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5. 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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8. The development of medical infographics to raise symptom awareness and promote communication to patients with cancer:A co-creation study

Author

Piil, Karin, Pedersen, P., Gyldenvang, H. Holm, Elsborg, A. Juhl, Skaarup, A. Bascuñan, Starklint, M., Kjølsen, T., Pappot, H., Piil, Karin, Pedersen, P., Gyldenvang, H. Holm, Elsborg, A. Juhl, Skaarup, A. Bascuñan, Starklint, M., Kjølsen, T., and Pappot, H.

Abstract

Objective: The study aims to develop medical infographics that have a potential to raise symptom awareness and promote symptom communication between patients diagnosed with cancer and healthcare professionals. Methods: This study comprised four phases: 1) development of medical infographics, 2) user testing with healthcare professionals and patients, 3) selection of specific medical infographics, and 4) interviews on these specific medical infographics with patients using the think-aloud method. Results: Design students created 22 medical infographics conveying information about six symptoms and concerns. Patients (n = 28) with cancer said that the colourful infographics evoked individual emotional responses and associations, and they facilitated their narratives of experiences with symptoms. Healthcare professionals (n = 29) thought the infographics were eye-catching and may promote dialogue on symptoms. Conclusions: The design of medical infographics must target a specific population. When introduced, the use of medical infographics may be influenced by the physical surroundings. Medical infographics can facilitate symptom communication by creating symptom awareness and providing patients with the vocabulary to describe their symptoms and concerns. Innovation: Medical infographics are engaging visual messages with the potential to help prepare cancer patients to communicate their symptom experiences and reduce the feeling of being alone in experiencing certain symptoms.

Published
2023

9. Symptom Patterns in Young Adults with Cancer: An App-Based Study

Author

Locatelli, G, Pasta, A, Bentsen, L, Hanghoj, S, Piil, K, Pappot, H, Locatelli, G, Pasta, A, Bentsen, L, Hanghoj, S, Piil, K, and Pappot, H

Abstract

Objectives: To investigate symptom patterns in young adults with cancer using a smartphone-based app. The authors sought to explore symptom frequency and severity, cluster patients based on their symptom severity, investigate the co-occurrence of severe symptoms, and explore the relationship between symptoms and activities. Data Sources: Data were collected, using a mobile app, from 161 young adults with cancer (mean age 25.5 years, 75% female, 59% with solid cancer). Symptom frequency/severity was investigated with descriptive statistics. K-means clustering technique was used to cluster patients based on the average symptom severity. Co-occurrence of severe symptoms was investigated with the association rule technique. The relationship between symptom severity and likelihood of performing a physical/social activity was explored with mixed-effects logistic regression. Conclusion: The most frequently reported symptom was mood disturbance, followed by fatigue, which was also the most severe one. Two clusters of patients were identified, experiencing higher and lower severity for all symptoms. Severe appetite disturbances were frequently reported together with severe lack of energy and nausea. Severe lack of energy, either alone or together with mood disturbance, was often reported together with severe fatigue. Higher mood disturbance was associated with lower probability of performing physical and social activities. This study provides new insights into the symptom experience of young adults with cancer. Implications for Nursing Practice: Using a symptoms-tracking app may be a valid strategy for healthcare professionals, nurses, and researchers to support patients in symptom monitoring and, consequently, to identify and implement tailored symptom-management strategies.

Published
2023

16. 1960O Identification of bladder cancer patients that could benefit from early post-cystectomy immunotherapy based on serial circulating tumour DNA (ctDNA) testing: Preliminary results from the TOMBOLA trial

Author

Bjerggaard Jensen, J., Birkenkamp-Demtröder, K., Nordentoft, I., Milling, R.V., Körner, S.K., Brandt, S.B., Knudsen, M., Lam, G.W., Dohn, L.H., Fabrin, K., Carus, A., Petersen, A., Joensen, U.N., Pappot, H., Holt, P.S., Jensen, N.V., Agerbæk, M., and Dyrskjot, L.

Published
2024
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17. 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

18. Feasibility, usability and acceptance of weekly electronic patient-reported outcomes among patients receiving pelvic CT- or online MR-guided radiotherapy – A prospective pilot study

Author

Møller, P. K., Pappot, H., Bernchou, U., Schytte, T., Mortensen, Z. V., Brúnni, M. F.Á., Dieperink, K. B., Møller, P. K., Pappot, H., Bernchou, U., Schytte, T., Mortensen, Z. V., Brúnni, M. F.Á., and Dieperink, K. B.

