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1. 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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3. 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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4. Real‐world outcomes using PD ‐1 antibodies and BRAF + MEK inhibitors for adjuvant melanoma treatment from 39 skin cancer centers in Germany, Austria and Switzerland

Author

Schumann, Katharina, primary, Mauch, Cornelia, additional, Klespe, Kai‐Christian, additional, Loquai, Carmen, additional, Nikfarjam, Ulrike, additional, Schlaak, Max, additional, Akçetin, Larissa, additional, Kölblinger, Peter, additional, Hoellwerth, Magdalena, additional, Meissner, Markus, additional, Mengi, Guelcin, additional, Braun, Andreas Dominik, additional, Mengoni, Miriam, additional, Dummer, Reinhard, additional, Mangana, Joanna, additional, Sindrilaru, Mihaela‐Anca, additional, Radmann, Dan, additional, Hafner, Christine, additional, Freund, Johann, additional, Rappersberger, Klemens, additional, Weihsengruber, Felix, additional, Meiss, Frank, additional, Reinhardt, Lydia, additional, Meier, Friedegund, additional, Rainer, Barbara, additional, Richtig, Erika, additional, Ressler, Julia Maria, additional, Höller, Christoph, additional, Eigentler, Thomas, additional, Amaral, Teresa, additional, Peitsch, Wiebke K., additional, Hillen, Uwe, additional, Harth, Wolfgang, additional, Ziller, Fabian, additional, Schatton, Kerstin, additional, Gambichler, Thilo, additional, Susok, Laura, additional, Maul, Lara Valeska, additional, Läubli, Heinz, additional, Debus, Dirk, additional, Weishaupt, Carsten, additional, Börger, Sevil, additional, Sievers, Katharina, additional, Haferkamp, Sebastian, additional, Zenderowski, Veronika, additional, Nguyen, Van Anh, additional, Wanner, Marina, additional, Gutzmer, Ralf, additional, Terheyden, Patrick, additional, Kähler, Katharina, additional, Emmert, Steffen, additional, Thiem, Alexander, additional, Sachse, Michael, additional, Gercken‐Riedel, Silke, additional, Kaune, Kjell Matthias, additional, Thoms, Kai‐Martin, additional, Heinzerling, Lucie, additional, Heppt, Markus Vincent, additional, Tratzmiller, Sabine, additional, Hoetzenecker, Wolfram, additional, Öllinger, Angela, additional, Steiner, Andreas, additional, Peinhaupt, Tobias, additional, Podda, Maurizio, additional, Schmid, Sabine, additional, Wollina, Uwe, additional, Biedermann, Tilo, additional, and Posch, Christian, additional

Published
2022
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5. Real world outcomes using PD-1 antibodies and BRAF+MEK inhibitors for adjuvant melanoma treatment from 39 skin cancer centers in Germany, Austria and Switzerland

Author

Schumann, Katharina, Mauch, Cornelia, Klespe, Kai‐Christian, Loquai, Carmen, Nikfarjam, Ulrike, Schlaak, Max, Akçetin, Larissa, Kölblinger, Peter, Hoellwerth, Magdalena, Meissner, Markus, Mengi, Guelcin, Braun, Andreas Dominik, Mengoni, Miriam, Dummer, Reinhard, Mangana, Joanna, Sindrilaru, Mihaela‐Anca, Radmann, Dan, Hafner, Christine, Freund, Johann, Rappersberger, Klemens, Weihsengruber, Felix, Meiss, Frank, Reinhardt, Lydia, Meier, Friedegund, Rainer, Barbara, Richtig, Erika, Ressler, Julia Maria, Höller, Christoph, Eigentler, Thomas, Amaral, Teresa, Peitsch, Wiebke K., Hillen, Uwe, Harth, Wolfgang, Ziller, Fabian, Schatton, Kerstin, Gambichler, Thilo, Susok, Laura, Maul, Lara Valeska, Läubli, Heinz, Debus, Dirk, Weishaupt, Carsten, Börger, Sevil, Sievers, Katharina, Haferkamp, Sebastian, Zenderowski, Veronika, Nguyen, Van Anh, Wanner, Marina, Gutzmer, Ralf, Terheyden, Patrick, Kähler, Katharina, Emmert, Steffen, Thiem, Alexander, Sachse, Michael, Gercken‐Riedel, Silke, Kaune, Kjell Matthias, Thoms, Kai‐Martin, Heinzerling, Lucie, Heppt, Markus Vincent, Tratzmiller, Sabine, Hoetzenecker, Wolfram, Öllinger, Angela, Steiner, Andreas, Peinhaupt, Tobias, Podda, Maurizio, Schmid, Sabine, Wollina, Uwe, Biedermann, Tilo, and Posch, Christian

Subjects
ddc:610
Abstract

Background Programmed death‐1 (PD‐1) antibodies and BRAF + MEK inhibitors are widely used for adjuvant therapy of fully resected high‐risk melanoma. Little is known about treatment efficacy outside of phase III trials. This real‐world study reports on clinical outcomes of modern adjuvant melanoma treatment in specialized skin cancer centers in Germany, Austria and Switzerland. Methods Multicenter, retrospective study investigating stage III–IV melanoma patients receiving adjuvant nivolumab (NIV), pembrolizumab (PEM) or dabrafenib + trametinib (D + T) between 1/2017 and 10/2021. The primary endpoint was 12‐month recurrence‐free survival (RFS). Further analyses included descriptive and correlative statistics, and a multivariate linear‐regression machine learning model to assess the risk of early melanoma recurrence. Results In total, 1198 patients from 39 skin cancer centers from Germany, Austria and Switzerland were analysed. The vast majority received anti PD‐1 therapies (n = 1003). Twelve‐month RFS for anti PD‐1 and BRAF + MEK inhibitor‐treated patients were 78.1% and 86.5%, respectively (hazard ratio [HR] 1.998 [95% CI 1.335–2.991]; p = 0.001). There was no statistically significant difference in overall survival (OS) in anti PD‐1 (95.8%) and BRAF + MEK inhibitor (96.9%) treated patients (p > 0.05) during the median follow‐up of 17 months. Data indicates that anti PD‐1 treated patients who develop immune‐related adverse events (irAEs) have lower recurrence rates compared to patients with no irAEs (HR 0.578 [95% CI 0.443–0.754], p = 0.001). BRAF mutation status did not affect overall efficacy of anti PD‐1 treatment (p > 0.05). In both, anti PD‐1 and BRAF + MEK inhibitor treated cohorts, data did not show any difference in 12‐month RFS and 12‐month OS comparing patients receiving total lymph node dissection (TLND) versus sentinel lymph node biopsy only (p > 0.05). The recurrence prediction model reached high specificity but only low sensitivity with an AUC = 0.65. No new safety signals were detected. Overall, recorded numbers and severity of adverse events were lower than reported in pivotal phase III trials. Conclusions Despite recent advances in adjuvant melanoma treatment, early recurrence remains a significant clinical challenge. This study shows that TLND does not reduce the risk of early melanoma recurrence and should only be considered in selected patients. Data further highlight that variables collected during clinical routine are unlikely to allow for a clinically relevant prediction of individual recurrence risk.

