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3. Natural history of pN1 prostate cancer after radical prostatectomy: Competing risk analysis from a large multi-institutional series

Author

Milonas, D., primary, Giesen, A., additional, Lorenzo, T., additional, Annouschka, L., additional, Zilvinas, V., additional, Devos, G., additional, Alberto, B., additional, Gontero, P., additional, Graefen, M., additional, Chlosta, P., additional, Gratzke, C., additional, Marchioro, G., additional, Sanchez-Salas, R., additional, Tombal, B., additional, Van Der Poel, H., additional, Van Poppel, H., additional, Karnes, R.J., additional, Spahn, M., additional, De Meerleer, G., additional, and Joniau, S., additional

Published
2024
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4. Efficacy and safety of darolutamide in combination with androgen-deprivation therapy and docetaxel in European patients from the phase 3 ARASENS trial

Author

Tombal, B., primary, Hussain, M., additional, Saad, F., additional, Fizazi, K., additional, Shore, N., additional, Kopyltsov, E., additional, Bögemann, M., additional, Mendez-Vidal, M.J., additional, Littleton, N., additional, Srinivasan, S., additional, Verholen, F., additional, and Smith, M.R., additional

Published
2024
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5. Baseline neutrophil-to-lymphocyte ratio as a predictive and prognostic biomarker in patients with metastatic castration-resistant prostate cancer treated with cabazitaxel versus abiraterone or enzalutamide in the CARD study

Author

de Wit, R., Wülfing, C., Castellano, D., Kramer, G., Eymard, J.-C., Sternberg, C.N., Fizazi, K., Tombal, B., Bamias, A., Carles, J., Iacovelli, R., Melichar, B., Sverrisdóttir, Á., Theodore, C., Feyerabend, S., Helissey, C., Foster, M.C., Ozatilgan, A., Geffriaud-Ricouard, C., and de Bono, J.

Published
2021
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8. Validation of metastasis-free survival as a surrogate endpoint for overall survival in localized prostate cancer in the era of docetaxel for castration-resistant prostate cancer

Author

Xie, W., primary, Ravi, P., additional, Buyse, M., additional, Halabi, S., additional, Kantoff, P., additional, Sartor, O., additional, Soule, H., additional, Clarke, N., additional, Dignam, J., additional, James, N., additional, Fizazi, K., additional, Gillessen, S., additional, Mottet, N., additional, Murphy, L., additional, Parulekar, W., additional, Sandler, H., additional, Tombal, B., additional, Williams, S., additional, and Sweeney, C.J., additional

Published
2023
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10. 1784P Prostate-specific antigen (PSA) outcomes with darolutamide (DARO): Androgen-deprivation therapy (ADT) and docetaxel (DOC) in patients (pts) with high- and low-volume metastatic hormone-sensitive prostate cancer (mHSPC) in ARASENS

Author

Saad, F., primary, Hussain, M., additional, Tombal, B., additional, Fizazi, K., additional, Sternberg, C.N., additional, Crawford, E.D., additional, Boegemann, M., additional, Tutrone, R., additional, Littleton, N., additional, Srinivasan, S., additional, Verholen, F., additional, Kuss, I., additional, and Smith, M.R., additional

Published
2023
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11. EAU–ESMO consensus statements on the management of advanced and variant bladder cancer—an international collaborative multi-stakeholder effort: under the auspices of the EAU and ESMO Guidelines Committees

Author

Horwich, A., Babjuk, M., Bellmunt, J., Bruins, H.M., De Reijke, T.M., De Santis, M., Gillessen, S., James, N., Maclennan, S., Palou, J., Powles, T., Ribal, M.J., Shariat, S.F., Van Der Kwast, T., Xylinas, E., Agarwal, N., Arends, T., Bamias, A., Birtle, A., Black, P.C., Bochner, B.H., Bolla, M., Boormans, J.L., Bossi, A., Briganti, A., Brummelhuis, I., Burger, M., Castellano, D., Cathomas, R., Chiti, A., Choudhury, A., Compérat, E., Crabb, S., Culine, S., De Bari, B., DeBlok, W., De Visschere, P.J.L., Decaestecker, K., Dimitropoulos, K., Dominguez-Escrig, J.L., Fanti, S., Fonteyne, V., Frydenberg, M., Futterer, J.J., Gakis, G., Geavlete, B., Gontero, P., Grubmüller, B., Hafeez, S., Hansel, D.E., Hartmann, A., Hayne, D., Henry, A.M., Hernandez, V., Herr, H., Herrmann, K., Hoskin, P., Huguet, J., Jereczek-Fossa, B.A., Jones, R., Kamat, A.M., Khoo, V., Kiltie, A.E., Krege, S., Ladoire, S., Lara, P.C., Leliveld, A., Linares-Espinós, E., Løgager, V., Lorch, A., Loriot, Y., Meijer, R., Carmen Mir, M., Moschini, M., Mostafid, H., Müller, A.-C., Müller, C.R., N’Dow, J., Necchi, A., Neuzillet, Y., Oddens, J.R., Oldenburg, J., Osanto, S., Oyen, W.J.G., Pacheco-Figueiredo, L., Pappot, H., Patel, M.I., Pieters, B.R., Plass, K., Remzi, M., Retz, M., Richenberg, J., Rink, M., Roghmann, F., Rosenberg, J.E., Rouprêt, M., Rouvière, O., Salembier, C., Salminen, A., Sargos, P., Sengupta, S., Sherif, A., Smeenk, R.J., Smits, A., Stenzl, A., Thalmann, G.N., Tombal, B., Turkbey, B., Vahr Lauridsen, S., Valdagni, R., Van Der Heijden, A.G., Van Poppel, H., Vartolomei, M.D., Veskimäe, E., Vilaseca, A., Vives Rivera, F.A., Wiegel, T., Wiklund, P., Williams, A., Zigeuner, R., and Witjes, J.A.

