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3. Adjuvant immunotherapy with nivolumab versus observation in completely resected Merkel cell carcinoma (ADMEC-O): disease-free survival results from a randomised, open-label, phase 2 trial

Author

van Akkooi, Alexander, van Houdt, Winan, Wilhelm, Tabea, Farmer, Kimberley, Ulrich, Claas, Gambichler, Thilo, Bluhm, Leonie, Schinagl, Heidemarie, Kellner, Ivonne, Herbst, Rudolf, Meiß, Frank, Rafei-Shamsabadi, David, Sell, Sabine, Kaatz, Martin, Wulfken, Lena, Hartmann, Martin, Kähler, Katharina, Ziemer, Mirjana, Simon, Jan, Terheyden, Patrick, Thaci, Diamant, Loquai, Carmen, Mitzel-Rink, Heidrun, Grabbe, Stephan, Stege, Henner, Gaiser, Maria, Utikal, Jochen, Berking, Carola, Heinzerling, Lucie, Schlaak, Max, Tomsitz, Dirk, Dyballa, Jörg, Magnolo, Nina, Weishaupt, Carsten, Berneburg, Mark, Garbe, Claus, Flatz, Lukas, Gesierich, Anja, Schilling, Bastian, Becker, Jürgen C, Ugurel, Selma, Leiter, Ulrike, Meier, Friedegund, Gutzmer, Ralf, Haferkamp, Sebastian, Zimmer, Lisa, Livingstone, Elisabeth, Eigentler, Thomas K, Hauschild, Axel, Kiecker, Felix, Hassel, Jessica C, Mohr, Peter, Fluck, Michael, Thomas, Ioannis, Garzarolli, Marlene, Grimmelmann, Imke, Drexler, Konstantin, Spillner, Alexandra N, Eckhardt, Sebastian, and Schadendorf, Dirk

Published
2023
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4. CLAUDIUS Study: Risk of materno-fetal transmission of melanoma cells in pregnant women with high grade melanoma – A retrospective multicenter study and literature review

Author

Wiedemann, Svenja Vanessa, Müller, Verena, Toth, Bettina, Erdmann, Michael, Bühler, Bodo, Dugas-Breit, Susanne, Schatton, Kerstin, Reinhardt, Lydia, Meissner, Markus, Mickler, Marion, Pföhler, Claudia, Weishaupt, Carsten, Herbst, Rudolf, Debus, Dirk, Susok, Laura, Tietze, Julia Katharina, Welzel, Julia, Arnold, Andreas, Dabrowski, Evelyn, Forschner, Andrea, Goetze, Steven, Hayani, Kinan, Lebbe, Céleste, Löhr, Florian, Mengoni, Miriam, Hermes, Barbara, Peitsch, Wiebke Katharina, Poch, Gabriela, Sachse, Michael Max, Sindrilaru, Anca, Wenk, Saskia, Ziemer, Mirjana, Kaune, Kjell, Meier-Naust, Lisette, Nikolakis, Georgios, Oberndörfer, Florian, Wesselmann, Ulrich, Utikal, Jochen Sven, and Gaiser, Maria Rita

Published
2023
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6. Adjuvant nivolumab plus ipilimumab or nivolumab alone versus placebo in patients with resected stage IV melanoma with no evidence of disease (IMMUNED): final results of a randomised, double-blind, phase 2 trial

Author

Livingstone, Elisabeth, Zimmer, Lisa, Hassel, Jessica C, Fluck, Michael, Eigentler, Thomas K, Loquai, Carmen, Haferkamp, Sebastian, Gutzmer, Ralf, Meier, Friedegund, Mohr, Peter, Hauschild, Axel, Schilling, Bastian, Menzer, Christian, Kiecker, Felix, Dippel, Edgar, Roesch, Alexander, Ziemer, Mirjana, Conrad, Beate, Körner, Silvia, Simon, Jan-Christoph, Herbst, Rudolf A, Berking, Carola, Utikal, Jochen, Sell, Sabine, Martens, Uwe M, Terheyden, Patrick, Stadler, Rudolf, Windemuth-Kieselbach, Christine, Schwarz, Leonora, Garbe, Claus, Becker, Jürgen C, and Schadendorf, Dirk

Published
2022
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9. Phase 3 study (PIVOTAL) of neoadjuvant intralesional daromun vs. immediate surgery in fully resectable melanoma with regional skin and/or nodal metastases.

