A Feasibility Study of Cyclophosphamide, Trastuzumab, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for HER-2+ Metastatic Breast Cancer
Identifieur interne : 004646 ( Main/Merge ); précédent : 004645; suivant : 004647A Feasibility Study of Cyclophosphamide, Trastuzumab, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for HER-2+ Metastatic Breast Cancer
Auteurs : G. Chen ; R. Gupta ; S. Petrik ; M. Laiko ; Jm Leatherman ; Jm Asquith ; Mm Daphtary ; E. Garrett-Mayer ; Ne Davidson ; K. Hirt ; M. Berg ; Jn Uram ; T. Dauses ; J. Fetting ; Em Duus ; S. Atay-Rosenthal ; X. Ye ; Ac Wolff ; V. Stearns ; Em Jaffee ; La EmensSource :
- Cancer immunology research [ 2326-6066 ] ; 2014.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Analyse de survie, Animaux, Anticorps monoclonaux humanisés (administration et posologie), Anticorps monoclonaux humanisés (effets indésirables), Antinéoplasiques (effets indésirables), Antinéoplasiques (usage thérapeutique), Association thérapeutique, Cyclophosphamide (administration et posologie), Cyclophosphamide (effets indésirables), Facteur de stimulation des colonies de granulocytes et de macrophages (métabolisme), Femelle, Humains, Hypersensibilité retardée (immunologie), Lignée cellulaire tumorale, Lymphocytes T CD8+ (immunologie), Métastase tumorale, Récepteur ErbB-2 (immunologie), Récepteur ErbB-2 (métabolisme), Souris transgéniques, Sujet âgé, Trastuzumab, Tumeurs du sein (), Tumeurs du sein (immunologie), Tumeurs du sein (métabolisme), Vaccins anticancéreux (effets indésirables), Vaccins anticancéreux (immunologie), Vaccins anticancéreux (usage thérapeutique), Études de faisabilité.
- MESH :
- administration et posologie : Anticorps monoclonaux humanisés, Cyclophosphamide.
- effets indésirables : Anticorps monoclonaux humanisés, Antinéoplasiques, Cyclophosphamide, Vaccins anticancéreux.
- immunologie : Hypersensibilité retardée, Lymphocytes T CD8+, Récepteur ErbB-2, Tumeurs du sein, Vaccins anticancéreux.
- métabolisme : Facteur de stimulation des colonies de granulocytes et de macrophages, Récepteur ErbB-2, Tumeurs du sein.
- usage thérapeutique : Antinéoplasiques, Vaccins anticancéreux.
- Adulte, Adulte d'âge moyen, Analyse de survie, Animaux, Association thérapeutique, Femelle, Humains, Lignée cellulaire tumorale, Métastase tumorale, Souris transgéniques, Sujet âgé, Trastuzumab, Tumeurs du sein, Études de faisabilité.
English descriptors
- KwdEn :
- Adult, Aged, Animals, Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Humanized (adverse effects), Antineoplastic Agents (adverse effects), Antineoplastic Agents (therapeutic use), Breast Neoplasms (immunology), Breast Neoplasms (metabolism), Breast Neoplasms (therapy), CD8-Positive T-Lymphocytes (immunology), Cancer Vaccines (adverse effects), Cancer Vaccines (immunology), Cancer Vaccines (therapeutic use), Cell Line, Tumor, Combined Modality Therapy, Cyclophosphamide (administration & dosage), Cyclophosphamide (adverse effects), Feasibility Studies, Female, Granulocyte-Macrophage Colony-Stimulating Factor (metabolism), Humans, Hypersensitivity, Delayed (immunology), Mice, Transgenic, Middle Aged, Neoplasm Metastasis, Receptor, ErbB-2 (immunology), Receptor, ErbB-2 (metabolism), Survival Analysis, Trastuzumab.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Cyclophosphamide.
- chemical , adverse effects : Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Cancer Vaccines, Cyclophosphamide.
- chemical , immunology : Cancer Vaccines, Receptor, ErbB-2.
- chemical , metabolism : Granulocyte-Macrophage Colony-Stimulating Factor, Receptor, ErbB-2.
- chemical , therapeutic use : Antineoplastic Agents, Cancer Vaccines.
- immunology : Breast Neoplasms, CD8-Positive T-Lymphocytes, Hypersensitivity, Delayed.
- metabolism : Breast Neoplasms.
- therapy : Breast Neoplasms.
- Adult, Aged, Animals, Cell Line, Tumor, Combined Modality Therapy, Feasibility Studies, Female, Humans, Mice, Transgenic, Middle Aged, Neoplasm Metastasis, Survival Analysis, Trastuzumab.
