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Serveur d'exploration sur les relations entre la France et l'Australie

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Correlation of KIT and PDGFRA mutational status with clinical benefit in patients with gastrointestinal stromal tumor treated with sunitinib in a worldwide treatment-use trial

Identifieur interne : 002F99 ( Ncbi/Merge ); précédent : 002F98; suivant : 003000

Correlation of KIT and PDGFRA mutational status with clinical benefit in patients with gastrointestinal stromal tumor treated with sunitinib in a worldwide treatment-use trial

Auteurs : Peter Reichardt [Allemagne] ; George D. Demetri [États-Unis] ; Hans Gelderblom [Pays-Bas] ; Piotr Rutkowski [Pologne] ; Seock-Ah Im [Corée du Sud] ; Sudeep Gupta [Inde] ; Yoon-Koo Kang [Corée du Sud] ; Patrick Schöffski [Belgique] ; Jochen Schuette [Allemagne] ; Denis Soulières ; Jean-Yves Blay [France] ; David Goldstein [Australie] ; Kolette Fly [États-Unis] ; Xin Huang [États-Unis] ; Massimo Corsaro [Italie] ; Maria Jose Lechuga [Italie] ; Jean-Francois Martini [États-Unis] ; Michael C. Heinrich [États-Unis]

Source :

RBID : PMC:4714485

Descripteurs français

English descriptors

Abstract

Background

Several small studies indicated that the genotype of KIT or platelet-derived growth factor receptor-α (PDGFRA) contributes in part to the level of clinical effectiveness of sunitinib in gastrointestinal stromal tumor (GIST) patients. This study aimed to correlate KIT and PDGFRA mutational status with clinical outcome metrics (progression-free survival [PFS], overall survival [OS], objective response rate [ORR]) in a larger international patient population.

Methods

This is a non-interventional, retrospective analysis in patients with imatinib-resistant or intolerant GIST who were treated in a worldwide, open-label treatment-use study (Study 1036; NCT00094029) in which sunitinib was administered at a starting dose of 50 mg/day on a 4-week-on, 2-week-off schedule. Molecular status was obtained in local laboratories with tumor samples obtained either pre-imatinib, post-imatinib/pre-sunitinib, or post-sunitinib treatment, and all available data were used in the analyses regardless of collection time. The primary analysis compared PFS in patients with primary KIT exon 11 versus exon 9 mutations (using a 2-sided log-rank test) and secondary analyses compared OS (using the same test) and ORR (using a 2-sided Pearson χ2 test) in the same molecular subgroups.

Results

Of the 1124 sunitinib-treated patients in the treatment-use study, 230 (20 %) were included in this analysis, and baseline characteristics were similar between the two study populations. Median PFS was 7.1 months. A significantly better PFS was observed in patients with a primary mutation in KIT exon 9 (n = 42) compared to those with a primary mutation in exon 11 (n = 143; hazard ratio = 0.59; 95 % confidence interval, 0.39–0.89; P = 0.011), with median PFS times of 12.3 and 7.0 months, respectively. Similarly, longer OS and higher ORR were observed in patients with a primary KIT mutation in exon 9 versus exon 11. The data available were limited to investigate the effects of additional KIT or PDGFRA mutations on the efficacy of sunitinib treatment.

Conclusions

This large retrospective analysis confirms the prognostic significance of KIT mutation status in patients with GIST. This analysis also confirms the effectiveness of sunitinib as a post-imatinib therapy, regardless of mutational status.

Trial registration

NCT01459757.

Electronic supplementary material

The online version of this article (doi:10.1186/s12885-016-2051-5) contains supplementary material, which is available to authorized users.