Published
2022

6. Impact of radiotherapy and sequencing of systemic therapy on survival outcomes in melanoma patients with previously untreated brain metastasis: a multicenter DeCOG study on 450 patients from the prospective skin cancer registry ADOREG

Author

Franklin, Cindy, primary, Mohr, Peter, additional, Bluhm, Leonie, additional, Grimmelmann, Imke, additional, Gutzmer, Ralf, additional, Meier, Friedegund, additional, Garzarolli, Marlene, additional, Weichenthal, Michael, additional, Pfoehler, Claudia, additional, Herbst, Rudolf, additional, Terheyden, Patrick, additional, Utikal, Jochen, additional, Ulrich, Jens, additional, Debus, Dirk, additional, Haferkamp, Sebastian, additional, Kaatz, Martin, additional, Forschner, Andrea, additional, Leiter, Ulrike, additional, Nashan, Dorothee, additional, Kreuter, Alexander, additional, Sachse, Michael, additional, Welzel, Julia, additional, Heinzerling, Lucie, additional, Meiss, Frank, additional, Weishaupt, Carsten, additional, Gambichler, Thilo, additional, Weyandt, Gerhard, additional, Dippel, Edgar, additional, Schatton, Kerstin, additional, Celik, Eren, additional, Trommer, Maike, additional, Helfrich, Iris, additional, Roesch, Alexander, additional, Zimmer, Lisa, additional, Livingstone, Elisabeth, additional, Schadendorf, Dirk, additional, Horn, Susanne, additional, and Ugurel, Selma, additional

Published
2022
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7. Genetic characterization of advanced conjunctival melanoma and response to systemic treatment

Author

Lodde, Georg C., primary, Jansen, Philipp, additional, Möller, Inga, additional, Sucker, Antje, additional, Hassel, Jessica C., additional, Forschner, Andrea, additional, Eckardt, Julia, additional, Meier, Friedegund, additional, Reinhardt, Lydia, additional, Kähler, Katharina C., additional, Ziemer, Mirjana, additional, Schlaak, Max, additional, Rahimi, Farnaz, additional, Schatton, Kerstin, additional, Meiss, Frank, additional, Gutzmer, Ralf, additional, Pföhler, Claudia, additional, Terheyden, Patrick, additional, Schilling, Bastian, additional, Sachse, Michael, additional, Heppt, Markus V., additional, Sindrilaru, Anca, additional, Leiter, Ulrike, additional, Zaremba, Anne, additional, Thielmann, Carl M., additional, Ugurel, Selma, additional, Zimmer, Lisa, additional, Hadaschik, Eva, additional, Bechrakis, Nikolaos E., additional, Schadendorf, Dirk, additional, Westekemper, Henrike, additional, Livingstone, Elisabeth, additional, and Griewank, Klaus G., additional

Published
2022
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8. Impact of radiotherapy and sequencing of systemic therapy on survival outcomes in melanoma patients with previously untreated brain metastasis: a multicenter DeCOG study on 450 patients from the prospective skin cancer registry ADOREG

Author

Franklin, Cindy, Mohr, Peter, Bluhm, Leonie, Grimmelmann, Imke, Gutzmer, Ralf, Meier, Friedegund, Garzarolli, Marlene, Weichenthal, Michael, Pfoehler, Claudia, Herbst, Rudolf, Terheyden, Patrick, Utikal, Jochen, Ulrich, Jens, Debus, Dirk, Haferkamp, Sebastian, Kaatz, Martin, Forschner, Andrea, Leiter, Ulrike, Nashan, Dorothee, Kreuter, Alexander, Sachse, Michael, Welzel, Julia, Heinzerling, Lucie, Meiss, Frank, Weishaupt, Carsten, Gambichler, Thilo, Weyandt, Gerhard, Dippel, Edgar, Schatton, Kerstin, Celik, Eren, Trommer, Maike, Helfrich, Iris, Roesch, Alexander, Zimmer, Lisa, Livingstone, Elisabeth, Schadendorf, Dirk, Horn, Susanne, Ugurel, Selma, Franklin, Cindy, Mohr, Peter, Bluhm, Leonie, Grimmelmann, Imke, Gutzmer, Ralf, Meier, Friedegund, Garzarolli, Marlene, Weichenthal, Michael, Pfoehler, Claudia, Herbst, Rudolf, Terheyden, Patrick, Utikal, Jochen, Ulrich, Jens, Debus, Dirk, Haferkamp, Sebastian, Kaatz, Martin, Forschner, Andrea, Leiter, Ulrike, Nashan, Dorothee, Kreuter, Alexander, Sachse, Michael, Welzel, Julia, Heinzerling, Lucie, Meiss, Frank, Weishaupt, Carsten, Gambichler, Thilo, Weyandt, Gerhard, Dippel, Edgar, Schatton, Kerstin, Celik, Eren, Trommer, Maike, Helfrich, Iris, Roesch, Alexander, Zimmer, Lisa, Livingstone, Elisabeth, Schadendorf, Dirk, Horn, Susanne, and Ugurel, Selma

Abstract

Background Despite of various therapeutic strategies, treatment of patients with melanoma brain metastasis (MBM) still is a major challenge. This study aimed at investigating the impact of type and sequence of immune checkpoint blockade (ICB) and targeted therapy (TT), radiotherapy, and surgery on the survival outcome of patients with MBM. Method We assessed data of 450 patients collected within the prospective multicenter real-world skin cancer registry ADOREG who were diagnosed with MBM before start of the first non-adjuvant systemic therapy. Study endpoints were progression-free survival (PFS) and overall survival (OS). Results Of 450 MBM patients, 175 (38.9%) received CTLA-4+PD-1 ICB, 161 (35.8%) PD-1 ICB, and 114 (25.3%) BRAF+MEK TT as first-line treatment. Additional to systemic therapy, 67.3% of the patients received radiotherapy (stereotactic radiosurgery (SRS); conventional radiotherapy (CRT)) and 24.4% had surgery of MBM. 199 patients (42.2%) received a second-line systemic therapy. Multivariate Cox regression analysis revealed the application of radiotherapy (HR for SRS: 0.213, 95% CI 0.094 to 0.485, p<0.001; HR for CRT: 0.424, 95% CI 0.210 to 0.855, p=0.016), maximal size of brain metastases (HR for MBM >1 cm: 1.977, 95% CI 1.117 to 3.500, p=0.019), age (HR for age >65 years: 1.802, 95% CI 1.016 to 3.197, p=0.044), and ECOG performance status (HR for ECOG >= 2: HR: 2.615, 95% CI 1.024 to 6.676, p=0.044) as independent prognostic factors of OS on first-line therapy. The type of first-line therapy (ICB vs TT) was not independently prognostic. As second-line therapy BRAF+MEK showed the best survival outcome compared with ICB and other therapies (HR for CTLA-4+PD-1 compared with BRAF+MEK: 13.964, 95% CI 3.6 to 54.4, p<0.001; for PD-1 vs BRAF+MEK: 4.587 95% CI 1.3 to 16.8, p=0.022 for OS). Regarding therapy sequencing, patients treated with ICB as first-line therapy and BRAF+MEK as second-line therapy showed an improved OS (HR for CTLA-4+PD-1 followed by BRAF

Published
2022

9. Real-world outcomes using PD-1 antibodies and BRAF + MEK inhibitors for adjuvant melanoma treatment from 39 skin cancer centers in Germany, Austria and Switzerland

