Muscle-invasive and advanced bladder cancer
Once bladder cancer has grown into the muscle it needs more than scraping out: chemotherapy then removal of the bladder, or chemoradiation to keep it. For cancer that has spread, the antibody-drug conjugate enfortumab vedotin with pembrolizumab has replaced platinum chemotherapy as the first treatment.
Overview
Muscle-invasive urothelial carcinoma is treated with cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy and urinary diversion, or by trimodality bladder preservation (maximal resection plus chemoradiation) in suitable patients. Perioperative immunotherapy has entered practice: adjuvant nivolumab after cystectomy (CheckMate 274) and durvalumab with neoadjuvant chemotherapy and after surgery (NIAGARA), which improved overall survival. For metastatic disease, enfortumab vedotin with pembrolizumab nearly doubled survival compared with platinum chemotherapy (EV-302) and became the standard first-line treatment in 2023; erdafitinib is used for FGFR3-altered tumours, and platinum chemotherapy followed by avelumab maintenance remains an option. Molecular subtypes (luminal, basal) and circulating tumour DNA are being used to select who needs adjuvant treatment.
State of the art
- EV-302 was the first trial in forty years to beat platinum chemotherapy first line, and it did so by a wide margin.
- Perioperative immunotherapy now improves survival around cystectomy, and circulating tumour DNA promises to select who needs it.
Show survival figures (1)
Averages across everyone diagnosed, often years ago. Your stage, subtype, age, fitness and the treatment you receive matter more than the average, and the numbers are improving quickly.
- Bladder preservation with chemoradiation gives survival similar to cystectomy in selected patients and is under-used.
Anatomy and lymph node drainage
Renal cell carcinoma comes from the kidney's filtering cortex, urothelial cancer from the lining of the collecting system and bladder, and the adrenal on top hosts cortical and medullary (neuroblastoma) tumours.
- Renal cortex (RCC)Variant histologies (squamous, small cell, plasmacytoid, micropapillary)
- Renal pelvis and ureter (upper tract urothelial)
- Bladder lining (non-muscle-invasive)Metastatic urothelial carcinoma · FGFR3-altered urothelial carcinoma · Variant histologies (squamous, small cell, plasmacytoid, micropapillary)
- Bladder muscle wall (muscle-invasive)Variant histologies (squamous, small cell, plasmacytoid, micropapillary)
- Adrenal cortex
- Adrenal medulla and sympathetic chain (neuroblastoma)
- Developing kidney (Wilms tumour)
- renal hilar
- para-aortic and paracaval
- obturator and iliac (bladder)
Same organ: Non-muscle-invasive bladder cancer, Bladder & urothelial cancer, Clear cell renal cell carcinoma, Papillary renal cell carcinoma, Chromophobe renal cell carcinoma, Renal cell carcinoma, Wilms tumour (nephroblastoma), Neuroblastoma (paediatric), Adrenocortical carcinoma, Pheochromocytoma and paraganglioma (PPGL), Urethral cancer, Penile cancer
Show survival figures (1)
Averages across everyone diagnosed, often years ago. Your stage, subtype, age, fitness and the treatment you receive matter more than the average, and the numbers are improving quickly.
- About a quarter of bladder cancers at diagnosis plus those that progress from superficial disease; half of patients with muscle invasion die of it within five years despite surgery, and metastatic disease had a median survival near a year until antibody-drug conjugates and immunotherapy changed it.
- AI in radiologyEstablished
- cfDNA fragmentomicsEstablished
- Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)Standard of care
- DNA methylation profilingEstablished
- HCC surveillance in cirrhosis (ultrasound + AFP)Standard of care
- High-risk pancreatic surveillance (CAPS / PRECEDE)Established
- A 28-day national pathway for people with a positive multi-cancer blood test
- A breath test to rule out cancer in people with vague symptoms
- A cancer blood test for older people arriving at A&E with unexplained symptoms
- A legislated, publicly reported 28-day standard from urgent referral to diagnosis
- A live national dashboard of stage at diagnosis as the scorecard for early detection
- A single 'cancer check at 60' appointment bundling all screening tests
Background: Alpha-fetoprotein (AFP), Barrett's oesophagus, CA 19-9, Early detection, Faecal immunochemical test (FIT). Also on OnCo: Symptoms and red flags · Early detection roadmap.
Cases by country
No country-level case numbers. This cancer is not mapped to a GLOBOCAN site.
Neoadjuvant cisplatin-based chemotherapy (dose-dense MVAC or gemcitabine-cisplatin) with durvalumab (NIAGARA), then radical cystectomy with lymph node dissection and adjuvant durvalumab; adjuvant nivolumab for high-risk residual disease (CheckMate 274).
Maximal transurethral resection followed by chemoradiation, with salvage cystectomy for recurrence, in patients with unifocal tumours and no carcinoma in situ or in those unfit for surgery.
Enfortumab vedotin plus pembrolizumab (EV-302); gemcitabine-platinum followed by avelumab maintenance where the combination is unavailable.
Erdafitinib for FGFR3 alterations; platinum chemotherapy or enfortumab vedotin if not given first line; clinical trials.