Author

Hauschild, Axel, primary, Hassel, Jessica Cecile, additional, Ziemer, Mirjana, additional, Rutkowski, Piotr, additional, Meier, Friedegund Elke, additional, Flatz, Lukas, additional, Gaudy-Marqueste, Caroline, additional, Santinami, Mario, additional, Russano, Francesco, additional, von Wasielewski, Imke, additional, Eigentler, Thomas, additional, Maio, Michele, additional, Zalaudek, Iris, additional, Haferkamp, Sebastian, additional, Quaglino, Pietro, additional, Ascierto, Paolo Antonio, additional, Garbe, Claus, additional, Robert, Caroline, additional, Schadendorf, Dirk, additional, and Kähler, Katharina C., additional

Published
2024
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10. Targeting of canonical WNT signaling ameliorates experimental sclerodermatous chronic graft-versus-host disease

Author

Zhang, Yun, Shen, Lichong, Dreißigacker, Katja, Zhu, Honglin, Trinh-Minh, Thuong, Meng, Xianyi, Tran-Manh, Cuong, Dees, Clara, Matei, Alexandru-Emil, Chen, Chih-Wei, Ditschkowski, Markus, Krauss, Stefan, Winkler, Julia, Wolff, Daniel, Ziemer, Mirjana, Beilhack, Andreas, Karrer, Sigrid, Herr, Wolfgang, Mackensen, Andreas, Schett, Georg, Spriewald, Bernd M., and Distler, Jörg H.W.

Published
2021
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12. Haut

Author

Mayer, Steffi, Ziemer, Mirjana, Lacher, Martin, editor, Hoffmann, Florian, editor, and Mayer, Steffi, editor

Published
2020
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14. S1‐Leitlinie Talgdrüsenkarzinom

Author

Utikal, Jochen, primary, Nagel, Pia, additional, Müller, Verena, additional, Becker, Jürgen C., additional, Dippel, Edgar, additional, Frisman, Alexander, additional, Gschnell, Martin, additional, Griewank, Klaus, additional, Hadaschik, Eva, additional, Helbig, Doris, additional, Hillen, Uwe, additional, Leiter, Ulrike, additional, Pföhler, Claudia, additional, Krönig, Lisa, additional, Ziemer, Mirjana, additional, and Ugurel, Selma, additional

Published
2024
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17. Genexpressionsprofile beim Porokarzinom deuten auf heterogene Tumorentwicklung hin und untermauern Porome als Vorläuferläsionen.

Author

Holst, Svenja, Weber, Anna K., Meier, Friedegund, Otte, Jörg, Petzsch, Patrick, Reifenberger, Julia, Wachtmeister, Thorsten, Westphal, Dana, Ziemer, Mirjana, Wruck, Wasco, Adjaye, James, Betz, Regina C., Rütten, Arno, Surowy, Harald M., and Redler, Silke

Abstract

Copyright of Journal der Deutschen Dermatologischen Gesellschaft is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2024
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18. Gene expression profiling in porocarcinoma indicates heterogeneous tumor development and substantiates poromas as precursor lesions.

Author

Holst, Svenja, Weber, Anna K., Meier, Friedegund, Otte, Jörg, Petzsch, Patrick, Reifenberger, Julia, Wachtmeister, Thorsten, Westphal, Dana, Ziemer, Mirjana, Wruck, Wasco, Adjaye, James, Betz, Regina C., Rütten, Arno, Surowy, Harald M., and Redler, Silke

