High response rates for T-VEC in early metastatic melanoma (stage IIIB/C-IVM1a).
Identifieur interne : 000017 ( Main/Curation ); précédent : 000016; suivant : 000018High 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 :
- International journal of cancer [ 1097-0215 ] ; 2019.
Descripteurs français
- KwdFr :
- Adulte (MeSH), Adulte d'âge moyen (MeSH), Femelle (MeSH), Herpèsvirus humain de type 1 (immunologie), Humains (MeSH), Immunothérapie (méthodes), Injections intralésionnelles (MeSH), Mâle (MeSH), Mélanome (immunologie), Mélanome (thérapie), Mélanome (virologie), Métastase tumorale (immunologie), Métastase tumorale (thérapie), Pays-Bas (MeSH), Sujet âgé (MeSH), Sujet âgé de 80 ans ou plus (MeSH), Thérapie virale de cancers (méthodes), Tumeurs cutanées (immunologie), Tumeurs cutanées (thérapie), Tumeurs cutanées (virologie), Virus oncolytiques (immunologie), Études prospectives (MeSH).
- MESH :
- immunologie : Herpèsvirus humain de type 1, Mélanome, Métastase tumorale, Tumeurs cutanées, Virus oncolytiques.
- méthodes : Immunothérapie, Thérapie virale de cancers.
- thérapie : Mélanome, Métastase tumorale, Tumeurs cutanées.
- virologie : Mélanome, Tumeurs cutanées.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Injections intralésionnelles, Mâle, Pays-Bas, Sujet âgé, Sujet âgé de 80 ans ou plus, Études prospectives.
- Wicri :
- geographic : Pays-Bas.
English descriptors
- KwdEn :
- Adult (MeSH), Aged (MeSH), Aged, 80 and over (MeSH), Female (MeSH), Herpesvirus 1, Human (immunology), Humans (MeSH), Immunotherapy (methods), Injections, Intralesional (MeSH), Male (MeSH), Melanoma (immunology), Melanoma (therapy), Melanoma (virology), Middle Aged (MeSH), Neoplasm Metastasis (immunology), Neoplasm Metastasis (therapy), Netherlands (MeSH), Oncolytic Virotherapy (methods), Oncolytic Viruses (immunology), Prospective Studies (MeSH), Skin Neoplasms (immunology), Skin Neoplasms (therapy), Skin Neoplasms (virology).
- MESH :
- geographic : Netherlands.
- immunology : Herpesvirus 1, Human, Melanoma, Neoplasm Metastasis, Oncolytic Viruses, Skin Neoplasms.
- methods : Immunotherapy, Oncolytic Virotherapy.
- therapy : Melanoma, Neoplasm Metastasis, Skin Neoplasms.
- virology : Melanoma, Skin Neoplasms.
- Adult, Aged, Aged, 80 and over, Female, Humans, Injections, Intralesional, Male, Middle Aged, Prospective Studies.
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
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<term>Aged, 80 and over (MeSH)</term>
<term>Female (MeSH)</term>
<term>Herpesvirus 1, Human (immunology)</term>
<term>Humans (MeSH)</term>
<term>Immunotherapy (methods)</term>
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<term>Melanoma (therapy)</term>
<term>Melanoma (virology)</term>
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<term>Skin Neoplasms (virology)</term>
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<term>Femelle (MeSH)</term>
<term>Herpèsvirus humain de type 1 (immunologie)</term>
<term>Humains (MeSH)</term>
<term>Immunothérapie (méthodes)</term>
<term>Injections intralésionnelles (MeSH)</term>
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<term>Mélanome (thérapie)</term>
<term>Mélanome (virologie)</term>
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<term>Tumeurs cutanées (thérapie)</term>
<term>Tumeurs cutanées (virologie)</term>
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<front><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>
</front>
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<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30694555</PMID>
<DateCompleted><Year>2019</Year>
<Month>12</Month>
<Day>03</Day>
</DateCompleted>
<DateRevised><Year>2019</Year>
<Month>12</Month>
<Day>03</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1097-0215</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>145</Volume>
<Issue>4</Issue>
<PubDate><Year>2019</Year>
<Month>08</Month>
<Day>15</Day>
</PubDate>
</JournalIssue>
<Title>International journal of cancer</Title>
<ISOAbbreviation>Int. J. Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>High response rates for T-VEC in early metastatic melanoma (stage IIIB/C-IVM1a).</ArticleTitle>
<Pagination><MedlinePgn>974-978</MedlinePgn>
</Pagination>
<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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