Abstract
Granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting tumor vaccines are bioactive, but limited by disease burden and immune tolerance. Cyclophosphamide (CY) augments vaccine activity in tolerant
Url:
DOI: 10.1158/2326-6066.CIR-14-0058
PubMed: 25116755
PubMed Central: 4211036
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PMC:4211036Le document en format XML
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Chen</name></author><author><name sortKey="Gupta, R" sort="Gupta, R" uniqKey="Gupta R" first="R" last="Gupta">R. Gupta</name></author><author><name sortKey="Petrik, S" sort="Petrik, S" uniqKey="Petrik S" first="S" last="Petrik">S. Petrik</name></author><author><name sortKey="Laiko, M" sort="Laiko, M" uniqKey="Laiko M" first="M" last="Laiko">M. Laiko</name></author><author><name sortKey="Leatherman, Jm" sort="Leatherman, Jm" uniqKey="Leatherman J" first="Jm" last="Leatherman">Jm Leatherman</name></author><author><name sortKey="Asquith, Jm" sort="Asquith, Jm" uniqKey="Asquith J" first="Jm" last="Asquith">Jm Asquith</name></author><author><name sortKey="Daphtary, Mm" sort="Daphtary, Mm" uniqKey="Daphtary M" first="Mm" last="Daphtary">Mm Daphtary</name></author><author><name sortKey="Garrett Mayer, E" sort="Garrett Mayer, E" uniqKey="Garrett Mayer E" first="E" last="Garrett-Mayer">E. Garrett-Mayer</name></author><author><name sortKey="Davidson, Ne" sort="Davidson, Ne" uniqKey="Davidson N" first="Ne" last="Davidson">Ne Davidson</name></author><author><name sortKey="Hirt, K" sort="Hirt, K" uniqKey="Hirt K" first="K" last="Hirt">K. Hirt</name></author><author><name sortKey="Berg, M" sort="Berg, M" uniqKey="Berg M" first="M" last="Berg">M. Berg</name></author><author><name sortKey="Uram, Jn" sort="Uram, Jn" uniqKey="Uram J" first="Jn" last="Uram">Jn Uram</name></author><author><name sortKey="Dauses, T" sort="Dauses, T" uniqKey="Dauses T" first="T" last="Dauses">T. Dauses</name></author><author><name sortKey="Fetting, J" sort="Fetting, J" uniqKey="Fetting J" first="J" last="Fetting">J. Fetting</name></author><author><name sortKey="Duus, Em" sort="Duus, Em" uniqKey="Duus E" first="Em" last="Duus">Em Duus</name></author><author><name sortKey="Atay Rosenthal, S" sort="Atay Rosenthal, S" uniqKey="Atay Rosenthal S" first="S" last="Atay-Rosenthal">S. Atay-Rosenthal</name></author><author><name sortKey="Ye, X" sort="Ye, X" uniqKey="Ye X" first="X" last="Ye">X. Ye</name></author><author><name sortKey="Wolff, Ac" sort="Wolff, Ac" uniqKey="Wolff A" first="Ac" last="Wolff">Ac Wolff</name></author><author><name sortKey="Stearns, V" sort="Stearns, V" uniqKey="Stearns V" first="V" last="Stearns">V. Stearns</name></author><author><name sortKey="Jaffee, Em" sort="Jaffee, Em" uniqKey="Jaffee E" first="Em" last="Jaffee">Em Jaffee</name></author><author><name sortKey="Emens, La" sort="Emens, La" uniqKey="Emens L" first="La" last="Emens">La Emens</name></author></analytic><series><title level="j">Cancer immunology research</title><idno type="ISSN">2326-6066</idno><idno type="eISSN">2326-6074</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Animals</term><term>Antibodies, Monoclonal, Humanized (administration & dosage)</term><term>Antibodies, Monoclonal, Humanized (adverse effects)</term><term>Antineoplastic Agents (adverse effects)</term><term>Antineoplastic Agents (therapeutic use)</term><term>Breast Neoplasms (immunology)</term><term>Breast Neoplasms (metabolism)</term><term>Breast Neoplasms (therapy)</term><term>CD8-Positive T-Lymphocytes (immunology)</term><term>Cancer Vaccines (adverse effects)</term><term>Cancer Vaccines (immunology)</term><term>Cancer Vaccines (therapeutic use)</term><term>Cell Line, Tumor</term><term>Combined Modality Therapy</term><term>Cyclophosphamide (administration & dosage)</term><term>Cyclophosphamide (adverse effects)</term><term>Feasibility Studies</term><term>Female</term><term>Granulocyte-Macrophage Colony-Stimulating Factor (metabolism)</term><term>Humans</term><term>Hypersensitivity, Delayed (immunology)</term><term>Mice, Transgenic</term><term>Middle Aged</term><term>Neoplasm Metastasis</term><term>Receptor, ErbB-2 (immunology)</term><term>Receptor, ErbB-2 (metabolism)</term><term>Survival Analysis</term><term>Trastuzumab</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Animaux</term><term>Anticorps monoclonaux humanisés (administration et posologie)</term><term>Anticorps monoclonaux humanisés (effets indésirables)</term><term>Antinéoplasiques (effets indésirables)</term><term>Antinéoplasiques (usage thérapeutique)</term><term>Association thérapeutique</term><term>Cyclophosphamide (administration et posologie)</term><term>Cyclophosphamide (effets indésirables)</term><term>Facteur de stimulation des colonies de granulocytes et de macrophages (métabolisme)</term><term>Femelle</term><term>Humains</term><term>Hypersensibilité retardée (immunologie)</term><term>Lignée