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Safety and efficacy of the anti-PD1 immunotherapy with nivolumab in trichoblastic carcinomas
Trichoblastic carcinoma is a rare malignant cutaneous adnexal tumor with a risk of local invasion and distant metastasis. As of today, there is no consensus for the treatment of locally advanced or metastatic trichoblastic carcinoma. “AcSé Nivolumab” is a multi-center Phase II basket clinical trial...
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| Published in: | Cancer Immunology, Immunotherapy Immunotherapy, 2023-08, Vol.72 (8), p.2649-2657 |
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| creator | Toulemonde, E. Chevret, S. Battistella, M. Neidhardt, E. M. Nardin, C. Le Du, F. Meyer, N. Véron, M. Gambotti, L. Lamrani-Ghaouti, A. Jamme, P. Chaffaut, C. De Pontville, M. Saada-Bouzid, E. Beylot-Barry, M. Simon, C. Jouary, T. Marabelle, A. Mortier, L. |
| description | Trichoblastic carcinoma is a rare malignant cutaneous adnexal tumor with a risk of local invasion and distant metastasis. As of today, there is no consensus for the treatment of locally advanced or metastatic trichoblastic carcinoma. “AcSé Nivolumab” is a multi-center Phase II basket clinical trial (NCT03012581) evaluating the safety and efficacy of nivolumab in several cohorts of rare, advanced cancers. Here we report the results of nivolumab in patients with trichoblastic carcinoma. Of the eleven patients enrolled in the study, five patients had been previously treated by sonic hedgehog inhibitors. The primary endpoint 12-week objective response rate was 9.1% (
N
= 1/11) with 1 partial response. Six patients who progressed under previous lines of treatment showed stable disease at 12 weeks, reflecting a good control of the disease with nivolumab. Furthermore, 54.5% of the patients (
N
= 6/11) had their disease under control at 6 months. The 1-year overall survival was 80%, and the median progression-free survival was 8.4 months (95%CI, 5.7 to NA). With 2 responders (2 complete responses), the best response rate to nivolumab at any time was 18.2% (95%CI, 2.3–51.8%). No new safety signals were identified, and adverse events observed herein were previously described and well known with nivolumab monotherapy. These results are promising, suggesting that nivolumab might be an option for patients with advanced trichoblastic carcinomas. Further studies on larger cohorts are necessary to confirm these results and define the role of nivolumab in the treatment of trichoblastic carcinomas. |
| doi_str_mv | 10.1007/s00262-023-03449-9 |
| format | article |
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N
= 1/11) with 1 partial response. Six patients who progressed under previous lines of treatment showed stable disease at 12 weeks, reflecting a good control of the disease with nivolumab. Furthermore, 54.5% of the patients (
N
= 6/11) had their disease under control at 6 months. The 1-year overall survival was 80%, and the median progression-free survival was 8.4 months (95%CI, 5.7 to NA). With 2 responders (2 complete responses), the best response rate to nivolumab at any time was 18.2% (95%CI, 2.3–51.8%). No new safety signals were identified, and adverse events observed herein were previously described and well known with nivolumab monotherapy. These results are promising, suggesting that nivolumab might be an option for patients with advanced trichoblastic carcinomas. Further studies on larger cohorts are necessary to confirm these results and define the role of nivolumab in the treatment of trichoblastic carcinomas.