Abstract

Introduction: The potential of patient symptoms being monitored longitudinally in radiotherapy (RT) is still unexploited. When novel technologies like online adaptive MR-guided radiotherapy (MRgRT) are evaluated, weekly electronic patient-reported outcomes (ePROs) may add knowledge about the symptom trajectory. This study aimed at evaluating feasibility, usability and acceptance of weekly ePRO among patients receiving pelvic radiotherapy. Materials and Methods: In a mixed-methods convergent design, a prospective pilot study enrolled patients referred to pelvic radiotherapy with curative intent. Patients used their own device at home to self-report PRO weekly during and four weeks following radiotherapy and week 8, 12, and 24 (paper-questionnaire as an alternative). Feasibility was extracted from the ePRO software. The Patient Feedback Form and patient interviews were used to explore usability and patient acceptance. Patients were informed that clinicians had no access to PRO responses. Results: In total, 40 patients were included; 32 patients with prostate cancer and 8 with cervical cancer (consent rate 87%), median age 68 (36–76). The majority did digital reporting (93%). 85% of patients responded to ≥80% of the weekly questionnaires with 91% average adherence to weekly completion (60% for follow-up), although lower for patients ≥age 70. Time spent on ePRO (97%) and frequency of reporting (92%) was considered appropriate. Interviews (n = 14) revealed the application was usable and the patients requested real-time feedback from the clinicians. Conclusion: Recruitment for ePRO during radiotherapy was feasible and adherence to weekly self-reporting high. The digital application was usable and weekly frequency and time spent acceptable. Real-time feedback from the clinicians is requested by the patients.

Published
2022

22. Selecting patient-reported outcomes to monitor symptomatic toxicities of immune-checkpoint inhibitors: A Delphi study

Author

Lopes, A. M. D. S., Colomer-Lahiguera, S., Mederos-Alfonso, N-N., Lopez, V. Aedo, Spurrier-Bernard, G., Tolstrup, L. K., Pappot, H., Aspeslagh, S., Rogiers, A., Neyns, B., Haanen, J. B. A. G., Mitchell, S. A., Addeo, A., Michielin, O. A., Eicher, M., Laboratory of Molecular and Medical Oncology, Clinical sciences, Medical Oncology, Radiation Therapy, and Laboratory of Molecullar and Cellular Therapy

Abstract

Background: Immune-related Adverse Events (IrAEs) present a new challenge to patient safety. The use of Patient-Reported Outcomes (PROs) to monitor adverse events is increasing. Existing measures like the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) do not offer clear guidance how to select the symptoms to monitor in different populations. The wide spectrum of toxicities of more recent treatments such as Immune Checkpoint Inhibitors (ICIs) is not fully covered. We aimed to a) reach expert consensus on PRO-CTCAE symptom to be monitored in cancer patients treated with ICIs; b) gather expert opinion on additional symptom terms that could be used to broaden its reach in the ICI toxicity spectrum; and c) reach expert consensus on a set of priority symptom terms to monitor symptomatic IrAEs in this population. Methods: We conducted a Delphi study with an international panel of eleven experts across four rounds. In round 1, experts assessed the relevance of PRO-CTCAEsymptom terms and suggested additional terms. Subsequent rounds aimed at consensus on the importance-to-monitor on three levels (level1 ¼ highest; level 3 ¼ lowest) of all relevant symptom terms. Results: All (n¼80) PRO-CTCAE Symptom terms were considered relevant. By round 4, consensus on the importance-to-monitor was reached for 82% (n¼65). Thirty terms reached consensus on level 1 importance, followed by 33 on level 2 and 2on level 3. Experts agreed on a set of 54 additional symptom terms to be considered to monitor ICI-related toxicities. Consensus on the importance-to-monitor was reached for 87% (n¼47) of these terms. Conclusions: To our knowledge, this is the first consensus of a prioritized list of symptom terms that should be considered for prospective surveillance of ICI-related toxicities. Additionally, they reveal the need to improve existing PRO measures to address the complex nature of IrAEs, and provide a first consensus on what symptom terms should be targeted by future work.

Published
2021

24. Correction to:Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy (Journal of Patient-Reported Outcomes, (2021), 5, 1, (47), 10.1186/s41687-021-00326-w)

Author

Møller, P K, Pappot, H, Bernchou, U, Schytte, T, and Dieperink, K B

Abstract

Following publication of the original article [1], the authors identified an error in the authors and affiliations lists. The current authors and affiliations lists read: P. K. Møller1,2, H. Pappot3,4, U. Bernchou2,5, T. Schytte2,6, K. B. Dieperink1,2 and Pia Krause Møller7* Department of Oncology, Odense University Hospital, AgeCare, Academy of Geriatric Cancer Research, Odense University Hospital, Odense, Denmark. 2 Department of Clinical Research, University of Southern Denmark, Odense, Denmark. 3 Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark. 4 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. 5 Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark. 6 Department of Oncology, Odense University Hospital, Odense, Denmark. 7 Odense University Hospital, Research Unit of Oncology, Kløvervænget 19, 5000 Odense C, Denmark The correct authors and affiliations lists should read P. K. Møller1,2, H. Pappot3,4, U. Bernchou2,5, T. Schytte2,6, K. B. Dieperink1,2 Department of Oncology, Odense University Hospital, AgeCare, Academy of Geriatric Cancer Research, Odense University Hospital, Odense, Denmark. 2 Department of Clinical Research, University of Southern Denmark, Odense, Denmark. 3 Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark. 4 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. 5 Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark. 6 Department of Oncology, Odense University Hospital, Odense, Denmark. The author group has been updated above and the original article [1] has been corrected.

