A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors.
Identifieur interne : 003305 ( Ncbi/Curation ); précédent : 003304; suivant : 003306A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors.
Auteurs : Steven A. Limentani [États-Unis] ; Mario Campone [France] ; Thierry Dorval [France] ; Giuseppe Curigliano [Italie] ; Richard De Boer [Australie] ; Charles Vogel [États-Unis] ; Shane White [Australie] ; Thomas Bachelot [France] ; Jean-Luc Canon [Belgique] ; Mary Disis [États-Unis] ; Ahmad Awada [Belgique] ; Martine Berlière [Belgique] ; Frédéric Amant [Belgique] ; Ellis Levine [États-Unis] ; Wivine Burny [Belgique] ; Andrea Callegaro [Belgique] ; Pedro Miguel De Sousa Alves [Belgique] ; Jamila Louahed [Belgique] ; Vincent Brichard [Belgique] ; Frédéric F. Lehmann [Belgique]Source :
- Breast cancer research and treatment [ 1573-7217 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Analyse de survie, Calcul des posologies, Calendrier d'administration des médicaments, Facteurs immunologiques (administration et posologie), Facteurs immunologiques (effets indésirables), Femelle, Humains, Immunothérapie, Protéines recombinantes (administration et posologie), Protéines recombinantes (immunologie), Relation dose-effet des médicaments, Récepteur ErbB-2 (immunologie), Récepteur ErbB-2 (métabolisme), Régulation de l'expression des gènes tumoraux, Régulation positive, Résultat thérapeutique, Sujet âgé, Tumeurs du sein (), Tumeurs du sein (métabolisme).
- MESH :
- administration et posologie : Facteurs immunologiques, Protéines recombinantes.
- effets indésirables : Facteurs immunologiques.
- immunologie : Protéines recombinantes, Récepteur ErbB-2.
- métabolisme : Récepteur ErbB-2, Tumeurs du sein.
- Adulte, Adulte d'âge moyen, Analyse de survie, Calcul des posologies, Calendrier d'administration des médicaments, Femelle, Humains, Immunothérapie, Relation dose-effet des médicaments, Régulation de l'expression des gènes tumoraux, Régulation positive, Résultat thérapeutique, Sujet âgé, Tumeurs du sein.
English descriptors
- KwdEn :
- Adult, Aged, Breast Neoplasms (metabolism), Breast Neoplasms (therapy), Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Dosage Calculations, Female, Gene Expression Regulation, Neoplastic, Humans, Immunologic Factors (administration & dosage), Immunologic Factors (adverse effects), Immunotherapy, Middle Aged, Receptor, ErbB-2 (immunology), Receptor, ErbB-2 (metabolism), Recombinant Proteins (administration & dosage), Recombinant Proteins (immunology), Survival Analysis, Treatment Outcome, Up-Regulation.
- MESH :
- chemical , administration & dosage : Immunologic Factors, Recombinant Proteins.
- chemical , adverse effects : Immunologic Factors.
- chemical , immunology : Receptor, ErbB-2, Recombinant Proteins.
- metabolism : Breast Neoplasms, Receptor, ErbB-2.
- therapy : Breast Neoplasms.
- Adult, Aged, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Dosage Calculations, Female, Gene Expression Regulation, Neoplastic, Humans, Immunotherapy, Middle Aged, Survival Analysis, Treatment Outcome, Up-Regulation.
Abstract
This Phase I dose-escalation study (NCT00058526) assessed the safety and immunogenicity of an anti-cancer immunotherapeutic (recombinant HER2 protein (dHER2) combined with the immunostimulant AS15) in patients with early-stage HER2-overexpressing breast cancer (BC). Sixty-one trastuzumab-naive patients with stage II-III HER2-positive BC received the dHER2 immunotherapeutic after surgical resection and adjuvant therapy. They were allocated into four cohorts receiving different doses of dHER2 (20, 100, 500 µg) combined with a fixed AS15 dose. Safety and immunogenicity (dHER2-specific antibody responses) were assessed. After completing the immunization schedule (three or six doses over 14 weeks) and a six-month follow-up, the patients were followed for 5 years for late toxicity, long-term immunogenicity, and clinical status. The immunizations were well tolerated, and increasing doses of dHER2 had no impact on the frequency or severity of adverse events. Few late toxicities were reported, and after 5 years 45/54 patients (83.3 %) were still alive, while 28/45 (62 %) with known disease status were disease free. Regarding the immunogenicity of the compound, a positive association was found between the dHER2 dose, the immunization schedule, and the prevalence of dHER2-specific humoral responses. Among the patients receiving the most intense immunization schedule with the highest dHER2 dose, 6/8 maintained their dHER2-specific antibody response 5 years after immunization. The dHER2 immunotherapeutic had an acceptable safety profile in early HER2-positive BC patients. dHER2-specific antibody responses were induced, with the rate of responders increasing with the dHER2 dose and the number and frequency of immunizations.
