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1. Frequency and characteristics of immune-related thyroid adverse events in patients with resected stage III/IV melanoma treated with adjuvant PD-1 inhibitors: a national cohort study

Author

Christensen, Stine K., Winther, Mette L., Laursen, Ida J., Madsen, Freja S., Brink, Carsten, Brix, Thomas H., Ellebaek, Eva, Svane, Inge Marie, Hansen, Frederikke S., Haslund, Charlotte, Laursen, Olivia K., Schmidt, Henrik, Larsen, Ida D., Bastholt, Lars, and Ruhlmann, Christina H.

Published
2024
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4. Earlier Recurrence Detection Using Routine FDG PET-CT Scans in Surveillance of Stage IIB to IIID Melanoma: A National Cohort Study of 1480 Patients

Author

Helvind, Neel Maria, Weitemeyer, Marie Brinch-Møller, Chakera, Annette Hougaard, Hendel, Helle Westergren, Ellebæk, Eva, Svane, Inge Marie, Kjærskov, Mette Wanscher, Bojesen, Sophie, Skyum, Helle, Petersen, Søren Kjær, Bastholt, Lars, Johansen, Christoffer, Bidstrup, Pernille Envold, and Hölmich, Lisbet Rosenkrantz

Published
2023
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7. European consensus-based interdisciplinary guideline for invasive cutaneous squamous cell carcinoma: Part 2. Treatment–Update 2023

Author

Stratigos, Alexander J., Garbe, Claus, Dessinioti, Clio, Lebbe, Celeste, van Akkooi, Alexander, Bataille, Veronique, Bastholt, Lars, Dreno, Brigitte, Dummer, Reinhard, Fargnoli, Maria Concetta, Forsea, Ana Maria, Harwood, Catherine A., Hauschild, Axel, Hoeller, Christoph, Kandolf-Sekulovic, Lidija, Kaufmann, Roland, Kelleners-Smeets, Nicole WJ, Lallas, Aimilios, Leiter, Ulrike, Malvehy, Josep, del Marmol, Veronique, Moreno-Ramirez, David, Pellacani, Giovanni, Peris, Ketty, Saiag, Philippe, Tagliaferri, Luca, Trakatelli, Myrto, Ioannides, Dimitrios, Vieira, Ricardo, Zalaudek, Iris, Arenberger, Petr, Eggermont, Alexander M.M., Röcken, Martin, Grob, Jean-Jacques, and Lorigan, Paul

Published
2023
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8. European consensus-based interdisciplinary guideline for invasive cutaneous squamous cell carcinoma. Part 1: Diagnostics and prevention–Update 2023

Author

Stratigos, Alexander J., Garbe, Claus, Dessinioti, Clio, Lebbe, Celeste, van Akkooi, Alexander, Bataille, Veronique, Bastholt, Lars, Dreno, Brigitte, Dummer, Reinhard, Fargnoli, Maria Concetta, Forsea, Ana Maria, Harwood, Catherine A., Hauschild, Axel, Hoeller, Christoph, Kandolf-Sekulovic, Lidija, Kaufmann, Roland, Kelleners-Smeets, Nicole WJ, Lallas, Aimilios, Leiter, Ulrike, Malvehy, Josep, del Marmol, Veronique, Moreno-Ramirez, David, Pellacani, Giovanni, Peris, Ketty, Saiag, Philippe, Tagliaferri, Luca, Trakatelli, Myrto, Ioannides, Dimitrios, Vieira, Ricardo, Zalaudek, Iris, Arenberger, Petr, Eggermont, Alexander M.M., Röcken, Martin, Grob, Jean-Jacques, and Lorigan, Paul

Published
2023
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10. European consensus-based interdisciplinary guideline for diagnosis and treatment of basal cell carcinoma—update 2023

Author

Peris, Ketty, Fargnoli, Maria Concetta, Kaufmann, Roland, Arenberger, Petr, Bastholt, Lars, Seguin, Nicole Basset, Bataille, Veronique, Brochez, Lieve, del Marmol, Veronique, Dummer, Reinhard, Forsea, Ana-Marie, Gaudy-Marqueste, Caroline, Harwood, Catherine A., Hauschild, Axel, Höller, Christoph, Kandolf, Lidija, Kellerners-Smeets, Nicole W.J., Lallas, Aimilios, Leiter, Ulrike, Malvehy, Josep, Marinović, Branka, Mijuskovic, Zeljko, Moreno-Ramirez, David, Nagore, Eduardo, Nathan, Paul, Stratigos, Alexander J., Stockfleth, Eggert, Tagliaferri, Luca, Trakatelli, Myrto, Vieira, Ricardo, Zalaudek, Iris, and Garbe, Claus

