TY - JOUR
T1 - Definitions, End Points, and Clinical Trial Designs for Bladder Cancer
T2 - Recommendations From the Society for Immunotherapy of Cancer and the International Bladder Cancer Group
AU - Kamat, Ashish M.
AU - Apolo, Andrea B.
AU - Babjuk, Marek
AU - Bivalacqua, Trinity J.
AU - Black, Peter C.
AU - Buckley, Roger
AU - Campbell, Matthew T.
AU - Compérat, Eva
AU - Efstathiou, Jason A.
AU - Grivas, Petros
AU - Gupta, Shilpa
AU - Kurtz, Neil J.
AU - Lamm, Donald
AU - Lerner, Seth P.
AU - Li, Roger
AU - McConkey, David J.
AU - Redorta, Joan Palou
AU - Powles, Thomas
AU - Psutka, Sarah P.
AU - Shore, Neal
AU - Steinberg, Gary D.
AU - Sylvester, Richard
AU - Witjes, J. Alfred
AU - Galsky, Matthew D.
N1 - Publisher Copyright:
© 2023 by American Society of Clinical Oncology.
PY - 2023/12/10
Y1 - 2023/12/10
N2 - PURPOSE There is a significant unmet need for new and efficacious therapies in urothelial cancer (UC). To provide recommendations on appropriate clinical trial designs across disease settings in UC, the Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG) convened a multidisciplinary, international consensus panel. METHODS Through open communication and scientific debate in small- and whole-group settings, surveying, and responses to clinical questionnaires, the consensus panel developed recommendations on optimal definitions of the disease state, end points, trial design, evaluations, sample size calculations, and pathology considerations for definitive studies in low- and intermediate-risk nonmuscle-invasive bladder cancer (NMIBC), high-risk NMIBC, muscle-invasive bladder cancer in the neoadjuvant and adjuvant settings, and metastatic UC. The expert panel also solicited input on the recommendations through presentations and public discussion during an open session at the 2021 Bladder Cancer Advocacy Network (BCAN) Think Tank (held virtually). RESULTS The consensus panel developed a set of stage-specific bladder cancer clinical trial design recommendations, which are summarized in the table that accompanies this text. CONCLUSION These recommendations developed by the SITC-IBCG Bladder Cancer Clinical Trial Design consensus panel will encourage uniformity among studies and facilitate drug development in this disease.
AB - PURPOSE There is a significant unmet need for new and efficacious therapies in urothelial cancer (UC). To provide recommendations on appropriate clinical trial designs across disease settings in UC, the Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG) convened a multidisciplinary, international consensus panel. METHODS Through open communication and scientific debate in small- and whole-group settings, surveying, and responses to clinical questionnaires, the consensus panel developed recommendations on optimal definitions of the disease state, end points, trial design, evaluations, sample size calculations, and pathology considerations for definitive studies in low- and intermediate-risk nonmuscle-invasive bladder cancer (NMIBC), high-risk NMIBC, muscle-invasive bladder cancer in the neoadjuvant and adjuvant settings, and metastatic UC. The expert panel also solicited input on the recommendations through presentations and public discussion during an open session at the 2021 Bladder Cancer Advocacy Network (BCAN) Think Tank (held virtually). RESULTS The consensus panel developed a set of stage-specific bladder cancer clinical trial design recommendations, which are summarized in the table that accompanies this text. CONCLUSION These recommendations developed by the SITC-IBCG Bladder Cancer Clinical Trial Design consensus panel will encourage uniformity among studies and facilitate drug development in this disease.
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U2 - 10.1200/JCO.23.00307
DO - 10.1200/JCO.23.00307
M3 - Article
C2 - 37793077
AN - SCOPUS:85179124556
SN - 0732-183X
VL - 41
SP - 5437
EP - 5447
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 35
ER -