CREST: phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer

References

• International Agency for Research on Cancer (IARC). Bladder (2020). Available at: https://gco.iarc.fr/today/data/factsheets/cancers/30-Bladder-fact-sheet.pdf (Accessed: 10January2023).
   Google Scholar
• Saginala K , BarsoukA , AluruJS , RawlaP , PadalaSA , BarsoukA. Epidemiology of bladder cancer. Med. Sci. (Basel)8(1), 15 (2020).
   PubMedGoogle Scholar
• Bilski K , ZapałaŁ , SkrzypczykMA , OszczudłowskiM , DobruchJ. Review on gender differences in non-muscle invasive bladder cancer. Transl. Androl. Urol.8(1), 12–20 (2019).
   PubMed Web of Science ®Google Scholar
• Palou J , SylvesterRJ , FabaORet al. Female gender and carcinoma in situ in the prostatic urethra are prognostic factors for recurrence, progression, and disease-specific mortality in T1G3 bladder cancer patients treated with bacillus Calmette-Guérin. Eur. Urol.62(1), 118–125 (2012).
   PubMed Web of Science ®Google Scholar
• Han MA , MaischP , JungJHet al. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst. Rev.6(6), CD009294 (2021).
   PubMedGoogle Scholar
• Kamat AM , ShoreN , HahnNet al. KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC. Future Oncology16(10), 507–516 (2020).
   PubMed Web of Science ®Google Scholar
• Williams SB , HowardLE , FosterMLet al. Estimated Costs and Long-term Outcomes of Patients With High-Risk Non-Muscle-Invasive Bladder Cancer Treated With Bacillus Calmette-Guérin in the Veterans Affairs Health System. JAMA Network Open4(3), e213800–e213800 (2021).
   PubMed Web of Science ®Google Scholar
• Babjuk M , BöhleA , BurgerMet al. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: update 2016. Eur. Urol.71(3), 447–461 (2017).
   PubMed Web of Science ®Google Scholar
• Redelman-Sidi G , GlickmanMS , BochnerBH. The mechanism of action of BCG therapy for bladder cancer–a current perspective. Nature Reviews Urology11(3), 153–162 (2014).
   PubMed Web of Science ®Google Scholar
• Han J , GuX , LiY , WuQ. Mechanisms of BCG in the treatment of bladder cancer-current understanding and the prospect. Biomedicine & Pharmacotherapy129, 110393 (2020).
   PubMed Web of Science ®Google Scholar
• Chang SS , BoorjianSA , ChouRet al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J. Urol.196(4), 1021–1029 (2016).
   PubMed Web of Science ®Google Scholar
• Babjuk M , BurgerM , CapounOet al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur. Urol.81(1), 75–94 (2022).
   PubMed Web of Science ®Google Scholar
• Oddens J , BrausiM , SylvesterRet al. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur. Urol.63(3), 462–472 (2013).
   PubMed Web of Science ®Google Scholar
• Shore ND , PalouRedorta J , RobertGet al. Non-muscle-invasive bladder cancer: an overview of potential new treatment options. Urol. Oncol.39(10), 642–663 (2021).
   PubMed Web of Science ®Google Scholar
• Gual Frau J , PalouJ , RodríguezO , ParadaR , BredaA , VillavicencioH. Failure of Bacillus Calmette-Guérin therapy in non-muscle-invasive bladder cancer: definition and treatment options. Arch. Esp. Urol.69(7), 423–433 (2016).
   PubMed Web of Science ®Google Scholar
• Cambier S , SylvesterRJ , ColletteLet al. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non-Muscle-invasive Stage Ta-T1 Urothelial Bladder Cancer Patients Treated with 1–3 Years of Maintenance Bacillus Calmette-Guérin. Eur. Urol.69(1), 60–69 (2016).
   PubMed Web of Science ®Google Scholar
• Spiess PE , AgarwalN , BangsRet al. Bladder Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology. Journal of the National Comprehensive Cancer Network J. Natl Compr. Canc. Netw.15(10), 1240–1267 (2017).
   PubMed Web of Science ®Google Scholar
• Audisio A , ButtiglieroC , DelcuratoloMDet al. New Perspectives in the Medical Treatment of Non-Muscle-Invasive Bladder Cancer: Immune Checkpoint Inhibitors and Beyond. Cells11(3), 357 (2022).
   PubMed Web of Science ®Google Scholar
• Choi H , ParkJY , BaeJH , TaeBS. Health-related quality of life after radical cystectomy. Transl. Androl. Urol.9(6), 2997–3006 (2020).
   PubMed Web of Science ®Google Scholar
• Clements MB , AtkinsonTM , DalbagniGMet al. Health-related Quality of Life for Patients Undergoing Radical Cystectomy: Results of a Large Prospective Cohort. Eur. Urol.81(3), 294–304 (2022).
