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Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial.

Identifieur interne : 001A96 ( PubMed/Curation ); précédent : 001A95; suivant : 001A97

Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial.

Auteurs : Stephanie M. De Boer [Pays-Bas] ; Melanie E. Powell [Royaume-Uni] ; Linda Mileshkin [Australie] ; Dionyssios Katsaros [Italie] ; Paul Bessette [Canada] ; Christine Haie-Meder [France] ; Petronella B. Ottevanger [Pays-Bas] ; Jonathan A. Ledermann [Royaume-Uni] ; Pearly Khaw [Australie] ; Alessandro Colombo [Italie] ; Anthony Fyles [Canada] ; Marie-Helene Baron [France] ; Henry C. Kitchener [Royaume-Uni] ; Hans W. Nijman [Pays-Bas] ; Roy F. Kruitwagen [Pays-Bas] ; Remi A. Nout [Pays-Bas] ; Karen W. Verhoeven-Adema [Pays-Bas] ; Vincent T. Smit [Pays-Bas] ; Hein Putter [Pays-Bas] ; Carien L. Creutzberg [Pays-Bas]

Source :

RBID : pubmed:27397040

Descripteurs français

English descriptors

Abstract

About 15% of patients with endometrial cancer have high-risk features and are at increased risk of distant metastases and endometrial cancer-related death. We designed the PORTEC-3 trial to investigate the benefit of adjuvant chemoradiotherapy compared with radiotherapy alone for women with high-risk endometrial cancer.