Published
2023
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12. ASO Visual Abstract: Earlier Recurrence Detection Using Routine FDG PET-CT Scans in Surveillance of Stage IIB to IIID Melanoma—A National Cohort Study of 1480 Patients

Author

Helvind, Neel Maria, Weitemeyer, Marie Brinch-Møller, Chakera, Annette Hougaard, Hendel, Helle Westergren, Ellebæk, Eva, Svane, Inge Marie, Kjærskov, Mette Wanscher, Bojesen, Sophie, Skyum, Helle, Petersen, Søren Kjær, Bastholt, Lars, Johansen, Christoffer, Bidstrup, Pernille Envold, and Hölmich, Lisbet Rosenkrantz

Published
2023
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15. Vandetanib in locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine therapy.

Author

Brose, Marcia S., Capdevila, Jaume, Elisei, Rossella, Bastholt, Lars, Führer-Sakel, Dagmar, Leboulleux, Sophie, Iwao Sugitani, Taylor, Matthew H., Zhuoying Wang, Wirth, Lori J., Worden, Francis P., Bernard, John, Caferra, Paolo, Colzani, Raffaella M., Shiguang Liu, and Schlumberger, Martin

Subjects
THYROID cancer, CLINICAL trials, IODINE isotopes, TERMINATION of treatment, PROTEIN-tyrosine kinases, PROGRESSION-free survival
Abstract

The VERIFY study aimed to determine the efficacy of vandetanib in patients with differentiated thyroid cancer (DTC) that is either locally advanced or metastatic and refractory to radioiodine (RAI) therapy. Specifically, VERIFY is a randomized, double-blind, multicenter phase III trial aimed to determine the efficacy and safety of vandetanib in tyrosine kinase inhibitor-naive patients with locally advanced or metastatic RAI-refractory DTC with documented progression (NCT01876784). Patients were randomized 1:1 to vandetanib or placebo. The primary endpoint was progression-free survival (PFS). Secondary endpoints included best objective response rate, overall survival (OS), safety, and tolerability. Patients continued to receive randomized treatment until disease progression or for as long as they were receiving clinical benefit unless criteria for treatment discontinuation were met. Following randomization, 117 patients received vandetanib, and 118 patients received a placebo. Median PFS was 10.0 months in the vandetanib group and 5.7 months in the placebo group (hazard ratio: 0.75; 95% CI: 0.55–1.03; P = 0.080). OS was not significantly different between treatment arms. Common Terminology Criteria for Adverse Events (CTCAE) of grade ≥3 were reported in 55.6% of patients in the vandetanib arm and 25.4% in the placebo arm. Thirty-three deaths (28.2%; one related to study treatment) occurred in the vandetanib arm compared with 16 deaths (13.6%; two related to treatment) in the placebo arm. No statistically significant improvement was observed in PFS in treatment versus placebo in patients with locally advanced or metastatic, RAI-refractory DTC. Moreover, active treatment was associated with more adverse events and more deaths than placebo, though the difference in OS was not statistically significant. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Safety and efficacy of nintedanib as second-line therapy for patients with differentiated or medullary thyroid cancer progressing after first-line therapy. A randomized phase II study of the EORTC Endocrine Task Force (protocol 1209-EnTF).

Author

Leboulleux, Sophie, Kapiteijn, Ellen, Litière, Saskia, Schöffski, Patrick, Godbert, Yann, Rodien, Patrice, Jarzab, Barbara, Salvatore, Domenico, Zanetta, Sylvie, Capdevila, Jaume, Bastholt, Lars, De La Fouchardiere, Christelle, Lalami, Yassine, Bardet, Stéphane, Cornélis, Frank, Dedecjus, Marek, Links, Thera, Sents, Ward, Schlumberger, Martin, and Locati, D. Laura

Subjects
MEDULLARY thyroid carcinoma, TASK forces, CANCER patients, LOG-rank test, OVERALL survival
Abstract

