References
- American Cancer Society. What is bladder cancer? 2022. https://www.cancer.org/cancer/types/bladder-cancer/about/what-is-bladder-cancer.html.
- Rouprêt M, Babjuk M, Burger M, et al. European Association of Urology guidelines on upper urinary tract urothelial carcinoma: 2020 update. Eur Urol. 2021;79(1):62–79. doi: 10.1016/j.eururo.2020.05.042.
- Johns Hopkins Greenberg Bladder Cancer Institute. Upper tract urothelial cancer. 2017. https://www.hopkinsmedicine.org/greenberg-bladder-cancer-institute/utuc/.
- Cumberbatch MGK, Noon AP. Epidemiology, aetiology and screening of bladder cancer. Transl Androl Urol. 2019;8(1):5–11. doi: 10.21037/tau.2018.09.11.
- American Joint Committee on Cancer. Cancer staging form supplement. 8th ed. New York: Springer; 2018.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer; V.5.2020.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer; V.1. 2020. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
- Witjes JA, Bruins HM, Cathomas R, et al. European Association of Urology guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2020 guidelines. Eur Urol. 2021;79(1):82–104. doi: 10.1016/j.eururo.2020.03.055.
- US Food and Drug Administration. FDA approves nivolumab for adjuvant treatment of urothelial carcinoma; 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-urothelial-carcinoma.
- Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384(22):2102–2114. doi: 10.1056/NEJMoa2034442.
- Galsky MD, Witjes JA, Gschwend JE, et al. Disease-free survival with longer follow-up from the phase 3 CheckMate 274 trial of adjuvant nivolumab in patients who underwent surgery for high-risk muscle-invasive urothelial carcinoma. Presented at: Society for Urologic Oncology 22nd Annual Meeting, December 1-3, Orlando, FL, USA, 2021.
- Brodtkorb T-H, Knight C, Kamgar F, et al. Cost-effectiveness of nivolumab versus surveillance for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence: a US payer perspective. J Med Econ. 2024. doi: 10.1080/13696998.2024.2329019.
- Woods B, Sideris E, Palmer S, et al. NICE DSU technical support document 19: partitioned survival analysis for decision modelling in health care: a critical review. Report by the Decision Support Unit. 2017. https://www.sheffield.ac.uk/sites/default/files/2022-02/TSD19-Partitioned-Survival-Analysis-final-report.pdf.
- Bullement A, Cranmer HL, Shields GE. A review of recent decision-analytic models used to evaluate the economic value of cancer treatments. Appl Health Econ Health Policy. 2019;17(6):771–780. doi: 10.1007/s40258-019-00513-3.
- Barkema AE, Simons C, Kurt M, et al. POSB302 assessing the viability of a surrogacy relationship between disease-free survival (DFS) and overall survival (OS) for the patients in clinical trials for adjuvant treatment of muscle-invasive urothelial carcinoma (MIUC) following radical cystectomy. Value Health. 2022;25(1): S203. doi: 10.1016/j.jval.2021.11.986.
- Sternberg C, Squifflet P, Burdett S, et al. 1746P Disease-free survival (DFS) and distant metastasis-free survival (DMFS) as surrogates for overall survival (OS) in adjuvant treatment of muscle-invasive bladder cancer (MIBC). Ann Oncol. 2022;33:S1335–S1336. doi: 10.1016/j.annonc.2022.07.1824.
- National Institute for Health and Care Excellence. NICE-TA424. Pertuzumab for the neoadjuvant treatment of HER2-positive breast cancer [ID767]. 2016. https://www.nice.org.uk/guidance/ta424/documents/committee-papers-2.
- National Institute for Health and Care Excellence. NICE-TA569. Pertuzumab for adjuvant treatment of HER2-positive early breast cancer [ID1192]. 2018. https://www.nice.org.uk/guidance/ta569/documents/committee-papers.
- National Institute for Health and Care Excellence. Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma. Technology appraisal guidance [TA544]. 2018. https://www.nice.org.uk/guidance/ta544.
- National Institute for Health and Care Excellence. NICE-TA580. Enzalutamide for treating non metastatic hormone-relapsed prostate cancer [ID1359]. 2019. https://www.nice.org.uk/guidance/ta580/evidence/appraisal-consultation-committee-papers-pdf-6781040029.