Published
2019
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18. The survival impact of neoadjuvant hormonal therapy before radical prostatectomy for treatment of high-risk prostate cancer

Author

Tosco, L, Laenen, A, Briganti, A, Gontero, P, Karnes, R J, Albersen, M, Bastian, P J, Chlosta, P, Claessens, F, Chun, F K, Everaerts, W, Gratzke, C, Graefen, M, Kneitz, B, Marchioro, G, Salas, R S, Tombal, B, Van den Broeck, T, Moris, L, Battaglia, A, van der Poel, H, Walz, J, Bossi, A, De Meerleer, G, Haustermans, K, Van Poppel, H, Spahn, M, and Joniau, S

Published
2017
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20. Management of patients with advanced prostate cancer: recommendations of the St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) 2015

Author

Gillessen, S., Omlin, A., Attard, G., de Bono, J.S., Efstathiou, E., Fizazi, K., Halabi, S., Nelson, P.S., Sartor, O., Smith, M.R., Soule, H.R., Akaza, H., Beer, T.M., Beltran, H., Chinnaiyan, A.M., Daugaard, G., Davis, I.D., De Santis, M., Drake, C.G., Eeles, R.A., Fanti, S., Gleave, M.E., Heidenreich, A., Hussain, M., James, N.D., Lecouvet, F.E., Logothetis, C.J., Mastris, K., Nilsson, S., Oh, W.K., Olmos, D., Padhani, A.R., Parker, C., Rubin, M.A., Schalken, J.A., Scher, H.I., Sella, A., Shore, N.D., Small, E.J., Sternberg, C.N., Suzuki, H., Sweeney, C.J., Tannock, I.F., and Tombal, B.

Published
2015
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22. 173P Clinical outcomes in stratification subgroups in the ARASENS study in metastatic hormone-sensitive prostate cancer (mHSPC)

Author

Parnis, F., primary, Tombal, B., additional, Hussain, M., additional, Saad, F., additional, Fizazi, K., additional, Sternberg, C.N., additional, Crawford, E.D., additional, Kopyltsov, E., additional, Rezazadeh Kalebasty, A., additional, Alekseev, B.Y., additional, Montesa Pino, A., additional, Ye, D., additional, Melo Cruz, F.J.S., additional, Tammela, T., additional, Suzuki, H., additional, Joensuu, H., additional, Thiele, S., additional, Li, R., additional, Kuss, I., additional, and Smith, M., additional

Published
2022
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23. Oral relugolix for androgen deprivation therapy in advanced prostate cancer: Detailed safety analysis from the randomized phase 3 HERO study

Author

Tombal, B., primary, Mehlhaff, B., additional, Shore, N.D., additional, George, D.J., additional, Cookson, M.S., additional, Saltzstein, D.R., additional, Tutrone, R.F., additional, Bailen, J.L, additional, Brown, B., additional, Langenberg, A.G.M., additional, Lu, S., additional, Fallick, M., additional, Hanson, S., additional, and Saad, F., additional

Published
2022
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26. 1360MO Quality of life and patient-relevant endpoints with darolutamide in the phase III ARASENS study

Author

Fizazi, K., primary, Smith, M.R., additional, Hussain, M., additional, Saad, F., additional, Sternberg, C., additional, Crawford, E.D., additional, Aragon-Ching, J.B., additional, Thiele, S., additional, Kapur, S., additional, Mohamed, A.F., additional, Srinivasan, S., additional, Li, R., additional, Kuss, I., additional, Joensuu, H., additional, and Tombal, B., additional

Published
2022
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27. 1394P Alkaline phosphatase (ALP) decline and pain response as markers for overall survival (OS) in patients (Pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (223Ra) in the REASSURE study