Published
2021

25. 1686P Selecting patient-reported outcomes to monitor symptomatic toxicities of immune-checkpoint inhibitors: A Delphi study

Author

Lopes, A.M.D.S., primary, Colomer-Lahiguera, S., additional, Mederos-Alfonso, N-N., additional, Lopez, V. Aedo, additional, Spurrier-Bernard, G., additional, Tolstrup, L.K., additional, Pappot, H., additional, Aspeslagh, S., additional, Rogiers, A., additional, Neyns, B., additional, Haanen, J.B.A.G., additional, Mitchell, S.A., additional, Addeo, A., additional, Michielin, O.A., additional, and Eicher, M., additional

Published
2021
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26. 698P Analysis of hard-to-treat subgroups from EV-301: A phase III trial of enfortumab vedotin (EV) vs chemotherapy for previously treated advanced urothelial carcinoma

Author

Rosenberg, J.E., primary, Powles, T., additional, Sonpavde, G.P., additional, Loriot, Y., additional, Duran, I., additional, Lee, J.L., additional, Matsubara, N., additional, Vulsteke, C., additional, Castellano, D., additional, Mamtani, R., additional, Sridhar, S.S., additional, Pappot, H., additional, Gurney, H.P., additional, Bedke, J., additional, van der Heijden, M.S., additional, Campbell, M., additional, Wu, C., additional, Matsangou, M., additional, and Petrylak, D.P., additional

Published
2021
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30. Effectiveness of a nurse-delivered (FOCUS plus ) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial

Author

Matthys, O, De Vleminck, A, Dierickx, S, Deliens, L, Van Goethem, V, Lapeire, L, Groenvold, M, Lund, L, Arnfeldt, CM, Sengeloev, L, Pappot, H, Johnsen, AT, Guerin, S, Larkin, PJ, Jordan, C, Connolly, M, D'Alton, P, Costantini, M, Di Leo, S, Guberti, M, Turola, E, van der Heide, A, Witkamp, E, Rietjens, J, van der Wel, M, Brazil, K, Prue, G, Reid, J, Scott, D, Bristowe, K, Harding, R, Normand, C, May, P, Cronin, C, Northouse, L, Hudson, P, Cohen, J, Matthys, O, De Vleminck, A, Dierickx, S, Deliens, L, Van Goethem, V, Lapeire, L, Groenvold, M, Lund, L, Arnfeldt, CM, Sengeloev, L, Pappot, H, Johnsen, AT, Guerin, S, Larkin, PJ, Jordan, C, Connolly, M, D'Alton, P, Costantini, M, Di Leo, S, Guberti, M, Turola, E, van der Heide, A, Witkamp, E, Rietjens, J, van der Wel, M, Brazil, K, Prue, G, Reid, J, Scott, D, Bristowe, K, Harding, R, Normand, C, May, P, Cronin, C, Northouse, L, Hudson, P, and Cohen, J

Abstract

BACKGROUND: Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers' quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads' emotional functioning and self-efficacy. METHODS: We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led face-to-face intervention (FOCUS+), 2) a web-based intervention (iFOCUS) or 3) a control group (care as usual). The two interventions offer tailored psychoeducational support for patient-family caregiver dyads. The nurse-led face-to-face intervention consists of two home visits and one online video session and the web-based intervention is completed independently by the patient-family caregiver dyad in four online sessions. The interventions are based on the FOCUS intervention, developed in the USA, that addresses five core components: family involvement, optimistic outlook, coping effectiveness, uncertainty reduction, and symptom management. The FOCUS intervention will be adapted to the European context. The primary outcomes are emotional functioning and self-efficacy of the patient and the family caregiver, respectively. The secondary outcomes are quality of life, benefits of illness, coping, dyadic communication, and ways of giving support of the patient and family caregiver. DISCUSSION: DIAdIC aims to develop c

Published
2021

35. Corrigendum to ‘EAU-ESMO Consensus Statements on the Management of Advanced and Variant Bladder Cancer—An International Collaborative Multistakeholder Effort Under the Auspices of the EAU-ESMO Guidelines Committees’ [European Urology 77 (2020) 223–250](S0302283819307638)(10.1016/j.eururo.2019.09.035)

Author

Witjes, J.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. De Blok, 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. Mir, M.C. 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. Lauridsen, S.V. Valdagni, R. Van Der Heijden, A.G. Van Poppel, H. Vartolomei, M.D. Veskimäe, E. Vilaseca, A. Rivera, F.A.V. Wiegel, T. Wiklund, P. Willemse, P.-P.M. Williams, A. Zigeuner, R. Horwich, A.

