A Joint Statement from the European Association of Urology Renal Cell Cancer Guidelines Panel and the International Kidney Cancer Coalition: The Rejection of Ipilimumab and Nivolumab for Renal Cancer by the Committee for Medicinal Products for Human Use Does not Change Evidence-based Guideline Recommendations

Axel Bex; Laurence Albiges; Michael Staehler; Karim Bensalah; Rachel H Giles; Saeed Dabestani; Fabian Hofmann; Milan Hora; Markus A Kuczyk; Thomas B Lam; Lorenzo Marconi; Axel S Merseburger; Sergio Fernández-Pello; Rana Tahbaz; Yasmin Abu-Ghanem; Alessandro Volpe; Börje Ljungberg; Bernard Escudier; Thomas Powles

doi:10.1016/j.eururo.2018.08.029

A Joint Statement from the European Association of Urology Renal Cell Cancer Guidelines Panel and the International Kidney Cancer Coalition: The Rejection of Ipilimumab and Nivolumab for Renal Cancer by the Committee for Medicinal Products for Human Use Does not Change Evidence-based Guideline Recommendations

Axel Bex
, Laurence Albiges
, Michael Staehler
, Karim Bensalah
, Rachel H Giles
, Saeed Dabestani
, Fabian Hofmann
, Milan Hora
, Markus A Kuczyk
, Thomas B Lam
, Lorenzo Marconi
, Axel S Merseburger
, Sergio Fernández-Pello
, Rana Tahbaz
, Yasmin Abu-Ghanem
, Alessandro Volpe
, Börje Ljungberg
, Bernard Escudier
, Thomas Powles^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Original language	English
Pages (from-to)	849-851
Number of pages	3
Journal	European Urology
Volume	74
Issue number	6
Early online date	7 Sept 2018
DOIs	https://doi.org/10.1016/j.eururo.2018.08.029
Publication status	Published - Dec 2018

Keywords

Letter
Kidney Neoplasms/drug therapy
Nephrology/standards
Ipilimumab/adverse effects
Humans
Nivolumab/adverse effects
Treatment Outcome
Drug Approval
Antineoplastic Combined Chemotherapy Protocols/adverse effects
Patient Selection
Evidence-Based Medicine/standards
Clinical Decision-Making
Carcinoma, Renal Cell/drug therapy
Urology/standards
Antineoplastic Agents, Immunological/adverse effects

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10.1016/j.eururo.2018.08.029

A human monoclonal antibody that specifically binds and inhibits the staphylococcal complement inhibitor protein SCINFinal published version, 1.2 MBLicence: Taverne

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Bex, A., Albiges, L., Staehler, M., Bensalah, K., Giles, R. H., Dabestani, S., Hofmann, F., Hora, M., Kuczyk, M. A., Lam, T. B., Marconi, L., Merseburger, A. S., Fernández-Pello, S., Tahbaz, R., Abu-Ghanem, Y., Volpe, A., Ljungberg, B., Escudier, B., & Powles, T. (2018). A Joint Statement from the European Association of Urology Renal Cell Cancer Guidelines Panel and the International Kidney Cancer Coalition: The Rejection of Ipilimumab and Nivolumab for Renal Cancer by the Committee for Medicinal Products for Human Use Does not Change Evidence-based Guideline Recommendations. European Urology, 74(6), 849-851. https://doi.org/10.1016/j.eururo.2018.08.029

Bex, Axel ; Albiges, Laurence ; Staehler, Michael et al. / A Joint Statement from the European Association of Urology Renal Cell Cancer Guidelines Panel and the International Kidney Cancer Coalition : The Rejection of Ipilimumab and Nivolumab for Renal Cancer by the Committee for Medicinal Products for Human Use Does not Change Evidence-based Guideline Recommendations. In: European Urology. 2018 ; Vol. 74, No. 6. pp. 849-851.

