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991 results on '"Eggermont, A M M"'

1. Influence of microbiota-associated metabolic reprogramming on clinical outcome in patients with melanoma from the randomized adjuvant dendritic cell-based MIND-DC trial

Author

Alves Costa Silva, Carolina, Piccinno, Gianmarco, Suissa, Déborah, Bourgin, Mélanie, Schreibelt, Gerty, Durand, Sylvère, Birebent, Roxanne, Fidelle, Marine, Sow, Cissé, Aprahamian, Fanny, Manghi, Paolo, Punčochář, Michal, Asnicar, Francesco, Pinto, Federica, Armanini, Federica, Terrisse, Safae, Routy, Bertrand, Drubay, Damien, Eggermont, Alexander M. M., Kroemer, Guido, Segata, Nicola, Zitvogel, Laurence, Derosa, Lisa, Bol, Kalijn F., and de Vries, I. Jolanda M.

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

Author

Bührer, Emanuel, Kicinski, Michal, Mandala, Mario, Pe, Madeline, Long, Georgina V, Atkinson, Victoria, Blank, Christian U, Haydon, Andrew, Dalle, Stéphane, Khattak, Adnan, Carlino, Matteo S, Meshcheryakov, Andrey, Sandhu, Shahneen, Puig, Susana, Schadendorf, Dirk, Jamal, Rahima, Rutkowski, Piotr, van den Eertwegh, Alfonsus J M, Coens, Corneel, Grebennik, Dmitri, Krepler, Clemens, Robert, Caroline, and Eggermont, Alexander M M

Published
2024
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4. Neoadjuvant immunotherapy for melanoma is now ready for clinical practice

Author

Garbe, Claus, Dummer, Reinhard, Amaral, Teresa, Amaria, Rodabe N., Ascierto, Paolo A., Burton, Elizabeth M., Dreno, Brigitte, Eggermont, Alexander M. M., Hauschild, Axel, Hoeller, Christoph, Kaufmann, Roland, Lebbe, Celeste, Mandala, Mario, Menzies, Alexander M., Moreno, David, Michielin, Olivier, Nathan, Paul, Patel, Sapna P., Robert, Caroline, Schadendorf, Dirk, Lorigan, Paul C., Scolyer, Richard A., Tawbi, Hussein A., van de Wiel, Bart A., Blank, Christian, and Long, Georgina V.

Published
2023
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5. Uncovering the mode of action of engineered T cells in patient cancer organoids

Author

Dekkers, Johanna F., Alieva, Maria, Cleven, Astrid, Keramati, Farid, Wezenaar, Amber K. L., van Vliet, Esmée J., Puschhof, Jens, Brazda, Peter, Johanna, Inez, Meringa, Angelo D., Rebel, Heggert G., Buchholz, Maj-Britt, Barrera Román, Mario, Zeeman, Amber L., de Blank, Sam, Fasci, Domenico, Geurts, Maarten H., Cornel, Annelisa M., Driehuis, Else, Millen, Rosemary, Straetemans, Trudy, Nicolasen, Mara J. T., Aarts-Riemens, Tineke, Ariese, Hendrikus C. R., Johnson, Hannah R., van Ineveld, Ravian L., Karaiskaki, Froso, Kopper, Oded, Bar-Ephraim, Yotam E., Kretzschmar, Kai, Eggermont, Alexander M. M., Nierkens, Stefan, Wehrens, Ellen J., Stunnenberg, Henk G., Clevers, Hans, Kuball, Jürgen, Sebestyen, Zsolt, and Rios, Anne C.

Published
2023
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7. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trial

Author

Long, Georgina V, Luke, Jason J, Khattak, Muhammad A, de la Cruz Merino, Luis, Del Vecchio, Michele, Rutkowski, Piotr, Spagnolo, Francesco, Mackiewicz, Jacek, Chiarion-Sileni, Vanna, Kirkwood, John M, Robert, Caroline, Grob, Jean-Jacques, de Galitiis, Federica, Schadendorf, Dirk, Carlino, Matteo S, Mohr, Peter, Dummer, Reinhard, Gershenwald, Jeffrey E, Yoon, Charles H, Wu, Xi Lawrence, Fukunaga-Kalabis, Mizuho, Krepler, Clemens, Eggermont, Alexander M M, and Ascierto, Paolo A

Published
2022
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8. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial

Author

Luke, Jason J, Rutkowski, Piotr, Queirolo, Paola, Del Vecchio, Michele, Mackiewicz, Jacek, Chiarion-Sileni, Vanna, de la Cruz Merino, Luis, Khattak, Muhammad A, Schadendorf, Dirk, Long, Georgina V, Ascierto, Paolo A, Mandala, Mario, De Galitiis, Federica, Haydon, Andrew, Dummer, Reinhard, Grob, Jean-Jacques, Robert, Caroline, Carlino, Matteo S, Mohr, Peter, Poklepovic, Andrew, Sondak, Vernon K, Scolyer, Richard A, Kirkwood, John M, Chen, Ke, Diede, Scott J, Ahsan, Sama, Ibrahim, Nageatte, and Eggermont, Alexander M M

Published
2022
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9. Adjuvant Systemic Therapy for High-Risk Melanoma Patients