Abstract

The authors regret that a co-author was mistakenly missed from the authorship. The following co-author should have been included in the authorship: Peter-Paul M. Willemse Department of Oncological Urology, University Medical Center, Utrecht Cancer Center, Utrecht, The Netherlands © 2019 European Society of Medical Oncology and European Association of Urology

Published
2020

36. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial

Author

Powles, T. van der Heijden, M.S. Castellano, D. Galsky, M.D. Loriot, Y. Petrylak, D.P. Ogawa, O. Park, S.H. Lee, J.-L. De Giorgi, U. Bögemann, M. Bamias, A. Eigl, B.J. Gurney, H. Mukherjee, S.D. Fradet, Y. Skoneczna, I. Tsiatas, M. Novikov, A. Suárez, C. Fay, A.P. Duran, I. Necchi, A. Wildsmith, S. He, P. Angra, N. Gupta, A.K. Levin, W. Bellmunt, J. van der Heijden, M.S. Lee, J.L. Eigl, B.J. Mukherjee, S.D. Suarez, C. Westgeest, H. Flechon, A. Ou, Y.-C. Park, I. Matveev, V. Pérez-Valderrama, B. Cheng, S. Frank, S. Anido, U. Hamzaj, A. Retz, M. Sridhar, S. Scagliotti, G.V. Voortman, J. Alekseev, B. Alyasova, A. Komyakov, B. Dumez, H. Pavic, M. Kimura, G. Mizokami, A. Osanto, S. Arranz, J.A. Piersma, D. Shin, S.J. Karyakin, O. Delgado, I. Gonzalez, J.L. Pang, S.-T. Tran, A. Lipatov, O. Su, W.-P. Flaig, T. Alva, A. Park Kyong, H. Kopyltsov, E. Almagro, E. Domenech, M. Chang, Y.-H. Sautois, B. Ravaux, A. Aravantinos, G. Georgoulias, V. Mulder, S. Kim, Y.J. Kater, F. Chevreau, C. Tagawa, S. Zalewski, P. Joly, F. Hatiboglu, G. Gianni, L. Morelli, F. Tambaro, R. Hashimoto, Y. Nosov, A. Font, A. Rodriguez-Vida, A.M. Jones, R. Vasudev, N. Srinivas, S. Zhang, J. Gil, T. Finch, D. Grimm, M.-O. Su, Y.-L. Chowdhury, S. Hocking, C. Plas, E. North, S. Jensen, N.V. Theodore, C. Imkamp, F. Peer, A. Kobayashi, T. Sakai, H. Sassa, N. Yoshimura, K. Aarts, M. Ferreira Castro, A. Topuzov, M. Rodriguez, J.F. Vazquez, F.J. Tsai, Y.-C. Crabb, S. Hussain, S. Bendell, J. Gross-Goupil, M. Gwenaelle, G. Berger, R. Statsenko, G. Evans, L. Drakaki, A. Somer, B. Davis, I. Lynam, J. Borges, G. Dettino, A. Fay, A.P. Martins, G. Zucca, L.E. Agerbaek, M. Kalofonos, H. Rosenbaum, E. Enokida, H. Kikukawa, H. Nishimura, K. Tamada, S. Uemura, M. Lopez, Y. Gietema, J. Slojewski, M. Fernandes, I. Smolin, A. Mazhar, D. Kalebasty, A.R. Carthon, B. Loidl, W. Franke, F. Girotto, G. Alimohamed, N. Macfarlane, R. Pappot, H. Niegisch, G. Mavroudis, D. Sella, A. Porta, C. Ebara, S. Nakamura, M. Obara, W. Okuno, N. Shinohara, N. Sugimoto, M. Suzuki, A. Tokuda, N. Uemura, H. Yamaguchi, A. Ramirez, F. Rozanowski, P. Wiechno, P. Keam, B. Kislov, N. Plaksin, D. Cicin, I. Kumar, S. Galsky, M.D. Petrylak, D.P. Rosales, J. Vaishampayan, U. Culine, S. Papandreou, C. Nara, T. Erman, M. Kreiger, L. Janoski, J. Rosa, D. Siqueira, M. Canil, C. Sengelov, L. Tourani, J.-M. Arai, G. Hashine, K. Kawakita, M. Nakaigawa, N. Nomi, H. Shiina, H. Suzuki, H. Yonese, J. Kuri, R. Macedo, E. Rivera, S. Villalobos Prieto, A. Polakiewicz-Gilowska, A. Zaucha, R. Lopes, F. Ponomarev, R. Pomerantz, M. Shariat, S. Luk, C. Lesniewski-Kmak, K.