@article{0783a739da604d7ca27f4967d861d761,

title = "A Joint Statement from the European Association of Urology Renal Cell Cancer Guidelines Panel and the International Kidney Cancer Coalition: The Rejection of Ipilimumab and Nivolumab for Renal Cancer by the Committee for Medicinal Products for Human Use Does not Change Evidence-based Guideline Recommendations",

keywords = "Letter, Kidney Neoplasms/drug therapy, Nephrology/standards, Ipilimumab/adverse effects, Humans, Nivolumab/adverse effects, Treatment Outcome, Drug Approval, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Patient Selection, Evidence-Based Medicine/standards, Clinical Decision-Making, Carcinoma, Renal Cell/drug therapy, Urology/standards, Antineoplastic Agents, Immunological/adverse effects",

author = "Axel Bex and Laurence Albiges and Michael Staehler and Karim Bensalah and Giles, \{Rachel H\} and Saeed Dabestani and Fabian Hofmann and Milan Hora and Kuczyk, \{Markus A\} and Lam, \{Thomas B\} and Lorenzo Marconi and Merseburger, \{Axel S\} and Sergio Fern{\'a}ndez-Pello and Rana Tahbaz and Yasmin Abu-Ghanem and Alessandro Volpe and B{\"o}rje Ljungberg and Bernard Escudier and Thomas Powles",

note = "Funding Information: Conflicts of interest: Professor Dr. Thomas Powles is a company consultant for Novartis, Pfizer, and GlaxoSmithKline; has received company speaker honoraria from Novartis, Pfizer, GlaxoSmithKline, BMS, MSD, and Genentech; has participated in trials for GlaxoSmithKline, Pfizer, BMS, Genentech, and Genetech; and has received grants/research support from GlaxoSmithKline, Pfizer, and Novartis. Professor Dr. Axel Bex has received company speaker honoraria from Pfizer; has participated in trials for Pfizer Europe; has participated in advisory boards for GlaxoSmithKline and Novartis; is a company consultant for Pfizer and Novartis; and has received grants/research support from Pfizer. Professor Dr. B{\"o}rje Ljungberg has received company speaker honoraria from GlaxoSmithKline, Roche, Pfizer, and Novartis; has participated in trials for GlaxoSmithKline, Medivation, Pfizer, and Janssen R\&D; and has been on advisory boards for Pfizer and GlaxoSmithKline. Professor Dr. B. Escudier has received honorarium from BMS. Professor Dr. Laurence Albiges has received consulting/advisory fees from BMS, Pfizer, Novartis, Sanofi, Amgen, Bristol-Myers Squibb, Bayer, and Cerulean; and has received research funding from Pfizer and Novartis. Professor Dr. Karim Bensalah has received grants/research support from Pfizer and honoraria or consultation fees from Intuitive Surgical. Professor Dr. Michael Staehler is a company consultant for Pfizer, Novartis, GlaxoSmithKline, Roche, Astellas, and Bayer; has received company speaker honoraria from Pfizer, Novartis, GlaxoSmithKline, Roche, Astellas, Bayer, and Aveo; has participated in trials for Pfizer, Novartis, GlaxoSmithKline, Roche, Bayer, Aveo, Wilex, and Immatics; has received fellowships and travel grants from Pfizer, Novartis, GlaxoSmithKline, Roche, and Bayer; has received grants/research support from Pfizer, Novartis, GlaxoSmithKline, Roche, Bayer, and Aveo; and took part in the S-TRAC trial as an investigator and is an author on the S-TRAC publication. Professor Dr. Milan Hora has received company speaker honoraria from Covidien, Olympus, Janssen, and Astellas; has participated in trials for Janssen; and has received grants/research support from Ipsen. Professor Dr. Markus A. Kuczyk is a stock shareholder of Bayer Healthcare, Astellas, Storz, Pfizer, Wyeth, and Novartis; is a company consultant for Karl Storz, Coloplast, AstraZeneca, Astellas, Storz, and Hexal; has received company speaker honoraria from Pfizer, Astellas, Bayer, GlaxoSmithKline, Pierre Fabre, Janssen Cilag, and Hexal; has participated in trials for the ProtecT Study, Millenium Study C21004, Millenium Study C21005, Astellas, Ipsen, and Janssen; and has received grants/research support from Wyeth and Pfizer. Dr. Thomas B. Lam is a company consultant for and has received company speaker honoraria from Pfizer, GlaxoSmithKline, Astellas, and Ipsen. Professor Dr. Axel S. Merseburger is a company consultant for Ipsen Pharma, Bayer, Astellas, Janssen Cilag, Novartis, and Pfizer; has received company speaker honoraria from Ipsen Pharma, Wyeth, Astellas, Novartis, Pfizer, and SEP; has participated in trials for AstraZeneca, Bayer, Pfizer, TEVA, Novartis, and Astellas; has received grants/research support from Wyeth; and has participated in a company-sponsored speakers bureau for TEVA, Janssen, Pfizer, Astellas, Ferring, and Novartis. Professor Dr. Rachel H. Giles, Professor Dr. Alessandro Volpe, Dr. Saeed Dabestani, Dr. Fabian Hofmann, Dr. Lorenzo Marconi, Dr. Sergio Fern{\'a}ndez-Pello, Dr. Rana Tahbaz, and Dr. Yasmin Abu-Ghanem have nothing to disclose.",

