Schumann, Katharina, Mauch, Cornelia, Klespe, Kai-Christian, Loquai, Carmen, Nikfarjam, Ulrike, Schlaak, Max, Akcetin, Larissa, Koelblinger, Peter, Hoellwerth, Magdalena ORCID: 0000-0002-2771-4041, 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 ORCID: 0000-0003-4340-9706, Rainer, Barbara, Richtig, Erika, Ressler, Julia Maria ORCID: 0000-0001-8602-0878, 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 . 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. J. Eur. Acad. Dermatol. Venereol.. HOBOKEN: WILEY. ISSN 1468-3083

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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 new safety signals were detected. Overall, recorded numbers and severity of adverse events were lower than reported in pivotal phase III trials. ConclusionsDespite 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Schumann, KatharinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mauch, CorneliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klespe, Kai-ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loquai, CarmenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nikfarjam, UlrikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schlaak, MaxUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Akcetin, LarissaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koelblinger, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoellwerth, MagdalenaUNSPECIFIEDorcid.org/0000-0002-2771-4041UNSPECIFIED
Meissner, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mengi, GuelcinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Braun, Andreas DominikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mengoni, MiriamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dummer, ReinhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mangana, JoannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sindrilaru, Mihaela-AncaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Radmann, DanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hafner, ChristineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Freund, JohannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rappersberger, KlemensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weihsengruber, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meiss, FrankUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reinhardt, LydiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meier, FriedegundUNSPECIFIEDorcid.org/0000-0003-4340-9706UNSPECIFIED
Rainer, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Richtig, ErikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ressler, Julia MariaUNSPECIFIEDorcid.org/0000-0001-8602-0878UNSPECIFIED
Hoeller, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eigentler, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Amaral, TeresaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Peitsch, Wiebke K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hillen, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Harth, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ziller, FabianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schatton, KerstinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gambichler, ThiloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Susok, LauraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maul, Lara ValeskaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Laubli, HeinzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Debus, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weishaupt, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boerger, SevilUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sievers, KatharinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haferkamp, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zenderowski, VeronikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nguyen, Van AnhUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wanner, MarinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gutzmer, RalfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Terheyden, PatrickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaehler, KatharinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Emmert, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thiem, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sachse, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gercken-Riedel, SilkeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaune, Kjell MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thoms, Kai-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinzerling, LucieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heppt, Markus VincentUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tratzmiller, SabineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoetzenecker, WolframUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oellinger, AngelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Steiner, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Peinhaupt, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Podda, MaurizioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmid, SabineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wollina, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Biedermann, TiloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Posch, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-699069
DOI: 10.1111/jdv.18779
Journal or Publication Title: J. Eur. Acad. Dermatol. Venereol.
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1468-3083
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
STAGE-III; MULTICENTER; IPILIMUMAB; NIVOLUMABMultiple languages
DermatologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69906

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