Abstract

Summary: Background and objectives: Malignant sweat gland tumors are rare, with the most common being eccrine porocarcinoma (EP). Approximately 18% of benign eccrine poroma (EPO) transit to EP. Previous research has provided first insights into the mutational landscape of EP. However, only few studies have performed gene expression analyses. This leaves a gap in the understanding of EP biology and potential drivers of malignant transformation from EPO to EP. Methods: Transcriptome profiling of 23 samples of primary EP and normal skin (NS). Findings from the EP samples were then tested in 17 samples of EPO. Results: Transcriptome profiling revealed diversity in gene expression and indicated biologically heterogeneous sub‐entities as well as widespread gene downregulation in EP. Downregulated genes included CD74, NDGR1, SRRM2, CDC42, ANXA2, KFL9 and NOP53. Expression levels of CD74, NDGR1, SRRM2, ANXA2, and NOP53 showed a stepwise‐reduction in expression from NS via EPO to EP, thus supporting the hypothesis that EPO represents a transitional state in EP development. Conclusions: We demonstrated that EP is molecularly complex and that evolutionary trajectories correspond to tumor initiation and progression. Our results provide further evidence implicating the p53 axis and the EGFR pathway. Larger samples are warranted to confirm our findings. [ABSTRACT FROM AUTHOR]

Published
2024
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23. Atypisches Fibroxanthom und pleomorphes dermales Sarkom – Genexpressionsanalyse im Vergleich zum entdifferenzierten Plattenepithelkarzinom der Haut

Author

Anders, Iris Marie, Schimmelpfennig, Carolin, Wiedemann, Karolin, Löffler, Dennis, Kämpf, Christoph, Blumert, Conny, Reiche, Kristin, Kunz, Manfred, Anderegg, Ulf, Simon, Jan-Christoph, Ziemer, Mirjana, and Publica

Subjects
Entdifferenziertes Plattenepithelkarzinom der Haut, Atypisches Fibroanthom, Dermatology, Pleomorphes dermales Sarkom
Abstract

Hintergrund: Der histogenetische Ursprung des atypischen Fibroxanthoms (AFX) und pleomorphen dermalen Sarkoms (PDS) ist nicht abschließend geklärt. Neben einem fibroblastären Ursprung wird aufgrund starker klinischer, histomorphologischer und molekulargenetischer Ähnlichkeiten zum entdifferenzierten Plattenepithelkarzinom der Haut (cutaneous squamous cell carcinoma, cSCC) eine keratinozytäre Differenzierung diskutiert. Patienten und Methodik: 56 Fälle (36 AFX, 8 PDS, 12 entdifferenzierte cSCC) wurden hinsichtlich ihrer klinischen, histomorphologischen und immunhistochemischen Charakteristika untersucht. An 18 Fällen (6 AFX/PDS, 6 entdifferenzierte cSCC, 6 differenzierte cSCC) wurde eine RNA-Transkriptomanalyse durchgeführt. Ergebnisse: Klinisch bestätigten sich starke Gemeinsamkeiten hinsichtlich Alter, Geschlecht und Lokalisation der Tumoren. Histomorphologisch ist es häufig ohne weiterführende immunhistochemische Färbungen nicht möglich AFX/PDS und entdifferenzierte cSCC voneinander abzugrenzen. In der Hauptkomponentenanalyse der RNA-Transkriptomanalyse konnte gezeigt werden, dass AFX/PDS und differenzierte cSCC jeweils ein eigenes Cluster bildeten, während sich die entdifferenzierten cSCC dazwischen einordneten, ohne ein eigenes Cluster zu bilden. Bei der Betrachtung differenziell exprimierter Gene (DEG) verdeutlichten die Heat Maps, dass es innerhalb der entdifferenzierten cSCC-Fälle gab, welche vom Expressionsprofil eher den AFX/PDS als den differenzierten cSCC zuzuordnen waren. Schlussfolgerungen: Die Ergebnisse der Gesamtuntersuchungen geben Hinweise auf molekulare Ähnlichkeiten zwischen AFX/PDS und entdifferenzierten cSCC und lassen einen gemeinsamen histogenetischen Ursprung vermuten.

