AustralieFrV1, Main, Exploration, bibRecord, 00B158

Improvements in quality of life and disease-related symptoms in Phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell Lung Cancer and other solid tumors

Identifieur interne : 00B158 ( Main/Exploration ); précédent : 00B157; suivant : 00B159

Improvements in quality of life and disease-related symptoms in Phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell Lung Cancer and other solid tumors

Auteurs : Patricia M. Lorusso [Australie] ; Roy S. Herbst [Australie] ; Danny Rischin [Australie] ; Malcolm Ranson [Royaume-Uni] ; Hilary Calvert [Royaume-Uni] ; Eric Raymond [France] ; Dirk Kieback [Pays-Bas] ; Stan Kaye [Royaume-Uni] ; Luca Gianni [Italie] ; Adrian Harris [Royaume-Uni] ; Thomas Bjork [Suède] ; Anne-Marie Maddox [États-Unis] ; Mace L. Rothenberg [États-Unis] ; Eric J. Small [États-Unis] ; Eric H. Rubin [États-Unis] ; Andrea Feyereislova [Royaume-Uni] ; Anne Heyes [Royaume-Uni] ; Steven D. Averbuch [États-Unis] ; Judith Ochs [États-Unis] ; José Baselga [Espagne]

Source :

Clinical cancer research [ 1078-0432 ] ; 2003.

RBID : Pascal:03-0412288

Descripteurs français

Pascal (Inist)
- Inhibiteur enzyme, Stade avancé, Protein-tyrosine kinase, Amélioration, Qualité vie, Symptomatologie, Essai clinique phase I, Voie orale, Homme, Tumeur solide, Traitement, Chimiothérapie, Anticancéreux, Bronchopulmonaire, Carcinome non petite cellule bronchopulmonaire, ZD 1839, Iressa, Récepteur EGFR.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Antineoplastic agent, Bronchopulmonary, Chemotherapy, Enzyme inhibitor, Epidermal growth factor receptor, Human, Improvement, Oral administration, Phase I trial, Protein-tyrosine kinase, Quality of life, Solid tumor, Symptomatology, Treatment.

Abstract

Purpose: The feasibility and utility of assessing quality of life (QoL) and disease-related symptoms in patients with advanced cancer have been evaluated in two Phase I clinical trials of p.o. administered ZD1839 ('Iressa'), an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced cancer. Experimental Design: Functional Assessment of Cancer Therapy (FACT) questionnaires, including disease-specific subscales for lung, head and neck, colorectal, prostate, and ovarian cancer, were completed by patients in two open-label, Phase I, escalating multiple-dose safety and tolerability trials. Results: In 157 patients, 92% of whom had received prior therapy, compliance in returning FACT questionnaires was 87% (European/Australian trial) and 57% (United States trial). This did not appear to be influenced by dose level or tumor type. For patients with colorectal, prostate, or ovarian cancer, median QoL [FACT and Trial Outcome Index (TOI)] scores deteriorated over time. In contrast, for patients with non-small cell lung cancer (NSCLC) or head and neck cancer, median FACT and TOI scores did not deteriorate significantly, and in the United States trial, head and neck cancer scores improved significantly over time. In patients with NSCLC, symptom-related scores measured by the Lung Cancer Subscale of FACT-L appeared sensitive to clinical change. Conclusions: QoL (FACT-L) questionnaires were used successfully in the Phase I clinical trials of ZD1839. They appeared to be a sensitive tool to monitor clinical changes for the five tumor types in these trials and showed that ZD1839 has the potential to improve patients' QoL.

Affiliations:

Australie, Espagne, France, Italie, Pays-Bas, Royaume-Uni, Suède, États-Unis
Angleterre, Arkansas, Californie, Catalogne, Delaware, Grand Manchester, Lombardie, New Jersey, Oxfordshire, Tennessee
Barcelone, Manchester, Milan, Oxford

Links toward previous steps (curation, corpus...)

to stream PascalFrancis, to step Corpus: 005257
to stream PascalFrancis, to step Curation: 000E69
to stream PascalFrancis, to step Checkpoint: 004F38
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Le document en format XML