Author

Najjar, Yana G., Massa, Ryan, Sondak, Vernon K., Eggermont, Alexander M. M., Gogas, Helen, Kirkwood, John M., Balch, Charles M., editor, Atkins, Michael B., editor, Garbe, Claus, editor, Gershenwald, Jeffrey E., editor, Halpern, Allan C., editor, Kirkwood, John M., editor, McArthur, Grant A., editor, Thompson, John F., editor, and Sober, Arthur J., editor

Published
2020
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10. 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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11. 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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12. Clinical and translational attributes of immune-related adverse events

Author

Infection & Immunity, Cancer, MS Medische Oncologie, CTI Van Wijk, Child Health, Suijkerbuijk, Karijn P M, van Eijs, Mick J M, van Wijk, Femke, Eggermont, Alexander M M, Infection & Immunity, Cancer, MS Medische Oncologie, CTI Van Wijk, Child Health, Suijkerbuijk, Karijn P M, van Eijs, Mick J M, van Wijk, Femke, and Eggermont, Alexander M M

Published
2024

15. Immunosurveillance in clinical cancer management.

Author

Kroemer, Guido, Chan, Timothy A., Eggermont, Alexander M. M., and Galluzzi, Lorenzo

Subjects
CANCER relapse, RADIOTHERAPY, DISEASE management, ANTINEOPLASTIC agents, IMMUNOTHERAPY, IMMUNOLOGY technique, IMMUNE system, CANCER chemotherapy, TUMORS, PATIENT monitoring, DISEASE progression
Abstract

The progression of cancer involves a critical step in which malignant cells escape from control by the immune system. Antineoplastic agents are particularly efficient when they succeed in restoring such control (immunosurveillance) or at least establish an equilibrium state that slows down disease progression. This is true not only for immunotherapies, such as immune checkpoint inhibitors (ICIs), but also for conventional chemotherapy, targeted anticancer agents, and radiation therapy. Thus, therapeutics that stress and kill cancer cells while provoking a tumor-targeting immune response, referred to as immunogenic cell death, are particularly useful in combination with ICIs. Modern oncology regimens are increasingly using such combinations, which are referred to as chemoimmunotherapy, as well as combinations of multiple ICIs. However, the latter are generally associated with severe side effects compared with single-agent ICIs. Of note, the success of these combinatorial strategies against locally advanced or metastatic cancers is now spurring successful attempts to move them past the postoperative (adjuvant) setting to the preoperative (neoadjuvant) setting, even for patients with operable cancers. Here, the authors critically discuss the importance of immunosurveillance in modern clinical cancer management. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial

Author

Coens, Corneel, Suciu, Stefan, Chiarion-Sileni, Vanna, Grob, Jean-Jacques, Dummer, Reinhard, Wolchok, Jedd D, Schmidt, Henrik, Hamid, Omid, Robert, Caroline, Ascierto, Paolo A, Richards, Jon M, Lebbé, Celeste, Ferraresi, Virginia, Smylie, Michael, Weber, Jeffrey S, Maio, Michele, Bottomley, Andrew, Kotapati, Srividya, de Pril, Veerle, Testori, Alessandro, and Eggermont, Alexander M M

Published
2017
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20. Uncovering the mode of action of engineered T cells in patient cancer organoids

Author

Dekkers, Johanna F, Alieva, Maria, Cleven, Astrid, Keramati, Farid, Wezenaar, Amber K L, van Vliet, Esmée J, Puschhof, Jens, Brazda, Peter, Johanna, Inez, Meringa, Angelo D, Rebel, Heggert G, Buchholz, Maj-Britt, Barrera Román, Mario, Zeeman, Amber L, de Blank, Sam, Fasci, Domenico, Geurts, Maarten H, Cornel, Annelisa M, Driehuis, Else, Millen, Rosemary, Straetemans, Trudy, Nicolasen, Mara J T, Aarts-Riemens, Tineke, Ariese, Hendrikus C R, Johnson, Hannah R, van Ineveld, Ravian L, Karaiskaki, Froso, Kopper, Oded, Bar-Ephraim, Yotam E, Kretzschmar, Kai, Eggermont, Alexander M M, Nierkens, Stefan, Wehrens, Ellen J, Stunnenberg, Henk G, Clevers, Hans, Kuball, Jürgen, Sebestyen, Zsolt, Rios, Anne C, Dekkers, Johanna F, Alieva, Maria, Cleven, Astrid, Keramati, Farid, Wezenaar, Amber K L, van Vliet, Esmée J, Puschhof, Jens, Brazda, Peter, Johanna, Inez, Meringa, Angelo D, Rebel, Heggert G, Buchholz, Maj-Britt, Barrera Román, Mario, Zeeman, Amber L, de Blank, Sam, Fasci, Domenico, Geurts, Maarten H, Cornel, Annelisa M, Driehuis, Else, Millen, Rosemary, Straetemans, Trudy, Nicolasen, Mara J T, Aarts-Riemens, Tineke, Ariese, Hendrikus C R, Johnson, Hannah R, van Ineveld, Ravian L, Karaiskaki, Froso, Kopper, Oded, Bar-Ephraim, Yotam E, Kretzschmar, Kai, Eggermont, Alexander M M, Nierkens, Stefan, Wehrens, Ellen J, Stunnenberg, Henk G, Clevers, Hans, Kuball, Jürgen, Sebestyen, Zsolt, and Rios, Anne C

Abstract

Extending the success of cellular immunotherapies against blood cancers to the realm of solid tumors will require improved in vitro models that reveal therapeutic modes of action at the molecular level. Here we describe a system, called BEHAV3D, developed to study the dynamic interactions of immune cells and patient cancer organoids by means of imaging and transcriptomics. We apply BEHAV3D to live-track >150,000 engineered T cells cultured with patient-derived, solid-tumor organoids, identifying a 'super engager' behavioral cluster comprising T cells with potent serial killing capacity. Among other T cell concepts we also study cancer metabolome-sensing engineered T cells (TEGs) and detect behavior-specific gene signatures that include a group of 27 genes with no previously described T cell function that are expressed by super engager killer TEGs. We further show that type I interferon can prime resistant organoids for TEG-mediated killing. BEHAV3D is a promising tool for the characterization of behavioral-phenotypic heterogeneity of cellular immunotherapies and may support the optimization of personalized solid-tumor-targeting cell therapies.

