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3. In Reply: Neoadjuvant TKI Study in Early- and Intermediate Stage Hepatocellular Carcinoma

Author

Osanto, S., Woei-A-Jin, F.J.S.H., Coenraad, M.J., Weijl, N.I., Burgmans, M.C., and Burggraaf, J.

Subjects
Cancer Research, Science & Technology, Carcinoma, Hepatocellular, Oncology, Liver Neoplasms, Humans, Life Sciences & Biomedicine, Neoadjuvant Therapy
Abstract

This letter to the editor responds to comments from Rizzo et al on recently reported results of a phase II study of dovitinib therapy for hepatocellular carcinoma. ispartof: ONCOLOGIST vol:27 issue:12 pages:E977-E978 ispartof: location:England status: published

Published
2022

4. International evaluation of the psychometrics of health-related quality of life questionnaires for use among long-term survivors of testicular and prostate cancer

Author

Leeuwen, M. van, Kieffer, J.M., Efficace, F., Fossa, S.D., Bolla, M., Collette, L., Colombel, M., Giorgi, U. de, Holzner, B., Poll-Franse, L.V.V. de, Poppel, H. van, White, J., Wit, R. de, Osanto, S., Aaronson, N.K., European Org Res Treatment Cancer, Genito-Urinary Cancers Grp, Radiation Oncology Grp, NCRN Testis Clinical Studies Grp, Medical Oncology, and Medical and Clinical Psychology

Subjects
Questionnaires, Male, medicine.medical_specialty, Testicular neoplasms, Psychometrics, Cross-sectional study, Context (language use), lcsh:Computer applications to medicine. Medical informatics, 03 medical and health sciences, 0302 clinical medicine, Physical medicine and rehabilitation, Quality of life, SDG 3 - Good Health and Well-being, Surveys and Questionnaires, Medicine, Humans, 030212 general & internal medicine, Survivors, Cancer, Aged, Response rate (survey), Aged, 80 and over, business.industry, Research, Public Health, Environmental and Occupational Health, Prostatic Neoplasms, Reproducibility of Results, General Medicine, social sciences, Middle Aged, medicine.disease, humanities, United Kingdom, 3. Good health, Clinical trial, Europe, Cross-Sectional Studies, Oncology, 030220 oncology & carcinogenesis, Family medicine, Quality of Life, lcsh:R858-859.7, business, Psychosocial
Abstract

Background: Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors. In this study we evaluated, in an international context, the psychometrics of HRQoL questionnaires for use among long-term, disease-free, survivors of testicular and prostate cancer.Methods: In this cross-sectional study, we recruited long-term survivors of testicular and prostate cancer from Northern and Southern Europe and from the United Kingdom who had participated in two phase III EORTC clinical trials. Participants completed the SF-36 Health Survey, the EORTC QLQ-C30 questionnaire, the QLQ-PR25 (for prostate cancer) or the QLQ-TC26 (for testicular cancer) questionnaires, and the Impact of Cancer questionnaire. Testicular cancer survivors also completed subscales from the Nordic Questionnaire for Monitoring the Age Diverse Workforce.Results: Two hundred forty-two men (66% response rate) were recruited into the study. The average time since treatment was more than 10 years. Overall, there were few missing questionnaire data, although scales related to sexuality, satisfaction with care and relationship concerns of men without partners were missing in more than 10% of cases. Debriefing showed that in general the questionnaires were accepted well. Many of the survivors scored at the upper extremes of the questionnaires, resulting in floor and ceiling effects in 64% of the scales. All of the questionnaires investigated met the threshold of 0.70 for group level reliability, with the exception of the QLQ-TC26 (mean reliability .64) and the QLQ-PR25 (mean reliability .69). The questionnaires were able to discriminate clearly between patients with and without comorbid conditions.Conclusions: The currently available HRQoL questionnaires exhibit acceptable psychometric properties and were well received by patients, but additional efforts are needed to ensure that the full range of survivor-specific issues is assessed

Published
2017

5. Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies: Challenges and opportunities