Abstract

Background: Survival outcomes are poor for patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy. We assessed the overall survival of patients who received durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor), as a first-line treatment for metastatic urothelial carcinoma. Methods: DANUBE is an open-label, randomised, controlled, phase 3 trial in patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1. We randomly assigned patients (1:1:1) to receive durvalumab monotherapy (1500 mg) administered intravenously every 4 weeks; durvalumab (1500 mg) plus tremelimumab (75 mg) administered intravenously every 4 weeks for up to four doses, followed by durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility) administered intravenously for up to six cycles. Randomisation was done through an interactive voice–web response system, with stratification by cisplatin eligibility, PD-L1 status, and presence or absence of liver metastases, lung metastases, or both. The coprimary endpoints were overall survival compared between the durvalumab monotherapy versus chemotherapy groups in the population of patients with high PD-L1 expression (the high PD-L1 population) and between the durvalumab plus tremelimumab versus chemotherapy groups in the intention-to-treat population (all randomly assigned patients). The study has completed enrolment and the final analysis of overall survival is reported. The trial is registered with ClinicalTrials.gov, NCT02516241, and the EU Clinical Trials Register, EudraCT number 2015-001633-24. Findings: Between Nov 24, 2015, and March 21, 2017, we randomly assigned 1032 patients to receive durvalumab (n=346), durvalumab plus tremelimumab (n=342), or chemotherapy (n=344). At data cutoff (Jan 27, 2020), median follow-up for survival was 41·2 months (IQR 37·9–43·2) for all patients. In the high PD-L1 population, median overall survival was 14·4 months (95% CI 10·4–17·3) in the durvalumab monotherapy group (n=209) versus 12·1 months (10·4–15·0) in the chemotherapy group (n=207; hazard ratio 0·89, 95% CI 0·71–1·11; p=0·30). In the intention-to-treat population, median overall survival was 15·1 months (13·1–18·0) in the durvalumab plus tremelimumab group versus 12·1 months (10·9–14·0) in the chemotherapy group (0·85, 95% CI 0·72–1·02; p=0·075). In the safety population, grade 3 or 4 treatment-related adverse events occurred in 47 (14%) of 345 patients in the durvalumab group, 93 (27%) of 340 patients in the durvalumab plus tremelimumab group, and in 188 (60%) of 313 patients in the chemotherapy group. The most common grade 3 or 4 treatment-related adverse event was increased lipase in the durvalumab group (seven [2%] of 345 patients) and in the durvalumab plus tremelimumab group (16 [5%] of 340 patients), and neutropenia in the chemotherapy group (66 [21%] of 313 patients). Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group. Deaths due to study drug toxicity were reported in two (1%) patients in the durvalumab group (acute hepatic failure and hepatitis), two (1%) patients in the durvalumab plus tremelimumab group (septic shock and pneumonitis), and one (

Published
2020

37. EAU-ESMO Consensus Statements on the Management of Advanced and Variant Bladder Cancer-An International Collaborative Multistakeholder Effort†: Under the Auspices of the EAU-ESMO Guidelines Committees

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, 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, Van Der Heijden AG, Van Poppel H, Vartolomei MD, Veskimäe E, Vilaseca A, Rivera FAV, Wiegel T, Wiklund P, Williams A, Zigeuner R, Horwich A.

Subjects
Consensus, Follow-up, education, Bladder cancer, Diagnosis, Treatment, Delphi
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 ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus). Results and limitations: Overall, 116 statements were included in the Delphi survey. Of these statements, 33 (28%) achieved level 1 consensus and 49 (42%) achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease, and the evolving role of checkpoint inhibitor therapy in metastatic disease. Conclusions: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time when further evidence is available to guide our approach. Patient summary: This report summarises findings from an international, multistakeholder project organised by the EAU and ESMO. In this project, a steering committee identified areas of bladder cancer management where there is currently no good-quality evidence to guide treatment decisions. From this, they developed a series of proposed statements, 71 of which achieved consensus by a large group of experts in the field of bladder cancer. It is anticipated that these statements will provide further guidance to health care professionals and could help improve patient outcomes until a time when good-quality evidence is available.