Background: Nintedanib is a triple-angiokinase inhibitor with potential activity in patients with advanced thyroid cancers, as radioiodine refractory differentiated thyroid cancer (RAIR DTC) and medullary thyroid cancer (MTC). Design: EORTC-1209 (NCT01788982) was a double-blind randomized (2:1 ratio) placebo-controlled phase II, multi-cohort study exploring the efficacy and safety of nintedanib in patients with progressive, locally advanced, and/or metastatic RAIR DTC and MTC. The primary endpoint was progression-free survival (PFS) in the per-protocol (PP) population for both cohorts. Secondary endpoints included response rate, duration of response, overall survival (OS), and safety. Results: RAIR DTC cohort: Seventy out of the 75 planned patients with RAIR DTC (median age, 66 years; 39 women) who had progressed after one (76%) or two lines (24%) of previous systemic therapy were randomized to receive either nintedanib (N = 45) or placebo (N = 25). Of these, 69 patients started treatment and 56 met all inclusion criteria (PP). At data cutoff, the median duration of follow-up was 26.3 months in the nintedanib arm and 19.8 months in the placebo arm. In the PP population, themedian PFS was 3.7 months [80% confidence interval (CI), 1.9-6.5] in the nintedanib arm and 2.9 months (80% CI, 2.0-5.6) in the placebo arm(HR = 0.65; 80% CI, 0.42-0.99; one-sided log-rank test P = 0.0947). No objective response was observed. The median OS was 29.6 months [80% CI, 15.2-not reached (NR)] in the nintedanib arm and not reached in the placebo arm. Grade 3-4 adverse events of any attribution occurred in 50% of patients receiving nintedanib and in 36% of patients receiving placebo. MTC cohort: Thirty-one out of the 67 planned patients with MTC (median age, 57 years; eight women) who had progressed after one (68%) or two (32%) lines of previous systemic therapy were randomized to receive either nintedanib (N = 22) or placebo (N = 9). Of these, 20 patients (15 in the nintedanib arm and five in the placebo arm) started treatment and met all inclusion criteria (PP). The median PFS was 7.0 months (80% CI, 1.9-8.7) in the nintedanib arm and 3.9 months (80% CI, 3.0-5.5) in the placebo arm (HR = 0.49; 95% CI, 0.16-1.53). No objective response was reported. The median OS was 16.4 months (80% CI, 12.1-24.9) in the nintedanib arm and 12.3 months (80% CI, 7.1-NR) in the placebo arm. Grade 3-4 adverse events of any attribution during the blinded period occurred in 59.1% of patients receiving nintedanib and in 33.3% of patients receiving placebo. Conclusion: This study did not suggest a clinically significant improvement of PFS with nintedanib over placebo in patients with pretreated RAIR DTC and MTC. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial

Author

Lesimple, Thierry, Maio, Michele, Linette, Gerald, Mortier, Laurent, Svane, Inge Marie, Schachter, Jacob, Brown, Michael, Hersey, Peter, Barrow, Catherine, Kudchadkar, Ragini, Dutriaux, Caroline, Song, Xinni, Quaglino, Pietro, Queirolo, Paola, Meier, Friedegund, Stroyakovskiy, Daniil, Guillot, Bernard, Romero, Pablo Luis Ortiz, Bastholt, Lars, Garbe, Claus, Grange, Florent, Mohr, Peter, Algazi, Alain, Bechter, Oliver, Hernberg, Micaela, Loquai, Carmen, Meiss, Frank, Chiarion Sileni, Vanna, Bar-Sela, Gil, Fitzharris, Bernard, Saiag, Philippe, Arnault, Jean-Philippe, Simon, Jan-Christoph, Stephens, Rosalie, Baurain, Jean-Francois, Lebbe, Célèste, Combemale, Patrick, Dummer, Reinhard, Hauschild, Axel, Parente, Phillip, Yamazaki, Naoya, Milhem, Mohammed, Leccia, Marie-Thérèse, Geoffrois, Lionel, Kretschmer, Lutz, Dunwoodie, Elaine, Walker, John, Lotem, Michal, Hendler, Daniel, Mackiewicz, Andrzej, Sekulovic, Lidija, Dzienis, Marcin, Hospers, Geke A.P., Siano, Marco, Hassel, Jessica, Corrie, Philippa, Passos, Maria-Jose, Levin, Max, Hoeller, Christoph, Machet, Laurent, Hallmeyer, Sigrun, Waterston, Ashita, Descamps, Vincent, Kiecker, Felix, Aarts, Maureen, Schmidt, Henrik, Raimundo, Ana, Nyakas, Marta, Lacour, Jean-Philippe, Berking, Carola, Ferrucci, Pier Francesco, Jameson, Michael, Kim, Kevin, Yokota, Kenji, Kerger, Joseph, Aubin, François, Groenewegen, Gerard, Kapiteijn, Helena, Boehncke, Wolf-Henning, Utikal, Jochen, Casasola, Richard, Marshall, Ernest, Ferraresi, Virginia, Richtig, Erika, Matkovic, Suzana, Inozume, Takashi, Crook, Timothy, McNeil, Catriona, Kiyohara, Yoshio, Avril, Marie-Francoise, Hein, Rüdiger, Terheyden, Patrick, Nathan, Paul, Aoi, Jun, Skytta, Tanja, Jouary, Thomas, Takenouchi, Tatsuya, Straume, Oddbjorn, Martins, César, Mukhametshina, Guzel, Bottomley, Andrew, Coens, Corneel, Mierzynska, Justyna, Blank, Christian U, Mandalà, Mario, Long, Georgina V, Atkinson, Victoria G, Dalle, Stéphane, Haydon, Andrew M, Meshcheryakov, Andrey, Khattak, Adnan, Carlino, Matteo S, Sandhu, Shahneen, Puig, Susana, Ascierto, Paolo A, Larkin, James, Lorigan, Paul C, Rutkowski, Piotr, Schadendorf, Dirk, Koornstra, Rutger, Hernandez-Aya, Leonel, Di Giacomo, Anna Maria, van den Eertwegh, Alfonsus J M, Grob, Jean-Jacques, Gutzmer, Ralf, Jamal, Rahima, van Akkooi, Alexander C J, Krepler, Clemens, Ibrahim, Nageatte, Marreaud, Sandrine, Kicinski, Michal, Suciu, Stefan, Robert, Caroline, and Eggermont, Alexander M M