Author

Leeuwen, M. van, Efficace, F., Fossa, S.D., Bolla, M., Giorgi, U. de, Wit, R. de, Holzner, B., Poll-Franse, L.V. van de, Poppel, H. van, White, J., Collette, L., Osanto, S., Aaronson, N.K., European Org Res Treatment Canc Q, Genito-Urinary Canc Grp, Radiation Oncology Grp, Medical and Clinical Psychology, Klinische Psychologie (Psychologie, FMG), and Medical Oncology

Subjects
Male, Quality of life, Cancer Research, medicine.medical_specialty, Long term follow up, Cancer survivorship, Alternative medicine, Phases of clinical research, Pilot Projects, Health outcomes research, Disease-Free Survival, Testicular Neoplasms, SDG 3 - Good Health and Well-being, Testicular cancer, Medicine, Humans, Survey research, Survivors, Long-term follow-up, Randomized Controlled Trials as Topic, Data collection, Prostate cancer, business.industry, Patient Selection, Cancer, Prostatic Neoplasms, medicine.disease, humanities, Clinical trial, Europe, Clinical research, Cross-Sectional Studies, Oncology, Clinical Trials, Phase III as Topic, Family medicine, business
Abstract

ObjectivesIn this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting such research.MethodsIn this cross-sectional study, we recruited long-term, disease-free survivors from two mature EORTC clinical trials in testicular and prostate cancer from centres in Northern and Southern Europe, and the United Kingdom (UK).ResultsA number of challenges were encountered in recruiting participating centres, obtaining medical ethical approval and in recruiting survivors and collecting the health-related quality of life (HRQoL) data in a timely manner. The efficiency with which the study could be conducted varied widely across centres and countries. Time to obtain medical ethical approval for the study ranged from 1.5 to 25 months. We encountered most problems with ethical approval in the UK, Italy and Belgium. In most cases, data collection was completed within 3 months (range 10 weeks–1 year). Completed questionnaires were obtained from 68% and 56%, respectively, of the testicular and prostate cancer survivors who were approached.ConclusionsHRQoL research among long-term survivors of EORTC phase III clinical trials is possible, but the process of ethical approval and data collection is a lengthy one. To minimise many of the logistical problems, long-term follow-up of patients should be an integral part of future clinical trials. Moreover, regulations governing medical ethical approval for clinical research within the EU should be carefully evaluated to facilitate long-term follow-up of cancer survivors in Europe.Keywords: Cancer survivorship, Quality of life, Prostate cancer, Testicular cancer, Long-term follow-up, Survey research, Health outcomes research

Published
2014

6. Penile cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Author

Poppel, H. van, Watkin, N.A., Osanto, S., Moonen, L., Horwich, A., Kataja, V., and ESMO Guidelines Working Grp

Subjects
Male, Lymphatic metastasis, medicine.medical_specialty, medicine.medical_treatment, Risk Assessment, medicine, Penile cancer, Humans, Penile Neoplasms, Neoplasm Staging, business.industry, General surgery, Papillomavirus Infections, Follow up studies, Hematology, Chemoradiotherapy, medicine.disease, Chemotherapy regimen, Surgery, Clinical Practice, Radiation therapy, Europe, Oncology, Diagnosis treatment, Circumcision, Male, Lymphatic Metastasis, Positron-Emission Tomography, Lymph Nodes, Neoplasm Recurrence, Local, business, Follow-Up Studies
Published
2013