year = "2018",

month = dec,

doi = "10.1016/j.eururo.2018.08.029",

language = "English",

volume = "74",

pages = "849--851",

journal = "European Urology",

issn = "0302-2838",

publisher = "Elsevier",

number = "6",

}

Bex, A, Albiges, L, Staehler, M, Bensalah, K, Giles, RH, Dabestani, S, Hofmann, F, Hora, M, Kuczyk, MA, Lam, TB, Marconi, L, Merseburger, AS, Fernández-Pello, S, Tahbaz, R, Abu-Ghanem, Y, Volpe, A, Ljungberg, B, Escudier, B & Powles, T 2018, 'A Joint Statement from the European Association of Urology Renal Cell Cancer Guidelines Panel and the International Kidney Cancer Coalition: The Rejection of Ipilimumab and Nivolumab for Renal Cancer by the Committee for Medicinal Products for Human Use Does not Change Evidence-based Guideline Recommendations', European Urology, vol. 74, no. 6, pp. 849-851. https://doi.org/10.1016/j.eururo.2018.08.029

A Joint Statement from the European Association of Urology Renal Cell Cancer Guidelines Panel and the International Kidney Cancer Coalition: The Rejection of Ipilimumab and Nivolumab for Renal Cancer by the Committee for Medicinal Products for Human Use Does not Change Evidence-based Guideline Recommendations. / Bex, Axel; Albiges, Laurence; Staehler, Michael et al.
In: European Urology, Vol. 74, No. 6, 12.2018, p. 849-851.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - A Joint Statement from the European Association of Urology Renal Cell Cancer Guidelines Panel and the International Kidney Cancer Coalition

T2 - The Rejection of Ipilimumab and Nivolumab for Renal Cancer by the Committee for Medicinal Products for Human Use Does not Change Evidence-based Guideline Recommendations

