Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy
Objective We sought to evaluate the safety and efficacy of TG4001 in patients with human papillomavirus (HPV) 16–related cervical intraepithelial neoplasia (CIN) 2/3 at 6 and 12 months. Study Design In all, 21 patients with HPV 16–related CIN 2/3 received 3 weekly subcutaneous injections of TG4001....
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| Veröffentlicht in: | American journal of obstetrics and gynecology 2011-02, Vol.204 (2), p.169.e1-169.e8 |
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| creator | Brun, Jean-Luc, MD Dalstein, Véronique, PhD Leveque, Jean, MD, PhD Mathevet, Patrice, MD, PhD Raulic, Patrick, MD Baldauf, Jean-Jacques, MD Scholl, Suzy, MD Huynh, Bernard, MD Douvier, Serge, MD, PhD Riethmuller, Didier, MD, PhD Clavel, Christine, PhD Birembaut, Philippe, MD, PhD Calenda, Valérie, PhD Baudin, Martine, MD, PhD Bory, Jean-Paul, MD |
| description | Objective We sought to evaluate the safety and efficacy of TG4001 in patients with human papillomavirus (HPV) 16–related cervical intraepithelial neoplasia (CIN) 2/3 at 6 and 12 months. Study Design In all, 21 patients with HPV 16–related CIN 2/3 received 3 weekly subcutaneous injections of TG4001. Regression of the CIN 2/3 lesion and the clearance of HPV 16 infection were monitored by cytology, colposcopy, and HPV DNA/messenger RNA (mRNA) detection. A clinical response was defined by no CIN 2/3 found on conization, or no conization performed because not suspected at cytology or colposcopy. Results Ten patients (48%) were evaluated as clinical responders at month 6. Nine patients experienced an improvement of their HPV 16 infection, by mRNA ± DNA eradication. HPV 16 mRNA clearance was associated with CIN 2/3 cytologic and colposcopic regression in 7 of 10 patients. At month 12, 7 of 8 patients without conization reported neither suspicion of CIN 2/3 relapse nor HPV 16 infection. The remaining patient was lost to follow-up. Conclusion These promising data warrant further development of TG4001 in CIN 2/3 treatment. |
| doi_str_mv | 10.1016/j.ajog.2010.09.020 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_hal_p</sourceid><recordid>TN_cdi_hal_primary_oai_HAL_hal_00874034v1</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S000293781001166X</els_id><sourcerecordid>849010707</sourcerecordid><originalsourceid>FETCH-LOGICAL-c474t-e40d844ce793913b1c47465e77c338828aa1d4ff815639d5939725ec2d5c7aab3</originalsourceid><addsrcrecordid>eNp9kl-L1DAUxYMo7rj6BXyQvoj40PHmT5sURFgW3RUGBF3BJ0Mmve2kdpqatCPz7U2ZcQUffAr38LuX3HMuIc8prCnQ8k23Np1v1wySANUaGDwgKwqVzEtVqodkBQAsr7hUF-RJjN1Ssoo9JheMMiWqUq3I98_YBozR-SHzTbZz7S5vg6kxsxgOzpo-c8MUDI5u2mHvUj2gH3sTncl-JS27uxEANJtMaHHCOnP7_Tz4BAczHp-SR43pIz47v5fk64f3d9e3-ebTzcfrq01uhRRTjgJqJYRFWfGK8i1d5LJAKS3nSjFlDK1F0yhalLyqi0RJVqBldWGlMVt-SV6f5u5Mr8fg9iYctTdO315t9KIBKCmAiwNN7KsTOwb_c8Y46b2LFvvepM3mqJMzyVEJMpHsRNrgYwzY3I-moJcIdKeXCPQSgYZKpwhS04vz-Hm7x_q-5Y_nCXh5BkxM_jbBDNbFvxxXBbBKJO7ticNk3MFh0NE6HCzWLqCddO3d___x7p9227thSfQHHjF2fg5DikRTHZkG_WW5juVWaEqTluU3_huxv7g8</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>849010707</pqid></control><display><type>article</type><title>Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Brun, Jean-Luc, MD ; Dalstein, Véronique, PhD ; Leveque, Jean, MD, PhD ; Mathevet, Patrice, MD, PhD ; Raulic, Patrick, MD ; Baldauf, Jean-Jacques, MD ; Scholl, Suzy, MD ; Huynh, Bernard, MD ; Douvier, Serge, MD, PhD ; Riethmuller, Didier, MD, PhD ; Clavel, Christine, PhD ; Birembaut, Philippe, MD, PhD ; Calenda, Valérie, PhD ; Baudin, Martine, MD, PhD ; Bory, Jean-Paul, MD</creator><creatorcontrib>Brun, Jean-Luc, MD ; Dalstein, Véronique, PhD ; Leveque, Jean, MD, PhD ; Mathevet, Patrice, MD, PhD ; Raulic, Patrick, MD ; Baldauf, Jean-Jacques, MD ; Scholl, Suzy, MD ; Huynh, Bernard, MD ; Douvier, Serge, MD, PhD ; Riethmuller, Didier, MD, PhD ; Clavel, Christine, PhD ; Birembaut, Philippe, MD, PhD ; Calenda, Valérie, PhD ; Baudin, Martine, MD, PhD ; Bory, Jean-Paul, MD</creatorcontrib><description>Objective We sought to evaluate the safety and efficacy of TG4001 in patients with human papillomavirus (HPV) 16–related cervical intraepithelial neoplasia (CIN) 2/3 at 6 and 12 months. Study Design In all, 21 patients with HPV 16–related CIN 2/3 received 3 weekly subcutaneous injections of TG4001. Regression of the CIN 2/3 lesion and the clearance of HPV 16 infection were monitored by cytology, colposcopy, and HPV DNA/messenger RNA (mRNA) detection. A clinical response was defined by no CIN 2/3 found on conization, or no conization performed because not suspected at cytology or colposcopy. Results Ten patients (48%) were evaluated as clinical responders at month 6. Nine patients experienced an improvement of their HPV 16 infection, by mRNA ± DNA eradication. HPV 16 mRNA clearance was associated with CIN 2/3 cytologic and colposcopic regression in 7 of 10 patients. At month 12, 7 of 8 patients without conization reported neither suspicion of CIN 2/3 relapse nor HPV 16 infection. The remaining patient was lost to follow-up. Conclusion These promising data warrant further development of TG4001 in CIN 2/3 treatment.</description><identifier>ISSN: 0002-9378</identifier><identifier>EISSN: 1097-6868</identifier><identifier>DOI: 10.1016/j.ajog.2010.09.020</identifier><identifier>PMID: 21284968</identifier><identifier>CODEN: AJOGAH</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Biological and medical sciences ; Cancer Vaccines ; Cancer Vaccines - immunology ; Cancer Vaccines - therapeutic use ; Cervical Intraepithelial Neoplasia ; Cervical Intraepithelial Neoplasia - immunology ; Cervical Intraepithelial Neoplasia - pathology ; Cervical Intraepithelial Neoplasia - therapy ; Female ; Female genital diseases ; Gynecology and obstetrics ; Gynecology. Andrology. Obstetrics ; Human health and pathology ; human papillomavirus ; Humans ; Immunotherapy ; Immunotherapy - methods ; Life Sciences ; Medical sciences ; Obstetrics and Gynecology ; targeted immunotherapy ; Treatment Outcome ; Tumors ; Uterine Cervical Neoplasms ; Uterine Cervical Neoplasms - immunology ; Uterine Cervical Neoplasms - pathology ; Uterine Cervical Neoplasms - therapy ; Vaginal Smears</subject><ispartof>American journal of obstetrics and gynecology, 2011-02, Vol.204 (2), p.169.e1-169.e8</ispartof><rights>Mosby, Inc.</rights><rights>2011 Mosby, Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Mosby, Inc. All rights reserved.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-e40d844ce793913b1c47465e77c338828aa1d4ff815639d5939725ec2d5c7aab3</citedby><cites>FETCH-LOGICAL-c474t-e40d844ce793913b1c47465e77c338828aa1d4ff815639d5939725ec2d5c7aab3</cites><orcidid>0000-0001-7222-2671</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ajog.2010.09.020$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,777,781,882,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23850294$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21284968$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-00874034$