Published
2020

38. EAU-ESMO Consensus Statements on the Management of Advanced and Variant Bladder Cancer-An International Collaborative Multistakeholder Effort Under the Auspices of the EAU-ESMO Guidelines Committees

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, Grubmueller, 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, Mueller, A-C, Mueller, CR, N'Dow, J, Necchi, A, Neuzillet, Y, Oddens, JR, Oldenburg, J, Osanto, S, Oyen, WJG, Pacheco-Figueiredo, L, Pappot, H, Patel, M, 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, 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, Grubmueller, 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, Mueller, A-C, Mueller, CR, N'Dow, J, Necchi, A, Neuzillet, Y, Oddens, JR, Oldenburg, J, Osanto, S, Oyen, WJG, Pacheco-Figueiredo, L, Pappot, H, Patel, M, 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

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 ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus). RESULTS AND LIMITATIONS: Overall, 116 statements were included in the Delphi survey. Of these statements, 33 (28%) achieved level 1 consensus and 49 (42%) achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease, and the evolving role of checkpoint inhibitor therapy in metastatic disease. CONCLUSIONS: These consensus stateme

Published
2020

40. 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. Witjes, J.A.

Subjects
education
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 before 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), 7–9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus). Results and limitations: Overall, 116 statements were included in the Delphi survey. Of these, 33 (28%) statements achieved level 1 consensus and 49 (42%) statements achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease and the evolving role of checkpoint inhibitor therapy in metastatic disease. Conclusions: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time where further evidence is available to guide our approach. © 2019 European Society for Medical Oncology

Published
2019

41. 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, Reijke, T M De, Santis, M De, Gillessen, S, James, N, Maclennan, S, Palou, J, Powles, T, Ribal, M J, Shariat, S F, Kwast, T Van Der, 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, Bari, B De, Blok, W De, 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, Mir, M Carmen, 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, Amir, Smeenk, R J, Smits, A, Stenzl, A, Thalmann, G N, Tombal, B, Turkbey, B, Lauridsen, S Vahr, Valdagni, R, Van Der Heijden, A G, Van Poppel, H, Vartolomei, M D, Veskimäe, E, Vilaseca, A, Rivera, F A Vives, Wiegel, T, Wiklund, P, Williams, A, Zigeuner, R, Witjes, J A, Horwich, A, Babjuk, M, Bellmunt, J, Bruins, H M, Reijke, T M De, Santis, M De, Gillessen, S, James, N, Maclennan, S, Palou, J, Powles, T, Ribal, M J, Shariat, S F, Kwast, T Van Der, 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, Bari, B De, Blok, W De, 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, Mir, M Carmen, 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, Amir, Smeenk, R J, Smits, A, Stenzl, A, Thalmann, G N, Tombal, B, Turkbey, B, Lauridsen, S Vahr, Valdagni, R, Van Der Heijden, A G, Van Poppel, H, Vartolomei, M D, Veskimäe, E, Vilaseca, A, Rivera, F A Vives, Wiegel, T, Wiklund, P, Williams, A, Zigeuner, R, and Witjes, J A

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 before 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), 7-9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus). RESULTS AND LIMITATIONS: Overall, 116 statements were included in the Delphi survey. Of these, 33 (28%) statements achieved level 1 consensus and 49 (42%) statements achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease and the evolving role of checkpoint inhibitor therapy in metastatic disease. CONCLUSIONS: These consensus sta

Published
2019
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42. 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

UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie, Witjes, J A, Van Der Heijden, A G, Smits, A, Stenzl, A, Thalmann, G N, Tombal, Bertrand, Turkbey, B, Lauridsen, S Vahr, Valdagni, R, Van Poppel, H, Sherif, A, Vartolomei, M D, Veskimäe, E, Vilaseca, A, Rivera, F A Vives, Wiegel, T, Wiklund, P, Williams, A, Zigeuner, R, Smeenk, R J, Horwich, A, Babjuk, M, Bellmunt, J, Bruins, H M, Reijke, T M De, Santis, M De, Gillessen, S, James, N, Maclennan, S, Palou, J, Powles, T, Ribal, M J, Shariat, S F, Kwast, T Van Der, 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, Bari, B De, Blok, W De, 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, Mir, M Carmen, 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, UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie, Witjes, J A, Van Der Heijden, A G, Smits, A, Stenzl, A, Thalmann, G N, Tombal, Bertrand, Turkbey, B, Lauridsen, S Vahr, Valdagni, R, Van Poppel, H, Sherif, A, Vartolomei, M D, Veskimäe, E, Vilaseca, A, Rivera, F A Vives, Wiegel, T, Wiklund, P, Williams, A, Zigeuner, R, Smeenk, R J, Horwich, A, Babjuk, M, Bellmunt, J, Bruins, H M, Reijke, T M De, Santis, M De, Gillessen, S, James, N, Maclennan, S, Palou, J, Powles, T, Ribal, M J, Shariat, S F, Kwast, T Van Der, 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, Bari, B De, Blok, W De, 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, Mir, M Carmen, 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, and Sengupta, S

