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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<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>
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<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>
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<author><name sortKey="Dorval, Thierry" sort="Dorval, Thierry" uniqKey="Dorval T" first="Thierry" last="Dorval">Thierry Dorval</name>
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<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>
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<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>
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<author><name sortKey="De Boer, Richard" sort="De Boer, Richard" uniqKey="De Boer R" first="Richard" last="De Boer">Richard De Boer</name>
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<wicri:noRegion>VIC</wicri:noRegion>
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<author><name sortKey="Vogel, Charles" sort="Vogel, Charles" uniqKey="Vogel C" first="Charles" last="Vogel">Charles Vogel</name>
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<author><name sortKey="White, Shane" sort="White, Shane" uniqKey="White S" first="Shane" last="White">Shane White</name>
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<country xml:lang="fr">Australie</country>
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<author><name sortKey="Bachelot, Thomas" sort="Bachelot, Thomas" uniqKey="Bachelot T" first="Thomas" last="Bachelot">Thomas Bachelot</name>
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<author><name sortKey="Canon, Jean Luc" sort="Canon, Jean Luc" uniqKey="Canon J" first="Jean-Luc" last="Canon">Jean-Luc Canon</name>
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<author><name sortKey="Disis, Mary" sort="Disis, Mary" uniqKey="Disis M" first="Mary" last="Disis">Mary Disis</name>
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<author><name sortKey="Awada, Ahmad" sort="Awada, Ahmad" uniqKey="Awada A" first="Ahmad" last="Awada">Ahmad Awada</name>
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<author><name sortKey="Berliere, Martine" sort="Berliere, Martine" uniqKey="Berliere M" first="Martine" last="Berlière">Martine Berlière</name>
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<country xml:lang="fr">Belgique</country>
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<author><name sortKey="Amant, Frederic" sort="Amant, Frederic" uniqKey="Amant F" first="Frédéric" last="Amant">Frédéric Amant</name>
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<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>
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<author><name sortKey="Burny, Wivine" sort="Burny, Wivine" uniqKey="Burny W" first="Wivine" last="Burny">Wivine Burny</name>
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<author><name sortKey="Callegaro, Andrea" sort="Callegaro, Andrea" uniqKey="Callegaro A" first="Andrea" last="Callegaro">Andrea Callegaro</name>
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<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>
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<author><name sortKey="Louahed, Jamila" sort="Louahed, Jamila" uniqKey="Louahed J" first="Jamila" last="Louahed">Jamila Louahed</name>
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<author><name sortKey="Brichard, Vincent" sort="Brichard, Vincent" uniqKey="Brichard V" first="Vincent" last="Brichard">Vincent Brichard</name>
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<author><name sortKey="Lehmann, Frederic F" sort="Lehmann, Frederic F" uniqKey="Lehmann F" first="Frédéric F" last="Lehmann">Frédéric F. Lehmann</name>
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<country xml:lang="fr">Belgique</country>
<wicri:regionArea>GSK Vaccines, Rixensart</wicri:regionArea>
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<series><title level="j">Breast cancer research and treatment</title>
<idno type="eISSN">1573-7217</idno>
<imprint><date when="2016" type="published">2016</date>
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<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>
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<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>
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