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Brun, Jean-Luc, MD</creatorcontrib><creatorcontrib>Dalstein, Véronique, PhD</creatorcontrib><creatorcontrib>Leveque, Jean, MD, PhD</creatorcontrib><creatorcontrib>Mathevet, Patrice, MD, PhD</creatorcontrib><creatorcontrib>Raulic, Patrick, MD</creatorcontrib><creatorcontrib>Baldauf, Jean-Jacques, MD</creatorcontrib><creatorcontrib>Scholl, Suzy, MD</creatorcontrib><creatorcontrib>Huynh, Bernard, MD</creatorcontrib><creatorcontrib>Douvier, Serge, MD, PhD</creatorcontrib><creatorcontrib>Riethmuller, Didier, MD, PhD</creatorcontrib><creatorcontrib>Clavel, Christine, PhD</creatorcontrib><creatorcontrib>Birembaut, Philippe, MD, PhD</creatorcontrib><creatorcontrib>Calenda, Valérie, PhD</creatorcontrib><creatorcontrib>Baudin, Martine, MD, PhD</creatorcontrib><creatorcontrib>Bory, Jean-Paul, MD</creatorcontrib><title>Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy</title><title>American journal of obstetrics and gynecology</title><addtitle>Am J Obstet Gynecol</addtitle><description>Objective We sought to evaluate the safety and efficacy of TG4001 in patients with human papillomavirus (HPV) 16–related cervical intraepithelial neoplasia (CIN) 2/3 at 6 and 12 months. Study Design In all, 21 patients with HPV 16–related CIN 2/3 received 3 weekly subcutaneous injections of TG4001. Regression of the CIN 2/3 lesion and the clearance of HPV 16 infection were monitored by cytology, colposcopy, and HPV DNA/messenger RNA (mRNA) detection. A clinical response was defined by no CIN 2/3 found on conization, or no conization performed because not suspected at cytology or colposcopy. Results Ten patients (48%) were evaluated as clinical responders at month 6. Nine patients experienced an improvement of their HPV 16 infection, by mRNA ± DNA eradication. HPV 16 mRNA clearance was associated with CIN 2/3 cytologic and colposcopic regression in 7 of 10 patients. At month 12, 7 of 8 patients without conization reported neither suspicion of CIN 2/3 relapse nor HPV 16 infection. The remaining patient was lost to follow-up. Conclusion These promising data warrant further development of TG4001 in CIN 2/3 treatment.</description><subject>Biological and medical sciences</subject><subject>Cancer Vaccines</subject><subject>Cancer Vaccines - immunology</subject><subject>Cancer Vaccines - therapeutic use</subject><subject>Cervical Intraepithelial Neoplasia</subject><subject>Cervical Intraepithelial Neoplasia - immunology</subject><subject>Cervical Intraepithelial Neoplasia - pathology</subject><subject>Cervical Intraepithelial Neoplasia - therapy</subject><subject>Female</subject><subject>Female genital diseases</subject><subject>Gynecology and obstetrics</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Human health and pathology</subject><subject>human papillomavirus</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Immunotherapy - methods</subject><subject>Life Sciences</subject><subject>Medical sciences</subject><subject>Obstetrics and Gynecology</subject><subject>targeted immunotherapy</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Uterine Cervical Neoplasms</subject><subject>Uterine Cervical Neoplasms - immunology</subject><subject>Uterine Cervical Neoplasms - pathology</subject><subject>Uterine Cervical Neoplasms - therapy</subject><subject>Vaginal