AU - Bex, Axel

AU - Albiges, Laurence

AU - Staehler, Michael

AU - Bensalah, Karim

AU - Giles, Rachel H

AU - Dabestani, Saeed

AU - Hofmann, Fabian

AU - Hora, Milan

AU - Kuczyk, Markus A

AU - Lam, Thomas B

AU - Marconi, Lorenzo

AU - Merseburger, Axel S

AU - Fernández-Pello, Sergio

AU - Tahbaz, Rana

AU - Abu-Ghanem, Yasmin

AU - Volpe, Alessandro

AU - Ljungberg, Börje

AU - Escudier, Bernard

AU - Powles, Thomas

N1 - Funding Information: Conflicts of interest: Professor Dr. Thomas Powles is a company consultant for Novartis, Pfizer, and GlaxoSmithKline; has received company speaker honoraria from Novartis, Pfizer, GlaxoSmithKline, BMS, MSD, and Genentech; has participated in trials for GlaxoSmithKline, Pfizer, BMS, Genentech, and Genetech; and has received grants/research support from GlaxoSmithKline, Pfizer, and Novartis. Professor Dr. Axel Bex has received company speaker honoraria from Pfizer; has participated in trials for Pfizer Europe; has participated in advisory boards for GlaxoSmithKline and Novartis; is a company consultant for Pfizer and Novartis; and has received grants/research support from Pfizer. Professor Dr. Börje Ljungberg has received company speaker honoraria from GlaxoSmithKline, Roche, Pfizer, and Novartis; has participated in trials for GlaxoSmithKline, Medivation, Pfizer, and Janssen R&D; and has been on advisory boards for Pfizer and GlaxoSmithKline. Professor Dr. B. Escudier has received honorarium from BMS. Professor Dr. Laurence Albiges has received consulting/advisory fees from BMS, Pfizer, Novartis, Sanofi, Amgen, Bristol-Myers Squibb, Bayer, and Cerulean; and has received research funding from Pfizer and Novartis. Professor Dr. Karim Bensalah has received grants/research support from Pfizer and honoraria or consultation fees from Intuitive Surgical. Professor Dr. Michael Staehler is a company consultant for Pfizer, Novartis, GlaxoSmithKline, Roche, Astellas, and Bayer; has received company speaker honoraria from Pfizer, Novartis, GlaxoSmithKline, Roche, Astellas, Bayer, and Aveo; has participated in trials for Pfizer, Novartis, GlaxoSmithKline, Roche, Bayer, Aveo, Wilex, and Immatics; has received fellowships and travel grants from Pfizer, Novartis, GlaxoSmithKline, Roche, and Bayer; has received grants/research support from Pfizer, Novartis, GlaxoSmithKline, Roche, Bayer, and Aveo; and took part in the S-TRAC trial as an investigator and is an author on the S-TRAC publication. Professor Dr. Milan Hora has received company speaker honoraria from Covidien, Olympus, Janssen, and Astellas; has participated in trials for Janssen; and has received grants/research support from Ipsen. Professor Dr. Markus A. Kuczyk is a stock shareholder of Bayer Healthcare, Astellas, Storz, Pfizer, Wyeth, and Novartis; is a company consultant for Karl Storz, Coloplast, AstraZeneca, Astellas, Storz, and Hexal; has received company speaker honoraria from Pfizer, Astellas, Bayer, GlaxoSmithKline, Pierre Fabre, Janssen Cilag, and Hexal; has participated in trials for the ProtecT Study, Millenium Study C21004, Millenium Study C21005, Astellas, Ipsen, and Janssen; and has received grants/research support from Wyeth and Pfizer. Dr. Thomas B. Lam is a company consultant for and has received company speaker honoraria from Pfizer, GlaxoSmithKline, Astellas, and Ipsen. Professor Dr. Axel S. Merseburger is a company consultant for Ipsen Pharma, Bayer, Astellas, Janssen Cilag, Novartis, and Pfizer; has received company speaker honoraria from Ipsen Pharma, Wyeth, Astellas, Novartis, Pfizer, and SEP; has participated in trials for AstraZeneca, Bayer, Pfizer, TEVA, Novartis, and Astellas; has received grants/research support from Wyeth; and has participated in a company-sponsored speakers bureau for TEVA, Janssen, Pfizer, Astellas, Ferring, and Novartis. Professor Dr. Rachel H. Giles, Professor Dr. Alessandro Volpe, Dr. Saeed Dabestani, Dr. Fabian Hofmann, Dr. Lorenzo Marconi, Dr. Sergio Fernández-Pello, Dr. Rana Tahbaz, and Dr. Yasmin Abu-Ghanem have nothing to disclose.

PY - 2018/12

Y1 - 2018/12

KW - Letter

KW - Kidney Neoplasms/drug therapy

KW - Nephrology/standards

KW - Ipilimumab/adverse effects

KW - Humans

KW - Nivolumab/adverse effects

KW - Treatment Outcome

KW - Drug Approval

KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects

KW - Patient Selection

KW - Evidence-Based Medicine/standards

KW - Clinical Decision-Making

KW - Carcinoma, Renal Cell/drug therapy

KW - Urology/standards

KW - Antineoplastic Agents, Immunological/adverse effects

UR - https://www.scopus.com/pages/publications/85056208512

U2 - 10.1016/j.eururo.2018.08.029

DO - 10.1016/j.eururo.2018.08.029

M3 - Article

C2 - 30201510

SN - 0302-2838

VL - 74

SP - 849

EP - 851

JO - European Urology

JF - European Urology

IS - 6

ER -

Bex A, Albiges L, Staehler M, Bensalah K, Giles RH, Dabestani S et al. A Joint Statement from the European Association of Urology Renal Cell Cancer Guidelines Panel and the International Kidney Cancer Coalition: The Rejection of Ipilimumab and Nivolumab for Renal Cancer by the Committee for Medicinal Products for Human Use Does not Change Evidence-based Guideline Recommendations. European Urology. 2018 Dec;74(6):849-851. Epub 2018 Sept 7. doi: 10.1016/j.eururo.2018.08.029

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