Published
2021
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19. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial

Author

Menzies, Alex, Lesimple, Thierry, Maio, Michele, Linette, Gerald, Brown, Michael, Hersey, Peter, Svane, Inge Marie, Mortier, Laurent, Schachter, Jacob, Barrow, Catherine, Kudchadkar, Ragini, Song, Xinni, Dutriaux, Caroline, Quaglino, Pietro, Meier, Friedegund, Queirolo, Paola, Stroyakovskiy, Daniil, Bastholt, Lars, Guillot, Bernard, Garbe, Claus, Ortiz Romero, Pablo Luis, Grange, Florent, Mohr, Peter, Algazi, Alain, Bechter, Oliver, Hernberg, Micaela, Arnault, Jean-Philippe, Saiag, Philippe, Loquai, Carmen, Meiss, Frank, Simon, Jan-Christoph, Bar-Sela, Gil, Chiarion Sileni, Vanna, Fitzharris, Bernard, McCrystal, Mike, Parente, Phillip, Baurain, Jean-Francois, Combemale, Patrick, Lebbe, Célèste, Hauschild, Axel, Yamazaki, Naoya, Dummer, Reinhard, Milhem, Mohammed, Dzienis, Marcin, Walker, John, Geoffrois, Lionel, Leccia, Marie-Thérèse, Kretschmer, Lutz, Hendler, Daniel, Lotem, Michal, Mackiewicz, Andrzej, Sekulovic, Lidija, Dunwoodie, Elaine, Hoeller, Christoph, Machet, Laurent, Hassel, Jessica, Hospers, Geke A.P., Passos, Maria-Jose, Levin, Max, Fehr, Martin, Corrie, Philippa, Waterston, Ashita, Hallmeyer, Sigrun, Schmidt, Henrik, Descamps, Vincent, Lacour, Jean-Philippe, Berking, Carola, Kiecker, Felix, Ferrucci, Pier Francesco, Yokota, Kenji, Aarts, Maureen, Jameson, Michael, Winge-Main, Anna Katharina, Ferreira, Paula, Kim, Kevin, McNeil, Catriona, Hofmann-Wellenhof, Reiner, Kerger, Joseph, Aubin, François, Utikal, Jochen, Ferraresi, Virginia, Inozume, Takashi, Kiyohara, Yoshio, Groenewegen, Gerard, Kapiteijn, Helena, Matkovic, Suzana, Boehncke, Wolf-Henning, Casasola, Richard, Crook, Timothy, Marshall, Ernest, Skytta, Tanja, Avril, Marie-Francoise, Jouary, Thomas, Hein, Rüdiger, Terheyden, Patrick, Aoi, Jun, Takenouchi, Tatsuya, Straume, Oddbjorn, Martins, César, Mukhametshina, Guzel, Nathan, Paul, Eggermont, Alexander M M, Blank, Christian U, Mandalà, Mario, Long, Georgina V, Atkinson, Victoria G, Dalle, Stéphane, Haydon, Andrew M, Meshcheryakov, Andrey, Khattak, Adnan, Carlino, Matteo S, Sandhu, Shahneen, Larkin, James, Puig, Susana, Ascierto, Paolo A, Rutkowski, Piotr, Schadendorf, Dirk, Koornstra, Rutger, Hernandez-Aya, Leonel, Di Giacomo, Anna Maria, van den Eertwegh, Alfonsus J M, Grob, Jean-Jacques, Gutzmer, Ralf, Jamal, Rahima, Lorigan, Paul C, van Akkooi, Alexander C J, Krepler, Clemens, Ibrahim, Nageatte, Marreaud, Sandrine, Kicinski, Michal, Suciu, Stefan, and Robert, Caroline