DOI: 10.1007/s10549-016-3751-x
PubMed: 26993131
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Bruxelles</orgName></affiliation></author><author><name sortKey="Berliere, Martine" sort="Berliere, Martine" uniqKey="Berliere M" first="Martine" last="Berlière">Martine Berlière</name><affiliation wicri:level="3"><nlm:affiliation>Clinique du sein, Centre du Cancer, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Clinique du sein, Centre du Cancer, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Amant, Frederic" sort="Amant, Frederic" uniqKey="Amant F" first="Frédéric" last="Amant">Frédéric Amant</name><affiliation wicri:level="1"><nlm:affiliation>Department of Oncology, KU Leuven and Department of Gynecologic Oncology, University Hospitals Leuven, Leuven, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Oncology, KU Leuven and Department of Gynecologic Oncology, University Hospitals Leuven, Leuven</wicri:regionArea><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Levine, Ellis" sort="Levine, Ellis" uniqKey="Levine E" first="Ellis" last="Levine">Ellis Levine</name><affiliation wicri:level="1"><nlm:affiliation>Roswell Park Cancer Institute, Buffalo, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Roswell Park Cancer Institute, Buffalo</wicri:regionArea><wicri:noRegion>Buffalo</wicri:noRegion></affiliation></author><author><name sortKey="Burny, Wivine" sort="Burny, Wivine" uniqKey="Burny W" first="Wivine" last="Burny">Wivine Burny</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, 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sort="Louahed, Jamila" uniqKey="Louahed J" first="Jamila" last="Louahed">Jamila Louahed</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea><wicri:noRegion>Rixensart</wicri:noRegion></affiliation></author><author><name sortKey="Brichard, Vincent" sort="Brichard, Vincent" uniqKey="Brichard V" first="Vincent" last="Brichard">Vincent Brichard</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea><wicri:noRegion>Rixensart</wicri:noRegion></affiliation></author><author><name sortKey="Lehmann, Frederic F" sort="Lehmann, Frederic F" uniqKey="Lehmann F" first="Frédéric F" last="Lehmann">Frédéric F. Lehmann</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea><wicri:noRegion>Rixensart</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26993131</idno><idno type="pmid">26993131</idno><idno type="doi">10.1007/s10549-016-3751-x</idno><idno type="wicri:Area/PubMed/Corpus">001F92</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001F92</idno><idno type="wicri:Area/PubMed/Curation">001F67</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001F67</idno><idno type="wicri:Area/PubMed/Checkpoint">001F67</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001F67</idno><idno type="wicri:Area/Ncbi/Merge">003305</idno><idno type="wicri:Area/Ncbi/Curation">003305</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors.</title><author><name sortKey="Limentani, Steven A" sort="Limentani, Steven A" uniqKey="Limentani S" first="Steven A" last="Limentani">Steven A. Limentani</name><affiliation wicri:level="2"><nlm:affiliation>Levine Cancer Institute, Charlotte, NC, USA. steven.limentani@msj.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Levine Cancer Institute, Charlotte, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Campone, Mario" sort="Campone, Mario" uniqKey="Campone M" first="Mario" last="Campone">Mario Campone</name><affiliation wicri:level="3"><nlm:affiliation>Institut de Cancérologie de l'Ouest, Nantes, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Institut de Cancérologie de l'Ouest, Nantes</wicri:regionArea><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Dorval, Thierry" sort="Dorval, Thierry" uniqKey="Dorval T" first="Thierry" last="Dorval">Thierry Dorval</name><affiliation wicri:level="3"><nlm:affiliation>Department of Medical Oncology, Institut Curie, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Medical Oncology, Institut Curie, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Curigliano, Giuseppe" sort="Curigliano, Giuseppe" uniqKey="Curigliano G" first="Giuseppe" last="Curigliano">Giuseppe Curigliano</name><affiliation wicri:level="3"><nlm:affiliation>Early Drug Development for Innovative Therapies Division, Istituto Europeo di Oncologia, Via Ripamonti, 435, 20141, Milan, Italy. giuseppe.curigliano@ieo.it.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Early Drug Development for Innovative Therapies Division, Istituto Europeo di Oncologia, Via Ripamonti, 435, 20141, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="De Boer, Richard" sort="De Boer, Richard" uniqKey="De Boer R" first="Richard" last="De Boer">Richard De Boer</name><affiliation wicri:level="1"><nlm:affiliation>Royal Melbourne Hospital, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Royal Melbourne Hospital, Parkville, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Vogel, Charles" sort="Vogel, Charles" uniqKey="Vogel C" first="Charles" last="Vogel">Charles Vogel</name><affiliation wicri:level="2"><nlm:affiliation>Sylvester Comprehensive Cancer Center at Deerfield Beach, Miller School of Medicine, University of