Smears</subject><issn>0002-9378</issn><issn>1097-6868</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kl-L1DAUxYMo7rj6BXyQvoj40PHmT5sURFgW3RUGBF3BJ0Mmve2kdpqatCPz7U2ZcQUffAr38LuX3HMuIc8prCnQ8k23Np1v1wySANUaGDwgKwqVzEtVqodkBQAsr7hUF-RJjN1Ssoo9JheMMiWqUq3I98_YBozR-SHzTbZz7S5vg6kxsxgOzpo-c8MUDI5u2mHvUj2gH3sTncl-JS27uxEANJtMaHHCOnP7_Tz4BAczHp-SR43pIz47v5fk64f3d9e3-ebTzcfrq01uhRRTjgJqJYRFWfGK8i1d5LJAKS3nSjFlDK1F0yhalLyqi0RJVqBldWGlMVt-SV6f5u5Mr8fg9iYctTdO315t9KIBKCmAiwNN7KsTOwb_c8Y46b2LFvvepM3mqJMzyVEJMpHsRNrgYwzY3I-moJcIdKeXCPQSgYZKpwhS04vz-Hm7x_q-5Y_nCXh5BkxM_jbBDNbFvxxXBbBKJO7ticNk3MFh0NE6HCzWLqCddO3d___x7p9227thSfQHHjF2fg5DikRTHZkG_WW5juVWaEqTluU3_huxv7g8</recordid><startdate>20110201</startdate><enddate>20110201</enddate><creator>Brun, Jean-Luc, MD</creator><creator>Dalstein, Véronique, PhD</creator><creator>Leveque, Jean, MD, PhD</creator><creator>Mathevet, Patrice, MD, PhD</creator><creator>Raulic, Patrick, MD</creator><creator>Baldauf, Jean-Jacques, MD</creator><creator>Scholl, Suzy, MD</creator><creator>Huynh, Bernard, MD</creator><creator>Douvier, Serge, MD, PhD</creator><creator>Riethmuller, Didier, MD, PhD</creator><creator>Clavel, Christine, PhD</creator><creator>Birembaut, Philippe, MD, PhD</creator><creator>Calenda, Valérie, PhD</creator><creator>Baudin, Martine, MD, PhD</creator><creator>Bory, Jean-Paul, MD</creator><general>Mosby, Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0001-7222-2671</orcidid></search><sort><creationdate>20110201</creationdate><title>Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy</title><author>Brun, Jean-Luc, MD ; Dalstein, Véronique, PhD ; Leveque, Jean, MD, PhD ; Mathevet, Patrice, MD, PhD ; Raulic, Patrick, MD ; Baldauf, Jean-Jacques, MD ; Scholl, Suzy, MD ; Huynh, Bernard, MD ; Douvier, Serge, MD, PhD ; Riethmuller, Didier, MD, PhD ; Clavel, Christine, PhD ; Birembaut, Philippe, MD, PhD ; Calenda, Valérie, PhD ; Baudin, Martine, MD, PhD ; Bory, Jean-Paul, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-e40d844ce793913b1c47465e77c338828aa1d4ff815639d5939725ec2d5c7aab3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Biological and medical sciences</topic><topic>Cancer Vaccines</topic><topic>Cancer Vaccines - immunology</topic><topic>Cancer Vaccines - therapeutic use</topic><topic>Cervical Intraepithelial Neoplasia</topic><topic>Cervical Intraepithelial Neoplasia - immunology</topic><topic>Cervical Intraepithelial Neoplasia - pathology</topic><topic>Cervical Intraepithelial Neoplasia - therapy</topic><topic>Female</topic><topic>Female genital diseases</topic><topic>Gynecology and obstetrics</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Human health and pathology</topic><topic>human papillomavirus</topic><topic>Humans</topic><topic>Immunotherapy</topic><topic>Immunotherapy - methods</topic><topic>Life Sciences</topic><topic>Medical sciences</topic><topic>Obstetrics and Gynecology</topic><topic>targeted immunotherapy</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Uterine Cervical Neoplasms</topic><topic>Uterine Cervical Neoplasms - immunology</topic><topic>Uterine Cervical Neoplasms - pathology</topic><topic>Uterine Cervical Neoplasms - therapy</topic><topic>Vaginal Smears</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brun, Jean-Luc, MD</creatorcontrib><creatorcontrib>Dalstein, Véronique, PhD</creatorcontrib><creatorcontrib>Leveque, Jean, MD, PhD</creatorcontrib><creatorcontrib>Mathevet, Patrice, MD, PhD</creatorcontrib><creatorcontrib>Raulic, Patrick, MD</creatorcontrib><creatorcontrib>Baldauf, Jean-Jacques, MD</creatorcontrib><creatorcontrib>Scholl, Suzy, MD</creatorcontrib><creatorcontrib>Huynh, Bernard, MD</creatorcontrib><creatorcontrib>Douvier, Serge, MD, PhD</creatorcontrib><creatorcontrib>Riethmuller, Didier, MD, PhD</creatorcontrib><creatorcontrib>Clavel, Christine, PhD</creatorcontrib><creatorcontrib>Birembaut, Philippe, MD, PhD</creatorcontrib><creatorcontrib>Calenda, Valérie, PhD</creatorcontrib><creatorcontrib>Baudin, Martine, MD, PhD</creatorcontrib><creatorcontrib>Bory, Jean-Paul, MD</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>American