Published
2021
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21. Stage-Specific Risk of Recurrence and Death From Melanoma in Denmark, 2008-2021

Author

Helvind, Neel M., primary, Brinch-Møller Weitemeyer, Marie, additional, Chakera, Annette H., additional, Hendel, Helle W., additional, Ellebæk, Eva, additional, Svane, Inge Marie, additional, Kjærskov, Mette W., additional, Bojesen, Sophie, additional, Skyum, Helle, additional, Petersen, Søren K., additional, Bastholt, Lars, additional, Johansen, Christoffer, additional, Bidstrup, Pernille E., additional, and Hölmich, Lisbet R., additional

Published
2023
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22. Tertiary lymphoid structures improve immunotherapy and survival in melanoma

Author

Cabrita, Rita, Lauss, Martin, Sanna, Adriana, Donia, Marco, Skaarup Larsen, Mathilde, Mitra, Shamik, Johansson, Iva, Phung, Bengt, Harbst, Katja, Vallon-Christersson, Johan, van Schoiack, Alison, Lövgren, Kristina, Warren, Sarah, Jirström, Karin, Olsson, Håkan, Pietras, Kristian, Ingvar, Christian, Isaksson, Karolin, Schadendorf, Dirk, Schmidt, Henrik, Bastholt, Lars, Carneiro, Ana, Wargo, Jennifer A., Svane, Inge Marie, and Jönsson, Göran

Published
2020
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25. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial

Author

Ascierto, Paolo A, Del Vecchio, Michele, Robert, Caroline, Mackiewicz, Andrzej, Chiarion-Sileni, Vanna, Arance, Ana, Lebbé, Céleste, Bastholt, Lars, Hamid, Omid, Rutkowski, Piotr, McNeil, Catriona, Garbe, Claus, Loquai, Carmen, Dreno, Brigitte, Thomas, Luc, Grob, Jean-Jacques, Liszkay, Gabriella, Nyakas, Marta, Gutzmer, Ralf, Pikiel, Joanna, Grange, Florent, Hoeller, Christoph, Ferraresi, Virginia, Smylie, Michael, Schadendorf, Dirk, Mortier, Laurent, Svane, Inge Marie, Hennicken, Delphine, Qureshi, Anila, and Maio, Michele

Published
2017
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27. Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA)

Author

Ho, Alan L., Dedecjus, Marek, Wirth, Lori J., Tuttle, R. Michael, Inabnet, William B., Tennvall, Jan, Vaisman, Fernanda, Bastholt, Lars, Gianoukakis, Andrew G., Rodien, Patrice, Paschke, Ralf, Elisei, Rossella, Viola, David, So, Karen, Carroll, Danielle, Hovey, Tina, Thakre, Bhavana, and Fagin, James A.

Subjects
Iodine Radioisotopes, Cancer Research, Clinical Trials, Phase III as Topic, Oncology, Humans, Benzimidazoles, ORIGINAL REPORTS, Thyroid Neoplasms, Mitogen-Activated Protein Kinases, Protein Kinase Inhibitors
Abstract

PURPOSE Selumetinib can increase radioactive iodine (RAI) avidity in RAI-refractory tumors. We investigated whether selumetinib plus adjuvant RAI improves complete remission (CR) rates in patients with differentiated thyroid cancer (DTC) at high risk of primary treatment failure versus RAI alone. METHODS ASTRA (ClinicalTrials.gov identifier: NCT01843062 ) is an international, phase III, randomized, placebo-controlled, double-blind trial. Patients with DTC at high risk of primary treatment failure (primary tumor > 4 cm; gross extrathyroidal extension outside the thyroid gland [T4 disease]; or N1a/N1b disease with ≥ 1 metastatic lymph node(s) ≥ 1 cm or ≥ 5 lymph nodes [any size]) were randomly assigned 2:1 to selumetinib 75 mg orally twice daily or placebo for approximately 5 weeks (no stratification). On treatment days 29-31, recombinant human thyroid-stimulating hormone (0.9 mg)–stimulated RAI (131I; 100 mCi/3.7 GBq) was administered, followed by 5 days of selumetinib/placebo. The primary end point (CR rate 18 months after RAI) was assessed in the intention-to-treat population. RESULTS Four hundred patients were enrolled (August 27, 2013-March 23, 2016) and 233 randomly assigned (selumetinib, n = 155 [67%]; placebo, n = 78 [33%]). No statistically significant difference in CR rate 18 months after RAI was observed (selumetinib n = 62 [40%]; placebo n = 30 [38%]; odds ratio 1.07 [95% CI, 0.61 to 1.87]; P = .8205). Treatment-related grade ≥ 3 adverse events were reported in 25/154 patients (16%) with selumetinib and none with placebo. The most common adverse event with selumetinib was dermatitis acneiform (n = 11 [7%]). No treatment-related deaths were reported. CONCLUSION Postoperative pathologic risk stratification identified patients with DTC at high risk of primary treatment failure, although the addition of selumetinib to adjuvant RAI failed to improve the CR rate for these patients. Future strategies should focus on tumor genotype–tailored drug selection and maintaining drug dosing to optimize RAI efficacy.