Miami, Miami, FL, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Sylvester Comprehensive Cancer Center at Deerfield Beach, Miller School of Medicine, University of Miami, Miami, FL</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="White, Shane" sort="White, Shane" uniqKey="White S" first="Shane" last="White">Shane White</name><affiliation wicri:level="1"><nlm:affiliation>The Northern Hospital, Cooper St, Epping, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>The Northern Hospital, Cooper St, Epping</wicri:regionArea><wicri:noRegion>Epping</wicri:noRegion></affiliation></author><author><name sortKey="Bachelot, Thomas" sort="Bachelot, Thomas" uniqKey="Bachelot T" first="Thomas" last="Bachelot">Thomas Bachelot</name><affiliation wicri:level="3"><nlm:affiliation>Department of Medical Oncology, Léon-Bérard Centre, Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Medical Oncology, Léon-Bérard Centre, 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="Canon, Jean Luc" sort="Canon, Jean Luc" uniqKey="Canon J" first="Jean-Luc" last="Canon">Jean-Luc Canon</name><affiliation wicri:level="1"><nlm:affiliation>Oncology-Hematology Department, Grand Hopital de Charleroi, Charleroi, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Oncology-Hematology Department, Grand Hopital de Charleroi, Charleroi</wicri:regionArea><wicri:noRegion>Charleroi</wicri:noRegion></affiliation></author><author><name sortKey="Disis, Mary" sort="Disis, Mary" uniqKey="Disis M" first="Mary" last="Disis">Mary Disis</name><affiliation wicri:level="4"><nlm:affiliation>Tumor Vaccine Group, Center for Translational Medicine in Women's Health, University of Washington, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Tumor Vaccine Group, Center for Translational Medicine in Women's Health, University of Washington, Seattle, WA</wicri:regionArea><placeName><region type="state">Washington (État)</region><settlement type="city">Seattle</settlement></placeName><orgName type="university">Université de Washington</orgName></affiliation></author><author><name sortKey="Awada, Ahmad" sort="Awada, Ahmad" uniqKey="Awada A" first="Ahmad" last="Awada">Ahmad Awada</name><affiliation wicri:level="4"><nlm:affiliation>Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Institut Jules Bordet, Université Libre de Bruxelles, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region><settlement type="city">Bruxelles</settlement></placeName><orgName type="university">Université libre de Bruxelles</orgName></affiliation></author><author><name sortKey="Berliere, Martine" sort="Berliere, Martine" uniqKey="Berliere M" first="Martine" last="Berlière">Martine Berlière</name><affiliation wicri:level="3"><nlm:affiliation>Clinique du sein, Centre du Cancer, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Clinique du sein, Centre du Cancer, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Amant, Frederic" sort="Amant, Frederic" uniqKey="Amant F" first="Frédéric" last="Amant">Frédéric Amant</name><affiliation wicri:level="1"><nlm:affiliation>Department of Oncology, KU Leuven and Department of Gynecologic Oncology, University Hospitals Leuven, Leuven, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Oncology, KU Leuven and Department of Gynecologic Oncology, University Hospitals Leuven, Leuven</wicri:regionArea><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Levine, Ellis" sort="Levine, Ellis" uniqKey="Levine E" first="Ellis" last="Levine">Ellis Levine</name><affiliation wicri:level="1"><nlm:affiliation>Roswell Park Cancer Institute, Buffalo, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Roswell Park Cancer Institute, Buffalo</wicri:regionArea><wicri:noRegion>Buffalo</wicri:noRegion></affiliation></author><author><name sortKey="Burny, Wivine" sort="Burny, Wivine" uniqKey="Burny W" first="Wivine" last="Burny">Wivine Burny</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea><wicri:noRegion>Rixensart</wicri:noRegion></affiliation></author><author><name sortKey="Callegaro, Andrea" sort="Callegaro, Andrea" uniqKey="Callegaro A" first="Andrea" last="Callegaro">Andrea Callegaro</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea><wicri:noRegion>Rixensart</wicri:noRegion></affiliation></author><author><name sortKey="De Sousa Alves, Pedro Miguel" sort="De Sousa Alves, Pedro Miguel" uniqKey="De Sousa Alves P" first="Pedro Miguel" last="De Sousa Alves">Pedro Miguel De Sousa Alves</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea><wicri:noRegion>Rixensart</wicri:noRegion></affiliation></author><author><name sortKey="Louahed, Jamila" sort="Louahed, Jamila" uniqKey="Louahed J" first="Jamila" last="Louahed">Jamila Louahed</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea><wicri:noRegion>Rixensart</wicri:noRegion></affiliation></author><author><name sortKey="Brichard, Vincent" sort="Brichard, Vincent" uniqKey="Brichard V" first="Vincent" last="Brichard">Vincent Brichard</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea><wicri:noRegion>Rixensart</wicri:noRegion></affiliation></author><author><name sortKey="Lehmann, Frederic F" sort="Lehmann, Frederic F" uniqKey="Lehmann F" first="Frédéric F" last="Lehmann">Frédéric