journal of obstetrics and gynecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brun, Jean-Luc, MD</au><au>Dalstein, Véronique, PhD</au><au>Leveque, Jean, MD, PhD</au><au>Mathevet, Patrice, MD, PhD</au><au>Raulic, Patrick, MD</au><au>Baldauf, Jean-Jacques, MD</au><au>Scholl, Suzy, MD</au><au>Huynh, Bernard, MD</au><au>Douvier, Serge, MD, PhD</au><au>Riethmuller, Didier, MD, PhD</au><au>Clavel, Christine, PhD</au><au>Birembaut, Philippe, MD, PhD</au><au>Calenda, Valérie, PhD</au><au>Baudin, Martine, MD, PhD</au><au>Bory, Jean-Paul, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy</atitle><jtitle>American journal of obstetrics and gynecology</jtitle><addtitle>Am J Obstet Gynecol</addtitle><date>2011-02-01</date><risdate>2011</risdate><volume>204</volume><issue>2</issue><spage>169.e1</spage><epage>169.e8</epage><pages>169.e1-169.e8</pages><issn>0002-9378</issn><eissn>1097-6868</eissn><coden>AJOGAH</coden><abstract>Objective We sought to evaluate the safety and efficacy of TG4001 in patients with human papillomavirus (HPV) 16–related cervical intraepithelial neoplasia (CIN) 2/3 at 6 and 12 months. Study Design In all, 21 patients with HPV 16–related CIN 2/3 received 3 weekly subcutaneous injections of TG4001. Regression of the CIN 2/3 lesion and the clearance of HPV 16 infection were monitored by cytology, colposcopy, and HPV DNA/messenger RNA (mRNA) detection. A clinical response was defined by no CIN 2/3 found on conization, or no conization performed because not suspected at cytology or colposcopy. Results Ten patients (48%) were evaluated as clinical responders at month 6. Nine patients experienced an improvement of their HPV 16 infection, by mRNA ± DNA eradication. HPV 16 mRNA clearance was associated with CIN 2/3 cytologic and colposcopic regression in 7 of 10 patients. At month 12, 7 of 8 patients without conization reported neither suspicion of CIN 2/3 relapse nor HPV 16 infection. The remaining patient was lost to follow-up. Conclusion These promising data warrant further development of TG4001 in CIN 2/3 treatment.</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>21284968</pmid><doi>10.1016/j.ajog.2010.09.020</doi><tpages>2</tpages><orcidid>https://orcid.org/0000-0001-7222-2671</orcidid></addata></record> |
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| subjects | Biological and medical sciences Cancer Vaccines Cancer Vaccines - immunology Cancer Vaccines - therapeutic use Cervical Intraepithelial Neoplasia Cervical Intraepithelial Neoplasia - immunology Cervical Intraepithelial Neoplasia - pathology Cervical Intraepithelial Neoplasia - therapy Female Female genital diseases Gynecology and obstetrics Gynecology. Andrology. Obstetrics Human health and pathology human papillomavirus Humans Immunotherapy Immunotherapy - methods Life Sciences Medical sciences Obstetrics and Gynecology targeted immunotherapy Treatment Outcome Tumors Uterine Cervical Neoplasms Uterine Cervical Neoplasms - immunology Uterine Cervical Neoplasms - pathology Uterine Cervical Neoplasms - therapy Vaginal Smears |
| title | Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy |
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