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 before 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), 7-9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus). RESULTS AND LIMITATIONS: Overall, 116 statements were included in the Delphi survey. Of these, 33 (28%) statements achieved level 1 consensus and 49 (42%) statements achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease and the evolving role of checkpoint inhibitor therapy in metastatic disease. CONCLUSIONS: These consensus sta

Published
2019

43. 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

Cancer, Verpleegkundig Specialisten, MS Urologische Oncologie, Horwich, A, Babjuk, M, Bellmunt, J, Bruins, H M, Reijke, T M De, Santis, M De, Gillessen, S, James, N, Maclennan, S, Palou, J, Powles, T, Ribal, M J, Shariat, S F, Kwast, T Van Der, 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, Bari, B De, Blok, W De, 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, Mir, M Carmen, 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, Lauridsen, S Vahr, Valdagni, R, Van Der Heijden, A G, Van Poppel, H, Vartolomei, M D, Veskimäe, E, Vilaseca, A, Rivera, F A Vives, Wiegel, T, Wiklund, P, Williams, A, Zigeuner, R, Witjes, J A, Cancer, Verpleegkundig Specialisten, MS Urologische Oncologie, Horwich, A, Babjuk, M, Bellmunt, J, Bruins, H M, Reijke, T M De, Santis, M De, Gillessen, S, James, N, Maclennan, S, Palou, J, Powles, T, Ribal, M J, Shariat, S F, Kwast, T Van Der, 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, Bari, B De, Blok, W De, 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, Mir, M Carmen, 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, Lauridsen, S Vahr, Valdagni, R, Van Der Heijden, A G, Van Poppel, H, Vartolomei, M D, Veskimäe, E, Vilaseca, A, Rivera, F A Vives, Wiegel, T, Wiklund, P, Williams, A, Zigeuner, R, and Witjes, J A

Published
2019

44. 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., Reijke, T. M.De, Santis, M. De, Gillessen, S., James, N., Maclennan, S., Palou, J., Powles, T., Ribal, M. J., Shariat, S. F., Kwast, T. Van Der, 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., Bari, B. De, Blok, W. De, 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., Mir, M. Carmen, 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., Lauridsen, S. Vahr, Valdagni, R., Van Der Heijden, A. G., Van Poppel, H., Vartolomei, M. D., Veskimäe, E., Vilaseca, A., Rivera, F. A.Vives, Wiegel, T., Wiklund, P., Williams, A., Zigeuner, R., Witjes, J. A., Horwich, A., Babjuk, M., Bellmunt, J., Bruins, H. M., Reijke, T. M.De, Santis, M. De, Gillessen, S., James, N., Maclennan, S., Palou, J., Powles, T., Ribal, M. J., Shariat, S. F., Kwast, T. Van Der, 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., Bari, B. De, Blok, W. De, 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., Mir, M. Carmen, 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., Lauridsen, S. Vahr, Valdagni, R., Van Der Heijden, A. G., Van Poppel, H., Vartolomei, M. D., Veskimäe, E., Vilaseca, A., Rivera, F. A.Vives, Wiegel, T., Wiklund, P., Williams, A., Zigeuner, R., and Witjes, J. A.

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 before 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), 7-9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus). RESULTS AND LIMITATIONS: Overall, 116 statements were included in the Delphi survey. Of these, 33 (28%) statements achieved level 1 consensus and 49 (42%) statements achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease and the evolving role of checkpoint inhibitor therapy in metastatic disease. CONCLUSIONS: These consensus

Published
2019

45. Quality of life in bladder cancer patients receiving medical oncological treatment; a systematic review of the literature

Author

Taarnhøj, G A, Johansen, C, Pappot, H, Taarnhøj, G A, Johansen, C, and Pappot, H

Abstract

BACKGROUND: Previous quality of life (QoL) literature in bladder cancer (BC) patients has focused on finding the preferred urinary diversion while little is known about the QoL of patients in medical oncological treatment (MOT). We performed a systematic review to assess the existing literature on QoL in patients with muscle-invasive BC (MIBC) undergoing MOT.METHODS: A systematic search of Pubmed and Embase was performed. Inclusion criteria were studies containing QoL data for patients undergoing chemo- and/or radiotherapy. We extracted all QoL scorings at different time intervals and on the six most prevalent domains: overall QoL, urinary, bowel sexual symptoms, pain and fatigue. The study was carried out according to PRISMA guidelines for systematic reviews and GRADE was used to rate the quality of evidence from the included studies.RESULTS: Of 208 papers reviewed, 21 papers were included. Twenty-one different QoL instruments were applied. The only data on QoL during chemotherapy was from patients in clinical trials investigating new treatments. No studies were found for patients in neoadjuvant treatment. The level of evidence at each time point was graded as very low to moderate. From the studies included the overall QoL seemed inversely related to the organ-specific impairment from sexual and urinary symptoms and increased with decreasing organ-specific symptoms for long term survivors > 6 months after treatment.CONCLUSIONS: Collection of data on QoL from patients with MIBC disease undergoing MOT has been sparse and diverse. The present data can act as a summary but prompts for more prospective collection of QoL data from BC patients.