8. An international expanded-access programme of everolimus: Addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy

Author

Grünwald, V, Karakiewicz, P, Bavbek, S, Miller, K, Machiels, J, Lee, S, Larkin, J, Bono, P, Rha, S, Castellano, D, Blank, C, Knox, J, Hawkins, R, Anak, O, Rosamilia, M, Booth, J, Pirotta, N, Bodrogi, I, Romedi, M, Ferrandini, S, Rondinon, M, Pittman, K, Goldstein, D, Shapiro, J, Troon, S, Yip, D, Mainwaring, P, Zigeuner, R, Loidl, W, Greil, R, Schmidinger, M, De Grève, J, Rottey, S, Vermorken, J, Gil, T, Gennigens, C, Roumeguere, T, Barrios, C, Mathias, C, Assi, H, Hotte, S, Spadafora, S, Wood, L, Zalewski, P, Mackensie, M, Bjarnason, G, Lalancette, A, Chan, A, Higgins, B, North, S, Soulieres, D, Asselah, J, Sperlich, C, Miller, W, Yadav, S, El Maraghi, R, Godoy, J, Prausová, J, Katolicka, J, Petruzelka, L, Kiss, I, Lapela, M, Bergmann, L, Beck, J, Jäger, E, Kindler, M, Overkamp, F, Wirth, M, Hölzer, W, Gschwend, J, Stenzl, A, Gauler, T, Niederwieser, D, Marschner, N, Lück, A, Tessen, H, Eichelberg, C, Steiner, T, Goebell, P, Kettner, E, Bakhshandeh Bath, A, Wilhelm, M, Schmitz, S, Jacob, A, Bierer, S, Kube, U, Staehler, M, Engel, E, Frambach, M, Schellenberger, U, Albers, P, Simon, J, Gleissler, M, Klotz, T, Repp, R, Kröning, H, Westermann, J, Rebmann, U, Brehmer, B, Niederle, N, Grund, C, Verpoort, K, Fonara, P, Rassweiler, J, Bamias, A, Fountzilas, G, Razis, E, Mouratidou, D, Georgoulias, V, Samantas, E, Mangel, L, Szanto, J, Berger, R, Pe'Er, A, Sella, A, Ben Yosef, R, Nechushtan, H, Crinò, L, Bracarda, S, Ciuffreda, L, Graiff, C, Falcone, A, Roselli, M, Sternberg, C, Santoro, A, Ruggeri, E, Bearz, A, Venturini, M, Aglietta, M, Amadori, D, Di Costanzo, F, Bari, M, Gebbia, N, Conte, P, Bonetti, A, Bordonaro, R, Cascinu, S, Contu, A, Cruciani, G, Gasparro, D, Nardi, M, Lelli, G, Lo Re, G, Boccardo, F, Lorusso, V, Maiello, E, Manente, P, Passalacqua, R, Piantedosi, F, Porta, C, Sacco, C, Tondini, C, De Placido, S, Carteni, G, Dogliotto, L, Rosti, G, Milella, M, Roila, F, Amoroso, D, Farina, G, Al Khatib, H, Kim, T, Ahn, J, Lim, H, Chung, I, Kim, J, Chung, J, Ghosn, M, Shameseddine, A, Lugo, R, Cabrera, P, Osanto, S, Groenewegen, G, van den Eertwegh, F, van Herpen, C, Oosting, S, Soetekouw, P, Lilleby, W, Klepp, O, Guren, T, Alcedo, J, Karlov, P, Nosov, D, Roman, L, Rusakov, I, Bazarbashi, S, Toh, C, Mardiak, J, del Muro Solans, F, Ray, J, Mollins, J, Martinez, I, Gonzalez, B, Santasusana, M, Piqueras, M, Fuentes, J, Larriba, J, Caro, R, Garcia, A, Aparicio, L, Lopez, N, Aragon, V, Morales, C, Figueiras, M, Ibanez, J, Billalabeitia, G, Estrada, E, Arranz, J, Sorrosal, J, Lozano, A, de Villena, M, Espinosa, E, Lopez, R, Perez, J, Laurell, A, Stierner, U, Cwikiel, M, Borner, M, Dietrich, P, Rothermundt, C, Pu, Y, Chang, Y, Ou, Y, Chuang, C, Liao, Y, Srimuninnimit, V, Sriuranpong, V, Buyukberber, S, Yalcin, B, Goker, E, Yalcin, S, Geldart, T, Wagstaff, J, Nicholson, S, Chowdhury, S, Bahl, A, Jones, R, Azzabi, A, Chao, D, Fife, K, Mead, G, Nathan, P, Pandha, H, Hajdenberg, J, Gabrail, N, Nimeh, N, Logan, T, Flaig, T, Schraeder, R, Rini, B, O'Rourke, M, Alemany, C, Kessinger, A, Amin, A, Arriaga, M, Rodriguez, J, Gauler, Thomas (Beitragende*r), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, and Laboratory of Molecular and Medical Oncology