Author

Schumann, Katharina, Mauch, Cornelia, Klespe, Kai-Christian, Loquai, Carmen, Nikfarjam, Ulrike, Schlaak, Max, Akçetin, Larissa, Kölblinger, Peter, Hoellwerth, Magdalena, Meissner, Markus, Mengi, Guelcin, Braun, Andreas Dominik, Mengoni, Miriam, Dummer, Reinhard, Mangana, Joanna, Sindrilaru, Mihaela-Anca, Radmann, Dan, Hafner, Christine, Freund, Johann, Rappersberger, Klemens, Weihsengruber, Felix, Meiss, Frank, Reinhardt, Lydia, Meier, Friedegund, Rainer, Barbara, Richtig, Erika, Ressler, Julia Maria, Höller, Christoph, Eigentler, Thomas, Amaral, Teresa, Peitsch, Wiebke K., Hillen, Uwe, Harth, Wolfgang, Ziller, Fabian, Schatton, Kerstin, Gambichler, Thilo, Susok, Laura, Maul, Lara Valeska, Läubli, Heinz, Debus, Dirk, Weishaupt, Carsten, Börger, Sevil, Sievers, Katharina, Haferkamp, Sebastian, Zenderowski, Veronika, Nguyen, Van Anh, Wanner, Marina, Gutzmer, Ralf, Terheyden, Patrick, Kähler, Katharina, Emmert, Steffen, Thiem, Alexander, Sachse, Michael, Gercken-Riedel, Silke, Kaune, Kjell Matthias, Thoms, Kai-Martin, Heinzerling, Lucie, Heppt, Markus Vincent, Tratzmiller, Sabine, Hoetzenecker, Wolfram, Öllinger, Angela, Steiner, Andreas, Peinhaupt, Tobias, Podda, Maurizio, Schmid, Sabine, Wollina, Uwe, Biedermann, Tilo, and Posch, Christian

Subjects
IMMUNE CHECK POINT AND BRAF-MEK INHIBITORS IN MELANOMA [ORIGINAL ARTICLE, SPECIAL ISSUE ON MELANOMA], ddc
Published
2021

10. Surveillance of patients with conjunctival melanoma in German-speaking countries: A multinational survey of the German dermatologic cooperative oncology group

Author

Alter, Mareike, Bayerl, Christiane, Bender, Armin, Bruning, Guido, Dabrowski, Evelyn, Debus, Dirk, Devereux, Nina, Dippel, Edgar, Drexler, Konstantin, Dücker, Pia, Dummer, Reinhard, Emmert, Steffen, Elsner, Peter, Enk, Alexander, Gebhardt, Christoffer, Gesierich, Anja, Goebeler, Matthias, Goerdt, Sergij, Goetze, Steven, Gutzmer, Ralf, Haferkamp, Sebastian, Hansel, Gesina, Hassel, Jessica C., Heinzerling, Lucie, Kähler, Katharina C., Kaume, Kjell M., Krapf, Wolfgang, Kreuzberg, Nicole, Lehmann, Percy, Livingstone, Elisabeth, Löffler, Harald, Loquai, Carmen, Mauch, Cornelia, Mangana, Johanna, Meier, Friedegund, Meissner, Markus, Moritz, Rose K.C., Maul, Lara Valeska, Müller, Verena, Mohr, Peter, Navarini, Alexander, Van Nguyen, Ahn, Pfeiffer, Christiane, Pföhler, Claudia, Posch, Christian, Richtig, Erika, Rompel, Rainer, Sachse, Michael M., Sauder, Stefanie, Schadendorf, Dirk, Schatton, Kerstin, Schulze, Hans-Joachim, Schultz, Erwin, Schilling, Bastian, Schmuth, Matthias, Simon, Jan C., Streit, Markus, Terheyden, Patrick, Thiem, Alexander, Tüting, Thomas, Welzel, Julia, Weyandt, Gerhard, Wesselmann, Ulrich, Wollina, Uwe, Ziemer, Mirjana, Zimmer, Lisa, Zutt, Markus, Wessely, Anja, Steeb, Theresa, Berking, Carola, Schlaak, Max, and Heppt, Markus V.

Published
2021
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11. Factors influencing the adjuvant therapy decision : Results of a real-world multicenter data analysis of 904 melanoma patients

Author

Lodde, Georg, Forschner, Andrea, Hassel, Jessica, Wulfken, Lena M., Meier, Friedegund, Mohr, Peter, Kähler, Katharina, Schilling, Bastian, Loquai, Carmen, Berking, Carola, Hüning, Svea, Schatton, Kerstin, Gebhardt, Christoffer, Eckardt, Julia, Gutzmer, Ralf, Reinhardt, Lydia, Glutsch, Valerie, Nikfarjam, Ulrike, Erdmann, Michael, Stang, Andreas, Kowall, Bernd, Roesch, Alexander, Ugurel, Selma, Zimmer, Lisa, Schadendorf, Dirk, and Livingstone, Elisabeth

Subjects
adjuvant treatment, Medizin, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Medizinische Fakultät » Universitätsklinikum Essen » Klinik für Dermatologie, targeted therapy, Article, BRAF, PD-1, melanoma, ddc:610, melanoma -- adjuvant treatment -- checkpoint blocker -- targeted therapy -- BRAF -- PD-1, checkpoint blocker, Medizinische Fakultät » Universitätsklinikum Essen » Institut für Medizinische Informatik, Biometrie und Epidemiologie, RC254-282
Abstract

Adjuvant treatment of melanoma patients with immune-checkpoint inhibition (ICI) and targeted therapy (TT) significantly improved recurrence-free survival. This study investigates the real-world situation of 904 patients from 13 German skin cancer centers with an indication for adjuvant treatment since the approval of adjuvant ICI and TT. From adjusted log-binomial regression models, we estimated relative risks for associations between various influence factors and treatment decisions (adjuvant therapy yes/no, TT vs. ICI in BRAF mutant patients). Of these patients, 76.9% (95% CI 74–80) opted for a systemic adjuvant treatment. The probability of starting an adjuvant treatment was 26% lower in patients &gt, 65 years (RR 0.74, 95% CI 68–80). The most common reasons against adjuvant treatment given by patients were age (29.4%, 95% CI 24–38), and fear of adverse events (21.1%, 95% CI 16–28) and impaired quality of life (11.9%, 95% CI 7–16). Of all BRAF-mutated patients who opted for adjuvant treatment, 52.9% (95% CI 47–59) decided for ICI. Treatment decision for TT or ICI was barely associated with age, gender and tumor stage, but with comorbidities and affiliated center. Shortly after their approval, adjuvant treatments have been well accepted by physicians and patients. Age plays a decisive role in the decision for adjuvant treatment, while pre-existing autoimmune disease and regional differences influence the choice between TT or ICI.