Published
2022

28. Supplementary Tables 1-2 from Phase II, Open-Label, Randomized Trial of the MEK1/2 Inhibitor Selumetinib as Monotherapy versus Temozolomide in Patients with Advanced Melanoma

Author

Kirkwood, John M., primary, Bastholt, Lars, primary, Robert, Caroline, primary, Sosman, Jeff, primary, Larkin, James, primary, Hersey, Peter, primary, Middleton, Mark, primary, Cantarini, Mireille, primary, Zazulina, Victoria, primary, Kemsley, Karin, primary, and Dummer, Reinhard, primary

Published
2023
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29. Data from Phase II, Open-Label, Randomized Trial of the MEK1/2 Inhibitor Selumetinib as Monotherapy versus Temozolomide in Patients with Advanced Melanoma

Author

Kirkwood, John M., primary, Bastholt, Lars, primary, Robert, Caroline, primary, Sosman, Jeff, primary, Larkin, James, primary, Hersey, Peter, primary, Middleton, Mark, primary, Cantarini, Mireille, primary, Zazulina, Victoria, primary, Kemsley, Karin, primary, and Dummer, Reinhard, primary

Published
2023
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30. Supplementary Figure Legend 1 from Phase II, Open-Label, Randomized Trial of the MEK1/2 Inhibitor Selumetinib as Monotherapy versus Temozolomide in Patients with Advanced Melanoma

Author

Kirkwood, John M., primary, Bastholt, Lars, primary, Robert, Caroline, primary, Sosman, Jeff, primary, Larkin, James, primary, Hersey, Peter, primary, Middleton, Mark, primary, Cantarini, Mireille, primary, Zazulina, Victoria, primary, Kemsley, Karin, primary, and Dummer, Reinhard, primary

Published
2023
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31. Supplementary Figure 1 from Phase II, Open-Label, Randomized Trial of the MEK1/2 Inhibitor Selumetinib as Monotherapy versus Temozolomide in Patients with Advanced Melanoma

Author

Kirkwood, John M., primary, Bastholt, Lars, primary, Robert, Caroline, primary, Sosman, Jeff, primary, Larkin, James, primary, Hersey, Peter, primary, Middleton, Mark, primary, Cantarini, Mireille, primary, Zazulina, Victoria, primary, Kemsley, Karin, primary, and Dummer, Reinhard, primary

Published
2023
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38. Author Correction: Tertiary lymphoid structures improve immunotherapy and survival in melanoma

Author

Cabrita, Rita, Lauss, Martin, Sanna, Adriana, Donia, Marco, Skaarup Larsen, Mathilde, Mitra, Shamik, Johansson, Iva, Phung, Bengt, Harbst, Katja, Vallon-Christersson, Johan, van Schoiack, Alison, Lövgren, Kristina, Warren, Sarah, Jirström, Karin, Olsson, Håkan, Pietras, Kristian, Ingvar, Christian, Isaksson, Karolin, Schadendorf, Dirk, Schmidt, Henrik, Bastholt, Lars, Carneiro, Ana, Wargo, Jennifer A., Svane, Inge Marie, and Jönsson, Göran

Published
2020
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39. European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment - Update 2022

Author

Garbe, Claus, primary, Amaral, Teresa, additional, Peris, Ketty, additional, Hauschild, Axel, additional, Arenberger, Petr, additional, Basset-Seguin, Nicole, additional, Bastholt, Lars, additional, Bataille, Veronique, additional, del Marmol, Veronique, additional, Dréno, Brigitte, additional, Fargnoli, Maria C., additional, Forsea, Ana-Maria, additional, Grob, Jean-Jacques, additional, Hoeller, Christoph, additional, Kaufmann, Roland, additional, Kelleners-Smeets, Nicole, additional, Lallas, Aimilios, additional, Lebbé, Celeste, additional, Lytvynenko, Bodhan, additional, Malvehy, Josep, additional, Moreno-Ramirez, David, additional, Nathan, Paul, additional, Pellacani, Giovanni, additional, Saiag, Philippe, additional, Stratigos, Alexander J., additional, Van Akkooi, Alexander C.J., additional, Vieira, Ricardo, additional, Zalaudek, Iris, additional, and Lorigan, Paul, additional

Published
2022
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40. European consensus-based interdisciplinary guideline for melanoma. Part 1: Diagnostics: Update 2022

