Definitions, End Points, and Clinical Trial Designs for Bladder Cancer: Recommendations From the Society for Immunotherapy of Cancer and the International Bladder Cancer Group

被引：26

作者：

Kamat, Ashish M. ^{[1
,25
]}

Apolo, Andrea B. ^{[2
]}

Babjuk, Marek ^{[3
]}

Bivalacqua, Trinity J. ^{[4
]}

Black, Peter C. ^{[5
]}

Buckley, Roger ^{[6
]}

Campbell, Matthew T. ^{[7
]}

Comperat, Eva ^{[8
]}

Efstathiou, Jason A. ^{[9
]}

Grivas, Petros ^{[10
,11
]}

Gupta, Shilpa ^{[12
]}

Kurtz, Neil J. ^{[13
]}

Lamm, Donald ^{[14
]}

Lerner, Seth P. ^{[15
]}

Li, Roger ^{[16
]}

Mcconkey, David J. ^{[17
]}

Redorta, Joan Palou ^{[16
]}

Powles, Thomas ^{[18
]}

Psutka, Sarah P. ^{[19
]}

Shore, Neal ^{[20
]}

Steinberg, Gary D. ^{[21
]}

Sylvester, Richard ^{[22
]}

Witjes, J. Alfred ^{[23
]}

Galsky, Matthew D. ^{[24
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Dept Urol, Houston, TX USA

[2] NCI, Ctr Canc Res, NIH, Bethesda, MD USA

[3] Charles Univ Prague, Teaching Hosp Motol, Fac Med 2, Dept Urol, Prague, Czech Republic

[4] Univ Penn, Dept Surg, Div Urol, Philadelphia, PA USA

[5] Univ British Columbia, Dept Urol Sci, Vancouver, BC, Canada

[6] North York Gen Hosp, Dept Urol, Toronto, ON, Canada

[7] Univ Texas MD Anderson Canc Ctr, Dept Genitourinary Med Oncol, Div Canc Med, Houston, TX USA

[8] Med Univ Vienna, Dept Pathol, Vienna, Austria

[9] Harvard Med Sch, Massachusetts Gen Hosp, Dept Radiat Oncol, Boston, MA USA

[10] Univ Washington, Dept Med, Div Oncol, Seattle, WA USA

[11] Fred Hutchinson Canc Ctr, Clin Res Div, Seattle, WA USA

[12] Taussig Canc Inst, Dept Hematol & Med Oncol, Cleveland Clin, Cleveland, OH USA

[13] Bladder Canc Advocacy Network BCAN, Patient Advocate, Bethesda, MD USA

[14] BCG Oncol, Phoenix, AZ USA

[15] Baylor Coll Med, Dan Duncan Canc Ctr, Scott Dept Urol, Houston, TX USA

[16] H Lee Moffitt Canc Ctr & Res Inst, Dept Genitourinary Oncol, Tampa, FL USA

[17] Johns Hopkins Univ, Johns Hopkins Greenberg Bladder Canc Inst, Baltimore, MD USA

[18] Queen Mary Univ London, London, England

[19] Univ Washington, Fred Hutchinson Canc Ctr, Dept Urol, Seattle, WA USA

[20] Carolina Urol Res Ctr, Myrtle Beach, SC USA

[21] Rush Univ, Med Ctr, Dept Urol, Chicago, IL USA

[22] EAU NMIBC Guidelines Panel, Arnhem, Netherlands

[23] Radboud Univ Nijmegen, Med Ctr, Nijmegen, Netherlands

[24] Tisch Canc Inst, Icahn Sch Med Mt Sinai, New York, NY USA

[25] Univ Texas MD Anderson Canc Ctr, Dept Urol, 1155 Pressler St,Unit 1373,CBP7 3269, Houston, TX 77030 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2023年 / 41卷 / 35期

关键词：

CARCINOMA IN-SITU; SEQUENTIAL INTRAVESICAL GEMCITABINE; UROTHELIAL CARCINOMA; NEOADJUVANT CHEMOTHERAPY; RADICAL CYSTECTOMY; TUMOR MARKERS; CISPLATIN; EFFICACY; DOCETAXEL; DIAGNOSIS;

D O I：

10.1200/JCO.23.00307

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PURPOSEThere 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.METHODSThrough 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).RESULTSThe consensus panel developed a set of stage-specific bladder cancer clinical trial design recommendations, which are summarized in the table that accompanies this text.CONCLUSIONThese 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.

引用

页码：5437 / +

页数：13

共 54 条

[31] The BCG Shortage [J].

Messing, Edward M. .

BLADDER CANCER, 2017, 3 (03) :227-228

[32] Oncological Outcomes of Sequential Intravesical Gemcitabine and Docetaxel in Patients with Non-Muscle Invasive Bladder Cancer [J].

Milbar, Niv ;

Kates, Max ;

Chappidi, Meera R. ;

Pederzoli, Filippo ;

Yoshida, Takahiro ;

Sankin, Alexander ;

Pierorazio, Phillip M. ;

Schoenberg, Mark P. ;

Bivalacqua, Trinity J. .

BLADDER CANCER, 2017, 3 (04) :293-303

[33] CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer [J].