Subjects
Nephrology, Oncology, Male, Cancer Research, mTOR inhibitor, Settore MED/06 - Oncologia Medica, Medizin, Advanced kidney cancer, RAD001, REACT, 0302 clinical medicine, Renal cell carcinoma, Receptors, 80 and over, Treatment Failure, Neoplasm Metastasis, Aged, 80 and over, 0303 health sciences, Vascular Endothelial Growth Factor, Sirolimus, Young Adult, Antineoplastic Agents, Humans, Aged, Immunosuppressive Agents, Protein Kinase Inhibitors, Receptors, Vascular Endothelial Growth Factor, Kidney Neoplasms, Adult, Carcinoma, Renal Cell, Middle Aged, Female, 3. Good health, 030220 oncology & carcinogenesis, Safety, medicine.drug, medicine.medical_specialty, SECOND LINE THERPAY, Second-line therapy, Everolimus, 03 medical and health sciences, Internal medicine, medicine, Adverse effect, 030304 developmental biology, business.industry, Carcinoma, Renal Cell, medicine.disease, Surgery, Clinical trial, Expanded access, business, Kidney cancer
Abstract

BACKGROUND AND OBJECTIVES: The RECORD-1 trial established the clinical benefit of everolimus in patients with metastatic renal cell carcinoma (mRCC) after failure of initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy. The REACT (RAD001 Expanded Access Clinical Trial in RCC) study was initiated to address an unmet medical need by providing everolimus prior to commercial availability, and also to further assess the safety and efficacy of everolimus in patients with VEGFr-TKI-refractory mRCC. PATIENTS AND METHODS: REACT (Clinicaltrials.gov: NCT00655252) was a global, open-label, expanded-access programme in patients with mRCC who were intolerant of, or who had progressed on or after stopping treatment with, any available VEGFr-TKI therapy. Patients received everolimus 10mg once daily, with dose and schedule modifications allowed for toxicity. Patients were closely monitored for the development of serious and grades 3/4 adverse events (AEs). Response was assessed by RECIST every 3months for the first year and every 6months thereafter. RESULTS: A total of 1367 patients were enroled. Safety findings and tumour responses were consistent with those observed in RECORD-1, with no new safety issues identified. The most commonly reported serious AEs were dyspnoea (5.0%), pneumonia (4.7%) and anaemia (4.1%), and the most commonly reported grades 3/4 AEs were anaemia (13.4%), fatigue (6.7%) and dyspnoea (6.5%). Best overall response was stable disease in 51.6% and partial response in 1.7% of patients. Median everolimus treatment duration was 14weeks. CONCLUSION: Everolimus is well tolerated in patients with mRCC and demonstrates a favourable risk-benefit ratio.

Published
2012

9. EAU-ESMO consensus statements on the management of advanced and variant bladder cancer-an international collaborative multi-stakeholder effort