Url:
DOI: 10.1186/s12885-016-2051-5
PubMed: 26772734
PubMed Central: 4714485

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PMC:4714485

Le document en format XML

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<name sortKey="Lechuga, Maria Jose" sort="Lechuga, Maria Jose" uniqKey="Lechuga M" first="Maria Jose" last="Lechuga">Maria Jose Lechuga</name>
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<name sortKey="Heinrich, Michael C" sort="Heinrich, Michael C" uniqKey="Heinrich M" first="Michael C." last="Heinrich">Michael C. Heinrich</name>
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<title xml:lang="en" level="a" type="main">Correlation of
<italic>KIT</italic>
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mutational status with clinical benefit in patients with gastrointestinal stromal tumor treated with sunitinib in a worldwide treatment-use trial</title>
<author>
<name sortKey="Reichardt, Peter" sort="Reichardt, Peter" uniqKey="Reichardt P" first="Peter" last="Reichardt">Peter Reichardt</name>
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<name sortKey="Rutkowski, Piotr" sort="Rutkowski, Piotr" uniqKey="Rutkowski P" first="Piotr" last="Rutkowski">Piotr Rutkowski</name>
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<name sortKey="Gupta, Sudeep" sort="Gupta, Sudeep" uniqKey="Gupta S" first="Sudeep" last="Gupta">Sudeep Gupta</name>
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<name sortKey="Kang, Yoon Koo" sort="Kang, Yoon Koo" uniqKey="Kang Y" first="Yoon-Koo" last="Kang">Yoon-Koo Kang</name>
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<name sortKey="Schoffski, Patrick" sort="Schoffski, Patrick" uniqKey="Schoffski P" first="Patrick" last="Schöffski">Patrick Schöffski</name>
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<name sortKey="Soulieres, Denis" sort="Soulieres, Denis" uniqKey="Soulieres D" first="Denis" last="Soulières">Denis Soulières</name>
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<name sortKey="Blay, Jean Yves" sort="Blay, Jean Yves" uniqKey="Blay J" first="Jean-Yves" last="Blay">Jean-Yves Blay</name>
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<name sortKey="Goldstein, David" sort="Goldstein, David" uniqKey="Goldstein D" first="David" last="Goldstein">David Goldstein</name>
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<name sortKey="Fly, Kolette" sort="Fly, Kolette" uniqKey="Fly K" first="Kolette" last="Fly">Kolette Fly</name>
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<region type="state">Connecticut</region>
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<name sortKey="Huang, Xin" sort="Huang, Xin" uniqKey="Huang X" first="Xin" last="Huang">Xin Huang</name>
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<region type="state">Californie</region>
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<wicri:cityArea>Pfizer Oncology, La Jolla</wicri:cityArea>
</affiliation>
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<name sortKey="Corsaro, Massimo" sort="Corsaro, Massimo" uniqKey="Corsaro M" first="Massimo" last="Corsaro">Massimo Corsaro</name>
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<nlm:aff id="Aff15">Pfizer Oncology, Milan, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Pfizer Oncology, Milan</wicri:regionArea>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Lechuga, Maria Jose" sort="Lechuga, Maria Jose" uniqKey="Lechuga M" first="Maria Jose" last="Lechuga">Maria Jose Lechuga</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff15">Pfizer Oncology, Milan, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Pfizer Oncology, Milan</wicri:regionArea>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Martini, Jean Francois" sort="Martini, Jean Francois" uniqKey="Martini J" first="Jean-Francois" last="Martini">Jean-Francois Martini</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff14">Pfizer Oncology, La Jolla, CA USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Pfizer Oncology, La Jolla</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Heinrich, Michael C" sort="Heinrich, Michael C" uniqKey="Heinrich M" first="Michael C." last="Heinrich">Michael C. Heinrich</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff16">VA Portland Health Care System and Oregon Health & Science University, Portland, OR USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Oregon</region>
</placeName>
<wicri:cityArea>VA Portland Health Care System and Oregon Health & Science University, Portland</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">BMC Cancer</title>
<idno type="eISSN">1471-2407</idno>
<imprint>
<date when="2016">2016</date>
</imprint>
</series>
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<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Disease-Free Survival</term>
<term>Drug Resistance, Neoplasm (genetics)</term>
<term>Female</term>
<term>Gastrointestinal Stromal Tumors (drug therapy)</term>
<term>Gastrointestinal Stromal Tumors (genetics)</term>
<term>Gastrointestinal Stromal Tumors (pathology)</term>
<term>Genotype</term>
<term>Humans</term>