Mostafid, A. Hugh ;

Porta, Nuria ;

Cresswell, Joanne ;

Griffiths, Thomas R. L. ;

Kelly, John D. ;

Penegar, Steven R. ;

Davenport, Kim ;

McGrath, John S. ;

Campain, Nicholas ;

Cooke, Peter ;

Masood, Shikohe ;

Knowles, Margaret A. ;

Feber, Andrew ;

Knight, Allen ;

Catto, James W. F. ;

Lewis, Rebecca ;

Hall, Emma .

BJU INTERNATIONAL, 2020, 125 (06) :817-826

[34] The 2022 World Health Organization Classification of Tumors of the Urinary System and Male Genital Organs-Part B: Prostate and Urinary Tract Tumors [J].

Netto, George J. ;

Amin, Mahul B. ;

Berney, Daniel M. ;

Comperat, Eva M. ;

Gill, Anthony J. ;

Hartmann, Arndt ;

Menon, Santosh ;

Raspollini, Maria R. ;

Rubin, Mark A. ;

Srigley, John R. ;

Tan, Puay Hoon ;

Tickoo, Satish K. ;

Tsuzuki, Toyonori ;

Turajlic, Samra ;

Cree, Ian ;

Moch, Holger .

EUROPEAN UROLOGY, 2022, 82 (05) :469-482

[35] Frequency of positive biopsies after visual disappearance of superficial bladder cancer marker lesions [J].

Oosterlinck, W ;

Bono, AV ;

Mack, D ;

Hall, R ;

Sylvester, R ;

de Balincourt, C ;

Brausi, M .

EUROPEAN UROLOGY, 2001, 40 (05) :515-517

[36] ctDNA guiding adjuvant immunotherapy in urothelial carcinoma [J].

Powles, Thomas ;

Assaf, Zoe June ;

Davarpanah, Nicole ;

Banchereau, Romain ;

Szabados, Bernadett E. ;

Yuen, Kobe C. ;

Grivas, Petros ;

Hussain, Maha ;

Oudard, Stephane ;

Gschwend, Jurgen E. ;

Albers, Peter ;

Castellano, Daniel ;

Nishiyama, Hiroyuki ;

Daneshmand, Siamak ;

Sharma, Shruti ;

Zimmermann, Bernhard G. ;

Sethi, Himanshu ;

Aleshin, Alexey ;

Perdicchio, Maurizio ;

Zhang, Jingbin ;

Shames, David S. ;

Degaonkar, Viraj ;

Shen, Xiaodong ;

Carter, Corey ;

Bais, Carlos ;

Bellmunt, Joaquim ;

Mariathasan, Sanjeev .

NATURE, 2021, 595 (7867) :432-+

[37] Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma [J].

Powles, Thomas ;

Park, Se Hoon ;

Voog, Eric ;

Caserta, Claudia ;

Valderrama, Begona P. ;

Gurney, Howard ;

Kalofonos, Haralabos ;

Radulovic, Sinisa ;

Demey, Wim ;

Ullen, Anders ;

Loriot, Yohann ;

Sridhar, Srikala S. ;

Tsuchiya, Norihiko ;

Kopyltsov, Evgeny ;

Sternberg, Cora N. ;

Bellmunt, Joaquim ;

Aragon-Ching, Jeanny B. ;

Petrylak, Daniel P. ;

Laliberte, Robert ;

Wang, Jing ;

Huang, Bo ;

Davis, Craig ;

Fowst, Camilla ;

Costa, Nuno ;

Blake-Haskins, John A. ;

di Pietro, Alessandra ;

Grivas, Petros .

NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (13) :1218-1230

[38] Optimal pathological response after neoadjuvant chemotherapy for muscle-invasive bladder cancer: results from a global, multicentre collaboration [J].

Ravi, Praful ;

Pond, Gregory R. ;

Diamantopoulos, Leonidas N. ;

Su, Christopher ;

Alva, Ajjai ;

Jain, Rohit K. ;

Skelton, William P. ;

Gupta, Sumati ;

Tward, Jonathan D. ;

Olson, Kathleen M. ;

Singh, Parminder ;

Grunewald, Camilla M. ;

Niegisch, Guenter ;

Lee, Jae-Lyun ;

Gallina, Andrea ;

Bandini, Marco ;

Necchi, Andrea ;

Mossanen, Matthew ;

McGregor, Bradley A. ;

Curran, Catherine ;

Grivas, Petros ;

Sonpavde, Guru P. .

BJU INTERNATIONAL, 2021, 128 (05) :607-614

[39] Re: International Bladder Cancer Group Consensus Statement on Clinical Trial Design for Patients With Bacillus Calmette-Guerin-exposed High-risk Non-muscle-invasive Bladder Cancer Editorial Comment [J].

McGregor, B. ;

O'Donnell, P. H. ;

Balar, A. .

JOURNAL OF UROLOGY, 2023, 210 (01) :217-218

[40] Safety and efficacy of immune checkpoint inhibitors (ICIs) in cancer patients with HIV, hepatitis B, or hepatitis C viral infection [J].

Shah, Neil J. ;

Al-Shbool, Ghassan ;

Blackburn, Matthew ;

Cook, Michael ;

Belouali, Anas ;

Liu, Stephen V. ;

Madhavan, Subha ;

He, Aiwu Ruth ;

Atkins, Michael B. ;

Gibney, Geoffrey T. ;

Kim, Chul .

JOURNAL FOR IMMUNOTHERAPY OF CANCER, 2019, 7 (01)

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