Published
2019

47. Combined treatment with pemetrexed and vinflunine in patients with metastatic urothelial cell carcinoma after prior platinum-containing chemotherapy:results of an exploratory phase I study

Author

Pappot, H, von der Maase, H, Ullén, A, Agerbæk, M, Pappot, H, von der Maase, H, Ullén, A, and Agerbæk, M

Abstract

Vinflunine is to date the only registered agent for second-line treatment of metastatic urothelial cell carcinoma (UCC) in Europe. However, the effect is modest. Pemetrexed has demonstrated some single-agent activity in this disease entity. In order to improve treatment possibilities for UCC patients, a phase I trial (VINTREX) was undertaken to assess the safety of vinflunine and pemetrexed in metastatic UCC patients. A dose escalation design was planned to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of a vinflunine/pemetrexed combination. Pemetrexed was added to vinflunine dosed at 280 mg/m2 on day 1 of a 21-day cycle. Three levels of pemetrexed were planned starting at 400 mg/m2. Four patients were enrolled with a mean age of 66 years and with a mean number of prior GC-cycles of 6,8. Two DLT's were observed at the lowest dose-level in cohort 1. One patient experienced grade 4 thrombocytopenia and a second demonstrated hepatobiliary toxicity grade 3 with an increase in alanine aminotransaminase. Most common grade 3 and 4 adverse events were anemia, thrombocytopenia and neutropenia. Three out of four patients received 3 cycles of pemetrexed and vinflunine, all had progressive disease. Based on these observations and due to protocol design, the study was interrupted at dose level 1 for safety reasons. The combined therapy of vinflunine (Javlor®, Pierre Fabre Pharma) and pemetrexed (Alimta®, Eli Lilly) is poorly tolerated in metastatic UCC patients. The combination cannot be recommended for further investigations in metastatic UCC.

Published
2018

48. Feasibility and acceptability of electronic symptom surveillance with clinician feedback using the patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) in Danish prostate cancer patients

Author

Johansen, C., Dalton, S.O., Hjollund, N.H., Pappot, H., Mitchell, S.A., Nissen, A., Basch, E., Bidstrup, P.E., and Baeksted, C.

Abstract

Background: The aim was to examine the feasibility, acceptability and clinical utility of electronic symptom surveillance with clinician feedback using a subset of items drawn from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a cancer treatment setting. Methods: Danish-speaking men with castration-resistant metastatic prostate cancer receiving treatment at the Department of Oncology, Rigshospitalet, Copenhagen between March 9, 2015 and June 8, 2015 were invited to participate (n = 63 eligible). Participants completed the PRO-CTCAE questionnaire on tablet computers using AmbuFlex software at each treatment visit in the outpatient clinic. In total, 22 symptomatic toxicities (41 PRO-CTCAE items), corresponding to the symptomatic adverse-events profile associated with the regimens commonly used for prostate cancer treatment (Docetaxel, Cabazitaxel, Abiraterone, Alpharadin), were selected. Participants’ PRO-CTCAE responses were presented graphically to their treating oncologists via an AmbuFlex dashboard, for real-time use to enhance the patient-clinician dialogue that occurs during the consultation prior to each treatment cycle. Technical and clinical barriers and acceptability were evaluated through semi-structured interviews with both patients and oncologists. Patients receiving active treatment at the end of the study period completed an evaluation questionnaire. Results: Fifty-four out of sixty-three (86%) eligible patients were enrolled. The PRO-CTCAE questionnaire was completed a total of 168 times by 54 participants (median number per patient was 3, range 1–5). Eight surveys were missed, resulting in a compliance rate of 97%. At the end of the study period, 35 patients (65%) were still receiving active treatment and completed the evaluation questionnaire. Patients reported that their PRO-CTCAE responses served as a communication tool. Oncologists stated that the availability of the PRO-CTCAE self-reports during the consultation improved patient-clinician communication about side effects. Conclusion: Electronic capture of symptomatic toxicities using PRO-CTCAE and the submission of self-reports to clinicians prior to consultation were feasible among metastatic prostate cancer patients receiving chemotherapy in an outpatient setting, and this procedure was acceptable to both patients and clinicians. Continued research, including a cluster-randomized trial, will evaluate the effects of submitting patients’ PRO-CTCAE results to clinicians prior to consultation on the quality of side-effects management and resultant clinical outcomes.

Published
2017
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