Published
2023
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24. Atypical fibroxanthoma and pleomorphic dermal sarcoma – gene expression analysis compared with undifferentiated cutaneous squamous cell carcinoma

Author

Anders, Iris Marie, Schimmelpfennig, Carolin, Wiedemann, Karolin, Löffler, Dennis, Kämpf, Christoph, Blumert, Conny, Reiche, Kristin, Kunz, Manfred, Anderegg, Ulf, Simon, Jan-Christoph, Ziemer, Mirjana, and Publica

Subjects
Atypical fibroxanthoma, Pleomorphic dermal sarcoma, Dermatology, Undifferentiated cutaneous squamous cell carinoma
Abstract

Background: The histogenetic origin of atypical fibroxanthoma (AFX) and pleomorphic dermal sarcoma (PDS) has not been definitively elucidated. In addition to a fibroblastic origin, a keratinocytic differentiation is discussed due to strong clinical, histomorphological and molecular genetic similarities with undifferentiated cutaneous squamous cell carcinoma (cSCC). Patients and Methods: 56 cases (36 AFXs, 8 PDSs, 12 undifferentiated cSCCs) were evaluated for their clinical, histomorphological, and immunohistochemical characteristics. RNA transcriptome analysis was performed on 18 cases (6 AFXs/PDSs, 6 undifferentiated cSCCs, 6 differentiated cSCCs). Results: Clinically, the strong similarities in age, gender and tumor location were confirmed. Without further immunohistochemical staining, histomorphological differentiation between AFX/PDS and undifferentiated cSCC is often impossible. Principal component analysis of the RNA transcriptome analysis showed that AFX/PDS and differentiated cSCC each formed their own cluster, while the undifferentiated cSCCs fall in between these two groups, but without forming a cluster of their own. When examining differentially expressed genes (DEGs), the heat maps showed that there were cases within the undifferentiated cSCC that were more likely to be AFX/PDS than differentiated cSCC based on their expression profile. Conclusions: The results provide evidence of molecular similarities between AFX/PDS and undifferentiated cSCC and suggest a common histogenetic origin.

Published
2023
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25. Analytical Validation of an Immunohistochemical 7-Biomarker Prognostic Assay (immunoprint®) for Early-Stage Cutaneous Melanoma in Archival Tissue of Patients with AJCC v8 T2–T3 Disease

Author

Ziemer, Mirjana, primary, Weidenthaler-Barth, Beate, additional, Gussek, Philipp, additional, Pfeiffer, Maja, additional, Kleemann, Johannes, additional, Bankov, Katrin, additional, Wild, Peter J., additional, Seibold, Silke, additional, Sureshkumar, Priyavathi, additional, Nickel, Patricia, additional, Strobel, Anton, additional, Werner, Markus, additional, and Grabbe, Stephan, additional

Published
2023
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26. Adjuvant immunotherapy with nivolumab versus observation in completely resected Merkel cell carcinoma (ADMEC-O): disease-free survival results from a randomised, open-label, phase 2 trial

Author

Becker, Jürgen C, primary, Ugurel, Selma, additional, Leiter, Ulrike, additional, Meier, Friedegund, additional, Gutzmer, Ralf, additional, Haferkamp, Sebastian, additional, Zimmer, Lisa, additional, Livingstone, Elisabeth, additional, Eigentler, Thomas K, additional, Hauschild, Axel, additional, Kiecker, Felix, additional, Hassel, Jessica C, additional, Mohr, Peter, additional, Fluck, Michael, additional, Thomas, Ioannis, additional, Garzarolli, Marlene, additional, Grimmelmann, Imke, additional, Drexler, Konstantin, additional, Spillner, Alexandra N, additional, Eckhardt, Sebastian, additional, Schadendorf, Dirk, additional, van Akkoi, Alexander, additional, van Houdt, Winan, additional, Wilhelm, Tabea, additional, Farmer, Kimberly, additional, Ulrich, Claas, additional, Gambichler, Thilo, additional, Bluhm, Leonie, additional, Schinagl, Heidemarie, additional, Kellner, Ivonne, additional, Herbst, Rudolf, additional, Meiß, Frank, additional, Rafei-Shamsabadi, David, additional, Sell, Sabine, additional, Kaatz, Martin, additional, Wulfken, Lena, additional, Hartmann, Martin, additional, Kähler, Katharina, additional, Ziemer, Mirjana, additional, Simon, Jan, additional, Terheyden, Patrick, additional, Thaci, Diamant, additional, Loquai, Carmen, additional, Mitzel-Rink, Heidrun, additional, Grabbe, Stephan, additional, Stege, Henner, additional, Gaiser, Maria, additional, Utikal, Jochen, additional, Berking, Carola, additional, Heinzerling, Lucie, additional, Schlaak, Max, additional, Tomsitz, Dirk, additional, Dyballa, Jörg, additional, Magnolo, Nina, additional, Weishaupt, Carsten, additional, Berneburg, Mark, additional, Garbe, Claus, additional, Flatz, Lukas, additional, Gesierich, Anja, additional, and Schilling, Bastian, additional

