References
- Antoni S , FerlayJ, SoerjomataramI, ZnaorA, JemalA, BrayF. Bladder cancer incidence and mortality: a global overview and recent trends. Eur. Urol.71(1), 96–108 (2017).
- Stein JP , LieskovskyG, CoteRet al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J. Clin. Oncol.19(3), 666–675 (2001).
- Burger M , CattoJW, DalbagniGet al. Epidemiology and risk factors of urothelial bladder cancer. Eur. Urol.63(2), 234–241 (2013).
- Miyazaki J , NishiyamaH. Epidemiology of urothelial carcinoma. Int. J. Urol.24(10), 730–734 (2017).
- von der Maase H , SengelovL, RobertsJTet al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J. Clin. Oncol.23(21), 4602–4608 (2005).
- Alfred Witjes J , LebretT, CompératEMet al. Updated 2016 EAU guidelines on muscle-invasive and metastatic bladder cancer. Eur. Urol.71(3), 462–475 (2017).
- Sternberg CN , de MulderPH, SchornagelJHet al. Randomized Phase III trial of high-dose-intensity methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) chemotherapy and recombinant human granulocyte colony-stimulating factor versus classic MVAC in advanced urothelial tract tumors: European Organization for Research and Treatment of Cancer Protocol no. 30924. J. Clin. Oncol.19(10), 2638–2646 (2001).
- Lorusso V , PolleraCF, AntimiMet al. A Phase II study of gemcitabine in patients with transitional cell carcinoma of the urinary tract previously treated with platinum. Italian Co-operative Group on Bladder Cancer. Eur. J. Cancer34(8), 1208–1212 (1998).
- Papamichael D , GallagherCJ, OliverRTet al. Phase II study of paclitaxel in pretreated patients with locally advanced/metastatic cancer of the bladder and ureter. Br. J. Cancer75(4), 606–607 (1997).
- Bellmunt J , ThéodoreC, Demkovet al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J. Clin. Oncol.27(27), 4454–4461 (2009).
- Galsky MD , HahnNM, RosenbergJet al. A consensus definition of patients with metastatic urothelial carcinoma who are unfit for cisplatin-based chemotherapy. Lancet Oncol.12(3), 211–214 (2011).
- De Santis M , BellmuntJ, MeadGet al. Randomized Phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer “unfit” for cisplatin-based chemotherapy: Phase II – results of EORTC study 30986. J. Clin. Oncol.27(33), 5634–5639 (2009).
- Barone A , HazarikaM, TheoretMRet al. FDA approval summary: pembrolizumab for the treatment of patients with unresectable or metastatic melanoma. Clin. Cancer Res.23(19), 5661–5665 (2017).
- Sul J , BlumenthalGM, JiangX, HeK, KeeganP, PazdurR. FDA approval summary: pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer whose tumors express programmed death-ligand 1. Oncologist21(5), 643–650 (2016).
- Larkins E , BlumenthalGM, YuanWet al. U.S. Food and Drug Administration approval summary: pembrolizumab for the treatment of recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. Oncologist22(7), 873–878 (2017).
- Kasamon YL , KasamonYL, de ClaroRAet al. FDA approval summary: nivolumab for the treatment of relapsed or progressive classical Hodgkin lymphoma. Oncologist22(5), 585–591 (2017).
- Xu JX , MaherVE, ZhangLet al. FDA approval summary: nivolumab in advanced renal cell carcinoma after anti-angiogenic therapy and exploratory predictive biomarker analysis. Oncologist22(3), 311–317 (2017).
- Ning YM , SuzmanD, MaherVEet al. FDA approval summary: atezolizumab for the treatment of patients with progressive advanced urothelial carcinoma after platinum-containing chemotherapy. Oncologist22(6) 743–749 (2017).
- Redelman-Sidi G , GlickmanMS, BochnerBH. The mechanism of action of BCG therapy for bladder cancer – a current perspective. Nat. Rev. Urol.11(3), 153–162 (2014).
- Meng X , HuangZ, TengF, XingL, YuJ. Predictive biomarkers in PD-1/PD-L1 checkpoint blockade immunotherapy. Cancer Treat. Rev.41(10), 868–876 (2015).
- Zibelman M , RamamurthyC, PlimackER. Emerging role of immunotherapy in urothelial carcinoma-advanced disease. Urol. Oncol.34(12), 538–547 (2016).
- Topalian SL , TaubeJM, AndersRA, PardollDM. Mechanism-driven biomarkers to guide immune checkpoint blockade in cancer therapy. Nat. Rev. Cancer16(5), 275–287 (2016).
- Pardoll DM . The blockade of immune checkpoints in cancer immunotherapy. Nat. Rev. Cancer12(4), 252–264 (2012).
- Aydin AM , WolduSL, HutchinsonRCet al. Spotlight on atezolizumab and its potential in the treatment of advanced urothelial bladder cancer. Onco. Targets Ther.10, 1487–1502 (2017).
- Krummel MF , AllisonJP. CD28 and CTLA-4 have opposing effects on the response of T cells to stimulation. J. Exp. Med.182(2), 459–465 (1995).
- Ohaegbulam KC , AssalA, Lazar-MolnarE, YaoY, ZangX. Human cancer immunotherapy with antibodies to the PD-1 and PD-L1 pathway. Trends Mol. Med.21(1), 24–33 (2015).
- Kostine M , ChicheL, LazaroEet al. Opportunistic autoimmunity secondary to cancer immunotherapy (OASI): an emerging challenge. Rev. Med. Interne38(8), 513–525 (2017).
- Herbst RS , SoriaJC, KowanetzMet al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature515(7528), 563–567 (2014).