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<author><name sortKey="Bjork, Thomas" sort="Bjork, Thomas" uniqKey="Bjork T" first="Thomas" last="Bjork">Thomas Bjork</name>
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<author><name sortKey="Maddox, Anne Marie" sort="Maddox, Anne Marie" uniqKey="Maddox A" first="Anne-Marie" last="Maddox">Anne-Marie Maddox</name>
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<author><name sortKey="Rothenberg, Mace L" sort="Rothenberg, Mace L" uniqKey="Rothenberg M" first="Mace L." last="Rothenberg">Mace L. Rothenberg</name>
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<author><name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J." last="Small">Eric J. Small</name>
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<author><name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="José" last="Baselga">José Baselga</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Improvements in quality of life and disease-related symptoms in Phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell Lung Cancer and other solid tumors</title>
<author><name sortKey="Lorusso, Patricia M" sort="Lorusso, Patricia M" uniqKey="Lorusso P" first="Patricia M." last="Lorusso">Patricia M. Lorusso</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Karmanos Cancer Institute, Wayne State University</s1>
<s2>Detroit, Michigan</s2>
<s3>AUS</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Detroit, Michigan</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Herbst, Roy S" sort="Herbst, Roy S" uniqKey="Herbst R" first="Roy S." last="Herbst">Roy S. Herbst</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Thoracic/Head and Neck Medical Oncology, University of Texas M. D. Anderson Cancer Center</s1>
<s2>Houston, Texas 77030</s2>
<s3>AUS</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Houston, Texas 77030</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Peter MacCallum Cancer Institute</s1>
<s2>Melbourne, Victoria</s2>
<s3>AUS</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Peter MacCallum Cancer Institute</wicri:noRegion>
</affiliation>
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<author><name sortKey="Ranson, Malcolm" sort="Ranson, Malcolm" uniqKey="Ranson M" first="Malcolm" last="Ranson">Malcolm Ranson</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Christie Hospital National Health Service Trust</s1>
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<region type="country">Angleterre</region>
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</affiliation>
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<author><name sortKey="Calvert, Hilary" sort="Calvert, Hilary" uniqKey="Calvert H" first="Hilary" last="Calvert">Hilary Calvert</name>
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<author><name sortKey="Raymond, Eric" sort="Raymond, Eric" uniqKey="Raymond E" first="Eric" last="Raymond">Eric Raymond</name>
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<author><name sortKey="Kieback, Dirk" sort="Kieback, Dirk" uniqKey="Kieback D" first="Dirk" last="Kieback">Dirk Kieback</name>
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<author><name sortKey="Kaye, Stan" sort="Kaye, Stan" uniqKey="Kaye S" first="Stan" last="Kaye">Stan Kaye</name>
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<author><name sortKey="Gianni, Luca" sort="Gianni, Luca" uniqKey="Gianni L" first="Luca" last="Gianni">Luca Gianni</name>
<affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Istituto Nazionale Tumori</s1>
<s2>Milan</s2>
<s3>ITA</s3>
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<author><name sortKey="Harris, Adrian" sort="Harris, Adrian" uniqKey="Harris A" first="Adrian" last="Harris">Adrian Harris</name>
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<author><name sortKey="Bjork, Thomas" sort="Bjork, Thomas" uniqKey="Bjork T" first="Thomas" last="Bjork">Thomas Bjork</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Universitetssjukhuset</s1>
<s2>Malmo</s2>
<s3>SWE</s3>
<sZ>11 aut.</sZ>
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<country>Suède</country>
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<author><name sortKey="Maddox, Anne Marie" sort="Maddox, Anne Marie" uniqKey="Maddox A" first="Anne-Marie" last="Maddox">Anne-Marie Maddox</name>
<affiliation wicri:level="2"><inist:fA14 i1="12"><s1>The Arkansas Cancer Research Center</s1>