Author

Antoine G. van der Heijden, Konstantinos Dimitropoulos, Joost L. Boormans, Bogdan Geavlete, Iris Brummelhuis, Andrew K. Williams, Christoph R. Müller, Susanne Vahr Lauridsen, Arturo Chiti, Manish I. Patel, Jonathan E. Rosenberg, Baris Turkbey, Carl Salembier, Thomas Wiegel, Anja Lorch, Valérie Fonteyne, Willem de Blok, Evanguelos Xylinas, Antti Salminen, Ann Henry, Karin Plass, Amir Sherif, Hugh Mostafid, Peter Wiklund, Erik Veskimäe, Hein Van Poppel, Max Bürger, Juan Palou, J. Domínguez-Escrig, Karel Decaestecker, Morgan Rouprêt, Helle Pappot, Paul Sargos, Berardino De Bari, Riccardo Valdagni, Luís Pacheco-Figueiredo, Jorge Huguet, Silke Gillessen, Olivier Rouvière, Maria J. Ribal, Yann Neuzillet, Richard Cathomas, Shaista Hafeez, Robert Jan Smeenk, Mark Frydenberg, Marek Babjuk, Antoni Vilaseca, Maria De Santis, Jonathan Richenberg, Annemarie Leliveld, Tom J.H. Arends, Shomik Sengupta, Vibeke Løgager, Harry W. Herr, Wim J.G. Oyen, Ananya Choudhury, Nicholas D. James, Susanne Osanto, Shahrokh F. Shariat, Vincent Khoo, A. Müller, Neeraj Agarwal, Pieter De Visschere, Bradley R. Pieters, Alberto Briganti, Robert Jones, Peter C. Black, Alberto Bossi, H. Maxim Bruins, Richard P. Meijer, Bertrand Tombal, Ken Herrmann, Donna E. Hansel, M. Carmen Mir, Stéphane Culine, J. Alfred Witjes, Virginia Hernández, Joaquim Bellmunt, Arnulf Stenzl, Eva Compérat, Alan Horwich, Alison Birtle, Jorg R. Oddens, Bernhard Grubmüller, Margitta Retz, Sylvain Ladoire, Marco Moschini, Aristotle Bamias, Simon J. Crabb, Michel Bolla, Theo H. van der Kwast, Steven MacLennan, Michael Rink, Anita Smits, Yohann Loriot, Estefania Linares-Espinós, James N'Dow, Theo M. de Reijke, Thomas Powles, Jurgen J. Fütterer, Arndt Hartmann, Daniel Castellano, Mesut Remzi, Paolo Gontero, Dickon Hayne, Anne E. Kiltie, Richard Zigeuner, Georgios Gakis, Franklin A. Vives Rivera, Stefano Fanti, Susanne Krege, Pedro C. Lara, Mihai Dorin Vartolomei, Ashish M. Kamat, Jan Oldenburg, Peter Hoskin, Andrea Necchi, Barbara Alicja Jereczek-Fossa, George N. Thalmann, Bernard H. Bochner, Florian Roghmann, Horwich, A, 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, Witjes, Ja, Radiation Oncology, Horwich A, 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, Compérat E, Crabb S, Culine S, De Bari B, DeBlok 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, 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, Carmen Mir M, Moschini M, Mostafid H, Müller AC, Müller 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, 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, Vahr Lauridsen S, Valdagni R, Van Der Heijden AG, Van Poppel H, Vartolomei MD, Veskimäe E, Vilaseca A, Vives Rivera FA, Wiegel T, Wiklund P, Williams A, Zigeuner R, Witjes JA., Universidade do Minho, APH - Personalized Medicine, APH - Quality of Care, CCA - Cancer Treatment and Quality of Life, Urology, Radiotherapy, UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie, and Pathology

Subjects
0301 basic medicine, Delphi Technique, diagnosis, International Cooperation, Medicina Básica [Ciências Médicas], Delphi method, Medizin, CISPLATIN-INELIGIBLE PATIENTS, Medical Oncology, Delphi, 0302 clinical medicine, PROGNOSTIC-FACTORS, Multidisciplinary approach, Surveys and Questionnaires, consensu, follow-up, SINGLE-ARM, Medicine, Statistical analysis, Multi stakeholder, TRANSITIONAL-CELL CARCINOMA, Societies, Medical, computer.programming_language, treatment, Consensus conference, Hematology, 3. Good health, Europe, diagnosi, Oncology, Urological cancers Radboud Institute for Health Sciences [Radboudumc 15], 030220 oncology & carcinogenesis, Ciências Médicas::Medicina Básica, Practice Guidelines as Topic, TUMOR RESPONSE, Special article, bladder cancer, RADICAL CYSTECTOMY, LYMPHOCYTE RATIO, medicine.medical_specialty, METASTATIC UROTHELIAL CARCINOMA, Urology, Urinary Bladder, education, Rare cancers Radboud Institute for Molecular Life Sciences [Radboudumc 9], LONG-TERM-SURVIVAL, 03 medical and health sciences, SDG 3 - Good Health and Well-being, Stakeholder Participation, Urological cancers Radboud Institute for Molecular Life Sciences [Radboudumc 15], Journal Article, Humans, Oligometastatic disease, Neoplasm Staging, Science & Technology, Bladder cancer, business.industry, medicine.disease, 030104 developmental biology, Urinary Bladder Neoplasms, consensus, Family medicine, business, computer
Abstract

Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial. 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, The authors would like to thank Peter E. Clark from Atrium Health, Levine Cancer Institute, Charlotte, NC, USA, for his contribution to the Delphi survey. Angela Corstorphine of Kstorfin Medical Communications Ltd provided medical writing support with the preparation of this manuscript; this support was funded jointly by EAU and ESMO.