- Deng R , BumbacaD, PastuskovasCVet al. Preclinical pharmacokinetics, pharmacodynamics, tissue distribution, and tumor penetration of anti-PD-L1 monoclonal antibody, an immune checkpoint inhibitor. MAbs8(3), 593–603 (2016).
- Bellmunt J , PowlesT, VogelzangNJ. A review on the evolution of PD-1/PD-L1 immunotherapy for bladder cancer: the future is now. Cancer Treat. Rev.54, 58–67 (2017).
- Powles T , EderJP, FineGDet al. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature515(7528), 558–562 (2014).
- Rosenberg JE , Hoffman-CensitsJ, PowlesTet al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, Phase II trial. Lancet387(10031), 1909–1920 (2016).
- Bellmunt J . IMvigor210: updated analyses of first-line (1L) atezolizumab (atezo) in cisplatin (cis)-ineligible locally advanced/metastatic urothelial carcinoma. Presented at: The European Society for Medical Oncology 2016 Congress.Copenhagen, Denmark, 7–11 October 2016.
- Galsky MD . Treatment of patients with metastatic urothelial cancer “unfit” for cisplatin-based chemotherapy. J. Clin. Oncol.29(17), 2432–2438 (2011).
- Balar AV , GalskyMD, RosenbergJEet al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, Phase 2 trial. Lancet389(10064), 67–76 (2017).
- Powles T . IMvigor211: a Phase III randomized study examining atezolizumab versus chemotherapy for platinum-treated advanced urothelial carcinoma. Presented at: EACR-AACR-SIC Special Conference 2017.Florence, Italy, 24–27 June 2017.
- Loriot Y . Atezolizumab (atezo) in platinum (plat)-treated locally advanced/metastatic urothelial carcinoma (mUC): updated OS, safety and biomarkers from the Phase 2 trial. Presented at: The European Society for Medical Oncology 2016 Congress.Copenhagen, Denmark, 7–11 October 2016.
- Taube JM , KleinA, BrahmerJRet al. Association of PD-1, PD-1 ligands, and other features of the tumor immune microenvironment with response to anti-PD-1 therapy. Clin. Cancer Res.20(19), 5064–5074 (2014).
- Festino L , BottiG, LoriganPet al. Cancer treatment with anti-PD-1/PD-L1 agents: is PD-L1 expression a biomarker for patient selection? Drugs 76(9), 925–945 (2016).
- Ratcliffe MJ , SharpeA, MidhaAet al. Agreement between programmed cell death ligand-1 diagnostic assays across multiple protein expression cutoffs in non-small cell lung cancer. Clin. Cancer Res.23(14), 3585–3591 (2017).
- Nakanishi J , WadaY, MatsumotoK, AzumaM, KikuchiK, UedaS. Overexpression of B7-H1 (PD-L1) significantly associates with tumor grade and postoperative prognosis in human urothelial cancers. Cancer Immunol. Immunother.56(8), 1173–1182 (2007).
- 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).
- Huang Y , ZhangSD, McCruddenC, ChanKW, LinY, KwokHF. The prognostic significance of PD-L1 in bladder cancer. Oncol. Rep.33(6), 3075–3084 (2015).
- No authors listed. First tissue-agnostic drug approval issued. Cancer Discov.7(7), 656 (2017).
- Skeldon SC , SemotiukK, AronsonMet al. Patients with Lynch syndrome mismatch repair gene mutations are at higher risk for not only upper tract urothelial cancer but also bladder cancer. Eur. Urol.63(2), 379–385 (2013).
- Li Q , BagrodiaA, ChaEK, ColemanJA. Prognostic genetic signatures in upper tract urothelial carcinoma. Curr. Urol. Rep.17(2), 12 (2016).
- Carlo MI , ZhangL, MandelkerDet al. Cancer predisposing germline mutations in patients (pts) with urothelial cancer (UC) of the renal pelvis (R-P), ureter (U) and bladder (B). Presented at: American Society of Clinical Oncology 2017 Annual Meeting.Chicago, IL, USA, 2–6 June 2017.
- Iyer G , AudenetF, MiddhaSet al. Mismatch repair (MMR) detection in urothelial carcinoma (UC) and correlation with immune checkpoint blockade (ICB) response. Presented at: American Society of Clinical Oncology 2017 Annual Meeting.Chicago, IL, USA, 2–6 June 2017.
- Teo MY , SeierK, OstrovnayaIet al. DNA damage repair and response (DDR) gene alterations (alt) and response to PD1/PDL1 blockade in platinum-treated metastatic urothelial carcinoma (mUC). Presented at: American Society of Clinical Oncology 2017 Annual Meeting.Chicago, IL, USA, 2–6 June 2017.
- Tumeh PC , HarviewCL, YearleyJHet al. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature515(7528), 568–571 (2014).
- Martens A , Wistuba-HamprechtK, Geukes FoppenMet al. Baseline peripheral blood biomarkers associated with clinical outcome of advanced melanoma patients treated with ipilimumab. Clin. Cancer Res.22(12), 2908–2918 (2016).
- Sivan A , CorralesL, HubertNet al. Commensal bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy. Science350(6264), 1084–1089 (2015).
- Vetizou M , PittJM, DaillèreRet al. Anticancer immunotherapy by CTLA-4 blockade relies on the gut microbiota. Science350(6264), 1079–1084 (2015).
- NICE . NICE appraisal consultation document – atezolizumab for treating locally advanced or metastatic urothelial carcinoma (2017). www.nice.org.uk/guidance/gid-ta10111/documents/appraisal-consultation-document