Author

Garbe, Claus, primary, Amaral, Teresa, additional, Peris, Ketty, additional, Hauschild, Axel, additional, Arenberger, Petr, additional, Basset-Seguin, Nicole, additional, Bastholt, Lars, additional, Bataille, Veronique, additional, del Marmol, Veronique, additional, Dréno, Brigitte, additional, Fargnoli, Maria C., additional, Forsea, Ana-Maria, additional, Grob, Jean-Jacques, additional, Höller, Christoph, additional, Kaufmann, Roland, additional, Kelleners-Smeets, Nicole, additional, Lallas, Aimilios, additional, Lebbé, Celeste, additional, Lytvynenko, Bohdan, additional, Malvehy, Josep, additional, Moreno-Ramirez, David, additional, Nathan, Paul, additional, Pellacani, Giovanni, additional, Saiag, Philippe, additional, Stratigos, Alexander J., additional, Van Akkooi, Alexander C.J., additional, Vieira, Ricardo, additional, Zalaudek, Iris, additional, and Lorigan, Paul, additional

Published
2022
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41. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial

Author

Brose, Marcia S, Nutting, Christopher M, Jarzab, Barbara, Elisei, Rossella, Siena, Salvatore, Bastholt, Lars, de la Fouchardiere, Christelle, Pacini, Furio, Paschke, Ralf, Shong, Young Kee, Sherman, Steven I, Smit, Johannes W A, Chung, John, Kappeler, Christian, Peña, Carol, Molnár, István, and Schlumberger, Martin J

Published
2014
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45. European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment - Update 2022

Author

Garbe, Claus, Amaral, Teresa, Peris, Ketty, Hauschild, Axel, Arenberger, Petr, Basset-Seguin, Nicole, Bastholt, Lars, Bataille, Veronique, Del Marmol, Veronique, Dréno, Brigitte, Fargnoli, Maria C, Forsea, Ana-Maria, Grob, Jean-Jacques, Hoeller, Christoph, Kaufmann, Roland, Kelleners-Smeets, Nicole, Lallas, Aimilios, Lebbé, Celeste, Lytvynenko, Bodhan, Malvehy, Josep, Moreno-Ramirez, David, Nathan, Paul, Pellacani, Giovanni, Saiag, Philippe, Stratigos, Alexander J, Van Akkooi, Alexander C J, Vieira, Ricardo, Zalaudek, Iris, Lorigan, Paul, European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO), and the European Organization for Research and Treatment of Cancer (EORTC), Garbe, Clau, Amaral, Teresa, Peris, Ketty, Hauschild, Axel, Arenberger, Petr, Basset-Seguin, Nicole, Bastholt, Lar, Bataille, Veronique, Del Marmol, Veronique, Dréno, Brigitte, Fargnoli, Maria C, Forsea, Ana-Maria, Grob, Jean-Jacque, Hoeller, Christoph, Kaufmann, Roland, Kelleners-Smeets, Nicole, Lallas, Aimilio, Lebbé, Celeste, Lytvynenko, Bodhan, Malvehy, Josep, Moreno-Ramirez, David, Nathan, Paul, Pellacani, Giovanni, Saiag, Philippe, Stratigos, Alexander J, Van Akkooi, Alexander C J, Vieira, Ricardo, Zalaudek, Iri, and Lorigan, Paul

Subjects
Proto-Oncogene Proteins B-raf, Cancer Research, Consensus, Skin Neoplasms, Consensu, Systemic treatment, Oxime, HIGH-RISK MELANOMA, Antineoplastic Combined Chemotherapy Protocols, Oximes, Humans, Excisional margins, Melanoma, SENTINEL-NODE BIOPSY, Tumor thickne, Neoplasm Staging, POSTOPERATIVE STEREOTACTIC RADIOSURGERY, LENTIGO MALIGNA MELANOMA, Antineoplastic Combined Chemotherapy Protocol, Manchester Cancer Research Centre, ResearchInstitutes_Networks_Beacons/mcrc, MOHS MICROGRAPHIC SURGERY, Metastasectomy, Sentinel lymph node dissection, Interferon-alpha, RANDOMIZED PHASE-III, Adjuvant treatment, Tumor thickness, Cutaneous melanoma, Interferon-α, Mutation, Systematic Reviews as Topic, SURGICAL EXCISION MARGINS, Oncology, PRIMARY CUTANEOUS MELANOMA, STAGE IV MELANOMA, Excisional margin, Settore MED/35 - MALATTIE CUTANEE E VENEREE, DABRAFENIB PLUS TRAMETINIB, Human
Abstract