cellulaire tumorale</term><term>Lymphocytes T CD8+ (immunologie)</term><term>Métastase tumorale</term><term>Récepteur ErbB-2 (immunologie)</term><term>Récepteur ErbB-2 (métabolisme)</term><term>Souris transgéniques</term><term>Sujet âgé</term><term>Trastuzumab</term><term>Tumeurs du sein ()</term><term>Tumeurs du sein (immunologie)</term><term>Tumeurs du sein (métabolisme)</term><term>Vaccins anticancéreux (effets indésirables)</term><term>Vaccins anticancéreux (immunologie)</term><term>Vaccins anticancéreux (usage thérapeutique)</term><term>Études de faisabilité</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Cyclophosphamide</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term><term>Antineoplastic Agents</term><term>Cancer Vaccines</term><term>Cyclophosphamide</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Cancer Vaccines</term><term>Receptor, ErbB-2</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Granulocyte-Macrophage Colony-Stimulating Factor</term><term>Receptor, ErbB-2</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents</term><term>Cancer Vaccines</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term><term>Cyclophosphamide</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term><term>Antinéoplasiques</term><term>Cyclophosphamide</term><term>Vaccins anticancéreux</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Hypersensibilité retardée</term><term>Lymphocytes T CD8+</term><term>Récepteur ErbB-2</term><term>Tumeurs du sein</term><term>Vaccins anticancéreux</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Breast Neoplasms</term><term>CD8-Positive T-Lymphocytes</term><term>Hypersensitivity, Delayed</term></keywords><keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Facteur de stimulation des colonies de granulocytes et de macrophages</term><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" qualifier="usage thérapeutique" xml:lang="fr"><term>Antinéoplasiques</term><term>Vaccins anticancéreux</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Animals</term><term>Cell Line, Tumor</term><term>Combined Modality Therapy</term><term>Feasibility Studies</term><term>Female</term><term>Humans</term><term>Mice, Transgenic</term><term>Middle Aged</term><term>Neoplasm Metastasis</term><term>Survival Analysis</term><term>Trastuzumab</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Animaux</term><term>Association thérapeutique</term><term>Femelle</term><term>Humains</term><term>Lignée cellulaire tumorale</term><term>Métastase tumorale</term><term>Souris transgéniques</term><term>Sujet âgé</term><term>Trastuzumab</term><term>Tumeurs du sein</term><term>Études de faisabilité</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p id="P1">Granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting tumor vaccines are bioactive, but limited by disease burden and immune tolerance. Cyclophosphamide (CY) augments vaccine activity in tolerant <italic>neu</italic> mice and metastatic breast cancer (MBC) patients. HER-2-specific monoclonal antibodies (MAb) enhance vaccine activity in <italic>neu</italic> mice. We hypothesized that CY-modulated vaccination with HER-2-specific MAb safely induces relevant HER-2-specific immunity in <italic>neu</italic> mice and HER-2<sup>+</sup> MBC patients. Adding both CY and the HER-2-specific MAb 7.16.4 to vaccination maximized HER-2-specific CD8<sup>+</sup> T-cell immunity and tumor-free survival in <italic>neu</italic> transgenic mice. We therefore conducted a single arm feasibility study of CY, an allogeneic HER-2<sup>+</sup> GM-CSF-secreting breast tumor vaccine, and weekly trastuzumab in 20 HER-2<sup>+</sup> MBC patients. Primary clinical trial objectives were safety and clinical benefit (CB), in which CB represents complete response+partial response+stable disease. Secondary study objectives were to assess HER-2-specific T-cell responses by delayed type hypersensitivity (DTH) and intracellular cytokine staining. Subjects received three monthly vaccinations, with a boost 6-8 months from trial entry. This combination immunotherapy was safe, with CB rates at 6 months and 1 year of 55% (95% CI:32-77%, p=0.013) and 40% (95% CI:19-64%) respectively. Median progression-free survival (PFS) and overall survival (OS) were 7 (95% CI:4-16) and 42 months (95% CI:22-70) respectively. Increased HER-2-specific DTH developed in 7/20 subjects (of whom 4 had CB (95% CI:18-90)), with a trend toward longer PFS and OS in DTH responders. Polyfunctional HER-2-specific CD8<sup>+</sup> T cells progressively expanded across vaccination cycles. Further investigation of CY-modulated vaccination with trastuzumab is warranted. (<ext-link ext-link-type="uri" xlink:href="http://Clinicaltrials.gov">Clinicaltrials.gov</ext-link> identifier: NCT00399529)</p></div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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