Author

O'Sullivan, J., primary, Heinrich, D., additional, Castro Marcos, E., additional, George, S., additional, Song, D.Y., additional, Dizdarevic, S., additional, Baldari, S., additional, Essler, M., additional, de Jong, I.J., additional, Lastoria, S., additional, Hammerer, P.G., additional, Tombal, B., additional, James, N.D., additional, Verholen, F., additional, Meltzer, J., additional, Sandström, P., additional, and Sartor, O., additional

Published
2022
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28. 1361MO 8-month PSA strongly predicts outcomes of men with metastatic castration-sensitive prostate cancer in the PEACE-1 phase III trial

Author

Gravis Mescam, G., primary, Maldonado, X., additional, Roubaud, G., additional, McDermott, R.S., additional, Flechon, A., additional, Tombal, B., additional, Supiot, S., additional, Berthold, D.R., additional, Philippe, R., additional, Kacso, G., additional, Calabrò, F., additional, Berdah, J.F., additional, Hasbini, A., additional, Silva, M., additional, Thiery-Vuillemin, A., additional, Rodriguez-Vida, A., additional, McCaffrey, J.A., additional, Ribault, H., additional, Foulon, S., additional, and Fizazi, K., additional

Published
2022
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29. 1421P Effect of abiraterone-prednisone in metastatic castration-sensitive prostate cancer (mCSPC) with neuroendocrine and very high-risk features in the PEACE-1 trial

Author

Bernard-Tessier, A., primary, Cancel, M., additional, Tombal, B., additional, Roubaud, G., additional, Carles Galceran, J., additional, Flechon, A., additional, McDermott, R.S., additional, Supiot, S., additional, Berthold, D.R., additional, Philippe, R., additional, Kacso, G., additional, Gravis Mescam, G., additional, Calabrò, F., additional, Berdah, J.F., additional, Hasbini, A., additional, Ricci, F., additional, Hennequin, C., additional, Ribault, H., additional, Foulon, S., additional, and Fizazi, K., additional

Published
2022
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33. Management of Patients with Advanced Prostate Cancer: Report from the Advanced Prostate Cancer Consensus Conference 2021

Author

Gillessen, S. Armstrong, A. Attard, G. Beer, T.M. Beltran, H. Bjartell, A. Bossi, A. Briganti, A. Bristow, R.G. Bulbul, M. Caffo, O. Chi, K.N. Clarke, C.S. Clarke, N. Davis, I.D. de Bono, J.S. Duran, I. Eeles, R. Efstathiou, E. Efstathiou, J. Ekeke, O.N. Evans, C.P. Fanti, S. Feng, F.Y. Fizazi, K. Frydenberg, M. George, D. Gleave, M. Halabi, S. Heinrich, D. Higano, C. Hofman, M.S. Hussain, M. James, N. Jones, R. Kanesvaran, R. Khauli, R.B. Klotz, L. Leibowitz, R. Logothetis, C. Maluf, F. Millman, R. Morgans, A.K. Morris, M.J. Mottet, N. Mrabti, H. Murphy, D.G. Murthy, V. Oh, W.K. Ost, P. O'Sullivan, J.M. Padhani, A.R. Parker, C. Poon, D.M.C. Pritchard, C.C. Rabah, D.M. Rathkopf, D. Reiter, R.E. Rubin, M. Ryan, C.J. Saad, F. Sade, J.P. Sartor, O. Scher, H.I. Shore, N. Skoneczna, I. Small, E. Smith, M. Soule, H. Spratt, D.E. Sternberg, C.N. Suzuki, H. Sweeney, C. Sydes, M.R. Taplin, M.-E. Tilki, D. Tombal, B. Türkeri, L. Uemura, H. Uemura, H. van Oort, I. Yamoah, K. Ye, D. Zapatero, A. Omlin, A.