F. Lehmann</name><affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Rixensart, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea><wicri:noRegion>Rixensart</wicri:noRegion></affiliation></author></analytic><series><title level="j">Breast cancer research and treatment</title><idno type="eISSN">1573-7217</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Breast Neoplasms (metabolism)</term><term>Breast Neoplasms (therapy)</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Drug Dosage Calculations</term><term>Female</term><term>Gene Expression Regulation, Neoplastic</term><term>Humans</term><term>Immunologic Factors (administration & dosage)</term><term>Immunologic Factors (adverse effects)</term><term>Immunotherapy</term><term>Middle Aged</term><term>Receptor, ErbB-2 (immunology)</term><term>Receptor, ErbB-2 (metabolism)</term><term>Recombinant Proteins (administration & dosage)</term><term>Recombinant Proteins (immunology)</term><term>Survival Analysis</term><term>Treatment Outcome</term><term>Up-Regulation</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Calcul des posologies</term><term>Calendrier d'administration des médicaments</term><term>Facteurs immunologiques (administration et posologie)</term><term>Facteurs immunologiques (effets indésirables)</term><term>Femelle</term><term>Humains</term><term>Immunothérapie</term><term>Protéines recombinantes (administration et posologie)</term><term>Protéines recombinantes (immunologie)</term><term>Relation dose-effet des médicaments</term><term>Récepteur ErbB-2 (immunologie)</term><term>Récepteur ErbB-2 (métabolisme)</term><term>Régulation de l'expression des gènes tumoraux</term><term>Régulation positive</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Tumeurs du sein ()</term><term>Tumeurs du sein (métabolisme)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Immunologic Factors</term><term>Recombinant Proteins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Immunologic Factors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Receptor, ErbB-2</term><term>Recombinant Proteins</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Facteurs immunologiques</term><term>Protéines recombinantes</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Facteurs immunologiques</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Protéines recombinantes</term><term>Récepteur ErbB-2</term></keywords><keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Breast Neoplasms</term><term>Receptor, ErbB-2</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Récepteur ErbB-2</term><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Drug Dosage Calculations</term><term>Female</term><term>Gene Expression Regulation, Neoplastic</term><term>Humans</term><term>Immunotherapy</term><term>Middle Aged</term><term>Survival Analysis</term><term>Treatment Outcome</term><term>Up-Regulation</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Calcul des posologies</term><term>Calendrier d'administration des médicaments</term><term>Femelle</term><term>Humains</term><term>Immunothérapie</term><term>Relation dose-effet des médicaments</term><term>Régulation de l'expression des gènes tumoraux</term><term>Régulation positive</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Tumeurs du sein</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This Phase I dose-escalation study (NCT00058526) assessed the safety and immunogenicity of an anti-cancer immunotherapeutic (recombinant HER2 protein (dHER2) combined with the immunostimulant AS15) in patients with early-stage HER2-overexpressing breast cancer (BC). Sixty-one trastuzumab-naive patients with stage II-III HER2-positive BC received the dHER2 immunotherapeutic after surgical resection and adjuvant therapy. They were allocated into four cohorts receiving different doses of dHER2 (20, 100, 500 µg) combined with a fixed AS15 dose. Safety and immunogenicity (dHER2-specific antibody responses) were assessed. After completing the immunization schedule (three or six doses over 14 weeks) and a six-month follow-up, the patients were followed for 5 years for late toxicity, long-term immunogenicity, and clinical status. The immunizations were well tolerated, and increasing doses of dHER2 had no impact on the frequency or severity of adverse events. Few late toxicities were reported, and after 5 years 45/54 patients (83.3 %) were still alive, while 28/45 (62 %) with known disease status were disease free. Regarding the immunogenicity of the compound, a positive association was found between the dHER2 dose, the immunization schedule, and the prevalence of dHER2-specific humoral responses. Among the patients receiving the most intense immunization schedule with the highest dHER2 dose, 6/8 maintained their dHER2-specific antibody response 5 years after immunization. The dHER2 immunotherapeutic had an acceptable safety profile in early HER2-positive BC patients. dHER2-specific antibody responses were induced, with the rate of responders increasing with the dHER2 dose and the number and frequency of immunizations.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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