Published
2021

13. Factors Influencing the Adjuvant Therapy Decision: Results of a Real-World Multicenter Data Analysis of 904 Melanoma Patients

Author

Lodde, Georg, primary, Forschner, Andrea, additional, Hassel, Jessica, additional, Wulfken, Lena M., additional, Meier, Friedegund, additional, Mohr, Peter, additional, Kähler, Katharina, additional, Schilling, Bastian, additional, Loquai, Carmen, additional, Berking, Carola, additional, Hüning, Svea, additional, Schatton, Kerstin, additional, Gebhardt, Christoffer, additional, Eckardt, Julia, additional, Gutzmer, Ralf, additional, Reinhardt, Lydia, additional, Glutsch, Valerie, additional, Nikfarjam, Ulrike, additional, Erdmann, Michael, additional, Stang, Andreas, additional, Kowall, Bernd, additional, Roesch, Alexander, additional, Ugurel, Selma, additional, Zimmer, Lisa, additional, Schadendorf, Dirk, additional, and Livingstone, Elisabeth, additional

Published
2021
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14. Risk Factors for Relapse after Intentional Discontinuation of Immune Checkpoint Inhibitors in Melanoma Patients

Author

Persa, Oana D., Schatton, Kerstin, Ruebben, Albert, Berking, Carola, Erdmann, Michael, Schlaak, Max, Mauch, Cornelia, Steeb, Theresa, Persa, Oana D., Schatton, Kerstin, Ruebben, Albert, Berking, Carola, Erdmann, Michael, Schlaak, Max, Mauch, Cornelia, and Steeb, Theresa

Abstract

Immune checkpoint inhibitors (ICIs) have tremendously changed the therapeutic landscape of melanoma since they are associated with a durable response, allowing for intentional discontinuation of therapy after complete or partial remission. However, a subset of patients develops a relapse after cessation of ICI treatment and may not respond to reinduction of ICIs. The aim of the present study was to identify risk factors for relapse after intentional discontinuation of ICI therapy. Patients with intentional discontinuation of ICI therapy for metastatic or unresectable melanoma from 5 German university hospitals were analyzed retrospectively. Clinicopathologic and follow-up data of 87 patients were collected and analyzed by univariate and multivariate Cox proportional-hazards models. The following parameters were associated with relapse after cessation of ICI treatment in the univariate Cox regression analysis: concurrent radiotherapy and ICI, best overall response, and presence of brain metastases. Duration of treatment, type of primary tumor, body mass index, programmed-death ligand 1 expression, and lactate dehydrogenase levels did not significantly influence the risk for relapse. In the multivariate analysis, partial remission [hazard ratio 4.217 (95% confidence interval: 1.424-12.49), P=0.009] and stable disease [3.327 (1.204-9.19), P=0.02] were associated with a significant decrease in progression-free survival compared with complete remission. Concurrent radiotherapy and ICI [3.619 (1.288-10.168), P=0.015] are additional independent risk factors for decreased progression-free survival upon ICI discontinuation, whereas the presence of brain metastasis did not reach statistical significance on multivariate analysis.

Published
2021

15. Sonografie der Haut und Subkutis einschließlich subkutaner Lymphknoten

Author

Kilian, Katharina, primary, Maier, Tanja, additional, Dill, Dorothee, additional, ElGammal, Stefan, additional, Freitag, Marcus, additional, Schatz, Harald, additional, Voit, Christiane, additional, Welzel, Julia, additional, Sattler, Elke, additional, Schatton, Kerstin, additional, Blum, Andreas, additional, Schmid-Wendtner, Monika-Hildegard, additional, Wiechert, Andreas, additional, and Hinz, Torsten, additional

Published
2013
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16. Surveillance of patients with conjunctival melanoma in German-speaking countries: A multinational survey of the German dermatologic cooperative oncology group

Author

Wessely, Anja, primary, Steeb, Theresa, additional, Berking, Carola, additional, Schlaak, Max, additional, Heppt, Markus V., additional, Alter, Mareike, additional, Bayerl, Christiane, additional, Bender, Armin, additional, Bruning, Guido, additional, Dabrowski, Evelyn, additional, Debus, Dirk, additional, Devereux, Nina, additional, Dippel, Edgar, additional, Drexler, Konstantin, additional, Dücker, Pia, additional, Dummer, Reinhard, additional, Emmert, Steffen, additional, Elsner, Peter, additional, Enk, Alexander, additional, Gebhardt, Christoffer, additional, Gesierich, Anja, additional, Goebeler, Matthias, additional, Goerdt, Sergij, additional, Goetze, Steven, additional, Gutzmer, Ralf, additional, Haferkamp, Sebastian, additional, Hansel, Gesina, additional, Hassel, Jessica C., additional, Heinzerling, Lucie, additional, Kähler, Katharina C., additional, Kaume, Kjell M., additional, Krapf, Wolfgang, additional, Kreuzberg, Nicole, additional, Lehmann, Percy, additional, Livingstone, Elisabeth, additional, Löffler, Harald, additional, Loquai, Carmen, additional, Mauch, Cornelia, additional, Mangana, Johanna, additional, Meier, Friedegund, additional, Meissner, Markus, additional, Moritz, Rose K.C., additional, Maul, Lara Valeska, additional, Müller, Verena, additional, Mohr, Peter, additional, Navarini, Alexander, additional, Van Nguyen, Ahn, additional, Pfeiffer, Christiane, additional, Pföhler, Claudia, additional, Posch, Christian, additional, Richtig, Erika, additional, Rompel, Rainer, additional, Sachse, Michael M., additional, Sauder, Stefanie, additional, Schadendorf, Dirk, additional, Schatton, Kerstin, additional, Schulze, Hans-Joachim, additional, Schultz, Erwin, additional, Schilling, Bastian, additional, Schmuth, Matthias, additional, Simon, Jan C., additional, Streit, Markus, additional, Terheyden, Patrick, additional, Thiem, Alexander, additional, Tüting, Thomas, additional, Welzel, Julia, additional, Weyandt, Gerhard, additional, Wesselmann, Ulrich, additional, Wollina, Uwe, additional, Ziemer, Mirjana, additional, Zimmer, Lisa, additional, and Zutt, Markus, additional

Published
2021
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17. Immune checkpoint inhibition therapy for advanced skin cancer in patients with concomitant hematological malignancy: a retrospective multicenter DeCOG study of 84 patients

Author

Leiter, Ulrike, primary, Loquai, Carmen, additional, Reinhardt, Lydia, additional, Rafei-Shamsabadi, David, additional, Gutzmer, Ralf, additional, Kaehler, Katharina, additional, Heinzerling, Lucie, additional, Hassel, Jessica C, additional, Glutsch, Valerie, additional, Sirokay, Judith, additional, Schlecht, Nora, additional, Rübben, Albert, additional, Gambichler, Thilo, additional, Schatton, Kerstin, additional, Pfoehler, Claudia, additional, Franklin, Cindy, additional, Terheyden, Patrick, additional, Haferkamp, Sebastian, additional, Mohr, Peter, additional, Bischof, Lena, additional, Livingstone, Elisabeth, additional, Zimmer, Lisa, additional, Weichenthal, Michael, additional, Schadendorf, Dirk, additional, Meiwes, Andreas, additional, Keim, Ulrike, additional, Garbe, Claus, additional, Becker, Jürgen Christian, additional, and Ugurel, Selma, additional

Published
2020
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18. Therapieentscheidung bei Indikation zur adjuvanten Therapie des Melanoms : Multizentrische Real World Data

Author

Lodde, Georg, Forschner, Andrea, Wulfken, Lena M., Meier, F., Mohr, Peter, Kaehler, Katharina C., Schilling, Bastian, Loquai, Carmen, Berking, Carola, Gebhardt, C., Huening, Svea, Schatton, Kerstin, Eckardt, Josephine, Gutzmer, Ralf, Reinhardt, Lydia, Glutsch, Valerie, Nikfarjam, Ulrike, Erdmann, Michael, Stang, Alexander, Ugurel, Selma, Zimmer, Lisa, Schadendorf, Dirk, and Livingstone, Elisabeth

Subjects
Medizin
Published
2020

19. Immune checkpoint inhibition therapy for advanced skin cancer in patients with concomitant hematological malignancy: a retrospective multicenter DeCOG study of 84 patients

