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Multi-institutional randomized phase II trial of Gefitinib for previously treated patients with advanced non-small-cell lung cancer

Identifieur interne : 00B119 ( Main/Exploration ); précédent : 00B118; suivant : 00B120

Multi-institutional randomized phase II trial of Gefitinib for previously treated patients with advanced non-small-cell lung cancer

Auteurs : Masahiro Fukuoka [Japon, France, Belgique, Australie, Afrique du Sud, Pays-Bas, États-Unis, Royaume-Uni, Espagne] ; Seiji Yano ; Giuseppe Giaccone ; Tomohide Tamura ; Kazuhiko Nakagawa ; Jean-Yves Douillard ; Yutaka Nishiwaki ; Johan Vansteenkiste ; Shinzoh Kudoh ; Danny Rischin ; Richard Eek ; Takeshi Horai ; Kazumasa Noda ; Ichiro Takata ; Egbert Smit ; Steven Averbuch ; Angela Macleod ; Andrea Feyereislova ; Rui-Ping Dong ; José Baselga

Source :

RBID : Pascal:03-0461261

Descripteurs français

English descriptors

Abstract

Purpose: To evaluate the efficacy and tolerability of two doses of gefitinib (Iressa [ZD1839]; AstraZeneca, Wilming-ton, DE), a novel epidermal growth factor receptor tyrosine kinase inhibitor, in patients with pretreated advanced non-small-cell lung cancer (NSCLC). Patients and Methods: This was a randomized, double-blind, parallel-group, multicenter phase II trial. Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens (at least one containing platinum) were randomized to receive either 250-mg or 500-mg oral doses of gefitinib once daily. Results: Efficacy was similar for the 250- and 500-mg/d groups. Objective tumor response rates were 18.4% (95% confidence interval [CI], 11.5 to 27.3) and 19.0% (95% Cl, 12.1 to 27.9); among evaluable patients, symptom improvement rates were 40.3% (95% Cl, 28.5 to 53.0) and 37.0% (95% Cl, 26.0 to 49.1); median progression-free survival times were 2.7 and 2.8 months; and median overall survival times were 7.6 and 8.0 months, respectively. Symptom improvements were recorded for 69.2% (250 mg/d) and 85.7% (500 mg/d) of patients with a tumor response. Adverse events (AEs) at both dose levels were generally mild (grade 1 or 2) and consisted mainly of skin reactions and diarrhea. Drug-related toxicities were more frequent in the higher-dose group. Withdrawal due to drug-related AEs was 1.9% and 9.4% for patients receiving gefitinib 250 and 500 mg/d, respectively. Conclusion: Gefitinib showed clinically meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients. At 250 mg/d, gefitinib had a favorable AE profile. Gefitinib 250 mg/d is an important, novel treatment option for patients with pretreated advanced NSCLC.


