Efficacy and safety of adjuvant therapy with nivolumab or placebo in high-risk patients with muscle-invasive urothelial carcinoma after radical surgery: review of the first results of the randomized phase III trial CheckMate 274
- Authors: Volkova M.I.1, Olshanskaya A.S.1,2, Kalinin S.A.2
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Affiliations:
- N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
- N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia
- Issue: Vol 17, No 1 (2021)
- Pages: 108-119
- Section: DIAGNOSIS AND TREATMENT OF URINARY SYSTEM TUMORS. URINARY BLADDER CANCER
- Published: 05.05.2021
- URL: https://oncourology.abvpress.ru/oncur/article/view/1442
- DOI: https://doi.org/10.17650/1726-9776-2021-17-1-108-119
- ID: 1442
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Abstract
This article analyzes first results of the randomized phase III clinical trial CheckMate 274 that has demonstrated the advantage of adjuvant immunotherapy with nivolumab, a PD-1 inhibitor, over placebo in high-risk patients with muscle-invasive urothelial carcinoma after radical surgery
About the authors
M. I. Volkova
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Author for correspondence.
Email: mivolkova@rambler.ru
ORCID iD: 0000-0001-7754-6624
24 Kashirskoe Shosse, Moscow 115478.
Russian FederationA. S. Olshanskaya
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia; N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia
ORCID iD: 0000-0003-0389-564X
24 Kashirskoe Shosse, Moscow 115478; 1 Ostrovityanova St., Moscow 117997.
Russian FederationS. A. Kalinin
N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia
ORCID iD: 0000-0002-0694-7911
1 Ostrovityanova St., Moscow 117997.
Russian FederationReferences
- Siegel R.L., Miller K.D., Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016;66(1):7-30. doi: 10.3322/caac.21332.
- Kamat A.M., Hahn N.M., Efstathiou J.A. et al. Bladder cancer. Lancet 2016;388(10061):2796-810. doi: 10.1016/S0140-6736(16)30512-8.
- Clinical guideline. Bladder cancer. Russian National Union “Russian Association of Oncologists”, 2021. (In Russ.).
- Flaig T.W., Spiess P.E., Agarwal N. et al. Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw 2020;18(3): 329-54. doi: 10.6004/jnccn.2020.0011.
- Witjes J.A. (Chair), Bruins H.M., Cathomas R. et al. Muscle-invasive and Metastatic Bladder Cancer. EAU Guidelines. 2020. Available at: https://uroweb.org/guideline/bladder-cancer-muscle-invasive-and-metastatic/#9.
- Raj G.V., Karavadia S., Schlomer B. et al. Contemporary use of perioperative cisplatin-based chemotherapy in patients with muscle-invasive bladder cancer. Cancer 2011;117(2):276-82. doi: 10.1002/cncr.25429.
- Donat S.M., Shabsigh A., Savage C. et al. Potential impact of postoperative early complications on the timing of adjuvant chemotherapy in patients undergoing radical cystectomy: a high-volume tertiary cancer center experience. Eur Urol 2009;55(1):177-86. doi: 10.1016/j.eururo.2008.07.018.
- Rosenberg J.E., Hoffman-Censits J., Powles T. et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinumbased chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet 2016;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4.
- Bellmunt J., de Wit R., Vaughn D.J. et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med 2017;376(11):1015-26. doi: 10.1056/NEJMoa1613683.
- Massard C., Gordon M.S., Sharma S. et al. Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J Clin Oncol 2016;34(26):3119-25. doi: 10.1200/JCO.2016.67.9761.
- Apolo A.B., Infante J.R., Hamid O. et al. Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic urothelial carcinoma from the JAVELIN solid tumor phase 1b trial: analysis of safety, clinical activity, and PD-L1 expression [abstract]. J Clin Oncol 2016;34:4514.
- Sharma P., Retz M., Siefker-Radtke A. et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol 2017;18(3):312-22. doi: 10.1016/S1470-2045(17)30065-7.
- Necchi A., Raggi D., Gallina A. et al. Updated results of PURE-01 with preliminary activity of neoadjuvant pembrolizumab in patients with muscle-invasive bladder carcinoma with variant histologies. Eur Urol 2020;77(4):439-46. doi: 10.1016/j.eururo.2019.10.026.
- Powles T., Rodriguez-Vida A., Duran I. et al. A phase II study investigating the safety and efficacy of neoadjuvant atezolizumab in muscle invasive bladder cancer (ABACUS). JCO 2018;36(15_suppl).
- Bajorin D.F., Witjes J.A., Gschwend J.E. et al. First results from the phase 3 CheckMate 274 trial of adjuvant nivolumab versus placebo in patients who underwent radical surgery for high-risk muscle-invasive urothelial carcinoma. Oral presentation at the 2021 Genitourinary Cancers Symposium (ASCO GU). February 11-13, 2021; Virtual Meeting.
- Kim H.S., Jeong C.W., Kwak C. et al. Disease-free survival at 2 and 3 years is a significant early surrogate marker predicting the 5-year overall survival in patients treated with radical cystectomy for urothelial carcinoma of the bladder: external evaluation and validation in a cohort of Korean patients. Front Oncol 2015;5:246. doi: 10.3389/fonc.2015.00246.
- Sonpavde G., Khan M.M., Lerner S.P. et al. Disease-free survival at 2 or 3 years correlates with 5-year overall survival of patients undergoing radical cystectomy for muscle invasive bladder cancer. J Urol 2011;185(2):456-61. doi: 10.1016/j.juro.2010.09.110.
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