Published
2019

10. 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

Thomas Powles, Michiel S van der Heijden, Daniel Castellano, Matthew D Galsky, Yohann Loriot, Daniel P Petrylak, Osamu Ogawa, Se Hoon Park, Jae-Lyun Lee, Ugo De Giorgi, Martin Bögemann, Aristotelis Bamias, Bernhard J Eigl, Howard Gurney, Som D Mukherjee, Yves Fradet, Iwona Skoneczna, Marinos Tsiatas, Andrey Novikov, Cristina Suárez, André P Fay, Ignacio Duran, Andrea Necchi, Sophie Wildsmith, Philip He, Natasha Angra, Ashok K Gupta, Wendy Levin, Joaquim Bellmunt, Michiel S. van der Heijden, Jae Lyun Lee, Bernhard J. Eigl, Som D. Mukherjee, Cristina Suarez, Hans Westgeest, Aude Flechon, Yen-Chuan Ou, Inkeun Park, Vsevolod Matveev, Begoña Pérez-Valderrama, Susanna Cheng, Stephen Frank, Urbano Anido, Alketa Hamzaj, Margitta Retz, Srikala Sridhar, Giorgio Vittorio Scagliotti, Jens Voortman, Boris Alekseev, Anna Alyasova, Boris Komyakov, Herlinde Dumez, Michel Pavic, Go Kimura, Atsushi Mizokami, Susanne Osanto, Jose Angel Arranz, Djura Piersma, Sang Joon Shin, Oleg Karyakin, Ignacio Delgado, Jose Luis Gonzalez, See-Tong Pang, Anna Tran, Oleg Lipatov, Wen-Pin Su, Thomas Flaig, Ajjai Alva, Hwa Park Kyong, Evgeny Kopyltsov, Elena Almagro, Monserrat Domenech, Yen-Hwa Chang, Brieuc Sautois, Andre Ravaux, Gerasimos Aravantinos, Vasileios Georgoulias, Sasja Mulder, Yu Jung Kim, Fabio Kater, Christine Chevreau, Scott Tagawa, Pawel Zalewski, Florence Joly, Gencay Hatiboglu, Luca Gianni, Franco Morelli, Rosa Tambaro, Yasuhiro Hashimoto, Alexander Nosov, Albert Font, Alejo M. Rodriguez-Vida, Robert Jones, Naveen Vasudev, Sandhya Srinivas, Jingsong Zhang, Thierry Gil, Daygen Finch, Marc-Oliver Grimm, Yu-Li Su, Simon Chowdhury, Christopher Hocking, Eugen Plas, Scott North, Niels Viggo Jensen, Christine Theodore, Florian Imkamp, Avivit Peer, Takashi Kobayashi, Hideki Sakai, Naoto Sassa, Kazuhiro Yoshimura, Maureen Aarts, Ana Ferreira Castro, Marlen Topuzov, Juan Francisco Rodriguez, Federico Jose Vazquez, Yu-Chieh Tsai, Simon Crabb, Syed Hussain, Johanna Bendell, Marine Gross-Goupil, Gravis Gwenaelle, Raanan Berger, Galina Statsenko, Linda Evans, Alexandra Drakaki, Bradley Somer, Ian Davis, James Lynam, Giuliano Borges, Aldo Dettino, André P. 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Subjects
0301 basic medicine, Male, medicine.medical_specialty, Urologic Neoplasms, Durvalumab, Time Factors, medicine.medical_treatment, Population, Neutropenia, Antibodies, Monoclonal, Humanized, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Antineoplastic Agents, Immunological, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, education, Immune Checkpoint Inhibitors, Aged, Chemotherapy, education.field_of_study, business.industry, Hazard ratio, Carcinoma, Antibodies, Monoclonal, Middle Aged, medicine.disease, Gemcitabine, Carboplatin, 030104 developmental biology, Treatment Outcome, Oncology, chemistry, 030220 oncology & carcinogenesis, Female, Urothelium, business, Tremelimumab, medicine.drug
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 (Interpretation: This study did not meet either of its coprimary endpoints. Further research to identify the patients with previously untreated metastatic urothelial carcinoma who benefit from treatment with immune checkpoint inhibitors, either alone or in combination regimens, is warranted.Funding: AstraZeneca.

Published
2020

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