Author

Leiter, Ulrike, Loquai, Carmen, Reinhardt, Lydia, Rafei-Shamsabadi, David, Gutzmer, Ralf, Kaehler, Katharina, Heinzerling, Lucie, Hassel, Jessica C., Glutsch, Valerie, Sirokay, Judith, Schlecht, Nora, Rubben, Albert, Gambichler, Thilo, Schatton, Kerstin, Pfoehler, Claudia, Franklin, Cindy, Terheyden, Patrick, Haferkamp, Sebastian, Mohr, Peter, Bischof, Lena, Livingstone, Elisabeth, Zimmer, Lisa, Weichenthal, Michael, Schadendorf, Dirk, Meiwes, Andreas, Keim, Ulrike, Garbe, Claus, Becker, Jurgen Christian, Ugurel, Selma, Leiter, Ulrike, Loquai, Carmen, Reinhardt, Lydia, Rafei-Shamsabadi, David, Gutzmer, Ralf, Kaehler, Katharina, Heinzerling, Lucie, Hassel, Jessica C., Glutsch, Valerie, Sirokay, Judith, Schlecht, Nora, Rubben, Albert, Gambichler, Thilo, Schatton, Kerstin, Pfoehler, Claudia, Franklin, Cindy, Terheyden, Patrick, Haferkamp, Sebastian, Mohr, Peter, Bischof, Lena, Livingstone, Elisabeth, Zimmer, Lisa, Weichenthal, Michael, Schadendorf, Dirk, Meiwes, Andreas, Keim, Ulrike, Garbe, Claus, Becker, Jurgen Christian, and Ugurel, Selma

Abstract

Background Skin cancers are known for their strong immunogenicity, which may contribute to a high treatment efficacy of immune checkpoint inhibition (ICI). However, a considerable proportion of patients with skin cancer is immuno-compromised by concomitant diseases. Due to their previous exclusion from clinical trials, the ICI treatment efficacy is poorly investigated in these patients. The present study analyzed the ICI treatment outcome in advanced patients with skin cancer with a concomitant hematological malignancy. Methods This retrospective multicenter study included patients who were treated with ICI for locally advanced or metastatic melanoma (MM), cutaneous squamous cell carcinoma (cSCC), or Merkel cell carcinoma (MCC), and had a previous diagnosis of a hematological malignancy irrespective of disease activity or need of therapy at ICI treatment start. Comparator patient cohorts without concomitant hematological malignancy were extracted from the prospective multicenter skin cancer registry ADOREG. Treatment outcome was measured as best overall response, progression-free (PFS), and overall survival (OS). Results 84 patients (MM, n=52; cSCC, n=15; MCC, n=17) with concomitant hematological malignancy were identified at 20 skin cancer centers. The most frequent concomitant hematological malignancies were non-Hodgkin's lymphoma (n=70), with chronic lymphocytic leukemia (n=32) being the largest entity. While 9 patients received ICI in an adjuvant setting, 75 patients were treated for advanced non-resectable disease (55 anti-PD-1; 8 anti-PD-L1; 5 anti-CTLA-4; 7 combinations). In the latter 75 patients, best objective response (complete response+partial response) was 28.0%, disease stabilization was 25.3%, and 38.6% showed progressive disease (PD). Subdivided by skin cancer entity, best objective response was 31.1% (MM), 26.7% (cSCC), and 18.8% (MCC). Median PFS was 8.4 months (MM), 4.0 months (cSCC), and 5.7 months (MCC). 1-year OS rates were 78.4% (MM), 65.8% (c

Published
2020

20. Final analysis of DECOG-SLT trial: Survival outcomes of complete lymph node dissection in melanoma patients with positive sentinel node.

Author

Leiter, Ulrike M., primary, Stadler, Rudolf, additional, Mauch, Cornelia, additional, Hohenberger, Werner, additional, Brockmeyer, Norbert, additional, Berking, Carola, additional, Sunderkötter, Cord, additional, Kaatz, Martin, additional, Schatton, Kerstin, additional, Lehmann, Percy, additional, Vogt, Thomas Michael Martin, additional, Ulrich, Jens, additional, Herbst, Rudolf, additional, Gehring, Wolfgang, additional, Simon, Jan-Christoph, additional, Keim, Ulrike, additional, Martus, Peter, additional, and Garbe, Claus, additional

Published
2018
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21. Final analysis of DECOG-SLT trial: Survival outcomes of complete lymph node dissection in melanoma patients with positive sentinel node.

Author

Leiter, Ulrike M., Stadler, Rudolf, Mauch, Cornelia, Hohenberger, Werner, Brockmeyer, Norbert, Berking, Carola, Sunderkoetter, Cord, Kaatz, Martin, Schatton, Kerstin, Lehmann, Percy, Martin Vogt, Thomas Michael, Ulrich, Jens, Herbst, Rudolf, Gehring, Wolfgang, Simon, Jan-Christoph, Keim, Ulrike, Martus, Peter, Garbe, Claus, Leiter, Ulrike M., Stadler, Rudolf, Mauch, Cornelia, Hohenberger, Werner, Brockmeyer, Norbert, Berking, Carola, Sunderkoetter, Cord, Kaatz, Martin, Schatton, Kerstin, Lehmann, Percy, Martin Vogt, Thomas Michael, Ulrich, Jens, Herbst, Rudolf, Gehring, Wolfgang, Simon, Jan-Christoph, Keim, Ulrike, Martus, Peter, and Garbe, Claus

Published
2018

22. Final Analysis of DeCOG-SLT Trial: No Survival Benefit for Complete Lymph Node Dissection in Patients With Melanoma With Positive Sentinel Node.

Author

Leiter, Ulrike, Stadler, Rudolf, Mauch, Cornelia, Hohenberger, Werner, Brockmeyer, Norbert H., Berking, Carola, Sunderkötter, Cord, Kaatz, Martin, Schatton, Kerstin, Lehmann, Percy, Vogt, Thomas, Ulrich, Jens, Herbst, Rudolf, Gehring, Wolfgang, Simon, Jan-Christoph, Keim, Ulrike, Verver, Danielle, Martus, Peter, Garbe, Claus, and German Dermatologic Cooperative Oncology Group

Published
2019
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25. Patterns of care and follow-up care of patients with uveal melanoma in German-speaking countries: a multinational survey of the German Dermatologic Cooperative Oncology Group (DeCOG)