</description><identifier>ISSN: 0340-7004</identifier><identifier>EISSN: 1432-0851</identifier><identifier>DOI: 10.1007/s00262-023-03449-9</identifier><identifier>PMID: 37067554</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Antineoplastic Combined Chemotherapy Protocols ; Cancer ; Cancer Research ; Carcinoma ; Hedgehog Proteins ; Humans ; Immunology ; Immunotherapy ; Medicine ; Medicine & Public Health ; Metastases ; Nivolumab ; Oncology ; Patients ; PD-1 protein ; Response rates ; Safety ; Skin Neoplasms - drug therapy ; Skin Neoplasms - pathology ; Survival</subject><ispartof>Cancer Immunology, Immunotherapy, 2023-08, Vol.72 (8), p.2649-2657</ispartof><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-40a5750b4db399e01c87dd747fa2cf90903292d0a19e64ccd9e025a230b338fc3</citedby><cites>FETCH-LOGICAL-c475t-40a5750b4db399e01c87dd747fa2cf90903292d0a19e64ccd9e025a230b338fc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10992174/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10992174/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,315,733,786,790,891,27957,27958,53827,53829</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37067554$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Toulemonde, E.</creatorcontrib><creatorcontrib>Chevret, S.</creatorcontrib><creatorcontrib>Battistella, M.</creatorcontrib><creatorcontrib>Neidhardt, E. M.</creatorcontrib><creatorcontrib>Nardin, C.</creatorcontrib><creatorcontrib>Le Du, F.</creatorcontrib><creatorcontrib>Meyer, N.</creatorcontrib><creatorcontrib>Véron, M.</creatorcontrib><creatorcontrib>Gambotti, L.</creatorcontrib><creatorcontrib>Lamrani-Ghaouti, A.</creatorcontrib><creatorcontrib>Jamme, P.</creatorcontrib><creatorcontrib>Chaffaut, C.</creatorcontrib><creatorcontrib>De Pontville, M.</creatorcontrib><creatorcontrib>Saada-Bouzid, E.</creatorcontrib><creatorcontrib>Beylot-Barry, M.</creatorcontrib><creatorcontrib>Simon, C.</creatorcontrib><creatorcontrib>Jouary, T.</creatorcontrib><creatorcontrib>Marabelle, A.</creatorcontrib><creatorcontrib>Mortier, L.</creatorcontrib><title>Safety and efficacy of the anti-PD1 immunotherapy with nivolumab in trichoblastic carcinomas</title><title>Cancer Immunology, Immunotherapy</title><addtitle>Cancer Immunol Immunother</addtitle><addtitle>Cancer Immunol Immunother</addtitle><description>Trichoblastic carcinoma is a rare malignant cutaneous adnexal tumor with a risk of local invasion and distant metastasis. As of today, there is no consensus for the treatment of locally advanced or metastatic trichoblastic carcinoma. “AcSé Nivolumab” is a multi-center Phase II basket clinical trial (NCT03012581) evaluating the safety and efficacy of nivolumab in several cohorts of rare, advanced cancers. Here we report the results of nivolumab in patients with trichoblastic carcinoma. Of the eleven patients enrolled in the study, five patients had been previously treated by sonic hedgehog inhibitors. The primary endpoint 12-week objective response rate was 9.1% (
N
= 1/11) with 1 partial response. Six patients who progressed under previous lines of treatment showed stable disease at 12 weeks, reflecting a good control of the disease with nivolumab. Furthermore, 54.5% of the patients (
N
= 6/11) had their disease under control at 6 months. The 1-year overall survival was 80%, and the median progression-free survival was 8.4 months (95%CI, 5.7 to NA). With 2 responders (2 complete responses), the best response rate to nivolumab at any time was 18.2% (95%CI, 2.3–51.8%). No new safety signals were identified, and adverse events observed herein were previously described and well known with nivolumab monotherapy. These results are promising, suggesting that nivolumab might be an option for patients with advanced trichoblastic carcinomas. Further studies on larger cohorts are necessary to confirm these results and define the role of nivolumab in the treatment of trichoblastic carcinomas.</description><subject>Antineoplastic Combined Chemotherapy Protocols</subject><subject>Cancer</subject><subject>Cancer Research</subject><subject>Carcinoma</subject><subject>Hedgehog Proteins</subject><subject>Humans</subject><subject>Immunology</subject><subject>Immunotherapy</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metastases</subject><subject>Nivolumab</subject><subject>Oncology</subject><subject>Patients</subject><subject>PD-1 protein</subject><subject>Response rates</subject><subject>Safety</subject><subject>Skin Neoplasms - drug therapy</subject><subject>Skin Neoplasms - pathology</subject><subject>Survival</subject><issn>0340-7004</issn><issn>1432-0851</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9kU9PVDEUxRujgQH5Ai5MEzdsnt7-m05XxgCiCYkm6o6k6etrmZL32qHtw8y3tziA4sJVm3N_99zeHoReEXhLAOS7AkCXtAPKOmCcq049QwvCWZNWgjxHi6ZCJwH4Pjoo5bpdKCi1h_aZhKUUgi_Q5TfjXd1iEwfsvA_W2C1OHte1a1oN3ddTgsM0zTE1KZvNFv8MdY1juE3jPJkeh4hrDnad-tGUGiy2JtsQ02TKS_TCm7G4o_vzEP34ePb95FN38eX888mHi85yKWrHwQgpoOdDz5RyQOxKDoPk0htqvQIFjCo6gCHKLbm1Q2OoMJRBz9jKW3aI3u98N3M_ucG6WLMZ9SaHyeStTibop5UY1voq3WrSvoMSyZvD8b1DTjezK1VPoVg3jia6NBdNV0A5ZUSKhr75B71Oc45tv0Zx4EQIdkfRHWVzKiU7__gaAvouPb1LT7f09O_0tGpNr__e47HlIa4GsB1QWileufxn9n9sfwFJJqXW</recordid><startdate>20230801</startdate><enddate>20230801</enddate><creator>Toulemonde, E.