Published
2023

21. Prognostic and predictive value of metformin in the European organisation for research and treatment of cancer 1325/KEYNOTE-054 phase III trial of pembrolizumab versus placebo in resected high-risk stage III melanoma

Author

Kennedy, Oliver J., Kicinski, Michal, Valpione, Sara, Gandini, Sara, Suciu, Stefan, Blank, Christian U., 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, Boers-Sonderen, Marye, Di Giacomo, Anna M., van der Eertwegh, Alfonsus J. M., Grob, Jean-Jacques, Gutzmer, Ralf, Jamal, Rahima, van Akkooi, Alexander C. J., Robert, Caroline, Eggermont, Alexander M. M., Lorigan, Paul, Mandala, Mario, Kennedy, Oliver J., Kicinski, Michal, Valpione, Sara, Gandini, Sara, Suciu, Stefan, Blank, Christian U., 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, Boers-Sonderen, Marye, Di Giacomo, Anna M., van der Eertwegh, Alfonsus J. M., Grob, Jean-Jacques, Gutzmer, Ralf, Jamal, Rahima, van Akkooi, Alexander C. J., Robert, Caroline, Eggermont, Alexander M. M., Lorigan, Paul, and Mandala, Mario

Abstract

Background: Metformin is a commonly prescribed and well-tolerated medication. In laboratory studies, metformin suppresses BRAF wild-type melanoma cells but accelerates the growth of BRAF-mutated cells. This study investigated the prognostic and predictive value of metformin, including with respect to BRAF mutation status, in the European Organisation for Research and Treatment of Cancer 1325/KEYNOTE-054 randomised controlled trial. Methods: Patients with resected high-risk stage IIIA, IIIB, or IIIC melanoma received 200 mg of pembrolizumab (n = 514) or placebo (n = 505) every 3 weeks for twelve months. Pembrolizumab prolonged recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) at approximately 42 months median follow-up (Eggermont et al., TLO, 2021). Multivariable Cox regression was used to estimate associations of metformin with RFS and DMFS. Interaction terms were used to model effect modification by treatment and BRAF mutation. Results: Fifty-four patients (0.5%) used metformin at baseline. Metformin was not significantly associated with RFS (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.52–1.45) and DMFS (HR 0.82, 95% CI 0.47–1.44). The interaction between metformin and the treatment arm was not significant for either RFS (p = 0.92) or DMFS (p = 0.93). Among patients with mutated BRAF, the association of metformin with RFS (HR 0.70, 95% CI 0.37–1.33) was greater in magnitude though not significantly different to those without mutated BRAF (HR 0.98, 95% CI 0.56–1.69). Conclusions: There was no significant impact of metformin use on pembrolizumab efficacy in resected high-risk stage III melanoma. However, larger studies or pooled analyses are needed, particularly to explore a possible effect of metformin in BRAF-mutated melanoma. © 2023

Published
2023

25. Global cancer surgery: delivering safe, affordable, and timely cancer surgery

Author

Sullivan, Richard, Alatise, Olusegun Isaac, Anderson, Benjamin O, Audisio, Riccardo, Autier, Philippe, Aggarwal, Ajay, Balch, Charles, Brennan, Murray F, Dare, Anna, D'Cruz, Anil, Eggermont, Alexander M M, Fleming, Kenneth, Gueye, Serigne Magueye, Hagander, Lars, Herrera, Cristian A, Holmer, Hampus, Ilbawi, André M, Jarnheimer, Anton, Ji, Jia-fu, Kingham, T Peter, Liberman, Jonathan, Leather, Andrew J M, Meara, John G, Mukhopadhyay, Swagoto, Murthy, Shilpa S, Omar, Sherif, Parham, Groesbeck P, Pramesh, C S, Riviello, Robert, Rodin, Danielle, Santini, Luiz, Shrikhande, Shailesh V, Shrime, Mark, Thomas, Robert, Tsunoda, Audrey T, van de Velde, Cornelis, Veronesi, Umberto, Vijaykumar, Dehannathparambil Kottarathil, Watters, David, Wang, Shan, Wu, Yi-Long, Zeiton, Moez, and Purushotham, Arnie

Published
2015
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26. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial

Author

Eggermont, Alexander M M, Chiarion-Sileni, Vanna, Grob, Jean-Jacques, Dummer, Reinhard, Wolchok, Jedd D, Schmidt, Henrik, Hamid, Omid, Robert, Caroline, Ascierto, Paolo A, Richards, Jon M, Lebbé, Céleste, Ferraresi, Virginia, Smylie, Michael, Weber, Jeffrey S, Maio, Michele, Konto, Cyril, Hoos, Axel, de Pril, Veerle, Gurunath, Ravichandra Karra, de Schaetzen, Gaetan, Suciu, Stefan, and Testori, Alessandro

