Serveur d'exploration sur la grippe aux Pays-Bas

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High response rates for T-VEC in early metastatic melanoma (stage IIIB/C-IVM1a).

Identifieur interne : 000013 ( Main/Exploration ); précédent : 000012; suivant : 000014

High response rates for T-VEC in early metastatic melanoma (stage IIIB/C-IVM1a).

Auteurs : Viola Franke [Pays-Bas] ; Danique M S. Berger [Pays-Bas] ; W Martin C. Klop [Pays-Bas] ; Bernies Van Der Hiel [Pays-Bas] ; Bart A. Van De Wiel [Pays-Bas] ; Sylvia Ter Meulen [Pays-Bas] ; Michel W J M. Wouters [Pays-Bas] ; Winan J. Van Houdt [Pays-Bas] ; Alexander C J. Van Akkooi [Pays-Bas]

Source :

RBID : pubmed:30694555

Descripteurs français

English descriptors

Abstract

Talimogene laherparepvec (T-VEC) is a modified herpes simplex virus, type 1 (HSV-1), which can be administered intralesionally in patients with stage IIIB/C-IVM1a unresectable melanoma (EMA label). The phase 3 OPTiM registration study showed an overall response rate (ORR) of 26%. Since December 2016, 48 eligible patients started treatment at the Netherlands Cancer Institute. We included 26 patients in this study with a follow up time ≥6 months, reporting Overall Response Rate (ORR), Disease Control Rate (DCR), Adverse Events (AE), prior treatment for melanoma and baseline characteristics, documented in a prospectively maintained database. In house developed treatment protocol consists of clinical evaluation, periodic PET-CT and histological biopsies for response evaluation. Median follow-up was 12.5 months. Of 26 patients, 16 (61.5%) had a Complete Response (CR) as their best response. Seven (26.9%) patients had a Partial Response (PR) as their best response, 1 (3.8%) patient Stable Disease (SD) and 2 (7.7%) patients Progressive Disease (PD). Best ORR was 88.5%. DCR was 92.3%. Grade 1-2 AEs occurred in all patients. Mostly, these consisted of fatigue, influenza-like symptoms and injection site erythema. All patients underwent prior treatment. Prior treatment did not influence response or toxicity of T-VEC. Best ORR for T-VEC monotherapy at our institute was 88.5% with 61.5% achieving a CR. This prospective study for T-VEC in early metastatic (stage IIIB/C-IVM1a) melanoma demonstrated superior results to the phase 3 OPTiM study and confirms the role of oncolytic immunotherapy for melanoma.

DOI: 10.1002/ijc.32172
PubMed: 30694555


Affiliations:


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Le document en format XML

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<div type="abstract" xml:lang="en">Talimogene laherparepvec (T-VEC) is a modified herpes simplex virus, type 1 (HSV-1), which can be administered intralesionally in patients with stage IIIB/C-IVM1a unresectable melanoma (EMA label). The phase 3 OPTiM registration study showed an overall response rate (ORR) of 26%. Since December 2016, 48 eligible patients started treatment at the Netherlands Cancer Institute. We included 26 patients in this study with a follow up time ≥6 months, reporting Overall Response Rate (ORR), Disease Control Rate (DCR), Adverse Events (AE), prior treatment for melanoma and baseline characteristics, documented in a prospectively maintained database. In house developed treatment protocol consists of clinical evaluation, periodic PET-CT and histological biopsies for response evaluation. Median follow-up was 12.5 months. Of 26 patients, 16 (61.5%) had a Complete Response (CR) as their best response. Seven (26.9%) patients had a Partial Response (PR) as their best response, 1 (3.8%) patient Stable Disease (SD) and 2 (7.7%) patients Progressive Disease (PD). Best ORR was 88.5%. DCR was 92.3%. Grade 1-2 AEs occurred in all patients. Mostly, these consisted of fatigue, influenza-like symptoms and injection site erythema. All patients underwent prior treatment. Prior treatment did not influence response or toxicity of T-VEC. Best ORR for T-VEC monotherapy at our institute was 88.5% with 61.5% achieving a CR. This prospective study for T-VEC in early metastatic (stage IIIB/C-IVM1a) melanoma demonstrated superior results to the phase 3 OPTiM study and confirms the role of oncolytic immunotherapy for melanoma.</div>
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<ELocationID EIdType="doi" ValidYN="Y">10.1002/ijc.32172</ELocationID>
<Abstract>
<AbstractText>Talimogene laherparepvec (T-VEC) is a modified herpes simplex virus, type 1 (HSV-1), which can be administered intralesionally in patients with stage IIIB/C-IVM1a unresectable melanoma (EMA label). The phase 3 OPTiM registration study showed an overall response rate (ORR) of 26%. Since December 2016, 48 eligible patients started treatment at the Netherlands Cancer Institute. We included 26 patients in this study with a follow up time ≥6 months, reporting Overall Response Rate (ORR), Disease Control Rate (DCR), Adverse Events (AE), prior treatment for melanoma and baseline characteristics, documented in a prospectively maintained database. In house developed treatment protocol consists of clinical evaluation, periodic PET-CT and histological biopsies for response evaluation. Median follow-up was 12.5 months. Of 26 patients, 16 (61.5%) had a Complete Response (CR) as their best response. Seven (26.9%) patients had a Partial Response (PR) as their best response, 1 (3.8%) patient Stable Disease (SD) and 2 (7.7%) patients Progressive Disease (PD). Best ORR was 88.5%. DCR was 92.3%. Grade 1-2 AEs occurred in all patients. Mostly, these consisted of fatigue, influenza-like symptoms and injection site erythema. All patients underwent prior treatment. Prior treatment did not influence response or toxicity of T-VEC. Best ORR for T-VEC monotherapy at our institute was 88.5% with 61.5% achieving a CR. This prospective study for T-VEC in early metastatic (stage IIIB/C-IVM1a) melanoma demonstrated superior results to the phase 3 OPTiM study and confirms the role of oncolytic immunotherapy for melanoma.</AbstractText>
<CopyrightInformation>© 2019 UICC.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Franke</LastName>
<ForeName>Viola</ForeName>
<Initials>V</Initials>
<Identifier Source="ORCID">0000-0002-0703-5092</Identifier>
<AffiliationInfo>
<Affiliation>Department of Surgical Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Berger</LastName>
<ForeName>Danique M S</ForeName>
<Initials>DMS</Initials>
<AffiliationInfo>
<Affiliation>Department of Head and Neck Surgery and Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Klop</LastName>
<ForeName>W Martin C</ForeName>
<Initials>WMC</Initials>
<AffiliationInfo>
<Affiliation>Department of Head and Neck Surgery and Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>van der Hiel</LastName>
<ForeName>Bernies</ForeName>
<Initials>B</Initials>
<AffiliationInfo>
<Affiliation>Departments of Nuclear Medicine, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>van de Wiel</LastName>
<ForeName>Bart A</ForeName>
<Initials>BA</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ter Meulen</LastName>
<ForeName>Sylvia</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Department of Surgical Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Wouters</LastName>
<ForeName>Michel W J M</ForeName>
<Initials>MWJM</Initials>
<AffiliationInfo>