Author

Steeb, Theresa, Wessely, Anja, Alter, Mareike, Bayerl, Christiane, Bender, Armin, Bruning, Guido, Dabrowski, Evelyn, Debus, Dirk, Devereux, Nina, Dippel, Edgar, Drexler, Konstantin, Duecker, Pia, Dummer, Reinhard, Emmert, Steffen, Elsner, Peter, Enk, Alexander, Gebhardt, Christoffer, Gesierich, Anja, Goebeler, Matthias, Goerdt, Sergij, Goetze, Steven, Gutzmer, Ralf, Haferkamp, Sebastian, Hansel, Gesina, Hassel, Jessica C., Heinzerling, Lucie, Kaehler, Katharina C., Kaume, Kjell M., Krapf, Wolfgang, Kreuzberg, Nicole, Lehmann, Percy, Livingstone, Elisabeth, Loeffler, Harald, Loquai, Carmen, Mauch, Cornelia, Mangana, Johanna, Meier, Friedegund, Meissner, Markus, Moritz, Rose K. C., Maul, Lara Valeska, Mueller, Verena, Mohr, Peter, Navarini, Alexander, Van Nguyen, Ahn, Pfeiffer, Christiane, Pfoehler, Claudia, Posch, Christian, Richtig, Erika, Rompel, Rainer, Sachse, Michael M., Sauder, Stefanie, Schadendorf, Dirk, Schatton, Kerstin, Schulze, Hans-Joachim, Schultz, Erwin, Schilling, Bastian, Schmuth, Matthias, Simon, Jan C., Streit, Markus, Terheyden, Patrick, Thiem, Alexander, Tueting, Thomas, Welzel, Julia, Weyandt, Gerhard, Wesselmann, Ulrich, Wollina, Uwe, Ziemer, Mirjana, Zimmer, Lisa, Zutt, Markus, Berking, Carola, Schlaak, Max, Heppt, Markus, V, Steeb, Theresa, Wessely, Anja, Alter, Mareike, Bayerl, Christiane, Bender, Armin, Bruning, Guido, Dabrowski, Evelyn, Debus, Dirk, Devereux, Nina, Dippel, Edgar, Drexler, Konstantin, Duecker, Pia, Dummer, Reinhard, Emmert, Steffen, Elsner, Peter, Enk, Alexander, Gebhardt, Christoffer, Gesierich, Anja, Goebeler, Matthias, Goerdt, Sergij, Goetze, Steven, Gutzmer, Ralf, Haferkamp, Sebastian, Hansel, Gesina, Hassel, Jessica C., Heinzerling, Lucie, Kaehler, Katharina C., Kaume, Kjell M., Krapf, Wolfgang, Kreuzberg, Nicole, Lehmann, Percy, Livingstone, Elisabeth, Loeffler, Harald, Loquai, Carmen, Mauch, Cornelia, Mangana, Johanna, Meier, Friedegund, Meissner, Markus, Moritz, Rose K. C., Maul, Lara Valeska, Mueller, Verena, Mohr, Peter, Navarini, Alexander, Van Nguyen, Ahn, Pfeiffer, Christiane, Pfoehler, Claudia, Posch, Christian, Richtig, Erika, Rompel, Rainer, Sachse, Michael M., Sauder, Stefanie, Schadendorf, Dirk, Schatton, Kerstin, Schulze, Hans-Joachim, Schultz, Erwin, Schilling, Bastian, Schmuth, Matthias, Simon, Jan C., Streit, Markus, Terheyden, Patrick, Thiem, Alexander, Tueting, Thomas, Welzel, Julia, Weyandt, Gerhard, Wesselmann, Ulrich, Wollina, Uwe, Ziemer, Mirjana, Zimmer, Lisa, Zutt, Markus, Berking, Carola, Schlaak, Max, and Heppt, Markus, V

Abstract

Purpose Uveal melanoma (UM) is an orphan cancer of high unmet medical need. Current patterns of care and surveillance remain unclear as they are situated in an interdisciplinary setting. Methods A questionnaire addressing the patterns of care and surveillance in the management of patients with uveal melanoma was distributed to 70 skin cancer centers in Austria, Germany and Switzerland. Frequency distributions of responses for each item of the questionnaire were calculated. Results 44 of 70 (62.9%) skin cancer centers completed the questionnaire. Thirty-nine hospitals were located in Germany (88.6%), three in Switzerland (6.8%) and two in Austria (4.5%). The majority (68.2%) represented university hospitals. Most patients with metastatic disease were treated in certified skin cancer centers (70.7%, 29/41). Besides, the majority of patients with UM were referred to the respective skin cancer center by ophthalmologists (87.2%, 34/39). Treatment and organization of follow-up of patients varied across the different centers. 35.1% (14/37) of the centers stated to not perform any screening measures. Conclusion Treatment patterns of patients with uveal melanoma in Germany, Austria and Switzerland remain extremely heterogeneous. A guideline for the treatment and surveillance is urgently needed.

26. Real-world outcomes using PD-1 antibodies and BRAF plus MEK inhibitors for adjuvant melanoma treatment from 39 skin cancer centers in Germany, Austria and Switzerland

Author

Schumann, Katharina, Mauch, Cornelia, Klespe, Kai-Christian, Loquai, Carmen, Nikfarjam, Ulrike, Schlaak, Max, Akcetin, Larissa, Koelblinger, Peter, Hoellwerth, Magdalena, Meissner, Markus, Mengi, Guelcin, Braun, Andreas Dominik, Mengoni, Miriam, Dummer, Reinhard, Mangana, Joanna, Sindrilaru, Mihaela-Anca, Radmann, Dan, Hafner, Christine, Freund, Johann, Rappersberger, Klemens, Weihsengruber, Felix, Meiss, Frank, Reinhardt, Lydia, Meier, Friedegund, Rainer, Barbara, Richtig, Erika, Ressler, Julia Maria, Hoeller, Christoph, Eigentler, Thomas, Amaral, Teresa, Peitsch, Wiebke K., Hillen, Uwe, Harth, Wolfgang, Ziller, Fabian, Schatton, Kerstin, Gambichler, Thilo, Susok, Laura, Maul, Lara Valeska, Laubli, Heinz, Debus, Dirk, Weishaupt, Carsten, Boerger, Sevil, Sievers, Katharina, Haferkamp, Sebastian, Zenderowski, Veronika, Nguyen, Van Anh, Wanner, Marina, Gutzmer, Ralf, Terheyden, Patrick, Kaehler, Katharina, Emmert, Steffen, Thiem, Alexander, Sachse, Michael, Gercken-Riedel, Silke, Kaune, Kjell Matthias, Thoms, Kai-Martin, Heinzerling, Lucie, Heppt, Markus Vincent, Tratzmiller, Sabine, Hoetzenecker, Wolfram, Oellinger, Angela, Steiner, Andreas, Peinhaupt, Tobias, Podda, Maurizio, Schmid, Sabine, Wollina, Uwe, Biedermann, Tilo, Posch, Christian, Schumann, Katharina, Mauch, Cornelia, Klespe, Kai-Christian, Loquai, Carmen, Nikfarjam, Ulrike, Schlaak, Max, Akcetin, Larissa, Koelblinger, Peter, Hoellwerth, Magdalena, Meissner, Markus, Mengi, Guelcin, Braun, Andreas Dominik, Mengoni, Miriam, Dummer, Reinhard, Mangana, Joanna, Sindrilaru, Mihaela-Anca, Radmann, Dan, Hafner, Christine, Freund, Johann, Rappersberger, Klemens, Weihsengruber, Felix, Meiss, Frank, Reinhardt, Lydia, Meier, Friedegund, Rainer, Barbara, Richtig, Erika, Ressler, Julia Maria, Hoeller, Christoph, Eigentler, Thomas, Amaral, Teresa, Peitsch, Wiebke K., Hillen, Uwe, Harth, Wolfgang, Ziller, Fabian, Schatton, Kerstin, Gambichler, Thilo, Susok, Laura, Maul, Lara Valeska, Laubli, Heinz, Debus, Dirk, Weishaupt, Carsten, Boerger, Sevil, Sievers, Katharina, Haferkamp, Sebastian, Zenderowski, Veronika, Nguyen, Van Anh, Wanner, Marina, Gutzmer, Ralf, Terheyden, Patrick, Kaehler, Katharina, Emmert, Steffen, Thiem, Alexander, Sachse, Michael, Gercken-Riedel, Silke, Kaune, Kjell Matthias, Thoms, Kai-Martin, Heinzerling, Lucie, Heppt, Markus Vincent, Tratzmiller, Sabine, Hoetzenecker, Wolfram, Oellinger, Angela, Steiner, Andreas, Peinhaupt, Tobias, Podda, Maurizio, Schmid, Sabine, Wollina, Uwe, Biedermann, Tilo, and Posch, Christian