Published
2015
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30. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention

Author

Stratigos, Alexander J, Garbe, Claus, Dessinioti, Clio, Lebbe, Celeste, Bataille, Veronique, Bastholt, Lars, Dreno, Brigitte, Fargnoli, Maria Concetta, Forsea, Ana Maria, Frenard, Cecille, Harwood, Catherine Α, Hauschild, Axel, Hoeller, Christoph, Kandolf-Sekulovic, Lidija, Kaufmann, R, Kelleners-Smeets, Nicole Wj, Malvehy, Josep, Del Marmol, Veronique, Middleton, Mark R, Moreno-Ramirez, David, Pellecani, Giovanni, Peris, Ketty, Saiag, Philippe, van den Beuken-van Everdingen, Marieke H J, Vieira, Ricardo, Zalaudek, Iris, Eggermont, Alexander M M, Grob, Jean-Jacques, European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC), National and Kapodistrian University of Athens (NKUA), Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Immunologie humaine, physiopathologie & immunothérapie (HIPI (UMR_S_976 / U976)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), North & East Hertfordshire NHS Trust [Northwood, UK], Odense University Hospital (OUH), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), University of L'Aquila [Italy] (UNIVAQ), University of Medicine and Pharmacy 'Carol Davila' Bucharest (UMPCD), Queen Mary University of London (QMUL), Kiel University, Medizinische Universität Wien = Medical University of Vienna, Military Medical Academy [Belgrade, Serbia] (2MA), Frankfurt University Hospital, Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), CIBER de Enfermedades Raras (CIBERER), Instituto de Salud Carlos III [Madrid] (ISC), Université libre de Bruxelles (ULB), Hôpital Erasme [Bruxelles], University of Oxford, Hospital Universitario Virgen Macarena [Sevilla, Spain] (HUVM), University - Hospital of Modena and Reggio Emilia [Modena, Italy], Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Istituto Neurologico Mediterraneo (NEUROMED I.R.C.C.S.), Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA)-University of Naples Federico II = Università degli studi di Napoli Federico II, Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie (BECCOH), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay, Hôpital Ambroise Paré [AP-HP], University Veterinary Hospital [Coimbra, Portugal], Università degli studi di Trieste = University of Trieste, Princess Máxima Center for Pediatric Oncology, Assistance Publique - Hôpitaux de Marseille (APHM), Aix Marseille Université (AMU), Novartis Les Laboratories Pierre Fabre Sanofi Bristol-Myers Squibb, BMS Pfizer Amgen Roche LEO Pharma Research Foundation Cilag Merck Meso Scale Diagnostics, MSD Genentech, The guidelines were supported by grants from the EADO for the guideline meetings. The authors did this work on a voluntary basis and did not receive any honorarium or reimbursements. Guidelines development group members stated their conflicts of interest in the relevant section., Dr. Stratigos reports personal fees and/or research support from Novartis , Roche , BMS , Abbvie , Sanofi , Regeneron , Genesis Pharma , outside the submitted work. Dr. Garbe reports personal fees from Amgen , personal fees from MSD , grants and personal fees from Novartis , grants and personal fees from NeraCare, grants and personal fees from BMS , personal fees from Pierre Fabre , personal fees from Philogen, grants and personal fees from Roche , grants and personal fees from Sanofi , outside the submitted work. Dr. Dessinioti has nothing to disclose. Dr. Lebbe reports grants and personal fees from Bristol-Myers Squibb , personal fees from MSD , personal fees from Novartis , personal fees from Amgen , grants and personal fees from Roche , personal fees from Avantis Medical Systems, personal fees from Pierre Fabre , personal fees from Pfizer , personal fees from Incyte, outside the submitted work. Dr. Bataille reports personal fees from Novartis , personal fees from Merck MSD , outside the submitted work. Dr. Bastholt reports personal fees for advisory board activity: BMS , Roche , Novartis , Pierre-Fabre, Astra Zeneca, InCyte, MSD / Merck , Bayer . Dr. Dréno reports grants and personal fees from BMS , personal fees from MSD , grants and personal fees from Roche , grants and personal fees from Fabre, grants and personal fees from Sanofi , outside the submitted work. Dr. Fargnoli reports grants and personal fees from Almirall, grants and personal fees from Leo Pharma, personal fees from Janssen, grants and personal fees from Novartis , personal fees from Lilly , grants and personal fees from Sanofi , personal fees from UCB , grants and personal fees from Abbvie , personal fees from Celgene , personal fees from Pierre Fabre , grants and personal fees from Galderma , personal fees from Mylan, personal fees from Medac Pharma, personal fees from Roche , personal fees from Sun Pharma , outside the submitted work. Dr. Forsea reports scientific consultant/speaker fee from Novartis , Leo Pharma, Solartium, Pierre-Fabre, outside the submitted work. Dr. Frenard has nothing to disclose. Dr. Harwood reports institutional research grants and honoraria from Sanofi , Novartis , Merck , Pfizer , Galderma , MEDA, Almirall, Pellepharm, Leo Pharma, CERIES. Dr. Hauschild reports honoraria and/or research grants from: Almirall, BMS , Roche , Novartis , Pierre-Fabre, Sunpharma, MerckSerono, SanofiAventis, Regeneron , MSD / Merck , Philogen, OncoSec outside the submitted work. Dr. Hoeller reports grants and personal fees from Amgen , personal fees from BMS , personal fees from MSD , personal fees from Novartis , personal fees from Pierre Fabre , personal fees from Roche , personal fees from Sanofi , personal fees from Incyte, outside the submitted work. Dr. Kandolf-Sekulovic reports speakers’ honoraria for Roche, Novartis, MSD, BMS, Janssen outside the submitted work. Dr. Kaufmann reports institutional research grants (clinical trials) from: AbbVie , Amgen , Biontech, BMS , Celgene , Galderma , Janssen, Leo, Lilly , Merck , MSD , Novartis , Pierre Fabre , Pfizer , Regeneron , Roche , Wyeth . Advisory Board and Honoraria from Merz, Roche, Novartis. Dr. Kelleners-Smeets reports grants from Netherlands Organization for Health Research and Development, other from Janssen-Cilag, other from AbbVie , other from Galderma , outside the submitted work. Dr. Malvehy reports research grants from Almirall, ISDIN, Leo Pharma, Galderma , GSK , Cantabria, participation in advisory board meetings for Almirall, Sunpharma, BMS , Roche , Novartis , Pierre-Fabre. Dr. del Marmol reports personal fees from MSD , from BMS , personal fees from Sanofi , grants and personal fees from ABVIE, grants from Jansen, outside the submitted work. Dr. Middleton reports personal fees and/or grants from Amgen , Roche , Astrazeneca, GSK , Novartis , Immunocore, BMS , Eisai and Merck . Institutional funding from Millennium, Vertex, Pfizer , Regeneron , TCBiopharma, BiolineRx, Replimune, outside the submitted work. Dr. Moreno-Ramírez has nothing to disclose. Dr. Pellecani reports grants from university of modena and reggio emilia, during the conduct of the study, grants from novartis, grants and personal fees from almirall, grants from leo pharma, from null, outside the submitted work. Dr. Peris reports honoraria for advisory board and grants from AbbVie , Almirall, Biogen Celgene , Lilly , Galderma , Leo Pharma, Novartis , Roche , Sanofi , Sun Pharma , Sandoz outside the submitted work. Dr. Saiag reports honoraria for advisory board and grants from Amgen , Bristol-Myers Squibb , MSD , Merck-Serono, Novartis , Pfizer , Roche- Genentech , Pierre Fabre , and Sanofi , outside the submitted work. Dr. van den Beuken-van Everdingen has nothing to disclose. Dr. Vieira has nothing to disclose. Dr. Zalaudek reports honoraria and advisory board and grants from Sanofi , Sun Pharma , Novartis , Galderma , Roche , Celgene , Almirall, Leofarma, Mylan, Difa Cooper, Cieffe Labs, La Roche Posay, Pierre Fabre . Dr. Eggermont reports over the last 5 years personal fees as a consultant advisor for Biocad, BioInvent, Bristol Myers Squibb ( BMS ), CatalYm, Ellipses, Glaxo Smith Kline ( GSK ), HalioDX, Incyte, IO Biotech, ISA Pharmaceuticals, Merck Sharpe & Dohme ( MSD ), Novartis , Pfizer , Polynoma, Regeneron , Sanofi , Sellas, SkylineDx. Dr. Grob reports personal fees for advisory board and as speaker from Amgen , Roche , GSK , Novartis , BMS , Pierre fabre, Merck , Sanofi , Merck , Pfizer outside the submitted work., European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC), HAL UVSQ, Équipe, Dermatologie, MUMC+: MA Dermatologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, RS: MHeNs - R3 - Neuroscience, MUMC+: TPZ Palliatieve Zorg (9), Stratigos, A. J., Garbe, C., Dessinioti, C., Lebbe, C., Bataille, V., Bastholt, L., Dreno, B., Fargnoli, M. C., Forsea, A. M., Frenard, C., Harwood, C. Alpha., Hauschild, A., Hoeller, C., Kandolf-Sekulovic, L., Kaufmann, R., Kelleners-Smeets, N. W., Malvehy, J., del Marmol, V., Middleton, M. R., Moreno-Ramirez, D., Pellecani, G., Peris, K., Saiag, P., van den Beuken-van Everdingen, M. H. J., Vieira, R., Zalaudek, I., Eggermont, A. M. M., Grob, J. -J., Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), and Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)