DOI: 10.1016/S1470-2045(16)30120-6
PubMed: 27397040

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pubmed:27397040

Le document en format XML

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<nlm:affiliation>Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands. Electronic address: s.m.de_boer.onco@lumc.nl.</nlm:affiliation>
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<name sortKey="Ottevanger, Petronella B" sort="Ottevanger, Petronella B" uniqKey="Ottevanger P" first="Petronella B" last="Ottevanger">Petronella B. Ottevanger</name>
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<nlm:affiliation>Department of Medical Oncology, Radboudumc, Nijmegen, Netherlands.</nlm:affiliation>
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<name sortKey="Khaw, Pearly" sort="Khaw, Pearly" uniqKey="Khaw P" first="Pearly" last="Khaw">Pearly Khaw</name>
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<name sortKey="Colombo, Alessandro" sort="Colombo, Alessandro" uniqKey="Colombo A" first="Alessandro" last="Colombo">Alessandro Colombo</name>
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<name sortKey="Fyles, Anthony" sort="Fyles, Anthony" uniqKey="Fyles A" first="Anthony" last="Fyles">Anthony Fyles</name>
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<nlm:affiliation>Department of Gynaecologic Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.</nlm:affiliation>
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<name sortKey="Kruitwagen, Roy F" sort="Kruitwagen, Roy F" uniqKey="Kruitwagen R" first="Roy F" last="Kruitwagen">Roy F. Kruitwagen</name>
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<wicri:regionArea>Department of Gynaecology and Obstetrics, and GROW-School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht</wicri:regionArea>
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<name sortKey="Nout, Remi A" sort="Nout, Remi A" uniqKey="Nout R" first="Remi A" last="Nout">Remi A. Nout</name>
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<name sortKey="Verhoeven Adema, Karen W" sort="Verhoeven Adema, Karen W" uniqKey="Verhoeven Adema K" first="Karen W" last="Verhoeven-Adema">Karen W. Verhoeven-Adema</name>
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<name sortKey="Smit, Vincent T" sort="Smit, Vincent T" uniqKey="Smit V" first="Vincent T" last="Smit">Vincent T. Smit</name>
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<nlm:affiliation>Department of Pathology, Leiden University Medical Center, Leiden, Netherlands.</nlm:affiliation>
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<name sortKey="Putter, Hein" sort="Putter, Hein" uniqKey="Putter H" first="Hein" last="Putter">Hein Putter</name>
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<nlm:affiliation>Department of Medical Statistics, Leiden University Medical Center, Leiden, Netherlands.</nlm:affiliation>
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<wicri:regionArea>Department of Medical Statistics, Leiden University Medical Center, Leiden</wicri:regionArea>
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<name sortKey="Creutzberg, Carien L" sort="Creutzberg, Carien L" uniqKey="Creutzberg C" first="Carien L" last="Creutzberg">Carien L. Creutzberg</name>
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<nlm:affiliation>Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Radiation Oncology, Leiden University Medical Center, Leiden</wicri:regionArea>
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<title xml:lang="en">Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial.</title>
<author>
<name sortKey="De Boer, Stephanie M" sort="De Boer, Stephanie M" uniqKey="De Boer S" first="Stephanie M" last="De Boer">Stephanie M. De Boer</name>
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<nlm:affiliation>Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands. Electronic address: s.m.de_boer.onco@lumc.nl.</nlm:affiliation>
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<name sortKey="Powell, Melanie E" sort="Powell, Melanie E" uniqKey="Powell M" first="Melanie E" last="Powell">Melanie E. Powell</name>
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<nlm:affiliation>Department of Clinical Oncology, Barts Health NHS Trust, London, UK.</nlm:affiliation>
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<name sortKey="Mileshkin, Linda" sort="Mileshkin, Linda" uniqKey="Mileshkin L" first="Linda" last="Mileshkin">Linda Mileshkin</name>
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<nlm:affiliation>Division of Cancer Medicine, Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia.</nlm:affiliation>
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<wicri:regionArea>Division of Cancer Medicine, Peter MacCallum Cancer Centre, East Melbourne, VIC</wicri:regionArea>
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<name sortKey="Katsaros, Dionyssios" sort="Katsaros, Dionyssios" uniqKey="Katsaros D" first="Dionyssios" last="Katsaros">Dionyssios Katsaros</name>
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<nlm:affiliation>Department of Surgical Sciences, Gynecologic Oncology, Città della Salute and S Anna Hospital, University of Torino, Torino, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Surgical Sciences, Gynecologic Oncology, Città della Salute and S Anna Hospital, University of Torino, Torino</wicri:regionArea>