Published
2023
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27. Prognostic factors and outcomes in metastatic uveal melanoma treated with programmed cell death-1 or combined PD-1/cytotoxic T-lymphocyte antigen-4 inhibition

Author

Heppt, Markus V., Heinzerling, Lucie, Kähler, Katharina C., Forschner, Andrea, Kirchberger, Michael C., Loquai, Carmen, Meissner, Markus, Meier, Friedegund, Terheyden, Patrick, Schell, Beatrice, Herbst, Rudolf, Göppner, Daniela, Kiecker, Felix, Rafei-Shamsabadi, David, Haferkamp, Sebastian, Huber, Margit A., Utikal, Jochen, Ziemer, Mirjana, Bumeder, Irmgard, Pfeiffer, Christiane, Schäd, Susanne G., Schmid-Tannwald, Christoph, Tietze, Julia K., Eigentler, Thomas K., and Berking, Carola

Published
2017
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28. S1‐Leitlinie Talgdrüsenkarzinom: S1‐Guideline Sebaceous Carcinoma.

Author

Utikal, Jochen, Nagel, Pia, Müller, Verena, Becker, Jürgen C., Dippel, Edgar, Frisman, Alexander, Gschnell, Martin, Griewank, Klaus, Hadaschik, Eva, Helbig, Doris, Hillen, Uwe, Leiter, Ulrike, Pföhler, Claudia, Krönig, Lisa, Ziemer, Mirjana, and Ugurel, Selma

Abstract

Copyright of Journal der Deutschen Dermatologischen Gesellschaft is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2024
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29. S1‐Guideline Sebaceous Carcinoma.

Author

Utikal, Jochen, Nagel, Pia, Müller, Verena, Becker, Jürgen C., Dippel, Edgar, Frisman, Alexander, Gschnell, Martin, Griewank, Klaus, Hadaschik, Eva, Helbig, Doris, Hillen, Uwe, Leiter, Ulrike, Pföhler, Claudia, Krönig, Lisa, Ziemer, Mirjana, and Ugurel, Selma

Abstract

Summary: Sebaceous gland carcinomas are rare malignant cutaneous adnexal tumors with sebocytic differentiation. The typical predilection area is the head and neck region, where sebaceous gland carcinomas are the most common malignant adnexal tumors of the skin. According to their localization a distinction is made between periocular and extraocular sebaceous gland carcinomas. Muir‐Torre syndrome (MTS) should always be ruled out if it is suspected. In terms of prognosis, sebaceous gland carcinomas are potentially aggressive tumors with a clear tendency to recur and metastasize. Only small extraocular sebaceous gland carcinomas that have been completely resected have a very good prognosis. Sebaceous gland carcinomas most frequently metastasize lymphogenously to regional or distant lymph nodes; organ metastasis occurs less frequently. Periocular sebaceous gland carcinomas have a higher metastasis rate (up to 15%) than extraocular sebaceous gland carcinomas (up to 2%). Complete micrographically controlled surgery (MCS) of the primary tumor is the therapy of first choice, regardless of periocular or extraocular localization. Adjuvant or therapeutic radiotherapy may be considered. There is currently no established standard therapy for advanced, inoperable, or metastatic sebaceous gland carcinomas. Local procedures and systemic therapies such as chemotherapy or immunotherapy can be considered. The procedure should be determined individually by an interdisciplinary tumor board. Close follow‐up care is recommended for these potentially aggressive carcinomas. [ABSTRACT FROM AUTHOR]

Published
2024
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32. RNA-seq analysis identifies different transcriptomic types and developmental trajectories of primary melanomas