<s2>Little Rock, Arkansas</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Arkansas</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Rothenberg, Mace L" sort="Rothenberg, Mace L" uniqKey="Rothenberg M" first="Mace L." last="Rothenberg">Mace L. Rothenberg</name>
<affiliation wicri:level="2"><inist:fA14 i1="13"><s1>The Vanderbilt-Ingram Cancer Center</s1>
<s2>Nashville, Tennessee</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Tennessee</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J." last="Small">Eric J. Small</name>
<affiliation wicri:level="2"><inist:fA14 i1="14"><s1>The University of California-San Francisco Comprehensive Cancer Center</s1>
<s2>San Francisco, California</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Rubin, Eric H" sort="Rubin, Eric H" uniqKey="Rubin E" first="Eric H." last="Rubin">Eric H. Rubin</name>
<affiliation wicri:level="2"><inist:fA14 i1="15"><s1>The Cancer Institute of New Jersey</s1>
<s2>New Brunswick, New Jersey</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Feyereislova, Andrea" sort="Feyereislova, Andrea" uniqKey="Feyereislova A" first="Andrea" last="Feyereislova">Andrea Feyereislova</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Macclesfield</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Heyes, Anne" sort="Heyes, Anne" uniqKey="Heyes A" first="Anne" last="Heyes">Anne Heyes</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Macclesfield</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Averbuch, Steven D" sort="Averbuch, Steven D" uniqKey="Averbuch S" first="Steven D." last="Averbuch">Steven D. Averbuch</name>
<affiliation wicri:level="2"><inist:fA14 i1="17"><s1>AstraZeneca Pharmaceuticals</s1>
<s2>Wilmington, Delaware</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Delaware</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ochs, Judith" sort="Ochs, Judith" uniqKey="Ochs J" first="Judith" last="Ochs">Judith Ochs</name>
<affiliation wicri:level="2"><inist:fA14 i1="17"><s1>AstraZeneca Pharmaceuticals</s1>
<s2>Wilmington, Delaware</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Delaware</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="José" last="Baselga">José Baselga</name>
<affiliation wicri:level="3"><inist:fA14 i1="18"><s1>Vall d'Hebron University Hospital</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>Espagne</country>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
<imprint><date when="2003">2003</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Antineoplastic agent</term>
<term>Bronchopulmonary</term>
<term>Chemotherapy</term>
<term>Enzyme inhibitor</term>
<term>Epidermal growth factor receptor</term>
<term>Human</term>
<term>Improvement</term>
<term>Oral administration</term>
<term>Phase I trial</term>
<term>Protein-tyrosine kinase</term>
<term>Quality of life</term>
<term>Solid tumor</term>
<term>Symptomatology</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Inhibiteur enzyme</term>
<term>Stade avancé</term>
<term>Protein-tyrosine kinase</term>
<term>Amélioration</term>
<term>Qualité vie</term>
<term>Symptomatologie</term>
<term>Essai clinique phase I</term>
<term>Voie orale</term>
<term>Homme</term>
<term>Tumeur solide</term>
<term>Traitement</term>
<term>Chimiothérapie</term>
<term>Anticancéreux</term>
<term>Bronchopulmonaire</term>
<term>Carcinome non petite cellule bronchopulmonaire</term>
<term>ZD 1839</term>
<term>Iressa</term>
<term>Récepteur EGFR</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose: The feasibility and utility of assessing quality of life (QoL) and disease-related symptoms in patients with advanced cancer have been evaluated in two Phase I clinical trials of p.o. administered ZD1839 ('Iressa'), an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced cancer. Experimental Design: Functional Assessment of Cancer Therapy (FACT) questionnaires, including disease-specific subscales for lung, head and neck, colorectal, prostate, and ovarian cancer, were completed by patients in two open-label, Phase I, escalating multiple-dose safety and tolerability trials. Results: In 157 patients, 92% of whom had received prior therapy, compliance in returning FACT questionnaires was 87% (European/Australian trial) and 57% (United States trial). This did not appear to be influenced by dose level or tumor type. For patients with colorectal, prostate, or ovarian cancer, median