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<name sortKey="Bessette, Paul" sort="Bessette, Paul" uniqKey="Bessette P" first="Paul" last="Bessette">Paul Bessette</name>
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<nlm:affiliation>NCIC-CTG, Department of Obstetrics and Gynaecology, University of Sherbrooke, QC, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>NCIC-CTG, Department of Obstetrics and Gynaecology, University of Sherbrooke, QC</wicri:regionArea>
</affiliation>
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<name sortKey="Haie Meder, Christine" sort="Haie Meder, Christine" uniqKey="Haie Meder C" first="Christine" last="Haie-Meder">Christine Haie-Meder</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Radiotherapy, Institut Gustave Roussy, Villejuif, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Radiotherapy, Institut Gustave Roussy, Villejuif</wicri:regionArea>
</affiliation>
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<name sortKey="Ottevanger, Petronella B" sort="Ottevanger, Petronella B" uniqKey="Ottevanger P" first="Petronella B" last="Ottevanger">Petronella B. Ottevanger</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Medical Oncology, Radboudumc, Nijmegen, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Medical Oncology, Radboudumc, Nijmegen</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Ledermann, Jonathan A" sort="Ledermann, Jonathan A" uniqKey="Ledermann J" first="Jonathan A" last="Ledermann">Jonathan A. Ledermann</name>
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<nlm:affiliation>Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London</wicri:regionArea>
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<name sortKey="Khaw, Pearly" sort="Khaw, Pearly" uniqKey="Khaw P" first="Pearly" last="Khaw">Pearly Khaw</name>
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<nlm:affiliation>Division of Radiation Oncology & Cancer Imaging, Peter MacCallum Cancer Center, East Melbourne, VIC, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Division of Radiation Oncology & Cancer Imaging, Peter MacCallum Cancer Center, East Melbourne, VIC</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Colombo, Alessandro" sort="Colombo, Alessandro" uniqKey="Colombo A" first="Alessandro" last="Colombo">Alessandro Colombo</name>
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<nlm:affiliation>Department of Radiation Oncology, Azienda Ospedaliera della Provincia di Lecco, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Radiation Oncology, Azienda Ospedaliera della Provincia di Lecco</wicri:regionArea>
</affiliation>
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<name sortKey="Fyles, Anthony" sort="Fyles, Anthony" uniqKey="Fyles A" first="Anthony" last="Fyles">Anthony Fyles</name>
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<nlm:affiliation>NCIC-CTG, Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, ON, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>NCIC-CTG, Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, ON</wicri:regionArea>
</affiliation>
</author>
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<name sortKey="Baron, Marie Helene" sort="Baron, Marie Helene" uniqKey="Baron M" first="Marie-Helene" last="Baron">Marie-Helene Baron</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Radiotherapy, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Radiotherapy, Centre Hospitalier Régional Universitaire de Besançon, Besançon</wicri:regionArea>
</affiliation>
</author>
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<name sortKey="Kitchener, Henry C" sort="Kitchener, Henry C" uniqKey="Kitchener H" first="Henry C" last="Kitchener">Henry C. Kitchener</name>
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<nlm:affiliation>Institute of Cancer Sciences, University of Manchester, Manchester, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Institute of Cancer Sciences, University of Manchester, Manchester</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Nijman, Hans W" sort="Nijman, Hans W" uniqKey="Nijman H" first="Hans W" last="Nijman">Hans W. Nijman</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Gynaecologic Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Gynaecologic Oncology, University Medical Center Groningen, University of Groningen, Groningen</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Kruitwagen, Roy F" sort="Kruitwagen, Roy F" uniqKey="Kruitwagen R" first="Roy F" last="Kruitwagen">Roy F. Kruitwagen</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Gynaecology and Obstetrics, and GROW-School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Gynaecology and Obstetrics, and GROW-School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Nout, Remi A" sort="Nout, Remi A" uniqKey="Nout R" first="Remi A" last="Nout">Remi A. Nout</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Radiation Oncology, Leiden University Medical Center, Leiden</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Verhoeven Adema, Karen W" sort="Verhoeven Adema, Karen W" uniqKey="Verhoeven Adema K" first="Karen W" last="Verhoeven-Adema">Karen W. Verhoeven-Adema</name>
<affiliation wicri:level="1">