Subjects
education
Abstract

Background: Innovations in treatments, imaging, and molecular characterisation in advanced prostate cancer have improved outcomes, but various areas of management still lack high-level evidence to inform clinical practice. The 2021 Advanced Prostate Cancer Consensus Conference (APCCC) addressed some of these questions to supplement guidelines that are based on level 1 evidence. Objective: To present the voting results from APCCC 2021. Design, setting, and participants: The experts identified three major areas of controversy related to management of advanced prostate cancer: newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), the use of prostate-specific membrane antigen ligands in diagnostics and therapy, and molecular characterisation of tissue and blood. A panel of 86 international prostate cancer experts developed the programme and the consensus questions. Outcome measurements and statistical analysis: The panel voted publicly but anonymously on 107 pre-defined questions, which were developed by both voting and non-voting panel members prior to the conference following a modified Delphi process. Results and limitations: The voting reflected the opinions of panellists and did not incorporate a standard literature review or formal meta-analysis. The answer options for the consensus questions received varying degrees of support from panellists, as reflected in this article and the detailed voting results reported in the Supplementary material. Conclusions: These voting results from a panel of experts in advanced prostate cancer can help clinicians and patients to navigate controversial areas of management for which high-level evidence is scant. However, diagnostic and treatment decisions should always be individualised according to patient characteristics, such as the extent and location of disease, prior treatment(s), comorbidities, patient preferences, and treatment recommendations, and should also incorporate current and emerging clinical evidence and logistic and economic constraints. Enrolment in clinical trials should be strongly encouraged. Importantly, APCCC 2021 once again identified salient questions that merit evaluation in specifically designed trials. Patient summary: The Advanced Prostate Cancer Consensus Conference is a forum for discussing current diagnosis and treatment options for patients with advanced prostate cancer. An expert panel votes on predefined questions focused on the most clinically relevant areas for treatment of advanced prostate cancer for which there are gaps in knowledge. The voting results provide a practical guide to help clinicians in discussing treatment options with patients as part of shared decision-making. © 2022 The Author(s)

Published
2022

34. Corrigendum to 'What Experts Think About Prostate Cancer Management During the COVID-19 Pandemic: Report from the Advanced Prostate Cancer Consensus Conference 2021' [Eur Urol 82(1):6–11] (European Urology (2022) 82(1) (6–11), (S0302283822016505), (10.1016/j.eururo.2022.02.010))

Author

Turco, F. Armstrong, A. Attard, G. Beer, T.M. Beltran, H. Bjartell, A. Bossi, A. Briganti, A. Bristow, R.G. Bulbul, M. Caffo, O. Chi, K.N. Clarke, C. Clarke, N. Davis, I.D. de Bono, J. Duran, I. Eeles, R. Efstathiou, E. Efstathiou, J. Evans, C.P. Fanti, S. Feng, F.Y. Fizazi, K. Frydenberg, M. George, D. Gleave, M. Halabi, S. Heinrich, D. Higano, C. Hofman, M.S. Hussain, M. James, N. Jones, R. Kanesvaran, R. Khauli, R.B. Klotz, L. Leibowitz, R. Logothetis, C. Maluf, F. Millman, R. Morgans, A.K. Morris, M.J. Mottet, N. Mrabti, H. Murphy, D.G. Murthy, V. Oh, W.K. Ekeke, O.N. Ost, P. O'Sullivan, J.M. Padhani, A.R. Parker, C. Poon, D.M.C. Pritchard, C.C. Rabah, D.M. Rathkopf, D. Reiter, R.E. Rubin, M. Ryan, C.J. Saad, F. Sade, J.P. Sartor, O. Scher, H.I. Shore, N. Skoneczna, I. Small, E. Smith, M. Soule, H. Spratt, D. Sternberg, C.N. Suzuki, H. Sweeney, C. Sydes, M. Taplin, M.-E. Tilki, D. Tombal, B. Türkeri, L. Uemura, H. Uemura, H. van Oort, I. Yamoah, K. Ye, D. Zapatero, A. Gillessen, S. Omlin, A.

Abstract

The authors regret that Axel Heidenreich was added to the author list in error. The author list is now corrected as above, however the affiliations of remaining authors have been retained. The authors would like to apologise for any inconvenience caused. © 2022 The Author(s)

Published
2022

35. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 x 2 factorial design

Author

Fizazi, K, Foulon, S, Carles, J, Roubaud, G, McDermott, R, Flechon, A, Tombal, B, Supiot, S, Berthold, D, Ronchin, P, Kacso, G, Gravis, G, Calabro, F, Berdah, JF, Hasbini, A, Silva, M, Thiery-Vuillemin, A, Latorzeff, I, Mourey, L, Laguerre, B, Abadie-Lacourtoisie, S, Martin, E, El Kouri, C, Escande, A, Rosello, A, Magne, N, Schlurmann, F, Priou, F, Chand-Fouche, ME, Freixa, SV, Jamaluddin, M, Rieger, I, and Bossi, A