Subjects
0301 basic medicine, Cancer Research, Skin Neoplasms, Staging, Medical Oncology, Palpation, Imaging, Low-risk, 0302 clinical medicine, Protective Clothing, Metastatic cSCC, Positron Emission Tomography Computed Tomography, Diagnosis, Epidemiology, Societies, Medical, AMERICAN JOINT COMMITTEE, Skin, Ultrasonography, Invasive cutaneous squamous cell carcinoma, medicine.diagnostic_test, NONSTEROIDAL ANTIINFLAMMATORY DRUGS, High-risk common primary cSCC, RANDOMIZED CONTROLLED-TRIAL, Prognosis, Magnetic Resonance Imaging, 3. Good health, LYMPH-NODE BIOPSY, Oncology, 030220 oncology & carcinogenesis, Carcinoma, Squamous Cell, Sunlight, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Diagnosi, medicine.medical_specialty, Consensus, Prognosi, Sentinel lymph node, Locally advanced Cscc, Prevention, Dermatology, Humans, Lymph Nodes, Neoplasm Staging, Patient Education as Topic, Risk Assessment, Sunscreening Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, Physical examination, PERINEURAL INVASION, 03 medical and health sciences, BASAL-CELL, [SDV.CAN] Life Sciences [q-bio]/Cancer, Medical, Biopsy, medicine, CANCER PREVENTION, ORGAN TRANSPLANT RECIPIENTS, business.industry, Carcinoma, Cancer, Magnetic resonance imaging, Guideline, medicine.disease, Cancérologie, HIGH-RISK, 030104 developmental biology, Squamous Cell, SUN PROTECTION, Societies, business
Abstract