<term>Indoles (administration & dosage)</term>
<term>Indoles (adverse effects)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Mutation</term>
<term>Prognosis</term>
<term>Protein Kinase Inhibitors (administration & dosage)</term>
<term>Proto-Oncogene Proteins c-kit (genetics)</term>
<term>Pyrroles (administration & dosage)</term>
<term>Pyrroles (adverse effects)</term>
<term>Receptor, Platelet-Derived Growth Factor alpha (genetics)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Génotype</term>
<term>Humains</term>
<term>Indoles (administration et posologie)</term>
<term>Indoles (effets indésirables)</term>
<term>Inhibiteurs de protéines kinases (administration et posologie)</term>
<term>Mutation</term>
<term>Mâle</term>
<term>Pronostic</term>
<term>Protéines proto-oncogènes c-kit (génétique)</term>
<term>Pyrroles (administration et posologie)</term>
<term>Pyrroles (effets indésirables)</term>
<term>Récepteur au PDGF alpha (génétique)</term>
<term>Résistance aux médicaments antinéoplasiques (génétique)</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Survie sans rechute</term>
<term>Tumeurs stromales gastro-intestinales (anatomopathologie)</term>
<term>Tumeurs stromales gastro-intestinales (génétique)</term>
<term>Tumeurs stromales gastro-intestinales (traitement médicamenteux)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Indoles</term>
<term>Protein Kinase Inhibitors</term>
<term>Pyrroles</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en">
<term>Indoles</term>
<term>Pyrroles</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr">
<term>Indoles</term>
<term>Inhibiteurs de protéines kinases</term>
<term>Pyrroles</term>
</keywords>
<keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr">
<term>Tumeurs stromales gastro-intestinales</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Gastrointestinal Stromal Tumors</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr">
<term>Indoles</term>
<term>Pyrroles</term>
</keywords>
<keywords scheme="MESH" qualifier="genetics" xml:lang="en">
<term>Drug Resistance, Neoplasm</term>
<term>Gastrointestinal Stromal Tumors</term>
<term>Proto-Oncogene Proteins c-kit</term>
<term>Receptor, Platelet-Derived Growth Factor alpha</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr">
<term>Protéines proto-oncogènes c-kit</term>
<term>Récepteur au PDGF alpha</term>
<term>Résistance aux médicaments antinéoplasiques</term>
<term>Tumeurs stromales gastro-intestinales</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en">
<term>Gastrointestinal Stromal Tumors</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr">
<term>Tumeurs stromales gastro-intestinales</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Disease-Free Survival</term>
<term>Female</term>
<term>Genotype</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Mutation</term>
<term>Prognosis</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Génotype</term>
<term>Humains</term>
<term>Mutation</term>
<term>Mâle</term>
<term>Pronostic</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Survie sans rechute</term>
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<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Background</title>
<p>Several small studies indicated that the genotype of
<italic>KIT</italic>
or platelet-derived growth factor receptor-α (
<italic>PDGFRA</italic>
) contributes in part to the level of clinical effectiveness of sunitinib in gastrointestinal stromal tumor (GIST) patients. This study aimed to correlate
<italic>KIT</italic>
and
<italic>PDGFRA</italic>
mutational status with clinical outcome metrics (progression-free survival [PFS], overall survival [OS], objective response rate [ORR]) in a larger international patient population.</p>
</sec>
<sec>
<title>Methods</title>
<p>This is a non-interventional, retrospective analysis in patients with imatinib-resistant or intolerant GIST who were treated in a worldwide, open-label treatment-use study (Study 1036; NCT00094029) in which sunitinib was administered at a starting dose of 50 mg/day on a 4-week-on, 2-week-off schedule. Molecular status was obtained in local laboratories with tumor samples obtained either pre-imatinib, post-imatinib/pre-sunitinib, or post-sunitinib treatment, and all available data were used in the analyses regardless of collection time. The primary analysis compared PFS in patients with primary
<italic>KIT</italic>
exon 11 versus exon 9 mutations (using a 2-sided log-rank test) and secondary analyses compared OS (using the same test) and ORR (using a 2-sided Pearson χ
<sup>2</sup>
test) in the same molecular subgroups.</p>
</sec>
<sec>
<title>Results</title>
<p>Of the 1124 sunitinib-treated patients in the treatment-use study, 230 (20 %) were included in this analysis, and baseline characteristics were similar between the two study populations. Median PFS was 7.1 months. A significantly better PFS was observed in patients with a primary mutation in
<italic>KIT</italic>
exon 9 (
<italic>n</italic>
 = 42) compared to those with a primary mutation in exon 11 (
<italic>n</italic>