Author

Kunz, Manfred, Löffler-Wirth, Henry, Dannemann, Michael, Willscher, Edith, Doose, Gero, Kelso, Janet, Kottek, Tina, Nickel, Birgit, Hopp, Lydia, Landsberg, Jenny, Hoffmann, Steve, Tüting, Thomas, Zigrino, Paola, Mauch, Cornelia, Utikal, Jochen, Ziemer, Mirjana, Schulze, Hans-Joachim, Hölzel, Michael, Roesch, Alexander, Kneitz, Susanne, Meierjohann, Svenja, Bosserhoff, Anja, Binder, Hans, and Schartl, Manfred

Published
2018
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34. Raising awareness of immune-related side effects in oncological patients under palliative care: a report of two cases

Author

Strunk, Anne, primary, Batzler, Yann-Nicolas, additional, Ziemer, Mirjana, additional, Neukirchen, Martin, additional, Schwartz, Jacqueline, additional, Sachse, Michael, additional, Garzarolli, Marlene, additional, Strasser, Cristin, additional, Reinhardt, Lydia, additional, Kaatz, Martin, additional, Schuler, Ulrich, additional, and Meier, Friedegund, additional

Published
2023
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37. S1‐Leitlinie dermales und subkutanes Leiomyosarkom

Author

Helbig, Doris, primary, Dippel, Edgar, additional, Erdmann, Michael, additional, Frisman, Alexander, additional, Kage, Paula, additional, Leiter, Ulrike, additional, Mentzel, Thomas, additional, Seidel, Clemens, additional, Weishaupt, Carsten, additional, Ziemer, Mirjana, additional, and Ugurel, Selma, additional

Published
2023
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38. NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: II. The 2014 Pathology Working Group Report

Author

Shulman, Howard M., Cardona, Diana M., Greenson, Joel K., Hingorani, Sangeeta, Horn, Thomas, Huber, Elisabeth, Kreft, Andreas, Longerich, Thomas, Morton, Thomas, Myerson, David, Prieto, Victor G., Rosenberg, Avi, Treister, Nathaniel, Washington, Kay, Ziemer, Mirjana, Pavletic, Steven Z., Lee, Stephanie J., Flowers, Mary E.D., Schultz, Kirk R., Jagasia, Madan, Martin, Paul J., Vogelsang, Georgia B., and Kleiner, David E.

Published
2015
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41. CLAUDIUS Study: Risk of Materno-Fetal Transmission of Melanoma Cells in Pregnant Women with High Grade Melanoma – A Retrospective Multicenter Study and Literature Review

Author

Wiedemann, Svenja Vanessa, primary, Müller, Verena, additional, Toth, Bettina, additional, Erdmann, Michael, additional, Bühler, Bodo, additional, Dugas-Breit, Susanne, additional, Schatton, Kerstin, additional, Reinhardt, Lydia, additional, Meissner, Markus, additional, Mickler, Marion, additional, Pföhler, Claudia, additional, Weishaupt, Carsten, additional, Herbst, Rudolf, additional, Debus, Dirk, additional, Susok, Laura, additional, Tietze, Julia Katharina, additional, Welzel, Julia, additional, Arnold, Andreas, additional, Dabrowski, Evelyn, additional, Forschner, Andrea, additional, Goetze, Steven, additional, Hayani, Kinan, additional, Lebbe, Céleste, additional, Löhr, Florian, additional, Mengoni, Miriam, additional, Hermes, Barbara, additional, Peitsch, Wiebke Katharina, additional, Poch, Gabriela, additional, Sachse, Michael, additional, Sindrilaru, Anca, additional, Wenk, Saskia, additional, Ziemer, Mirjana, additional, Kaune, Kjell, additional, Meier-Naust, Lisette, additional, Nikolakis, Georgios, additional, Oberndörfer, Florian, additional, Wesselmann, Ulrich, additional, Utikal, Jochen, additional, and Gaiser, Maria Rita, additional

Published
2023
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42. S1-Guideline: Microscopically controlled surgery

Author

Kofler, Lukas, Ziemer, Mirjana, Andrulis, Mindaugas, Horn, Dominik, Kulas, Philipp, Kunte, Christian, and Müller, Cornelia Sigrid Lissi