QoL [FACT and Trial Outcome Index (TOI)] scores deteriorated over time. In contrast, for patients with non-small cell lung cancer (NSCLC) or head and neck cancer, median FACT and TOI scores did not deteriorate significantly, and in the United States trial, head and neck cancer scores improved significantly over time. In patients with NSCLC, symptom-related scores measured by the Lung Cancer Subscale of FACT-L appeared sensitive to clinical change. Conclusions: QoL (FACT-L) questionnaires were used successfully in the Phase I clinical trials of ZD1839. They appeared to be a sensitive tool to monitor clinical changes for the five tumor types in these trials and showed that ZD1839 has the potential to improve patients' QoL.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>Suède</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Arkansas</li>
<li>Californie</li>
<li>Catalogne</li>
<li>Delaware</li>
<li>Grand Manchester</li>
<li>Lombardie</li>
<li>New Jersey</li>
<li>Oxfordshire</li>
<li>Tennessee</li>
</region>
<settlement><li>Barcelone</li>
<li>Manchester</li>
<li>Milan</li>
<li>Oxford</li>
</settlement>
</list>
<tree><country name="Australie"><noRegion><name sortKey="Lorusso, Patricia M" sort="Lorusso, Patricia M" uniqKey="Lorusso P" first="Patricia M." last="Lorusso">Patricia M. Lorusso</name>
</noRegion>
<name sortKey="Herbst, Roy S" sort="Herbst, Roy S" uniqKey="Herbst R" first="Roy S." last="Herbst">Roy S. Herbst</name>
<name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Ranson, Malcolm" sort="Ranson, Malcolm" uniqKey="Ranson M" first="Malcolm" last="Ranson">Malcolm Ranson</name>
</region>
<name sortKey="Calvert, Hilary" sort="Calvert, Hilary" uniqKey="Calvert H" first="Hilary" last="Calvert">Hilary Calvert</name>
<name sortKey="Feyereislova, Andrea" sort="Feyereislova, Andrea" uniqKey="Feyereislova A" first="Andrea" last="Feyereislova">Andrea Feyereislova</name>
<name sortKey="Harris, Adrian" sort="Harris, Adrian" uniqKey="Harris A" first="Adrian" last="Harris">Adrian Harris</name>
<name sortKey="Heyes, Anne" sort="Heyes, Anne" uniqKey="Heyes A" first="Anne" last="Heyes">Anne Heyes</name>
<name sortKey="Kaye, Stan" sort="Kaye, Stan" uniqKey="Kaye S" first="Stan" last="Kaye">Stan Kaye</name>
</country>
<country name="France"><noRegion><name sortKey="Raymond, Eric" sort="Raymond, Eric" uniqKey="Raymond E" first="Eric" last="Raymond">Eric Raymond</name>
</noRegion>
</country>
<country name="Pays-Bas"><noRegion><name sortKey="Kieback, Dirk" sort="Kieback, Dirk" uniqKey="Kieback D" first="Dirk" last="Kieback">Dirk Kieback</name>
</noRegion>
</country>
<country name="Italie"><region name="Lombardie"><name sortKey="Gianni, Luca" sort="Gianni, Luca" uniqKey="Gianni L" first="Luca" last="Gianni">Luca Gianni</name>
</region>
</country>
<country name="Suède"><noRegion><name sortKey="Bjork, Thomas" sort="Bjork, Thomas" uniqKey="Bjork T" first="Thomas" last="Bjork">Thomas Bjork</name>
</noRegion>
</country>
<country name="États-Unis"><region name="Arkansas"><name sortKey="Maddox, Anne Marie" sort="Maddox, Anne Marie" uniqKey="Maddox A" first="Anne-Marie" last="Maddox">Anne-Marie Maddox</name>
</region>
<name sortKey="Averbuch, Steven D" sort="Averbuch, Steven D" uniqKey="Averbuch S" first="Steven D." last="Averbuch">Steven D. Averbuch</name>
<name sortKey="Ochs, Judith" sort="Ochs, Judith" uniqKey="Ochs J" first="Judith" last="Ochs">Judith Ochs</name>
<name sortKey="Rothenberg, Mace L" sort="Rothenberg, Mace L" uniqKey="Rothenberg M" first="Mace L." last="Rothenberg">Mace L. Rothenberg</name>
<name sortKey="Rubin, Eric H" sort="Rubin, Eric H" uniqKey="Rubin E" first="Eric H." last="Rubin">Eric H. Rubin</name>
<name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J." last="Small">Eric J. Small</name>
</country>
<country name="Espagne"><region name="Catalogne"><name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="José" last="Baselga">José Baselga</name>
</region>
</country>
</tree>
</affiliations>
</record>

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Improvements in quality of life and disease-related symptoms in Phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell Lung Cancer and other solid tumors

Improvements in quality of life and disease-related symptoms in Phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell Lung Cancer and other solid tumors

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