 = 143; hazard ratio = 0.59; 95 % confidence interval, 0.39–0.89;
<italic>P</italic>
 = 0.011), with median PFS times of 12.3 and 7.0 months, respectively. Similarly, longer OS and higher ORR were observed in patients with a primary
<italic>KIT</italic>
mutation in exon 9 versus exon 11. The data available were limited to investigate the effects of additional
<italic>KIT</italic>
or
<italic>PDGFRA</italic>
mutations on the efficacy of sunitinib treatment.</p>
</sec>
<sec>
<title>Conclusions</title>
<p>This large retrospective analysis confirms the prognostic significance of
<italic>KIT</italic>
mutation status in patients with GIST. This analysis also confirms the effectiveness of sunitinib as a post-imatinib therapy, regardless of mutational status.</p>
</sec>
<sec>
<title>Trial registration</title>
<p>
<ext-link ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov/ct2/show/NCT01459757?term=NCT01459757">NCT01459757.</ext-link>
</p>
</sec>
<sec>
<title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12885-016-2051-5) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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<region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Demetri, George D" sort="Demetri, George D" uniqKey="Demetri G" first="George D." last="Demetri">George D. Demetri</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff2">Ludwig Center at Harvard and Dana-Farber Cancer Institute, Boston, MA USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Ludwig Center at Harvard and Dana-Farber Cancer Institute, Boston</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Gelderblom, Hans" sort="Gelderblom, Hans" uniqKey="Gelderblom H" first="Hans" last="Gelderblom">Hans Gelderblom</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff3">Leiden University Medical Center, Leiden, The Netherlands</nlm:aff>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Leiden University Medical Center, Leiden</wicri:regionArea>
<placeName>
<settlement type="city">Leyde</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Rutkowski, Piotr" sort="Rutkowski, Piotr" uniqKey="Rutkowski P" first="Piotr" last="Rutkowski">Piotr Rutkowski</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff4">Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland</nlm:aff>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw</wicri:regionArea>
<wicri:noRegion>Warsaw</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Im, Seock Ah" sort="Im, Seock Ah" uniqKey="Im S" first="Seock-Ah" last="Im">Seock-Ah Im</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff5">Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea</nlm:aff>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul</wicri:regionArea>
<placeName>
<settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Gupta, Sudeep" sort="Gupta, Sudeep" uniqKey="Gupta S" first="Sudeep" last="Gupta">Sudeep Gupta</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff6">Tata Memorial Centre, Mumbai, India</nlm:aff>
<country xml:lang="fr">Inde</country>
<wicri:regionArea>Tata Memorial Centre, Mumbai</wicri:regionArea>
<wicri:noRegion>Mumbai</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Kang, Yoon Koo" sort="Kang, Yoon Koo" uniqKey="Kang Y" first="Yoon-Koo" last="Kang">Yoon-Koo Kang</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff7">Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea</nlm:aff>
<country xml:lang="fr">Corée du Sud</country>
<wicri:regionArea>Asan Medical Center, University of Ulsan College of Medicine, Seoul</wicri:regionArea>
<placeName>
<settlement type="city">Séoul</settlement>
<region type="capital">Région capitale de Séoul</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Schoffski, Patrick" sort="Schoffski, Patrick" uniqKey="Schoffski P" first="Patrick" last="Schöffski">Patrick Schöffski</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff8">University Hospitals Leuven, Leuven Cancer Institute, and Laboratory of Experimental Oncology, KU Leuven, Leuven, Belgium</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>University Hospitals Leuven, Leuven Cancer Institute, and Laboratory of Experimental Oncology, KU Leuven, Leuven</wicri:regionArea>
<wicri:noRegion>Leuven</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Schuette, Jochen" sort="Schuette, Jochen" uniqKey="Schuette J" first="Jochen" last="Schuette">Jochen Schuette</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff9">Hämatoonkologische Schwerpunktpraxis, Düsseldorf, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Hämatoonkologische Schwerpunktpraxis, Düsseldorf</wicri:regionArea>
<placeName>
<region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region>
<region type="district" nuts="2">District de Düsseldorf</region>
<settlement type="city">Düsseldorf</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Soulieres, Denis" sort="Soulieres, Denis" uniqKey="Soulieres D" first="Denis" last="Soulières">Denis Soulières</name>
<affiliation>
<nlm:aff id="Aff10">Centre Hospitalier de l’Université de Montreal, Montreal, QC Canada</nlm:aff>
