I trials. Eligible CWR patients had progressed on the chest wall after prior hormone therapy, chemotherapy, and radiotherapy. Patients were to get six cycles of LTLD every 21–35 days, followed immediately by chest wall MLHT for 1 hour at 40–42 °C. In the first trial 18 subjects received LTLD at 20, 30, or 40 mg/m<sup>2</sup>; in the second trial, 11 subjects received LTLD at 40 or 50 mg/m<sup>2</sup>.</p></sec><sec><title>Results</title><p>The median age of all 29 patients enrolled was 57 years. Thirteen patients (45%) had distant metastases on enrolment. Patients had received a median dose of 256 mg/m<sup>2</sup> of prior anthracyclines and a median dose of 61 Gy of prior radiation. The median number of study treatments that subjects completed was four. The maximum tolerated dose was 50 mg/m<sup>2</sup>, with seven subjects (24%) developing reversible grade 3–4 neutropenia and four (14%) reversible grade 3–4 leucopenia. The rate of overall local response was 48% (14/29, 95% CI: 30–66%), with. five patients (17%) achieving complete local responses and nine patients (31%) having partial local responses.</p></sec><sec><title>Conclusion</title><p>LTLD at 50 mg/m<sup>2</sup> and MLHT is safe. This combined therapy produces objective responses in heavily pretreated CWR patients. 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