Abstract

Background Current standard of care for metastatic castration-sensitive prostate cancer supplements androgen deprivation therapy with either docetaxel, second-generation hormonal therapy, or radiotherapy. We aimed to evaluate the efficacy and safety of abiraterone plus prednisone, with or without radiotherapy, in addition to standard of care. Methods We conducted an open-label, randomised, phase 3 study with a 2 x 2 factorial design (PEACE-1) at 77 hospitals across Belgium, France, Ireland, Italy, Romania, Spain, and Switzerland. Eligible patients were male, aged 18 years or older, with histologically confirmed or cytologically confirmed de novo metastatic prostate adenocarcinoma, and an Eastern Cooperative Oncology Group performance status of 0-1 (or 2 due to bone pain). Participants were randomly assigned (1: 1:1:1) to standard of care (androgen deprivation therapy alone or with intravenous docetaxel 75 mg/m(2) once every 3 weeks), standard of care plus radiotherapy, standard of care plus abiraterone (oral 1000 mg abiraterone once daily plus oral 5 mg prednisone twice daily), or standard of care plus radiotherapy plus abiraterone. Neither the investigators nor the patients were masked to treatment allocation. The coprimary endpoints were radiographic progression-free survival and overall survival. Abiraterone efficacy was first assessed in the overall population and then in the population who received androgen deprivation therapy with docetaxel as standard of care (population of interest). This study is ongoing and is registered with ClinicalTrials.gov, NCT01957436. Findings Between Nov 27, 2013, and Dec 20, 2018, 1173 patients were enrolled (one patient subsequently withdrew consent for analysis of his data) and assigned to receive standard of care (n=296), standard of care plus radiotherapy (n=293), standard of care plus abiraterone (n=292), or standard of care plus radiotherapy plus abiraterone (n=291). Median follow-up was 3.5 years (IQR 2.8-4.6) for radiographic progression-free survival and 4.4 years (3.5-5.4) for overall survival. Adjusted Cox regression modelling revealed no interaction between abiraterone and radiotherapy, enabling the pooled analysis of abiraterone efficacy. In the overall population, patients assigned to receive abiraterone (n=583) had longer radiographic progression-free survival (hazard ratio [HR] 0.54, 99.9% CI 0.41-0.71; p