Abstract

BackgroundProgrammed death-1 (PD-1) antibodies and BRAF + MEK inhibitors are widely used for adjuvant therapy of fully resected high-risk melanoma. Little is known about treatment efficacy outside of phase III trials. This real-world study reports on clinical outcomes of modern adjuvant melanoma treatment in specialized skin cancer centers in Germany, Austria and Switzerland. MethodsMulticenter, retrospective study investigating stage III-IV melanoma patients receiving adjuvant nivolumab (NIV), pembrolizumab (PEM) or dabrafenib + trametinib (D + T) between 1/2017 and 10/2021. The primary endpoint was 12-month recurrence-free survival (RFS). Further analyses included descriptive and correlative statistics, and a multivariate linear-regression machine learning model to assess the risk of early melanoma recurrence. ResultsIn total, 1198 patients from 39 skin cancer centers from Germany, Austria and Switzerland were analysed. The vast majority received anti PD-1 therapies (n = 1003). Twelve-month RFS for anti PD-1 and BRAF + MEK inhibitor-treated patients were 78.1% and 86.5%, respectively (hazard ratio [HR] 1.998 [95% CI 1.335-2.991]; p = 0.001). There was no statistically significant difference in overall survival (OS) in anti PD-1 (95.8%) and BRAF + MEK inhibitor (96.9%) treated patients (p > 0.05) during the median follow-up of 17 months. Data indicates that anti PD-1 treated patients who develop immune-related adverse events (irAEs) have lower recurrence rates compared to patients with no irAEs (HR 0.578 [95% CI 0.443-0.754], p = 0.001). BRAF mutation status did not affect overall efficacy of anti PD-1 treatment (p > 0.05). In both, anti PD-1 and BRAF + MEK inhibitor treated cohorts, data did not show any difference in 12-month RFS and 12-month OS comparing patients receiving total lymph node dissection (TLND) versus sentinel lymph node biopsy only (p > 0.05). The recurrence prediction model reached high specificity but only low sensitivity with an AUC = 0.65. No n

27. Patterns of care and follow-up care of patients with uveal melanoma in German-speaking countries: a multinational survey of the German Dermatologic Cooperative Oncology Group (DeCOG)

Author

Steeb, Theresa, Wessely, Anja, Alter, Mareike, Bayerl, Christiane, Bender, Armin, Bruning, Guido, Dabrowski, Evelyn, Debus, Dirk, Devereux, Nina, Dippel, Edgar, Drexler, Konstantin, Duecker, Pia, Dummer, Reinhard, Emmert, Steffen, Elsner, Peter, Enk, Alexander, Gebhardt, Christoffer, Gesierich, Anja, Goebeler, Matthias, Goerdt, Sergij, Goetze, Steven, Gutzmer, Ralf, Haferkamp, Sebastian, Hansel, Gesina, Hassel, Jessica C., Heinzerling, Lucie, Kaehler, Katharina C., Kaume, Kjell M., Krapf, Wolfgang, Kreuzberg, Nicole, Lehmann, Percy, Livingstone, Elisabeth, Loeffler, Harald, Loquai, Carmen, Mauch, Cornelia, Mangana, Johanna, Meier, Friedegund, Meissner, Markus, Moritz, Rose K. C., Maul, Lara Valeska, Mueller, Verena, Mohr, Peter, Navarini, Alexander, Van Nguyen, Ahn, Pfeiffer, Christiane, Pfoehler, Claudia, Posch, Christian, Richtig, Erika, Rompel, Rainer, Sachse, Michael M., Sauder, Stefanie, Schadendorf, Dirk, Schatton, Kerstin, Schulze, Hans-Joachim, Schultz, Erwin, Schilling, Bastian, Schmuth, Matthias, Simon, Jan C., Streit, Markus, Terheyden, Patrick, Thiem, Alexander, Tueting, Thomas, Welzel, Julia, Weyandt, Gerhard, Wesselmann, Ulrich, Wollina, Uwe, Ziemer, Mirjana, Zimmer, Lisa, Zutt, Markus, Berking, Carola, Schlaak, Max, Heppt, Markus, V, Steeb, Theresa, Wessely, Anja, Alter, Mareike, Bayerl, Christiane, Bender, Armin, Bruning, Guido, Dabrowski, Evelyn, Debus, Dirk, Devereux, Nina, Dippel, Edgar, Drexler, Konstantin, Duecker, Pia, Dummer, Reinhard, Emmert, Steffen, Elsner, Peter, Enk, Alexander, Gebhardt, Christoffer, Gesierich, Anja, Goebeler, Matthias, Goerdt, Sergij, Goetze, Steven, Gutzmer, Ralf, Haferkamp, Sebastian, Hansel, Gesina, Hassel, Jessica C., Heinzerling, Lucie, Kaehler, Katharina C., Kaume, Kjell M., Krapf, Wolfgang, Kreuzberg, Nicole, Lehmann, Percy, Livingstone, Elisabeth, Loeffler, Harald, Loquai, Carmen, Mauch, Cornelia, Mangana, Johanna, Meier, Friedegund, Meissner, Markus, Moritz, Rose K. C., Maul, Lara Valeska, Mueller, Verena, Mohr, Peter, Navarini, Alexander, Van Nguyen, Ahn, Pfeiffer, Christiane, Pfoehler, Claudia, Posch, Christian, Richtig, Erika, Rompel, Rainer, Sachse, Michael M., Sauder, Stefanie, Schadendorf, Dirk, Schatton, Kerstin, Schulze, Hans-Joachim, Schultz, Erwin, Schilling, Bastian, Schmuth, Matthias, Simon, Jan C., Streit, Markus, Terheyden, Patrick, Thiem, Alexander, Tueting, Thomas, Welzel, Julia, Weyandt, Gerhard, Wesselmann, Ulrich, Wollina, Uwe, Ziemer, Mirjana, Zimmer, Lisa, Zutt, Markus, Berking, Carola, Schlaak, Max, and Heppt, Markus, V

Abstract

Purpose Uveal melanoma (UM) is an orphan cancer of high unmet medical need. Current patterns of care and surveillance remain unclear as they are situated in an interdisciplinary setting. Methods A questionnaire addressing the patterns of care and surveillance in the management of patients with uveal melanoma was distributed to 70 skin cancer centers in Austria, Germany and Switzerland. Frequency distributions of responses for each item of the questionnaire were calculated. Results 44 of 70 (62.9%) skin cancer centers completed the questionnaire. Thirty-nine hospitals were located in Germany (88.6%), three in Switzerland (6.8%) and two in Austria (4.5%). The majority (68.2%) represented university hospitals. Most patients with metastatic disease were treated in certified skin cancer centers (70.7%, 29/41). Besides, the majority of patients with UM were referred to the respective skin cancer center by ophthalmologists (87.2%, 34/39). Treatment and organization of follow-up of patients varied across the different centers. 35.1% (14/37) of the centers stated to not perform any screening measures. Conclusion Treatment patterns of patients with uveal melanoma in Germany, Austria and Switzerland remain extremely heterogeneous. A guideline for the treatment and surveillance is urgently needed.

28. Real-world outcomes using PD-1 antibodies and BRAF + MEK inhibitors for adjuvant melanoma treatment from 39 skin cancer centers in Germany, Austria and Switzerland.