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Le document en format XML

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<name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name>
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<name sortKey="Tamura, Tomohide" sort="Tamura, Tomohide" uniqKey="Tamura T" first="Tomohide" last="Tamura">Tomohide Tamura</name>
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<name sortKey="Nakagawa, Kazuhiko" sort="Nakagawa, Kazuhiko" uniqKey="Nakagawa K" first="Kazuhiko" last="Nakagawa">Kazuhiko Nakagawa</name>
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<author>
<name sortKey="Douillard, Jean Yves" sort="Douillard, Jean Yves" uniqKey="Douillard J" first="Jean-Yves" last="Douillard">Jean-Yves Douillard</name>
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<name sortKey="Nishiwaki, Yutaka" sort="Nishiwaki, Yutaka" uniqKey="Nishiwaki Y" first="Yutaka" last="Nishiwaki">Yutaka Nishiwaki</name>
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<name sortKey="Vansteenkiste, Johan" sort="Vansteenkiste, Johan" uniqKey="Vansteenkiste J" first="Johan" last="Vansteenkiste">Johan Vansteenkiste</name>
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<name sortKey="Kudoh, Shinzoh" sort="Kudoh, Shinzoh" uniqKey="Kudoh S" first="Shinzoh" last="Kudoh">Shinzoh Kudoh</name>
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<name sortKey="Horai, Takeshi" sort="Horai, Takeshi" uniqKey="Horai T" first="Takeshi" last="Horai">Takeshi Horai</name>
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<name sortKey="Noda, Kazumasa" sort="Noda, Kazumasa" uniqKey="Noda K" first="Kazumasa" last="Noda">Kazumasa Noda</name>
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<name sortKey="Takata, Ichiro" sort="Takata, Ichiro" uniqKey="Takata I" first="Ichiro" last="Takata">Ichiro Takata</name>
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<name sortKey="Smit, Egbert" sort="Smit, Egbert" uniqKey="Smit E" first="Egbert" last="Smit">Egbert Smit</name>
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<name sortKey="Averbuch, Steven" sort="Averbuch, Steven" uniqKey="Averbuch S" first="Steven" last="Averbuch">Steven Averbuch</name>
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<name sortKey="Macleod, Angela" sort="Macleod, Angela" uniqKey="Macleod A" first="Angela" last="Macleod">Angela Macleod</name>
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<author>
<name sortKey="Feyereislova, Andrea" sort="Feyereislova, Andrea" uniqKey="Feyereislova A" first="Andrea" last="Feyereislova">Andrea Feyereislova</name>
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<name sortKey="Dong, Rui Ping" sort="Dong, Rui Ping" uniqKey="Dong R" first="Rui-Ping" last="Dong">Rui-Ping Dong</name>
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<name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="José" last="Baselga">José Baselga</name>
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<title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
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<date when="2003">2003</date>
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<title level="j" type="main">Journal of clinical oncology</title>
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<term>Enzyme inhibitor</term>
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<term>Carcinome non petite cellule</term>
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<term>Inhibiteur enzyme</term>
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<term>Prétraitement</term>
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<term>Randomisation</term>
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<term>Complication</term>
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<front>
<div type="abstract" xml:lang="en">Purpose: To evaluate the efficacy and tolerability of two doses of gefitinib (Iressa [ZD1839]; AstraZeneca, Wilming-ton, DE), a novel epidermal growth factor receptor tyrosine kinase inhibitor, in patients with pretreated advanced non-small-cell lung cancer (NSCLC). Patients and Methods: This was a randomized, double-blind, parallel-group, multicenter phase II trial. Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens (at least one containing platinum) were randomized to receive either 250-mg or 500-mg oral doses of gefitinib once daily. Results: Efficacy was similar for the 250- and 500-mg/d groups. Objective tumor response rates were 18.4% (95% confidence interval [CI], 11.5 to 27.3) and 19.0% (95% Cl, 12.1 to 27.9); among evaluable patients, symptom improvement rates were 40.3% (95% Cl, 28.5 to 53.0) and 37.0% (95% Cl, 26.0 to 49.1); median progression-free survival times were 2.7 and 2.8 months; and median overall survival times were 7.6 and 8.0 months, respectively. Symptom improvements were recorded for 69.2% (250 mg/d) and 85.7% (500 mg/d) of patients with a tumor response. Adverse events (AEs) at both dose levels were generally mild (grade 1 or 2) and consisted mainly of skin reactions and diarrhea. Drug-related toxicities were more frequent in the higher-dose group. Withdrawal due to drug-related AEs was 1.9% and 9.4% for patients receiving gefitinib 250 and 500 mg/d, respectively. Conclusion: Gefitinib showed clinically meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients. At 250 mg/d, gefitinib had a favorable AE profile. Gefitinib 250 mg/d is an important, novel treatment option for patients with pretreated advanced NSCLC.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Afrique du Sud</li>
<li>Australie</li>
<li>Belgique</li>
<li>Espagne</li>
<li>France</li>
<li>Japon</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region>
<li>Catalogne</li>
<li>Hollande-Septentrionale</li>
<li>Région de Kantō</li>
<li>Victoria (État)</li>
</region>
<settlement>
<li>Amsterdam</li>
<li>Barcelone</li>
<li>Melbourne</li>
<li>Tokyo</li>
</settlement>
</list>
<tree>
<noCountry>
<name sortKey="Averbuch, Steven" sort="Averbuch, Steven" uniqKey="Averbuch S" first="Steven" last="Averbuch">Steven Averbuch</name>
<name sortKey="Baselga, Jose" sort="Baselga, Jose" uniqKey="Baselga J" first="José" last="Baselga">José Baselga</name>
<name sortKey="Dong, Rui Ping" sort="Dong, Rui Ping" uniqKey="Dong R" first="Rui-Ping" last="Dong">Rui-Ping Dong</name>
<name sortKey="Douillard, Jean Yves" sort="Douillard, Jean Yves" uniqKey="Douillard J" first="Jean-Yves" last="Douillard">Jean-Yves Douillard</name>
<name sortKey="Eek, Richard" sort="Eek, Richard" uniqKey="Eek R" first="Richard" last="Eek">Richard Eek</name>
<name sortKey="Feyereislova, Andrea" sort="Feyereislova, Andrea" uniqKey="Feyereislova A" first="Andrea" last="Feyereislova">Andrea Feyereislova</name>
<name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name>
<name sortKey="Horai, Takeshi" sort="Horai, Takeshi" uniqKey="Horai T" first="Takeshi" last="Horai">Takeshi Horai</name>
<name sortKey="Kudoh, Shinzoh" sort="Kudoh, Shinzoh" uniqKey="Kudoh S" first="Shinzoh" last="Kudoh">Shinzoh Kudoh</name>
<name sortKey="Macleod, Angela" sort="Macleod, Angela" uniqKey="Macleod A" first="Angela" last="Macleod">Angela Macleod</name>
<name sortKey="Nakagawa, Kazuhiko" sort="Nakagawa, Kazuhiko" uniqKey="Nakagawa K" first="Kazuhiko" last="Nakagawa">Kazuhiko Nakagawa</name>
<name sortKey="Nishiwaki, Yutaka" sort="Nishiwaki, Yutaka" uniqKey="Nishiwaki Y" first="Yutaka" last="Nishiwaki">Yutaka Nishiwaki</name>
<name sortKey="Noda, Kazumasa" sort="Noda, Kazumasa" uniqKey="Noda K" first="Kazumasa" last="Noda">Kazumasa Noda</name>
<name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name>
<name sortKey="Smit, Egbert" sort="Smit, Egbert" uniqKey="Smit E" first="Egbert" last="Smit">Egbert Smit</name>
<name sortKey="Takata, Ichiro" sort="Takata, Ichiro" uniqKey="Takata I" first="Ichiro" last="Takata">Ichiro Takata</name>
<name sortKey="Tamura, Tomohide" sort="Tamura, Tomohide" uniqKey="Tamura T" first="Tomohide" last="Tamura">Tomohide Tamura</name>
<name sortKey="Vansteenkiste, Johan" sort="Vansteenkiste, Johan" uniqKey="Vansteenkiste J" first="Johan" last="Vansteenkiste">Johan Vansteenkiste</name>
<name sortKey="Yano, Seiji" sort="Yano, Seiji" uniqKey="Yano S" first="Seiji" last="Yano">Seiji Yano</name>
</noCountry>
<country name="Japon">
<noRegion>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</noRegion>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</country>
<country name="France">
<noRegion>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</noRegion>
</country>
<country name="Belgique">
<noRegion>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</noRegion>
</country>
<country name="Australie">
<region name="Victoria (État)">
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</region>
</country>
<country name="Afrique du Sud">
<noRegion>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</noRegion>
</country>
<country name="Pays-Bas">
<region name="Hollande-Septentrionale">
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</region>
</country>
<country name="États-Unis">
<noRegion>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</noRegion>
</country>
<country name="Royaume-Uni">
<noRegion>
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</noRegion>
</country>
<country name="Espagne">
<region name="Catalogne">
<name sortKey="Fukuoka, Masahiro" sort="Fukuoka, Masahiro" uniqKey="Fukuoka M" first="Masahiro" last="Fukuoka">Masahiro Fukuoka</name>
</region>
</country>
</tree>
</affiliations>
</record>

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