Published
2022

36. EAU-ESMO consensus statements on the management of advanced and variant bladder cancer

Author

Witjes JA, Babjuk M, Bellmunt J, Bruins HM, De Reijke TM, De Santis M, Gillessen S, James N, Maclennan S, Palou J, Powles T, Ribal MJ, Shariat SF, Van der Kwast T, Xylinas E, Agarwal N, Arends T, Bamias A, Birtle A, Black PC, Bochner BH, Bolla M, Boormans JL, Bossi A, Briganti A, Brummelhuis I, Burger M, Castellano D, Cathomas R, Chiti A, Choudhury A, Comperat E, Crabb S, Culine S, De Bari B, De Blok W, De Visschere PJL, Decaestecker K, Dimitropoulos K, Dominguez-Escrig JL, Fanti S, Fonteyne V, Frydenberg M, Futterer JJ, Gakis G, Geavlete B, Gontero P, Grubmuller B, Hafeez S, Hansel DE, Hartmann A, Hayne D, Henry AM, Hernandez V, Herr H, Herrmann K, Hoskin P, Huguet J, Jereczek-Fossa BA, Jones R, Kamat AM, Khoo V, Kiltie AE, Krege S, Ladoire S, Lara PC, Leliveld A, Linares-Espinos E, Logager V, Lorch A, Loriot Y, Meijer R, Mir MC, Moschini M, Mostafid H, Muller AC, Muller CR, N'Dow J, Necchi A, Neuzillet Y, Oddens JR, Oldenburg J, Osanto S, Oyen WJG, Pacheco-Figueiredo L, Pappot H, Patel MI, Pieters BR, Plass K, Remzi M, Retz M, Richenberg J, Rink M, Roghmann F, Rosenberg JE, Roupret M, Rouviere O, Salembier C, Salminen A, Sargos P, Sengupta S, Sherif A, Smeenk RJ, Smits A, Stenzl A, Thalmann GN, Tombal B, Turkbey B, Lauridsen SV, Valdagni R, Van der Heijden AG, Van Poppel H, Vartolomei MD, Veskimae E, Vilaseca A, Rivera FAV, Wiegel T, Wiklund P, Williams A, Zigeuner R, Horwich A, Witjes JA, Babjuk M, Bellmunt J, Bruins HM, De Reijke TM, De Santis M, Gillessen S, James N, Maclennan S, Palou J, Powles T, Ribal MJ, Shariat SF, Der Kwast TV, Xylinas E, Agarwal N, Arends T, Bamias A, Birtle A, Black PC, Bochner BH, Bolla M, Boormans JL, Bossi A, Briganti A, Brummelhuis I, Burger M, Castellano D, Cathomas R, Chiti A, Choudhury A, Compérat E, Crabb S, Culine S, De Bari B, De Blok W, J L De Visschere P, Decaestecker K, Dimitropoulos K, Dominguez-Escrig JL, Fanti S, Fonteyne V, Frydenberg M, Futterer JJ, Gakis G, Geavlete B, Gontero P, Grubmüller B, Hafeez S, Hansel DE, Hartmann A, Hayne D, Henry AM, Hernandez V, Herr H, Herrmann K, Hoskin P, Huguet J, Jereczek-Fossa BA, Jones R, Kamat AM, Khoo V, Kiltie AE, Krege S, Ladoire S, Lara PC, Leliveld A, Linares-Espinós E, Løgager V, Lorch A, Loriot Y, Meijer R, Mir MC, Moschini M, Mostafid H, Müller AC, Müller CR, N'Dow J, Necchi A, Neuzillet Y, Oddens JR, Oldenburg J, Osanto S, J G Oyen W, Pacheco-Figueiredo L, Pappot H, Patel MI, Pieters BR, Plass K, Remzi M, Retz M, Richenberg J, Rink M, Roghmann F, Rosenberg JE, Rouprêt M, Rouvière O, Salembier C, Salminen A, Sargos P, Sengupta S, Sherif A, Smeenk RJ, Smits A, Stenzl A, Thalmann GN, Tombal B, Turkbey B, Lauridsen SV, Valdagni R, Der Heijden AGV, Van Poppel H, Vartolomei MD, Veskimäe E, Vilaseca A, Rivera FAV, Wiegel T, Wiklund P, Williams A, Zigeuner R, Horwich A., UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie, Witjes, Ja, Babjuk, M, Bellmunt, J, Bruins, Hm, De Reijke, Tm, De Santis, M, Gillessen, S, James, N, Maclennan, S, Palou, J, Powles, T, Ribal, Mj, Shariat, Sf, Van der Kwast, T, Xylinas, E, Agarwal, N, Arends, T, Bamias, A, Birtle, A, Black, Pc, Bochner, Bh, Bolla, M, Boormans, Jl, Bossi, A, Briganti, A, Brummelhuis, I, Burger, M, Castellano, D, Cathomas, R, Chiti, A, Choudhury, A, Comperat, E, Crabb, S, Culine, S, De Bari, B, De Blok, W, De Visschere, Pjl, Decaestecker, K, Dimitropoulos, K, Dominguez-Escrig, Jl, Fanti, S, Fonteyne, V, Frydenberg, M, Futterer, Jj, Gakis, G, Geavlete, B, Gontero, P, Grubmuller, B, Hafeez, S, Hansel, De, Hartmann, A, Hayne, D, Henry, Am, Hernandez, V, Herr, H, Herrmann, K, Hoskin, P, Huguet, J, Jereczek-Fossa, Ba, Jones, R, Kamat, Am, Khoo, V, Kiltie, Ae, Krege, S, Ladoire, S, Lara, Pc, Leliveld, A, Linares-Espinos, E, Logager, V, Lorch, A, Loriot, Y, Meijer, R, Mir, Mc, Moschini, M, Mostafid, H, Muller, Ac, Muller, Cr, N'Dow, J, Necchi, A, Neuzillet, Y, Oddens, Jr, Oldenburg, J, Osanto, S, Oyen, Wjg, Pacheco-Figueiredo, L, Pappot, H, Patel, Mi, Pieters, Br, Plass, K, Remzi, M, Retz, M, Richenberg, J, Rink, M, Roghmann, F, Rosenberg, Je, Roupret, M, Rouviere, O, Salembier, C, Salminen, A, Sargos, P, Sengupta, S, Sherif, A, Smeenk, Rj, Smits, A, Stenzl, A, Thalmann, Gn, Tombal, B, Turkbey, B, Lauridsen, Sv, Valdagni, R, Van der Heijden, Ag, Van Poppel, H, Vartolomei, Md, Veskimae, E, Vilaseca, A, Rivera, Fav, Wiegel, T, Wiklund, P, Williams, A, Zigeuner, R, and Horwich, A

Subjects
Treatment, Consensus, Follow-up, education, Bladder cancer, Diagnosis, Consensu, Delphi, Diagnosi
Abstract

Background: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial.Objective: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management.Design: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts prior to voting during a consensus conference.Setting: Online Delphi survey and consensus conference.Participants: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management.Outcome measurements and statistical analysis: Statements were ranked by experts according to their level of agreement: 1-3 (disagree), 4-6 (equivocal), and 7-9 (agree). A priori (level 1) consensus was defined as >= 70% agreement and

Published
2020

37. Leuprolide acetate 1-, 3- and 6-monthly depot formulations in androgen deprivation therapy for prostate cancer in nine European countries: evidence review and economic evaluation

Author

Wex J, Sidhu M, Odeyemi I, Abou-Setta AM, Retsa P, and Tombal B

Subjects
Medicine (General), R5-920, Therapeutics. Pharmacology, RM1-950
Abstract