Author

Schumann K, Mauch C, Klespe KC, Loquai C, Nikfarjam U, Schlaak M, Akçetin L, Kölblinger P, Hoellwerth M, Meissner M, Mengi G, Braun AD, Mengoni M, Dummer R, Mangana J, Sindrilaru MA, Radmann D, Hafner C, Freund J, Rappersberger K, Weihsengruber F, Meiss F, Reinhardt L, Meier F, Rainer B, Richtig E, Ressler JM, Höller C, Eigentler T, Amaral T, Peitsch WK, Hillen U, Harth W, Ziller F, Schatton K, Gambichler T, Susok L, Maul LV, Läubli H, Debus D, Weishaupt C, Börger S, Sievers K, Haferkamp S, Zenderowski V, Nguyen VA, Wanner M, Gutzmer R, Terheyden P, Kähler K, Emmert S, Thiem A, Sachse M, Gercken-Riedel S, Kaune KM, Thoms KM, Heinzerling L, Heppt MV, Tratzmiller S, Hoetzenecker W, Öllinger A, Steiner A, Peinhaupt T, Podda M, Schmid S, Wollina U, Biedermann T, and Posch C

Subjects
Humans, Proto-Oncogene Proteins B-raf genetics, Austria, Switzerland, Retrospective Studies, Antineoplastic Combined Chemotherapy Protocols adverse effects, Adjuvants, Immunologic therapeutic use, Mitogen-Activated Protein Kinase Kinases therapeutic use, Melanoma, Cutaneous Malignant, Melanoma pathology, Skin Neoplasms pathology
Abstract

Background: Programmed death-1 (PD-1) antibodies and BRAF + MEK inhibitors are widely used for adjuvant therapy of fully resected high-risk melanoma. Little is known about treatment efficacy outside of phase III trials. This real-world study reports on clinical outcomes of modern adjuvant melanoma treatment in specialized skin cancer centers in Germany, Austria and Switzerland., Methods: Multicenter, retrospective study investigating stage III-IV melanoma patients receiving adjuvant nivolumab (NIV), pembrolizumab (PEM) or dabrafenib + trametinib (D + T) between 1/2017 and 10/2021. The primary endpoint was 12-month recurrence-free survival (RFS). Further analyses included descriptive and correlative statistics, and a multivariate linear-regression machine learning model to assess the risk of early melanoma recurrence., Results: In total, 1198 patients from 39 skin cancer centers from Germany, Austria and Switzerland were analysed. The vast majority received anti PD-1 therapies (n = 1003). Twelve-month RFS for anti PD-1 and BRAF + MEK inhibitor-treated patients were 78.1% and 86.5%, respectively (hazard ratio [HR] 1.998 [95% CI 1.335-2.991]; p = 0.001). There was no statistically significant difference in overall survival (OS) in anti PD-1 (95.8%) and BRAF + MEK inhibitor (96.9%) treated patients (p > 0.05) during the median follow-up of 17 months. Data indicates that anti PD-1 treated patients who develop immune-related adverse events (irAEs) have lower recurrence rates compared to patients with no irAEs (HR 0.578 [95% CI 0.443-0.754], p = 0.001). BRAF mutation status did not affect overall efficacy of anti PD-1 treatment (p > 0.05). In both, anti PD-1 and BRAF + MEK inhibitor treated cohorts, data did not show any difference in 12-month RFS and 12-month OS comparing patients receiving total lymph node dissection (TLND) versus sentinel lymph node biopsy only (p > 0.05). The recurrence prediction model reached high specificity but only low sensitivity with an AUC = 0.65. No new safety signals were detected. Overall, recorded numbers and severity of adverse events were lower than reported in pivotal phase III trials., Conclusions: Despite recent advances in adjuvant melanoma treatment, early recurrence remains a significant clinical challenge. This study shows that TLND does not reduce the risk of early melanoma recurrence and should only be considered in selected patients. Data further highlight that variables collected during clinical routine are unlikely to allow for a clinically relevant prediction of individual recurrence risk., (© 2022 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Published
2023
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29. Patterns of care and follow-up care of patients with uveal melanoma in German-speaking countries: a multinational survey of the German Dermatologic Cooperative Oncology Group (DeCOG).

Author

Steeb T, Wessely A, Alter M, Bayerl C, Bender A, Bruning G, Dabrowski E, Debus D, Devereux N, Dippel E, Drexler K, Dücker P, Dummer R, Emmert S, Elsner P, Enk A, Gebhardt C, Gesierich A, Goebeler M, Goerdt S, Goetze S, Gutzmer R, Haferkamp S, Hansel G, Hassel JC, Heinzerling L, Kähler KC, Kaume KM, Krapf W, Kreuzberg N, Lehmann P, Livingstone E, Löffler H, Loquai C, Mauch C, Mangana J, Meier F, Meissner M, Moritz RKC, Maul LV, Müller V, Mohr P, Navarini A, Van Nguyen A, Pfeiffer C, Pföhler C, Posch C, Richtig E, Rompel R, Sachse MM, Sauder S, Schadendorf D, Schatton K, Schulze HJ, Schultz E, Schilling B, Schmuth M, Simon JC, Streit M, Terheyden P, Thiem A, Tüting T, Welzel J, Weyandt G, Wesselmann U, Wollina U, Ziemer M, Zimmer L, Zutt M, Berking C, Schlaak M, and Heppt MV

Subjects
Austria epidemiology, Cross-Sectional Studies, Follow-Up Studies, Germany epidemiology, Health Services Needs and Demand statistics & numerical data, Humans, Mass Screening methods, Mass Screening statistics & numerical data, Melanoma epidemiology, Melanoma pathology, Neoplasm Metastasis, Neoplasm Recurrence, Local epidemiology, Population Surveillance methods, Referral and Consultation standards, Referral and Consultation statistics & numerical data, Skin Neoplasms epidemiology, Skin Neoplasms pathology, Skin Neoplasms therapy, Surveys and Questionnaires, Switzerland epidemiology, Uveal Neoplasms epidemiology, Uveal Neoplasms pathology, Aftercare methods, Aftercare statistics & numerical data, Melanoma therapy, Monitoring, Physiologic methods, Monitoring, Physiologic statistics & numerical data, Practice Patterns, Physicians' statistics & numerical data, Uveal Neoplasms therapy
Abstract

Purpose: Uveal melanoma (UM) is an orphan cancer of high unmet medical need. Current patterns of care and surveillance remain unclear as they are situated in an interdisciplinary setting., Methods: A questionnaire addressing the patterns of care and surveillance in the management of patients with uveal melanoma was distributed to 70 skin cancer centers in Austria, Germany and Switzerland. Frequency distributions of responses for each item of the questionnaire were calculated., Results: 44 of 70 (62.9%) skin cancer centers completed the questionnaire. Thirty-nine hospitals were located in Germany (88.6%), three in Switzerland (6.8%) and two in Austria (4.5%). The majority (68.2%) represented university hospitals. Most patients with metastatic disease were treated in certified skin cancer centers (70.7%, 29/41). Besides, the majority of patients with UM were referred to the respective skin cancer center by ophthalmologists (87.2%, 34/39). Treatment and organization of follow-up of patients varied across the different centers. 35.1% (14/37) of the centers stated to not perform any screening measures., Conclusion: Treatment patterns of patients with uveal melanoma in Germany, Austria and Switzerland remain extremely heterogeneous. A guideline for the treatment and surveillance is urgently needed.

Published
2021
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