<nlm:affiliation>Comprehensive Cancer Center The Netherlands, Leiden, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Comprehensive Cancer Center The Netherlands, Leiden</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Smit, Vincent T" sort="Smit, Vincent T" uniqKey="Smit V" first="Vincent T" last="Smit">Vincent T. Smit</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Pathology, Leiden University Medical Center, Leiden, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Pathology, Leiden University Medical Center, Leiden</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Putter, Hein" sort="Putter, Hein" uniqKey="Putter H" first="Hein" last="Putter">Hein Putter</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Medical Statistics, Leiden University Medical Center, Leiden, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Medical Statistics, Leiden University Medical Center, Leiden</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Creutzberg, Carien L" sort="Creutzberg, Carien L" uniqKey="Creutzberg C" first="Carien L" last="Creutzberg">Carien L. Creutzberg</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Radiation Oncology, Leiden University Medical Center, Leiden</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">The Lancet. Oncology</title>
<idno type="eISSN">1474-5488</idno>
<imprint>
<date when="2016" type="published">2016</date>
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<term>Aged</term>
<term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term>
<term>Carboplatin (administration & dosage)</term>
<term>Case-Control Studies</term>
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<term>Cisplatin (administration & dosage)</term>
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<term>Cystadenocarcinoma, Serous (therapy)</term>
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<term>Endometrial Neoplasms (radiotherapy)</term>
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<term>Female</term>
<term>Follow-Up Studies</term>
<term>Gastrointestinal Diseases (diagnosis)</term>
<term>Gastrointestinal Diseases (etiology)</term>
<term>Hematologic Diseases (diagnosis)</term>
<term>Hematologic Diseases (etiology)</term>
<term>Humans</term>
<term>Lymphatic Metastasis</term>
<term>Middle Aged</term>
<term>Neoplasm Grading</term>
<term>Neoplasm Invasiveness</term>
<term>Neoplasm Staging</term>
<term>Nervous System Diseases (diagnosis)</term>
<term>Nervous System Diseases (etiology)</term>
<term>Paclitaxel (administration & dosage)</term>
<term>Prognosis</term>
<term>Quality of Life</term>
<term>Radiotherapy, Adjuvant (adverse effects)</term>
<term>Survival Rate</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adulte d'âge moyen</term>
<term>Adénocarcinome à cellules claires ()</term>
<term>Adénocarcinome à cellules claires (radiothérapie)</term>
<term>Adénocarcinome à cellules claires (secondaire)</term>
<term>Carboplatine (administration et posologie)</term>
<term>Chimioradiothérapie adjuvante (effets indésirables)</term>
<term>Cisplatine (administration et posologie)</term>
<term>Cystadénocarcinome séreux ()</term>
<term>Cystadénocarcinome séreux (radiothérapie)</term>
<term>Cystadénocarcinome séreux (secondaire)</term>
<term>Femelle</term>
<term>Grading des tumeurs</term>
<term>Humains</term>
<term>Hémopathies (diagnostic)</term>
<term>Hémopathies (étiologie)</term>
<term>Invasion tumorale</term>
<term>Maladies du système nerveux (diagnostic)</term>
<term>Maladies du système nerveux (étiologie)</term>
<term>Maladies gastro-intestinales (diagnostic)</term>
<term>Maladies gastro-intestinales (étiologie)</term>
<term>Métastase lymphatique</term>
<term>Paclitaxel (administration et posologie)</term>
<term>Pronostic</term>
<term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term>
<term>Qualité de vie</term>
<term>Radiothérapie adjuvante (effets indésirables)</term>
<term>Stade de la tumeur</term>
<term>Sujet âgé</term>
<term>Taux de survie</term>
<term>Tumeurs de l'endomètre ()</term>
<term>Tumeurs de l'endomètre (anatomopathologie)</term>
<term>Tumeurs de l'endomètre (radiothérapie)</term>
<term>Études cas-témoins</term>
<term>Études de suivi</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Carboplatin</term>
<term>Cisplatin</term>
<term>Paclitaxel</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr">
<term>Carboplatine</term>
<term>Cisplatine</term>
<term>Paclitaxel</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en">
<term>Antineoplastic Combined Chemotherapy Protocols</term>
<term>Chemoradiotherapy, Adjuvant</term>
<term>Radiotherapy, Adjuvant</term>
</keywords>
<keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr">
<term>Tumeurs de l'endomètre</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en">
<term>Gastrointestinal Diseases</term>
<term>Hematologic Diseases</term>
<term>Nervous System Diseases</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr">
<term>Hémopathies</term>
<term>Maladies du système nerveux</term>
<term>Maladies gastro-intestinales</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr">
<term>Chimioradiothérapie adjuvante</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
<term>Radiothérapie adjuvante</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en">
<term>Gastrointestinal Diseases</term>