<wicri:noCountry code="subfield">QC Canada</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Blay, Jean Yves" sort="Blay, Jean Yves" uniqKey="Blay J" first="Jean-Yves" last="Blay">Jean-Yves Blay</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff11">Centre Léon Bérard, Université Claude Bernard, Lyon, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Centre Léon Bérard, Université Claude Bernard, Lyon</wicri:regionArea>
<placeName>
<region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Goldstein, David" sort="Goldstein, David" uniqKey="Goldstein D" first="David" last="Goldstein">David Goldstein</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff12">Prince of Wales Hospital, Sydney, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Prince of Wales Hospital, Sydney</wicri:regionArea>
<placeName>
<settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Fly, Kolette" sort="Fly, Kolette" uniqKey="Fly K" first="Kolette" last="Fly">Kolette Fly</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff13">Pfizer Oncology, Groton, CT USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Connecticut</region>
</placeName>
<wicri:cityArea>Pfizer Oncology, Groton</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Huang, Xin" sort="Huang, Xin" uniqKey="Huang X" first="Xin" last="Huang">Xin Huang</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff14">Pfizer Oncology, La Jolla, CA USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Pfizer Oncology, La Jolla</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Corsaro, Massimo" sort="Corsaro, Massimo" uniqKey="Corsaro M" first="Massimo" last="Corsaro">Massimo Corsaro</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff15">Pfizer Oncology, Milan, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Pfizer Oncology, Milan</wicri:regionArea>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Lechuga, Maria Jose" sort="Lechuga, Maria Jose" uniqKey="Lechuga M" first="Maria Jose" last="Lechuga">Maria Jose Lechuga</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff15">Pfizer Oncology, Milan, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Pfizer Oncology, Milan</wicri:regionArea>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Martini, Jean Francois" sort="Martini, Jean Francois" uniqKey="Martini J" first="Jean-Francois" last="Martini">Jean-Francois Martini</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff14">Pfizer Oncology, La Jolla, CA USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Pfizer Oncology, La Jolla</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Heinrich, Michael C" sort="Heinrich, Michael C" uniqKey="Heinrich M" first="Michael C." last="Heinrich">Michael C. Heinrich</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff16">VA Portland Health Care System and Oregon Health & Science University, Portland, OR USA</nlm:aff>
<country>États-Unis</country>
<placeName>
<region type="state">Oregon</region>
</placeName>
<wicri:cityArea>VA Portland Health Care System and Oregon Health & Science University, Portland</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">BMC Cancer</title>
<idno type="eISSN">1471-2407</idno>
<imprint>
<date when="2016">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass></textClass>
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</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Background</title>
<p>Several small studies indicated that the genotype of
<italic>KIT</italic>
or platelet-derived growth factor receptor-α (
<italic>PDGFRA</italic>
) contributes in part to the level of clinical effectiveness of sunitinib in gastrointestinal stromal tumor (GIST) patients. This study aimed to correlate
<italic>KIT</italic>
and
<italic>PDGFRA</italic>
mutational status with clinical outcome metrics (progression-free survival [PFS], overall survival [OS], objective response rate [ORR]) in a larger international patient population.</p>
</sec>
<sec>
<title>Methods</title>
<p>This is a non-interventional, retrospective analysis in patients with imatinib-resistant or intolerant GIST who were treated in a worldwide, open-label treatment-use study (Study 1036; NCT00094029) in which sunitinib was administered at a starting dose of 50 mg/day on a 4-week-on, 2-week-off schedule. Molecular status was obtained in local laboratories with tumor samples obtained either pre-imatinib, post-imatinib/pre-sunitinib, or post-sunitinib treatment, and all available data were used in the analyses regardless of collection time. The primary analysis compared PFS in patients with primary
<italic>KIT</italic>
exon 11 versus exon 9 mutations (using a 2-sided log-rank test) and secondary analyses compared OS (using the same test) and ORR (using a 2-sided Pearson χ
<sup>2</sup>
test) in the same molecular subgroups.</p>
</sec>
<sec>
<title>Results</title>
<p>Of the 1124 sunitinib-treated patients in the treatment-use study, 230 (20 %) were included in this analysis, and baseline characteristics were similar between the two study populations. Median PFS was 7.1 months. A significantly better PFS was observed in patients with a primary mutation in
<italic>KIT</italic>
exon 9 (
<italic>n</italic>