   PubMedGoogle Scholar
• Lobo N , BreeKK , HensleyPJet al. Reduced-dose bacillus Calmette-Guérin (BCG) in an era of BCG shortage: real-world experience from a tertiary cancer centre. BJU International130(3), 323–330 (2022).
   PubMed Web of Science ®Google Scholar
• Shiravand Y , KhodadadiF , KashaniSMAet al. Immune Checkpoint Inhibitors in Cancer Therapy. Current Oncology29(5), 3044–3060 (2022).
   PubMed Web of Science ®Google Scholar
• Bellmunt J , MullaneSA , WernerLet al. Association of PD-L1 expression on tumor-infiltrating mononuclear cells and overall survival in patients with urothelial carcinoma. Ann. Oncol.26(4), 812–817 (2015).
   PubMed Web of Science ®Google Scholar
• Escors D , Gato-CañasM , ZuazoMet al. The intracellular signalosome of PD-L1 in cancer cells. Signal Transduction and Targeted Therapy3(1), 26 (2018).
   PubMed Web of Science ®Google Scholar
• Hashizume A , UmemotoS , YokoseTet al. Enhanced expression of PD-L1 in non-muscle-invasive bladder cancer after treatment with Bacillus Calmette-Guerin. Oncotarget9(75), 34066–34078 (2018).
   PubMedGoogle Scholar
• Roumiguie M , ComperatE , NeuzilletYet al. PD-L1/PD-1 expression as a predictor of response to BCG in patients with high-risk non-muscle invasive bladder cancer. J. Clin. Oncol.37(Suppl. 15), 4550–4550 (2019).
   Google Scholar
• Inman BA , SeboTJ , FrigolaXet al. PD-L1 (B7-H1) expression by urothelial carcinoma of the bladder and BCG-induced granulomata: associations with localized stage progression. Cancer109(8), 1499–1505 (2007).
   PubMed Web of Science ®Google Scholar
• Wang Y , LiuJ , YangXet al. Bacillus Calmette-Guérin and anti-PD-L1 combination therapy boosts immune response against bladder cancer. Onco. Targets Ther.11, 2891–2899 (2018).
   PubMed Web of Science ®Google Scholar
• Balar AV , KamatAM , KulkarniGSet al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, Phase II study. The Lancet Oncology22(7), 919–930 (2021).
   PubMed Web of Science ®Google Scholar
• García-Perdomo HA , SánchezAL , SpiessPE. Immune checkpoints inhibitors in the management of high-risk non-muscle-invasive bladder cancer. A scoping review. Urol. Oncol.40(9), 409.e401–409.e408 (2022).
   Web of Science ®Google Scholar
• Hahn N , O’DonnellM , EfstathiouJet al. Phase 1 trial of durvalumab in combination with BCG or external beam radiation in BCG-unresponsive non-muscle invasive bladder cancer patients. Presented at: 21st Annual Meeting of the Society of Urologic Oncology.Virtual Meeting (3–5 December 2020).
   Google Scholar
• Alanee S , SanaS , El-ZawahryAet al. Phase I trial of intravesical Bacillus Calmette-Guérin combined with intravenous pembrolizumab in recurrent or persistent high-grade non-muscle-invasive bladder cancer after previous Bacillus Calmette-Guérin treatment. World J. Urol.39(10), 3807–3813 (2021).
   PubMed Web of Science ®Google Scholar
• Al-Khami AA , YoussefS , AbdicheYet al. Pharmacologic properties and preclinical activity of sasanlimab, a high-affinity engineered anti-human PD-1 antibody. Mol. Cancer Ther.19(10), 2105–2116 (2020).
   PubMed Web of Science ®Google Scholar
• Johnson ML , BraitehF , Grilley-OlsonJEet al. Assessment of Subcutaneous vs Intravenous Administration of Anti-PD-1 Antibody PF-06801591 in Patients With Advanced Solid Tumors: A Phase 1 Dose-Escalation Trial. JAMA Oncol.5(7), 999–1007 (2019).
   PubMed Web of Science ®Google Scholar
• Cho BC , PenkovK , BondarenkoIet al. 1055P Updated results of subcutaneous (SC) anti-programmed cell death 1 (PD-1) receptor antibody PF-06801591 for locally advanced or metastatic non-small cell lung cancer (NSCLC) or urothelial carcinoma (UC). Ann. Oncol.31(Suppl. 4), S721 (2020).
   Google Scholar
• Chan A-W , TetzlaffJM , AltmanDGet al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann. Intern. Med.158(3), 200–207 (2013).
   PubMed Web of Science ®Google Scholar