Jaro Wex,1 Manpreet Sidhu,2 Isaac Odeyemi,2 Ahmed M Abou-Setta,1 Peny Retsa,2 Bertrand Tombal31PharmArchitecture Limited, London, UK; 2Astellas Pharma Europe Ltd, Chertsey, UK; 3Cliniques Universitaires Saint-Luc, Brussels, BelgiumObjective: Leuprolide is an established luteinizing hormone–releasing hormone (LHRH) agonist used as first-line treatment in advanced prostate cancer. As different formulations and dosing schedules are likely to have economic implications, we aimed to evaluate their efficacy, safety, and costs in nine European countries: Austria, Belgium, Czech Republic, Hungary, Italy, Latvia, Netherlands, Poland, and Portugal.Methods: Database searches identified 13 clinical trials of leuprolide 1- (1 M), 3- (3 M) and 6-monthly (6 M). Only data on leuprolide with Atrigel were compared for all three formulations, which had the same efficacy, safety, and adherence. Cost-minimization analysis accounting for cost of Eligard®, specialist consultations, and diagnostics during up to 12 months follow-up was conducted. The perspective was that of public payers.Results: No significant differences were observed in the percentages of intention-to-treat patients achieving testosterone levels ≤ 50 ng/dL following treatment with Eligard® 1 M (93.3%), 3 M (98.3%), and 6 M (97.3%) (P > 0.05), and adverse event profiles of the three formulations were comparable. Overall, 6 M was the least expensive, with average total annual costs from €788 (Belgium) to €1839 (Portugal). The 3 M option was between 2.5% (Hungary) and 37.6% (Belgium) more expensive than 6 M; 1 M formulation was the most expensive, with costs 15.5% and 151.6% more expensive than 6 M for those countries, respectively. The 3 M option was 11.2%–45.3% less expensive than 1 M. Total costs were associated with frequency of visits for injection and monitoring. The 1 M required twelve visits, 3 M 4.4–4.8 visits, and 6 M 2.1–2.3 visits. Up to 50% additional visits could be funded with the savings resulting from switching eligible patients from 1 M and 3 M to 6 M. Results were stable in univariate and probabilistic sensitivity analyses.Conclusion: Eligard® formulations offer comparable efficacy and safety, but different dosing schedules require different number of visits. The 6 M formulation offers the greatest cost savings and should be considered the treatment of choice in eligible patients in Europe.Keywords: prostate, cancer, androgen, leuprolide, Eligard, cost-effectiveness

Published
2013

41. Sustained castration to < 20 ng/dl for relugolix vs. leuprolide in men with advanced prostate cancer: Results from the phase 3 HERO study

Author

Tombal, B., primary, Shore, N.D., additional, George, D.J., additional, Cookson, M.S., additional, Saltzstein, D.R., additional, Mehlhaff, B., additional, Tutrone, R., additional, Bailen, J.L., additional, Brown, B., additional, Lu, S., additional, Schulmann, T., additional, Hanson, S., additional, and Saad, F., additional

Published
2022
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43. Chemoprevention of prostate cancer with nutrients and supplements

Author

Van Poppel H and Tombal B

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Hendrik Van Poppel1, Bertrand Tombal21Department of Urology, University Hospital, KU Leuven, Leuven, Belgium; 2Service d’Urologie, Cliniques Universtaires Saint Luc, Brussels, BelgiumAbstract: As the adult population is increasing, prostate cancer (PCa) will become a considerable health problem in the next millennium. This has raised public interest in potential chemoprevention of this disease. As PCa is extremely common and generally slow to progress it is regarded as an ideal candidate for chemoprevention. At present, the 5 alpha-reductase inhibitors finasteride and dutasteride have been identified as preventive agents. This review describes whether selenium, alpha-tocopherol, isoflavones, lycopene green tea polyphenols, calcium, and resveratrol may be useful for decreasing the risk of PCa in men. Although encouraging results are present, some studies show negative results. Differences in study design, sample size, dose administered, and/or concentrations achieved in the body may be the reason for these inconsistencies. Today, chemopreventive agents may be appropriate for high-risk patients like those with high-grade prostatic intraepithelial neoplasia and other high-risk groups such as patients with elevated prostate specific antigen (PSA) and negative biopsy, rapid PSA velocity, and with a family history of PCa. Although larger randomized controlled studies are needed and epidemiologic evidence should be placed in a clinical context, physicians must be aware of these preventive opportunities in PCa care. Combinations of chemopreventive agents should be carefully investigated because mechanisms of action may be additive or synergistic.Keywords: alpha-tocopherol, chemoprevention, isoflavones, lycopene, polyphenols, prostate cancer, selenium