 = 42) compared to those with a primary mutation in exon 11 (
<italic>n</italic>
 = 143; hazard ratio = 0.59; 95 % confidence interval, 0.39–0.89;
<italic>P</italic>
 = 0.011), with median PFS times of 12.3 and 7.0 months, respectively. Similarly, longer OS and higher ORR were observed in patients with a primary
<italic>KIT</italic>
mutation in exon 9 versus exon 11. The data available were limited to investigate the effects of additional
<italic>KIT</italic>
or
<italic>PDGFRA</italic>
mutations on the efficacy of sunitinib treatment.</p>
</sec>
<sec>
<title>Conclusions</title>
<p>This large retrospective analysis confirms the prognostic significance of
<italic>KIT</italic>
mutation status in patients with GIST. This analysis also confirms the effectiveness of sunitinib as a post-imatinib therapy, regardless of mutational status.</p>
</sec>
<sec>
<title>Trial registration</title>
<p>
<ext-link ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov/ct2/show/NCT01459757?term=NCT01459757">NCT01459757.</ext-link>
</p>
</sec>
<sec>
<title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12885-016-2051-5) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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<term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Disease-Free Survival</term>
<term>Drug Resistance, Neoplasm (genetics)</term>
<term>Female</term>
<term>Gastrointestinal Stromal Tumors (drug therapy)</term>
<term>Gastrointestinal Stromal Tumors (genetics)</term>
<term>Gastrointestinal Stromal Tumors (pathology)</term>
<term>Genotype</term>
<term>Humans</term>
<term>Indoles (administration & dosage)</term>
<term>Indoles (adverse effects)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Mutation</term>
<term>Prognosis</term>
<term>Protein Kinase Inhibitors (administration & dosage)</term>
<term>Proto-Oncogene Proteins c-kit (genetics)</term>
<term>Pyrroles (administration & dosage)</term>
<term>Pyrroles (adverse effects)</term>
<term>Receptor, Platelet-Derived Growth Factor alpha (genetics)</term>
</keywords>
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<term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Génotype</term>
<term>Humains</term>
<term>Indoles (administration et posologie)</term>
<term>Indoles (effets indésirables)</term>
<term>Inhibiteurs de protéines kinases (administration et posologie)</term>
<term>Mutation</term>
<term>Mâle</term>
<term>Pronostic</term>
<term>Protéines proto-oncogènes c-kit (génétique)</term>
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<term>Pyrroles (effets indésirables)</term>
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<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
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<term>Tumeurs stromales gastro-intestinales (anatomopathologie)</term>
<term>Tumeurs stromales gastro-intestinales (génétique)</term>
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<term>Indoles</term>
<term>Pyrroles</term>
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<term>Inhibiteurs de protéines kinases</term>
<term>Pyrroles</term>
</keywords>
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<term>Tumeurs stromales gastro-intestinales</term>
</keywords>
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<term>Gastrointestinal Stromal Tumors</term>
</keywords>
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<term>Indoles</term>
<term>Pyrroles</term>
</keywords>
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<term>Drug Resistance, Neoplasm</term>
<term>Gastrointestinal Stromal Tumors</term>
<term>Proto-Oncogene Proteins c-kit</term>
<term>Receptor, Platelet-Derived Growth Factor alpha</term>
</keywords>
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<term>Protéines proto-oncogènes c-kit</term>
<term>Récepteur au PDGF alpha</term>
<term>Résistance aux médicaments antinéoplasiques</term>
<term>Tumeurs stromales gastro-intestinales</term>
</keywords>
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<term>Gastrointestinal Stromal Tumors</term>
</keywords>
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<term>Tumeurs stromales gastro-intestinales</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Disease-Free Survival</term>
<term>Female</term>
<term>Genotype</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Mutation</term>
<term>Prognosis</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Génotype</term>
<term>Humains</term>
<term>Mutation</term>
<term>Mâle</term>
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<front>
<div type="abstract" xml:lang="en">Several small studies indicated that the genotype of KIT or platelet-derived growth factor receptor-α (PDGFRA) contributes in part to the level of clinical effectiveness of sunitinib in gastrointestinal stromal tumor (GIST) patients. This study aimed to correlate KIT and PDGFRA mutational status with clinical outcome metrics (progression-free survival [PFS], overall survival [OS], objective response rate [ORR]) in a larger international patient population.</div>
</front>
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