Invasive cutaneous squamous cell carcinoma (cSCC) is one of the most common cancers in the white populations, accounting for 20% of all cutaneous malignancies. Factors implicated in cSCC etiopathogenesis include ultraviolet radiation exposure and chronic photoaging, age, male sex, immunosuppression, smoking and genetic factors. A collaboration of multidisciplinary experts from the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organisation of Research and Treatment of Cancer (EORTC) was formed to update recommendations on cSCC classification, diagnosis, risk stratification, staging and prevention, based on current literature, staging systems and expert consensus. Common cSCCs are typically indolent tumors, and most have a good prognosis with 5-year cure rates of greater than 90%, and a low rate of metastases (, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2020

31. Engaging European society at the forefront of cancer research and care: How discussions at the 5th Gago Conference on European Science policy led to the Heidelberg Manifesto.

Author

Baumann, Michael, Celis, Julio, Ringborg, Ulrik, Heitor, Manuel, Berns, Anton, Albreht, Tit, Arabadjiev, Jeliazko, Boutros, Michael, Brandenburg, Mario, Canhao, Helena, Carneiro, Fatima, Chomienne, Christine, De Lorenzo, Francesco, Eggermont, Alexander M. M., Font, Angel, Garralda, Elena, Goulart, Margarida, Henrique, Rui, Lawler, Mark, and Maier‐Hein, Lena

Abstract

European cancer research stakeholders met in October 2022 in Heidelberg, Germany, at the 5th Gago conference on European Cancer Policy, to discuss the current cancer research and cancer care policy landscape in Europe. Meeting participants highlighted gaps in the existing European programmes focusing on cancer research, including Europe's Beating Cancer Plan (EBCP), the Mission on Cancer (MoC), Understanding Cancer (UNCAN.eu), and the joint action CRANE, and put forward the next priorities, in the form of the Heidelberg Manifesto for cancer research. This meeting report presents all discussions that shed light on how infrastructures can be effectively shaped for translational, prevention, clinical and outcomes cancer research, with a focus on implementation and sustainability and while engaging patients and the public. In addition, we summarize recommendations on how to introduce frameworks for the digitalization of European cancer research. Finally, we discuss what structures, commitment, and resources are needed to establish a collaborative cancer research environment in Europe to achieve the scale required for innovation. [ABSTRACT FROM AUTHOR]

Published
2023
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34. Uncovering the mode of action of engineered T cells in patient cancer organoids

Author

Dekkers, Johanna F., primary, Alieva, Maria, additional, Cleven, Astrid, additional, Keramati, Farid, additional, Wezenaar, Amber K. L., additional, van Vliet, Esmée J., additional, Puschhof, Jens, additional, Brazda, Peter, additional, Johanna, Inez, additional, Meringa, Angelo D., additional, Rebel, Heggert G., additional, Buchholz, Maj-Britt, additional, Barrera Román, Mario, additional, Zeeman, Amber L., additional, de Blank, Sam, additional, Fasci, Domenico, additional, Geurts, Maarten H., additional, Cornel, Annelisa M., additional, Driehuis, Else, additional, Millen, Rosemary, additional, Straetemans, Trudy, additional, Nicolasen, Mara J. T., additional, Aarts-Riemens, Tineke, additional, Ariese, Hendrikus C. R., additional, Johnson, Hannah R., additional, van Ineveld, Ravian L., additional, Karaiskaki, Froso, additional, Kopper, Oded, additional, Bar-Ephraim, Yotam E., additional, Kretzschmar, Kai, additional, Eggermont, Alexander M. M., additional, Nierkens, Stefan, additional, Wehrens, Ellen J., additional, Stunnenberg, Henk G., additional, Clevers, Hans, additional, Kuball, Jürgen, additional, Sebestyen, Zsolt, additional, and Rios, Anne C., additional

Published
2022
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38. Uncovering the mode of action of engineered T cells in patient cancer organoids

Author

Dekkers, Johanna F, Alieva, Maria, Cleven, Astrid, Keramati, Farid, Wezenaar, Amber K L, van Vliet, Esmée J, Puschhof, Jens, Brazda, Peter, Johanna, Inez, Meringa, Angelo D, Rebel, Heggert G, Buchholz, Maj-Britt, Barrera Román, Mario, Zeeman, Amber L, de Blank, Sam, Fasci, Domenico, Geurts, Maarten H, Cornel, Annelisa M, Driehuis, Else, Millen, Rosemary, Straetemans, Trudy, Nicolasen, Mara J T, Aarts-Riemens, Tineke, Ariese, Hendrikus C R, Johnson, Hannah R, van Ineveld, Ravian L, Karaiskaki, Froso, Kopper, Oded, Bar-Ephraim, Yotam E, Kretzschmar, Kai, Eggermont, Alexander M M, Nierkens, Stefan, Wehrens, Ellen J, Stunnenberg, Henk G, Clevers, Hans, Kuball, Jürgen, Sebestyen, Zsolt, Rios, Anne C, Dekkers, Johanna F, Alieva, Maria, Cleven, Astrid, Keramati, Farid, Wezenaar, Amber K L, van Vliet, Esmée J, Puschhof, Jens, Brazda, Peter, Johanna, Inez, Meringa, Angelo D, Rebel, Heggert G, Buchholz, Maj-Britt, Barrera Román, Mario, Zeeman, Amber L, de Blank, Sam, Fasci, Domenico, Geurts, Maarten H, Cornel, Annelisa M, Driehuis, Else, Millen, Rosemary, Straetemans, Trudy, Nicolasen, Mara J T, Aarts-Riemens, Tineke, Ariese, Hendrikus C R, Johnson, Hannah R, van Ineveld, Ravian L, Karaiskaki, Froso, Kopper, Oded, Bar-Ephraim, Yotam E, Kretzschmar, Kai, Eggermont, Alexander M M, Nierkens, Stefan, Wehrens, Ellen J, Stunnenberg, Henk G, Clevers, Hans, Kuball, Jürgen, Sebestyen, Zsolt, and Rios, Anne C