Subjects
Dermatology
Abstract

Microscopically controlled surgery (MCS) comprises various methods allowing histologically proven complete resection of malignant tumors while at the same time sparing the tumor-free tissue in the immediate vicinity as much as possible. All procedures subsumed under MCS have in common the marking of the excised tissue for topographical orientation, which provides an assignment of remaining tumor remnants. Indications for MCS are malignant skin tumors in problem localizations as well as aggressive subtypes of skin tumors. Established indications for MCS include basal cell carcinoma, cutaneous squamous cell carcinoma, Bowen's disease as well as Bowen's carcinoma, dermatofibrosarcoma protuberans, melanoma in chronically light-damaged skin as well as acral lentiginous melanoma and Merkel cell carcinoma. For other tumors such as extramammary Paget's disease and various cutaneous sarcomas, evidence exists that MCS has demonstrated benefits, such as local recurrence rates. In addition, MCS is indicated when it is foreseeable that a complex closure technique is required and complete resection of the tumor must be assured. Various methods of MCS have been described, including 3D histology, horizontal method and Mohs surgery. A close cooperation of qualified surgeons and (dermato)pathologists as well as laboratory staff is essential for the successful application of MCS.

Published
2022

43. Immune checkpoint inhibition and targeted therapy for melanoma: A patient‐oriented cross‐sectional comparative multicentre study

Author

Thiem, Alexander, primary, Mashhadiakbar, Pegah, additional, Cussigh, Christiane, additional, Hassel, Jessica C., additional, Grimmelmann, Imke, additional, Gutzmer, Ralf, additional, Schlaak, Max, additional, Heppt, Markus V., additional, Dücker, Pia, additional, Hüning, Svea, additional, Schulmeyer, Lena, additional, Schilling, Bastian, additional, Haferkamp, Sebastian, additional, Ziemer, Mirjana, additional, Moritz, Rose K. C., additional, Hagelstein, Victoria, additional, Terheyden, Patrick, additional, Posch, Christian, additional, Gaiser, Maria R., additional, Kropp, Peter, additional, Emmert, Steffen, additional, Müller, Britta, additional, and Tietze, Julia K., additional

Published
2022
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46. Analytical Validation of an Immunohistochemical 7-Biomarker Prognostic Assay (immunoprint ®) for Early-Stage Cutaneous Melanoma in Archival Tissue of Patients with AJCC v8 T2–T3 Disease.

Author

Ziemer, Mirjana, Weidenthaler-Barth, Beate, Gussek, Philipp, Pfeiffer, Maja, Kleemann, Johannes, Bankov, Katrin, Wild, Peter J., Seibold, Silke, Sureshkumar, Priyavathi, Nickel, Patricia, Strobel, Anton, Werner, Markus, and Grabbe, Stephan

Subjects
*MELANOMA, *LABORATORY personnel, *PROGNOSTIC tests, *CLINICAL trials, *TISSUES, *STATISTICAL reliability
Abstract

Selected patients with early-stage melanoma have a "hidden high risk" of poor oncologic outcomes. They might benefit from clinical trials, and ultimately, if warranted by trial results, judicious everyday use of adjuvant therapy. A promising tool to identify these individuals is the immunoprint® assay. This immunohistochemical 7-biomarker prognostic test was clinically validated in three independent cohorts (N = 762) to classify early-stage patients as high-risk or low-risk regarding melanoma recurrence and mortality. Using College of American Pathologists (CAP) recommendations, we analytically validated this assay in primary melanoma specimens (N = 20 patients). We assessed assay precision by determining consistency of risk classification under repeated identical conditions (repeatability) or across varying conditions (reproducibility), involving separate assay runs, operators (laboratory scientists), and/or observers (e.g., dermatopathologists). Reference classification was followed by five analytical validation phases: intra-run/intra-operator, intra-observer, inter-run, inter-operator, and inter-observer. Concordance of classifications in each phase was assessed via Fleiss' kappa (primary endpoint) and percent agreement (secondary endpoint). Seven-marker signature classification demonstrated high consistency across validation categories (Fleiss' kappa 0.864–1.000; overall percent agreement 95–100%), in 9/10 cases, exceeding, and in 1/10 cases, closely approaching, CAP's recommended 0.9 level. The 7-marker assay has now been verified to provide excellent repeatability, reproducibility, and precision, besides having been clinically validated. [ABSTRACT FROM AUTHOR]

Published
2023
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