<term>Hematologic Diseases</term>
<term>Nervous System Diseases</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en">
<term>Endometrial Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="radiotherapy" xml:lang="en">
<term>Adenocarcinoma, Clear Cell</term>
<term>Cystadenocarcinoma, Serous</term>
<term>Endometrial Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="radiothérapie" xml:lang="fr">
<term>Adénocarcinome à cellules claires</term>
<term>Cystadénocarcinome séreux</term>
<term>Tumeurs de l'endomètre</term>
</keywords>
<keywords scheme="MESH" qualifier="secondaire" xml:lang="fr">
<term>Adénocarcinome à cellules claires</term>
<term>Cystadénocarcinome séreux</term>
</keywords>
<keywords scheme="MESH" qualifier="secondary" xml:lang="en">
<term>Adenocarcinoma, Clear Cell</term>
<term>Cystadenocarcinoma, Serous</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Adenocarcinoma, Clear Cell</term>
<term>Cystadenocarcinoma, Serous</term>
<term>Endometrial Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="étiologie" xml:lang="fr">
<term>Hémopathies</term>
<term>Maladies du système nerveux</term>
<term>Maladies gastro-intestinales</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Aged</term>
<term>Case-Control Studies</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Lymphatic Metastasis</term>
<term>Middle Aged</term>
<term>Neoplasm Grading</term>
<term>Neoplasm Invasiveness</term>
<term>Neoplasm Staging</term>
<term>Prognosis</term>
<term>Quality of Life</term>
<term>Survival Rate</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adulte d'âge moyen</term>
<term>Adénocarcinome à cellules claires</term>
<term>Cystadénocarcinome séreux</term>
<term>Femelle</term>
<term>Grading des tumeurs</term>
<term>Humains</term>
<term>Invasion tumorale</term>
<term>Métastase lymphatique</term>
<term>Pronostic</term>
<term>Qualité de vie</term>
<term>Stade de la tumeur</term>
<term>Sujet âgé</term>
<term>Taux de survie</term>
<term>Tumeurs de l'endomètre</term>
<term>Études cas-témoins</term>
<term>Études de suivi</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">About 15% of patients with endometrial cancer have high-risk features and are at increased risk of distant metastases and endometrial cancer-related death. We designed the PORTEC-3 trial to investigate the benefit of adjuvant chemoradiotherapy compared with radiotherapy alone for women with high-risk endometrial cancer.</div>
</front>
</TEI>
<pubmed>
<MedlineCitation Status="MEDLINE" Owner="NLM">
<PMID Version="1">27397040</PMID>
<DateCreated>
<Year>2016</Year>
<Month>08</Month>
<Day>11</Day>
</DateCreated>
<DateCompleted>
<Year>2017</Year>
<Month>06</Month>
<Day>05</Day>
</DateCompleted>
<DateRevised>
<Year>2017</Year>
<Month>08</Month>
<Day>23</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1474-5488</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>17</Volume>
<Issue>8</Issue>
<PubDate>
<Year>2016</Year>
<Month>Aug</Month>
</PubDate>
</JournalIssue>
<Title>The Lancet. Oncology</Title>
<ISOAbbreviation>Lancet Oncol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial.</ArticleTitle>
<Pagination>
<MedlinePgn>1114-1126</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S1470-2045(16)30120-6</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(16)30120-6</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">About 15% of patients with endometrial cancer have high-risk features and are at increased risk of distant metastases and endometrial cancer-related death. We designed the PORTEC-3 trial to investigate the benefit of adjuvant chemoradiotherapy compared with radiotherapy alone for women with high-risk endometrial cancer.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">PORTEC-3 was a multicentre, open-label, randomised, international trial. Women with high-risk endometrial cancer were randomly allocated (1:1) to radiotherapy alone (48·6 Gy) in 1·8 Gy fractions five times a week or chemoradiotherapy (two cycles concurrent cisplatin 50 mg/m(2) and four adjuvant cycles of carboplatin area under the curve [AUC] 5 and paclitaxel 175 mg/m(2)) using a biased coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage of cancer, and histological type. The primary endpoints of the PORTEC-3 trial were overall survival and failure-free survival analysed in the intention-to-treat population. This analysis focuses on 2-year toxicity and health-related quality of life as secondary endpoints; analysis was done according to treatment received. Health-related quality of life was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) the cervix cancer module and chemotherapy and neuropathy subscales of the ovarian cancer module at baseline, after radiotherapy and at 6, 12, 24, 36, and 60 months after randomisation. Adverse events were graded with Common Terminology Criteria for Adverse Events version 3.0. The study was closed on Dec 20, 2013, after achieving complete accrual, and follow-up remains ongoing for the primary outcomes analysis. This trial is registered with ISRCTN.com, number ISRCTN14387080, and with ClinicalTrials.gov, number NCT00411138.</AbstractText>
<AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Sept 15, 2006, and Dec 20, 2013, 686 women were randomly allocated in the PORTEC-3 trial. Of these, 660 met eligibility criteria, and 570 (86%) were evaluable for health-related quality of life. Median follow-up was 42·3 months (IQR 25·8-55·1). At completion of radiotherapy and at 6 months, EORTC QLQ-C30 functioning scales were significantly lower (worse functioning) and health-related quality of life symptom scores higher (worse symptoms) for the chemoradiotherapy group compared with radiotherapy alone, improving with time. At 12 and 24 months, global health or quality of life was similar between groups, whereas physical functioning scores remained slightly lower in patients who received chemoradiotherapy compared with patients who received radiotherapy alone. At 24 months, 48 (25%) of 194 patients in the chemoradiotherapy group reported severe tingling or numbness compared with 11 (6%) of 170 patients in the radiotherapy alone group (p<0·0001). Grade 2 or worse adverse events were found during treatment in 309 (94%) of 327 patients in the chemoradiotherapy group versus 145 (44%) of 326 patients in the radiotherapy alone group, and grade 3 or worse events were found in 198 (61%) of 327 patients in the chemoradiotherapy group versus 42 (13%) of 326 patients in the radiotherapy alone group (p<0·0001), with most of the grade 3 adverse events being haematological (45%). At 12 and 24 months, no significant differences in grade 3 or worse adverse events were found between groups; only grade 2 or higher sensory neuropathy adverse events persisted at 24 months (25 [10%] of 240 patients in the chemoradiotherapy group vs one [<1%] of 247 patients in the radiotherapy alone group; p<0·0001).</AbstractText>
<AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Despite the increased physician and patient-reported toxicities, this schedule of adjuvant chemotherapy given during and after radiotherapy in patients with high-risk endometrial cancer is feasible, with rapid recovery after treatment, but with persistence of patient-reported sensory neurological symptoms in 25% of patients. We await the analysis of primary endpoints before final conclusions are made.</AbstractText>
<AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Dutch Cancer Society, Cancer Research UK, National Health and Medical Research Council, Project Grant, Cancer Australia Grant, Italian Medicines Agency, and Canadian Cancer Society Research Institute.</AbstractText>
<CopyrightInformation>Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND license. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>de Boer</LastName>
<ForeName>Stephanie M</ForeName>
<Initials>SM</Initials>
<AffiliationInfo>
<Affiliation>Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands. Electronic address: s.m.de_boer.onco@lumc.nl.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Powell</LastName>
<ForeName>Melanie E</ForeName>
<Initials>ME</Initials>
<AffiliationInfo>
<Affiliation>Department of Clinical Oncology, Barts Health NHS Trust, London, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Mileshkin</LastName>
<ForeName>Linda</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Division of Cancer Medicine, Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Katsaros</LastName>
<ForeName>Dionyssios</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Department of Surgical Sciences, Gynecologic Oncology, Città della Salute and S Anna Hospital, University of Torino, Torino, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bessette</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>NCIC-CTG, Department of Obstetrics and Gynaecology, University of Sherbrooke, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Haie-Meder</LastName>
<ForeName>Christine</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Department of Radiotherapy, Institut Gustave Roussy, Villejuif, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ottevanger</LastName>
<ForeName>Petronella B</ForeName>
<Initials>PB</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Radboudumc, Nijmegen, Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ledermann</LastName>
<ForeName>Jonathan A</ForeName>
<Initials>JA</Initials>
<AffiliationInfo>
<Affiliation>Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Khaw</LastName>
<ForeName>Pearly</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>Division of Radiation Oncology & Cancer Imaging, Peter MacCallum Cancer Center, East Melbourne, VIC, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Colombo</LastName>
<ForeName>Alessandro</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Department of Radiation Oncology, Azienda Ospedaliera della Provincia di Lecco, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Fyles</LastName>
<ForeName>Anthony</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>NCIC-CTG, Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, ON, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Baron</LastName>
<ForeName>Marie-Helene</ForeName>
<Initials>MH</Initials>
<AffiliationInfo>
<Affiliation>Department of Radiotherapy, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Kitchener</LastName>
<ForeName>Henry C</ForeName>
<Initials>HC</Initials>
<AffiliationInfo>
<Affiliation>Institute of Cancer Sciences, University of Manchester, Manchester, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Nijman</LastName>
<ForeName>Hans W</ForeName>