Abstract

Extending the success of cellular immunotherapies against blood cancers to the realm of solid tumors will require improved in vitro models that reveal therapeutic modes of action at the molecular level. Here we describe a system, called BEHAV3D, developed to study the dynamic interactions of immune cells and patient cancer organoids by means of imaging and transcriptomics. We apply BEHAV3D to live-track >150,000 engineered T cells cultured with patient-derived, solid-tumor organoids, identifying a 'super engager' behavioral cluster comprising T cells with potent serial killing capacity. Among other T cell concepts we also study cancer metabolome-sensing engineered T cells (TEGs) and detect behavior-specific gene signatures that include a group of 27 genes with no previously described T cell function that are expressed by super engager killer TEGs. We further show that type I interferon can prime resistant organoids for TEG-mediated killing. BEHAV3D is a promising tool for the characterization of behavioral-phenotypic heterogeneity of cellular immunotherapies and may support the optimization of personalized solid-tumor-targeting cell therapies.

Published
2022

39. Prognosis of Patients With Primary Melanoma Stage I and II According to American Joint Committee on Cancer Version 8 Validated in Two Independent Cohorts: Implications for Adjuvant Treatment

Author

Garbe, C., Keim, U., Amaral, T., Berking, C., Eigentler, T. K., Flatz, L., Gesierich, A., Leiter, U., Stadler, R., Sunderkotter, C., Tuting, T., Utikal, J., Wollina, U., Zimmer, L., Zouboulis, C. C., Ascierto, P. A., Eggermont, A. M. M., Grob, J. -J., Hauschild, A., Sekulovic, L. K., Long, G. V., Luke, J. J., Michielin, O., Peris, Ketty, Schadendorf, D., Kirkwood, J. M., Lorigan, P. C., Peris K. (ORCID:0000-0002-5237-0463), Garbe, C., Keim, U., Amaral, T., Berking, C., Eigentler, T. K., Flatz, L., Gesierich, A., Leiter, U., Stadler, R., Sunderkotter, C., Tuting, T., Utikal, J., Wollina, U., Zimmer, L., Zouboulis, C. C., Ascierto, P. A., Eggermont, A. M. M., Grob, J. -J., Hauschild, A., Sekulovic, L. K., Long, G. V., Luke, J. J., Michielin, O., Peris, Ketty, Schadendorf, D., Kirkwood, J. M., Lorigan, P. C., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

PURPOSEThe first randomized trial of adjuvant treatment with checkpoint inhibitor in stage II melanoma reported a significant reduction in risk of tumor recurrence. This study evaluates two independent data sets to further document survival probabilities for patients with primary stage I and II melanoma.PATIENTS AND METHODSThe Central Malignant Melanoma Registry (CMMR) in Germany evaluated 17,544 patients with a primary diagnosis of stage I and II melanoma from 2000 to 2015. The exploratory cohort consisted of 6,725 patients from the Center for Dermato-Oncology at the University of Tübingen, and the confirmatory cohort consisted of 10,819 patients from 11 other German centers. Survival outcomes were compared with published American Joint Committee on Cancer version 8 (AJCCv8) stage I and II survival data.RESULTSFor the two CMMR cohorts in stage IA compared with the AJCCv8 cohort, melanoma-specific survival rates at 10 years were 95.1%-95.6% versus 98%; 89.7%-90.9% versus 94% in stage IB; 80.7%-83.1% versus 88% in stage IIA; 72.0%-79.9% versus 82% in stage IIB; and 57.6%-64.7% versus 75% in stage IIC, respectively. Recurrence rates were approximately twice as high as melanoma-specific mortality rates in stages IA-IIA.CONCLUSIONThe melanoma-specific survival rates in the two CMMR cohorts across stages I and II are less favorable than published in AJCCv8. This has important implications for the consideration of adjuvant treatment in this population.