<Affiliation>Department of Surgical Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>van Houdt</LastName>
<ForeName>Winan J</ForeName>
<Initials>WJ</Initials>
<AffiliationInfo>
<Affiliation>Department of Surgical Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>van Akkooi</LastName>
<ForeName>Alexander C J</ForeName>
<Initials>ACJ</Initials>
<AffiliationInfo>
<Affiliation>Department of Surgical Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic">
<Year>2019</Year>
<Month>02</Month>
<Day>21</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo>
<Country>United States</Country>
<MedlineTA>Int J Cancer</MedlineTA>
<NlmUniqueID>0042124</NlmUniqueID>
<ISSNLinking>0020-7136</ISSNLinking>
</MedlineJournalInfo>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D018259" MajorTopicYN="N">Herpesvirus 1, Human</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D007167" MajorTopicYN="N">Immunotherapy</DescriptorName>
<QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015552" MajorTopicYN="N">Injections, Intralesional</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008545" MajorTopicYN="N">Melanoma</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
<QualifierName UI="Q000821" MajorTopicYN="Y">virology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D009362" MajorTopicYN="N">Neoplasm Metastasis</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D009426" MajorTopicYN="N" Type="Geographic">Netherlands</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D050130" MajorTopicYN="N">Oncolytic Virotherapy</DescriptorName>
<QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D050504" MajorTopicYN="N">Oncolytic Viruses</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012878" MajorTopicYN="N">Skin Neoplasms</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000628" MajorTopicYN="N">therapy</QualifierName>
<QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="Y">T-VEC</Keyword>
<Keyword MajorTopicYN="Y">Talimogene Laherparepvec</Keyword>
<Keyword MajorTopicYN="Y">immunotherapy</Keyword>
<Keyword MajorTopicYN="Y">melanoma</Keyword>
<Keyword MajorTopicYN="Y">oncolytic virus</Keyword>
<Keyword MajorTopicYN="Y">response evaluation</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData>
<History>
<PubMedPubDate PubStatus="received">
<Year>2018</Year>
<Month>09</Month>
<Day>24</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised">
<Year>2018</Year>
<Month>12</Month>
<Day>18</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2019</Year>
<Month>01</Month>
<Day>15</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed">
<Year>2019</Year>
<Month>1</Month>
<Day>30</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline">
<Year>2019</Year>
<Month>12</Month>
<Day>4</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2019</Year>
<Month>1</Month>
<Day>30</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList>
<ArticleId IdType="pubmed">30694555</ArticleId>
<ArticleId IdType="doi">10.1002/ijc.32172</ArticleId>
</ArticleIdList>
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</pubmed>
<affiliations>
<list>
<country>
<li>Pays-Bas</li>
</country>
<region>
<li>Hollande-Septentrionale</li>
</region>
<settlement>
<li>Amsterdam</li>
</settlement>
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<country name="Pays-Bas">
<region name="Hollande-Septentrionale">
<name sortKey="Franke, Viola" sort="Franke, Viola" uniqKey="Franke V" first="Viola" last="Franke">Viola Franke</name>
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<name sortKey="Berger, Danique M S" sort="Berger, Danique M S" uniqKey="Berger D" first="Danique M S" last="Berger">Danique M S. Berger</name>
<name sortKey="Klop, W Martin C" sort="Klop, W Martin C" uniqKey="Klop W" first="W Martin C" last="Klop">W Martin C. Klop</name>
<name sortKey="Ter Meulen, Sylvia" sort="Ter Meulen, Sylvia" uniqKey="Ter Meulen S" first="Sylvia" last="Ter Meulen">Sylvia Ter Meulen</name>
<name sortKey="Van Akkooi, Alexander C J" sort="Van Akkooi, Alexander C J" uniqKey="Van Akkooi A" first="Alexander C J" last="Van Akkooi">Alexander C J. Van Akkooi</name>
<name sortKey="Van De Wiel, Bart A" sort="Van De Wiel, Bart A" uniqKey="Van De Wiel B" first="Bart A" last="Van De Wiel">Bart A. Van De Wiel</name>
<name sortKey="Van Der Hiel, Bernies" sort="Van Der Hiel, Bernies" uniqKey="Van Der Hiel B" first="Bernies" last="Van Der Hiel">Bernies Van Der Hiel</name>
<name sortKey="Van Houdt, Winan J" sort="Van Houdt, Winan J" uniqKey="Van Houdt W" first="Winan J" last="Van Houdt">Winan J. Van Houdt</name>
<name sortKey="Wouters, Michel W J M" sort="Wouters, Michel W J M" uniqKey="Wouters M" first="Michel W J M" last="Wouters">Michel W J M. Wouters</name>
</country>
</tree>
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</record>

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