A unique collaboration of multidisciplinary experts from the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO), and the European Organization of Research and Treatment of Cancer (EORTC) was formed to make recommendations on cutaneous melanoma diagnosis and treatment, based on the systematic literature reviews and the experts' experience. Cutaneous melanomas are excised with one to 2-cm safety margins. Sentinel lymph node dissection shall be performed as a staging procedure in patients with tumor thickness ≥1.0mm or ≥0.8mm with additional histological risk factors, although there is as yet no clear survival benefit for this approach. Therapeutic decisions in stage III/IV patients should be primarily made by an interdisciplinary oncology team ("tumor board"). Adjuvant therapies can be proposed in stage III/completely resected stage IV patients and are primarily anti-PD-1, independent of mutational status, or alternatively dabrafenib plus trametinib for BRAF mutant patients. In distant metastases (stage IV), either resected or not, systemic treatment is always indicated. For first-line treatment particularly in BRAF wild-type patients, immunotherapy with PD-1 antibodies alone or in combination with CTLA-4 antibodies shall be considered. In stage IV melanoma with a BRAF-V600E/K mutation, first-line therapy with BRAF/MEK inhibitors can be offered as an alternative to immunotherapy. In patients with primary resistance to immunotherapy and harboring a BRAF-V600E/K mutation, this therapy shall be offered as second-line therapy. Systemic therapy in stage III/IV melanoma is a rapidly changing landscape, and it is likely that these recommendations may change in the near future.

Published
2022

47. Additional file 1 of Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial

Author

Tolstrup, L��rke K., Pappot, Helle, Bastholt, Lars, M��ller, S��ren, and Dieperink, Karin B.

Abstract

Additional file 1. Supplemental table 1: Overview QoL data (FACT-M and EQ-5D-5L) for melanoma patients included in the PROMelanoma study - - intervention group vs. control group. Supplemental table 2: Overview QoL data (FACT-M and EQ-5D-5L) for melanoma patients included in the PROMelanoma study - grade 3 or 4 irAEs vs. no grade 3 or 4 irAEs

Published
2022
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48. EMRseq : Registry-based outcome analysis on 1,000 patients with BRAF V600–mutated metastatic melanoma in Europe treated with either immune checkpoint or BRAF-/MEK inhibition

Author

Weichenthal, Michael, Svane, Inge Marie, Kandolf Sekulovic, Lidija, Mangana, Joanna, Mohr, Peter, Marquez-Rodas, Ivan, Schmidt, Henrik, Ziogas, Dimitrios C., Bender, Marc, Ellebaek, Eva, Urch, Kristina, Shalamanova-Deleva, Gergana, Gavrilova, Iva, Espinosa, Enrique, Dummer, Reinhard, Rutkowski, Piotr, Ascierto, Paolo Antonio, Gogas, Helen, Schadendorf, Dirk, and Bastholt, Lars

Subjects
Medizin
Published
2022

50. Seasonal variation in effect of anti‐PD‐1 initiation on overall survival among patients with advanced melanoma.

Author

Ellebaek, Eva, Schina, Aimilia, Schmidt, Henrik, Haslund, Charlotte Aaquist, Bastholt, Lars, Svane, Inge Marie, and Donia, Marco

Subjects
OVERALL survival, SEASONAL variations of diseases, MELANOMA, SEASONS, CIRCADIAN rhythms, PROGRAMMED cell death 1 receptors, BRAF genes
Abstract

Melanoma is a highly immunogenic cancer, and circannual rhythms influence the activity of the immune system. We retrospectively collected information on all cases with metastatic melanoma (ocular melanoma excluded) that initiated treatment with BRAF‐inhibitor‐based therapy (BRAFi) or anti‐PD‐1 monotherapy (PD‐1). Cases were divided in two groups based on treatment initiation in the summer half‐year (April to September) or winter half‐year (October to March). We collected a total of 1054 (BRAF‐i) and 1205 (PD‐1) patient cases. Median follow‐up was 39.7 (BRAFi) and 47.5 (PD‐1) months. We did not observe differences in outcomes across patients who were treated in summer versus winter in the BRAFi cohort. Furthermore, we did not observe significant differences in ORR, CRR, and PFS in the PD‐1 cohort. However, in patients with BRAF wild‐type disease of the PD‐1 cohort, treatment initiation in summer was associated with an improved OS (mOS 39.7 months [summer] versus 21.3 months [winter]; HR 0.70, 95% CI 0.57–0.86, p =.0007). This result remained robust to multivariable proportional hazards adjustment (HR 0.70, 95% CI 0.57–0.87, p =.001). Initiation of immunotherapy in summer is associated with prolonged survival in patients with BRAF wild‐type melanoma living in Denmark. [ABSTRACT FROM AUTHOR]

Published
2023
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