- National Institute for Health and Care Excellence. NICE-TA612. Neratinib for extended adjuvant treatment of hormone receptor-positive, HER2-positive early stage breast cancer after adjuvant trastuzumab [ID981]. 2019. https://www.nice.org.uk/guidance/ta612/evidence/appraisal-consultation-committee-papers-pdf-6967189694.
- National Institute for Health and Care Excellence. NICE-TA632. Trastuzumab emtansine for adjuvant treatment of HER2-positive early breast cancer [ID1516]. 2020. https://www.nice.org.uk/guidance/ta632/evidence/committee-papers-pdf-8771187997.
- National Institute for Health and Care Excellence. NICE-TA761. Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection [ID3835]. 2021. https://www.nice.org.uk/guidance/ta761/documents/committee-papers-3.
- National Institute for Health and Care Excellence. Pembrolizumab for adjuvant treatment of completely resected stage 3 melanoma. Technology appraisal guidance [TA766]. 2022. https://www.nice.org.uk/guidance/ta766.
- Ozbir S, Girgin C, Kara C, et al. Local and systemic recurrence patterns of urothelial cancer after radical cystectomy. Kaohsiung J Med Sci. 2014;30(10):504–509. doi: 10.1016/j.kjms.2014.03.011.
- Mitra AP, Quinn DI, Dorff TB, et al. Factors influencing post‐recurrence survival in bladder cancer following radical cystectomy. BJU Int. 2012;109(6):846–854. doi: 10.1111/j.1464-410X.2011.10455.x.
- Sternberg CN, de Mulder P, Schornagel JH, et al. Seven year update of an EORTC phase III trial of high-dose intensity M-VAC chemotherapy and G-CSF versus classic M-VAC in advanced urothelial tract tumours. Eur J Cancer. 2006;42(1):50–54. doi: 10.1016/j.ejca.2005.08.032.
- Bullement A, Latimer NR, Bell Gorrod H. Survival extrapolation in cancer immunotherapy: a validation-based case study. Value Health. 2019;22(3):276–283. doi: 10.1016/j.jval.2018.10.007.
- Rothwell B, Kiff C, Ling C, et al. Cost effectiveness of nivolumab in patients with advanced, previously treated squamous and non-squamous non-small-cell lung cancer in England. Pharmacoecon Open. 2021;5(2):251–260. doi: 10.1007/s41669-020-00245-4.
- Bellmunt J, von der Maase H, Mead GM, et al. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine and gemcitabine/cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy: EORTC intergroup study 30987. J Clin Oncol. 2012;30(10):1107–1113. doi: 10.1200/JCO.2011.38.6979.
- Latimer NR. Survival analysis for economic evaluations alongside clinical trials–extrapolation with patient-level data: inconsistencies, limitations, and a practical guide. Med Decis Making. 2013;33(6):743–754. doi: 10.1177/0272989X12472398.
- Rutherford MJ, Lambert PC, Sweeting MJ, et al. NICE DSU technical support document 21: flexible methods for survival analysis. 2020. http://www.nicedsu.org.uk.
- Sternberg CN, Bellmunt J, Sonpavde G, et al. ICUD-EAU international consultation on bladder cancer 2012: chemotherapy for urothelial carcinoma—neoadjuvant and adjuvant settings. Eur Urol. 2013;63(1):58–66. doi: 10.1016/j.eururo.2012.08.010.
- Karakiewicz PI, Palapattu GS, Lotan Y, et al. Outcomes of radical cystectomy for transitional cell carcinoma of the bladder: a contemporary series from the Bladder Cancer Research Consortium. J Urol. 2006;176(6 Pt 1):2414–2422; discussion 2422. doi: 10.1016/j.juro.2006.08.004.
- Kamgar F, Ho S, Hawe E, et al. EE228 a review of treatment effect waning methods for immuno-oncology therapies in National Institute for Health and Care Excellence technology appraisals. Value Health. 2022;25(12):S98. doi: 10.1016/j.jval.2022.09.476.
- Jackson C, Stevens J, Ren S, et al. Extrapolating survival from randomized trials using external data: a review of methods. Med Decis Making. 2017;37(4):377–390. doi: 10.1177/0272989X16639900.
- National Institute for Health and Care Excellence. Pertuzumab for adjuvant treatment of early HER2-positive breast cancer. Technology appraisal guidance [TA569]. 2019. https://www.nice.org.uk/guidance/ta569.