Published
2022

40. Adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma: Health-related quality of life from the randomized phase 3 KEYNOTE-716 study

Author

Khattak, Muhammad A., Luke, Jason J., Long, Georgina V., Ascierto, Paolo A., Rutkowski, Piotr, Schadendorf, Dirk, Robert, Caroline, Grob, Jean-Jacques, de la Cruz Merino, Luis, Del Vecchio, Michele, Spagnolo, Francesco, Mackiewicz, Jacek, Chiarion-Sileni, Vanna, Carlino, Matteo S., Mohr, Peter, De Galitiis, Federica, Ross, Merrick I., Eroglu, Zeynep, Chen, Ke, Jiang, Ruixuan, Fukunaga-Kalabis, Mizuho, Krepler, Clemens, Eggermont, Alexander M. M., Kirkwood, John M., Khattak, Muhammad A., Luke, Jason J., Long, Georgina V., Ascierto, Paolo A., Rutkowski, Piotr, Schadendorf, Dirk, Robert, Caroline, Grob, Jean-Jacques, de la Cruz Merino, Luis, Del Vecchio, Michele, Spagnolo, Francesco, Mackiewicz, Jacek, Chiarion-Sileni, Vanna, Carlino, Matteo S., Mohr, Peter, De Galitiis, Federica, Ross, Merrick I., Eroglu, Zeynep, Chen, Ke, Jiang, Ruixuan, Fukunaga-Kalabis, Mizuho, Krepler, Clemens, Eggermont, Alexander M. M., and Kirkwood, John M.

Abstract

Background: Adjuvant pembrolizumab significantly improved recurrence-free survival (RFS) versus placebo in resected stage IIB and IIC melanoma in the phase 3 KEYNOTE-716 study. Health-related quality of life (HRQoL) results are reported. Methods: Patients were randomly assigned 1:1 to pembrolizumab 200 mg (2 mg/kg, patients ≥ 12 to < 18 years) Q3W or placebo for ≤ 17 cycles or until disease recurrence, unacceptable toxicity, or withdrawal. Change from baseline in EORTC QLQ-C30 global health status (GHS)/quality of life (QoL) was a prespecified exploratory end point. Change in EORTC QLQ-C30 functioning, symptom, and single-item scales, and EQ-5D-5L visual analog scale (VAS) were also summarized. Primary analyses were performed at week 48 to ensure adequate completion/compliance. The HRQoL population comprised patients who received ≥ 1 dose of treatment and completed ≥ 1 assessment. Results: The HRQoL population included 969 patients (pembrolizumab, n = 483; placebo, n = 486). Compliance at week 48 was ≥ 80 % for both instruments. EORTC QLQ-C30 GHS/QoL, physical functioning, role functioning, and EQ-5D-5L VAS scores were stable from baseline to week 48 in both arms, with no clinically meaningful decline observed. Scores did not differ significantly between pembrolizumab and placebo. EORTC QLQ-C30 GHS/QoL, physical functioning, role functioning, and EQ-5D-5L VAS scores remained stable through week 96 in both arms. Conclusions: HRQoL was stable with adjuvant pembrolizumab, with no clinically meaningful decline observed. Change from baseline in HRQoL was similar between arms. These results, in conjunction with the improved RFS and manageable safety previously reported, support the use of adjuvant pembrolizumab for high-risk stage II melanoma.

Published
2022

46. PIVOT-12: a Phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence

Author

Eggermont, Alexander M. M. Ascierto, Paolo A. Khushalani, I, Nikhil Schadendorf, Dirk Boland, Genevieve Weber, Jeffrey and Lewis, Karl D. Johnson, Daniel Rivalland, Gareth and Khattak, Adnan Majem, Margarita Gogas, Helen Long, V, Georgina Currie, Sue L. Chien, David Tagliaferri, Mary A. and Carlino, Matteo S. Diab, Adi

Abstract

Bempegaldesleukin (BEMPEG: NKTR-214) is an immunostimulatory IL-2 cytokine prodrug engineered to deliver a controlled, sustained and preferential IL-2 pathway signal. Nivolumab (NIVO), a PD-L1 inhibitor, has been shown to prolong survival in patients with advanced melanoma and recurrence-free survival in the adjuvant setting. PIVOT-02 showed that BEMPEG plus NIVO was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. PIVOT-12 is a randomized, Phase Ill, global, multicenter, open-label study comparing adjuvant therapy with BEMPEG plus NIVO versus NIVO alone in adult and adolescent patients with completely resected cutaneous stage III/IV melanoma at high risk of recurrence. The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO. Lay abstract: Following surgery, patients with advanced melanoma may require further treatment to reduce the likelihood of disease recurrence. Nivolumab (NIVO), a checkpoint inhibitor, reduces the risk of melanoma recurrence by enhancing the ability of the immune system to fight disease. Despite the availability of NIVO and other therapies, many patients with melanoma still experience disease recurrence after surgery. This article presents information on a clinical trial named PIVOT-12, which aims to assess the effectiveness of a new investigational drug called bempegaldesleukin that modifies the immune system and is given with NIVO to patients with stage III/IV melanoma following surgery. The main end point being measured is recurrence-free survival, which measures the time between a patient starting the study and the date of disease recurrence.

Published
2022

49. Isolated Hepatic Perfusion with Tumor Necrosis Factor α and Melphalan: Experimental Studies in Pigs and Phase I Data from Humans

Author

de Vries, M. R., Rinkes, I. H. Borel, van de Velde, C. J. H., Wiggers, T., Tollenaar, R. A. E. M., Kuppen, P. J. K., Vahrmeijer, A. L., Eggermont, A. M. M., Schlag, P. M., editor, Senn, H.-J., editor, Diehl, V., editor, Parkin, D. M., editor, Rajewsky, M. F., editor, Rubens, R., editor, Wannenmacher, M., editor, Oldhafer, Karl J., editor, Lang, Hauke, editor, and Pichlmayr, Rudolf, editor

Published
1998
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