Published
2011

45. Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project†

Author

Kramar, A., Negrier, S., Sylvester, R., Joniau, S., Mulders, P., Powles, T., Bex, A., Bonnetain, F., Bossi, A., Bracarda, S., Bukowski, R., Catto, J., Choueiri, T. K., Crabb, S., Eisen, T., El Demery, M., Fitzpatrick, J., Flamand, V., Goebell, P. J., Gravis, G., Houédé, N., Jacqmin, D., Kaplan, R., Malavaud, B., Massard, C., Melichar, B., Mourey, L., Nathan, P., Pasquier, D., Porta, C., Pouessel, D., Quinn, D., Ravaud, A., Rolland, F., Schmidinger, M., Tombal, B., Tosi, D., Vauleon, E., Volpe, A., Wolter, P., Escudier, B., Filleron, T., Kramar, Andrew, Sylvester, Richard, Filleron, Thomas, Negrier, Sylvie, Joniau, Steven, Mulders, Peter, Powles, Thomas, Escudier, Bernard, Bex, Axel, Bonnetain, Franck, Bossi, Alberto, Braccarda, Sergio, Bukowski, Ronald, Catto, James, Choueiri, Toni, Crabb, Simon, Eisen, Tim, El Demery, Mounira, Fitzpatrick, John, Flamand, Vincent, Goebell, Peter J., Gravis, Gwendael, Houédé, Nadine, Jacqmin, Didier, Kaplan, Richard, Malavaud, Bernard, Massard, Christophe, Melichar, Bohuslav, Mourey, Loïc, Nathan, Paul, Pasquier, David, Porta, Camillo, Pouessel, Damien, Quinn, David, Ravaud, Alain, Rolland, Frédéric, Schmidinger, Manuela, Tombal, Bertrand, Tosi, Diego, Vauleon, Elodie, Volpe, Alessandro, and Wolter, Pascal

Published
2015
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46. 622P Geographical assessment of efficacy and safety of relugolix: A subgroup analysis from the randomized, phase III HERO study vs leuprolide (LEU) in men with advanced prostate cancer (APC)

Author

Bossi, A., primary, Shore, N.D., additional, Tutrone, R., additional, Cookson, M.S., additional, George, D.J., additional, Saltzstein, D.R., additional, Akaza, H., additional, Brown, B., additional, Selby, B., additional, Lu, S., additional, Walling, J., additional, Tombal, B., additional, and Saad, F., additional

Published
2021
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47. LBA5 A phase III trial with a 2x2 factorial design in men with de novo metastatic castration-sensitive prostate cancer: Overall survival with abiraterone acetate plus prednisone in PEACE-1

Author

Fizazi, K., primary, Carles Galceran, J., additional, Foulon, S., additional, Roubaud, G., additional, McDermott, R., additional, Fléchon, A., additional, Tombal, B., additional, Supiot, S., additional, Berthold, D.R., additional, Ronchin, P., additional, Kacso, G., additional, Gravis Mescam, G., additional, Calabro', F., additional, Berdah, J.F., additional, Hasbini, A., additional, Silva, M., additional, Thiery-Vuillemin, A., additional, Latorzeff, I., additional, Rieger, I., additional, and Bossi, A., additional

Published
2021
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48. 621P Efficacy and safety of relugolix vs leuprolide (LEU) in men with advanced prostate cancer (APC): Clinical subgroup analysis from the phase III HERO study

Author

Saltzstein, D.R., primary, Shore, N.D., additional, Saad, F., additional, George, D.J., additional, Cookson, M.S., additional, Tutrone, R., additional, Akaza, H., additional, Bossi, A., additional, Brown, B., additional, Selby, B., additional, Lu, S., additional, Walling, J., additional, and Tombal, B., additional

Published
2021
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49. 614P Circulating tumor cell (CTC) morphologic sub-types present prior to treatment in the CARD trial identify therapy resistance

Author

de Bono, J.S., primary, Pantel, K., additional, Efstathiou, E., additional, Sternberg, C.N., additional, Gauna, D. Castellano, additional, Fizazi, K., additional, Tombal, B., additional, Wülfing, C., additional, Schonhoft, J.D., additional, Tubbs, A., additional, Chu, L., additional, Wenstrup, R., additional, Ozatilgan, A., additional, Geffriaud-Ricouard, C., additional, Macé, S., additional, and de Wit, R., additional

Published
2021
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50. 1839P Circulating tumor DNA (ctDNA) low pass whole genome sequencing (lpWGS) studies identify genomic alterations associating with taxane outcomes in prospective phase III taxane trials for metastatic castration resistant prostate cancer (mCRPC) sufferers

Author

Seed, G., Greening, S., Goodall, J., Rekowski, J., Christova, R., Mehra, N., Eisenberger, M., Fizazi, K., Tombal, B., Wülfing, C., Sternberg, C.N., Castellano Gauna, D.E., Oudard, S., Sartor, O., Geffriaud-Ricouard, C., Chadjaa, M., Mace, S., Carreira, S., Yuan, W., and de Bono, J.S.

Published
2023
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