</creator><creator>Chevret, S.</creator><creator>Battistella, M.</creator><creator>Neidhardt, E. 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M.</au><au>Nardin, C.</au><au>Le Du, F.</au><au>Meyer, N.</au><au>Véron, M.</au><au>Gambotti, L.</au><au>Lamrani-Ghaouti, A.</au><au>Jamme, P.</au><au>Chaffaut, C.</au><au>De Pontville, M.</au><au>Saada-Bouzid, E.</au><au>Beylot-Barry, M.</au><au>Simon, C.</au><au>Jouary, T.</au><au>Marabelle, A.</au><au>Mortier, L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of the anti-PD1 immunotherapy with nivolumab in trichoblastic carcinomas</atitle><jtitle>Cancer Immunology, Immunotherapy</jtitle><stitle>Cancer Immunol Immunother</stitle><addtitle>Cancer Immunol Immunother</addtitle><date>2023-08-01</date><risdate>2023</risdate><volume>72</volume><issue>8</issue><spage>2649</spage><epage>2657</epage><pages>2649-2657</pages><issn>0340-7004</issn><eissn>1432-0851</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><abstract>Trichoblastic carcinoma is a rare malignant cutaneous adnexal tumor with a risk of local invasion and distant metastasis. As of today, there is no consensus for the treatment of locally advanced or metastatic trichoblastic carcinoma. “AcSé Nivolumab” is a multi-center Phase II basket clinical trial (NCT03012581) evaluating the safety and efficacy of nivolumab in several cohorts of rare, advanced cancers. Here we report the results of nivolumab in patients with trichoblastic carcinoma. Of the eleven patients enrolled in the study, five patients had been previously treated by sonic hedgehog inhibitors. The primary endpoint 12-week objective response rate was 9.1% (
N
= 1/11) with 1 partial response. Six patients who progressed under previous lines of treatment showed stable disease at 12 weeks, reflecting a good control of the disease with nivolumab. Furthermore, 54.5% of the patients (
N
= 6/11) had their disease under control at 6 months. The 1-year overall survival was 80%, and the median progression-free survival was 8.4 months (95%CI, 5.7 to NA). With 2 responders (2 complete responses), the best response rate to nivolumab at any time was 18.2% (95%CI, 2.3–51.8%). No new safety signals were identified, and adverse events observed herein were previously described and well known with nivolumab monotherapy. These results are promising, suggesting that nivolumab might be an option for patients with advanced trichoblastic carcinomas. Further studies on larger cohorts are necessary to confirm these results and define the role of nivolumab in the treatment of trichoblastic carcinomas.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>37067554</pmid><doi>10.1007/s00262-023-03449-9</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Cancer Immunology, Immunotherapy, 2023-08, Vol.72 (8), p.2649-2657 |
| issn | 0340-7004 1432-0851 |
| language | eng |
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| source | Springer Nature:Jisc Collections:Springer Nature Read and Publish 2023-2025: Springer Reading List; PubMed Central |
| subjects | Antineoplastic Combined Chemotherapy Protocols Cancer Cancer Research Carcinoma Hedgehog Proteins Humans Immunology Immunotherapy Medicine Medicine & Public Health Metastases Nivolumab Oncology Patients PD-1 protein Response rates Safety Skin Neoplasms - drug therapy Skin Neoplasms - pathology Survival |
| title | Safety and efficacy of the anti-PD1 immunotherapy with nivolumab in trichoblastic carcinomas |
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