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References
  1. US Food & Drug Administration. FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1. www.fda.gov/Drugs/DrugSafety/ucm608075.htm. Accessed March 19, 2019.
  2. The ASCO Post. FDA updates prescribing information for pembrolizumab and atezolizumab in urothelial carcinoma. www.ascopost.com/News/59182. Updated September 14, 2018. Accessed March 19, 2019.
  3. Prescribers' Digital Reference. Cisplatin - drug summary. www.pdr.net/drug-summary/Cisplatin-cisplatin-1472.4558. Accessed March 19, 2019.
  4. Pal SK, Rosenberg JE, Hoffman-Censits, et al. Efficacy of BGJ398, a fibroblast growth factor receptor 1-3 inhibitor, in patients with previously treated advanced urothelial carcinoma with FGFR3 alterations. Cancer Discov. 2018;8(7):812-821.
  5. Zhu J, Armstrong AJ, Friedlander TW, et al. Biomarkers of immunotherapy in urothelial and renal cell carcinoma: PD-L1, tumor mutational burden, and beyond. J Immunother Cancer. 2018;6(1):4.
  6. Galsky MD, Hahn NM, Rosenberg J, et al. Treatment of patients with metastatic urothelial cancer “unfit” for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.
  7. De Santis M, Bellmunt J, Mead G, et al. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. J Clin Oncol. 2012;30(2):191-199.
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  9. National Cancer Institute. FDA alters approved use of two checkpoint inhibitors of bladder cancer. www.cancer.gov/news-events/cancer-currents-blog/2018/bladder-cancer-checkpoint-inhibitor-change. Updated July 26, 2018. Accessed March 7, 2019.
  10. The ASCO Post. FDA grants atezolizumab accelerated approval as initial treatment for some advanced bladder cancers. www.ascopost.com/News/55526. Updated April 18, 2017. Accessed March 19, 2019.
  11. US Food and Drug Administration. Pembrolizumab (Keytruda): advanced or metastatic urothelial carcinoma. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559300.htm. Updated May 19, 2017. Accessed March 7, 2019.
  12. Necchi A, Joseph RW, Loriot Y, et al. Atezolizumab in platinum-treated locally advanced or metastatic urothelial carcinoma: post-progression outcomes from the phase II IMvigor210 study. Ann Oncol. 2017;28(12):3044-3050.
  13. Pembrolizumab [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme; February 2019.
  14. Atezolizumab [package insert]. South San Francisco, CA: Genentech; March 2019.
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  16. Seymour L, Bogaerts J, Perrone A, et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017;18(3):e143-e152.
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  18. Wolchok JD, Hamid O, Ribas A, et al. Atypical patterns of response in patients (pts) with metastatic melanoma treated with pembrolizumab (MK-3475) in KEYNOTE-001. J Clin Oncol. 2015;33(15 Suppl):3000.
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