<Initials>HW</Initials>
<AffiliationInfo>
<Affiliation>Department of Gynaecologic Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Kruitwagen</LastName>
<ForeName>Roy F</ForeName>
<Initials>RF</Initials>
<AffiliationInfo>
<Affiliation>Department of Gynaecology and Obstetrics, and GROW-School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Nout</LastName>
<ForeName>Remi A</ForeName>
<Initials>RA</Initials>
<AffiliationInfo>
<Affiliation>Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Verhoeven-Adema</LastName>
<ForeName>Karen W</ForeName>
<Initials>KW</Initials>
<AffiliationInfo>
<Affiliation>Comprehensive Cancer Center The Netherlands, Leiden, Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Smit</LastName>
<ForeName>Vincent T</ForeName>
<Initials>VT</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, Leiden University Medical Center, Leiden, Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Putter</LastName>
<ForeName>Hein</ForeName>
<Initials>H</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Statistics, Leiden University Medical Center, Leiden, Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Creutzberg</LastName>
<ForeName>Carien L</ForeName>
<Initials>CL</Initials>
<AffiliationInfo>
<Affiliation>Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<CollectiveName>PORTEC study group</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y">
<DataBank>
<DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList>
<AccessionNumber>NCT00411138</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
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<PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D003160">Comparative Study</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic">
<Year>2016</Year>
<Month>07</Month>
<Day>07</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo>
<Country>England</Country>
<MedlineTA>Lancet Oncol</MedlineTA>
<NlmUniqueID>100957246</NlmUniqueID>
<ISSNLinking>1470-2045</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList>
<Chemical>
<RegistryNumber>BG3F62OND5</RegistryNumber>
<NameOfSubstance UI="D016190">Carboplatin</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>P88XT4IS4D</RegistryNumber>
<NameOfSubstance UI="D017239">Paclitaxel</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>Q20Q21Q62J</RegistryNumber>
<NameOfSubstance UI="D002945">Cisplatin</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D018262" MajorTopicYN="N">Adenocarcinoma, Clear Cell</DescriptorName>
<QualifierName UI="Q000532" MajorTopicYN="N">radiotherapy</QualifierName>
<QualifierName UI="Q000556" MajorTopicYN="N">secondary</QualifierName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D016190" MajorTopicYN="N">Carboplatin</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D059186" MajorTopicYN="N">Chemoradiotherapy, Adjuvant</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D002945" MajorTopicYN="N">Cisplatin</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D018284" MajorTopicYN="N">Cystadenocarcinoma, Serous</DescriptorName>
<QualifierName UI="Q000532" MajorTopicYN="N">radiotherapy</QualifierName>
<QualifierName UI="Q000556" MajorTopicYN="N">secondary</QualifierName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D016889" MajorTopicYN="N">Endometrial Neoplasms</DescriptorName>
<QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName>
<QualifierName UI="Q000532" MajorTopicYN="N">radiotherapy</QualifierName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005500" MajorTopicYN="N">Follow-Up Studies</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005767" MajorTopicYN="N">Gastrointestinal Diseases</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006402" MajorTopicYN="N">Hematologic Diseases</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008207" MajorTopicYN="N">Lymphatic Metastasis</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D060787" MajorTopicYN="N">Neoplasm Grading</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D009361" MajorTopicYN="N">Neoplasm Invasiveness</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D009367" MajorTopicYN="N">Neoplasm Staging</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D009422" MajorTopicYN="N">Nervous System Diseases</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D017239" MajorTopicYN="N">Paclitaxel</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011379" MajorTopicYN="N">Prognosis</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011788" MajorTopicYN="Y">Quality of Life</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D018714" MajorTopicYN="N">Radiotherapy, Adjuvant</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015996" MajorTopicYN="N">Survival Rate</DescriptorName>
</MeshHeading>
</MeshHeadingList>
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<PubMedPubDate PubStatus="received">
<Year>2016</Year>
<Month>03</Month>
<Day>04</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised">
<Year>2016</Year>
<Month>04</Month>
<Day>22</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2016</Year>
<Month>04</Month>
<Day>25</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2016</Year>
<Month>7</Month>
<Day>12</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<Month>7</Month>
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