Subtypes & biomarkers
top- Muscle-invasive, organ-confined (T2)
- Locally advanced (T3 to T4, node-positive)
- Metastatic urothelial carcinoma
- FGFR3-altered urothelial carcinoma
- Variant histologies (squamous, small cell, plasmacytoid, micropapillary)
- Cisplatin eligibility (kidney function, hearing, performance status)
- PD-L1 expression (selects immunotherapy in some settings)
- FGFR3 mutations and fusions (erdafitinib)
- Nectin-4 expression (near universal; enfortumab vedotin target)
- Circulating tumour DNA after cystectomy (adjuvant selection)
How often this target appears
- 1985MVAC chemotherapy established for advanced disease
- 2003Neoadjuvant MVAC improves survival before cystectomy (SWOG 8710)
- 2016Atezolizumab: first immunotherapy approval in bladder cancer
- 2019Erdafitinib: first targeted drug for FGFR3-altered urothelial cancer
- 2021Adjuvant nivolumab (CheckMate 274)
- 2023EV-302: enfortumab vedotin plus pembrolizumab replaces platinum first line
- 2024NIAGARA: perioperative durvalumab improves survival
What is in development for Muscle-invasive and advanced bladder cancer, drawn from the whole corpus: 0 items. Drugs are grouped by the most advanced trial phase they have reached anywhere; approved treatments sit under standard of care. Technologies are the methods being tested for this cancer, trials are the studies recorded here, and ideas are proposals not yet in a trial.
Nothing recorded in development for this cancer yet.
Open problems and what is being done
Cisplatin-ineligible patients still have fewer options.
Choosing between cystectomy and bladder preservation lacks randomised evidence.
Variant histologies are excluded from most trials.
Cost and access to antibody-drug conjugates.
and how the field plans to fix it →What is being done about thisCost and accessAvailable now- HPV & HBV vaccinationStandard of care
- ImatinibApproved
- Trastuzumab biosimilarsApproved
In trials- Gefitinib vs gefitinib plus pemetrexed-carboplatin in EGFR-mutant lung cancer (Tata Memorial)Positive
- IARC India HPV vaccine dose study (one, two or three doses)Positive
- IMAGINE (varnimcabtagene autoleucel, Immuneel)Positive
- Low-dose nivolumab plus metronomic chemotherapy (Tata Memorial)Positive
- Low-dose olanzapine for cancer anorexia (Tata Memorial)Positive
- METRO PLUS (Tata Memorial Centre, Varanasi)Positive
Ideas and roadmaps- 90-day reliance approval for cancer drugs cleared by two stringent regulators
- A cheap old tablet to restore appetite
- A combination pricing rule so two-drug regimens are not priced as two monopolies
- A coordinated reserve and shared schedule for the world's medical isotope reactors
- A dedicated global financing window for cancer, modelled on the Global Fund
- A delinked market-entry reward paid by payers when a repurposed generic wins approval
Background: Accelerated approval, Biosimilar, Real-world evidence. Also on OnCo: Financial help · Coverage by country · HTA decisions.
Trials
topTrials recruiting now
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Landmark trials
Expert centres
topExpert centres
- Johns Hopkins Hospital / Sidney Kimmel Comprehensive Cancer CenterBaltimore, USNewsweek oncology #10NCI comprehensivevia Pembrolizumab
- IRCCS Humanitas Research HospitalRozzano (Milan), ITvia Durvalumab, IMRT / IGRT (modern external beam)
- Aarhus University HospitalAarhus, DKvia IMRT / IGRT (modern external beam)
- via Nivolumab
- Alliance for Clinical Trials in OncologyChicago, IL, USvia Pembrolizumab
- American Society for Radiation OncologyArlington, VA, USvia IMRT / IGRT (modern external beam)
- Centre Antoine LacassagneNice, FRvia IMRT / IGRT (modern external beam)
- Centre Oscar LambretLille, FRvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- Comprehensive Cancer Center Freiburg (CCCF)Freiburg im Breisgau, DEvia IMRT / IGRT (modern external beam)
- via Nivolumab
- European Society for Radiotherapy and OncologyBrussels, BEvia IMRT / IGRT (modern external beam)
- Geneva University Hospitals (HUG)Geneva, CHvia IMRT / IGRT (modern external beam)
- German Breast Group (GBG)Neu-Isenburg, DEvia Durvalumab
- German Hodgkin Study GroupCologne, DEvia Nivolumab
- GOG FoundationPhiladelphia, PA, USvia Pembrolizumab
- Groote Schuur Hospital / University of Cape TownCape Town, ZAvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- Hacettepe University Cancer InstituteAnkara, TRvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- Ho Chi Minh City Oncology HospitalHo Chi Minh City, VNvia IMRT / IGRT (modern external beam)
- Hokkaido University HospitalSapporo, JPvia IMRT / IGRT (modern external beam)
- Hospital Universitario 12 de OctubreMadrid, ESvia Durvalumab
- Hunan Cancer HospitalChangsha, CNvia IMRT / IGRT (modern external beam)
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, IN, USNCI comprehensivevia Cisplatin
- Institut BergoniéBordeaux, FRvia IMRT / IGRT (modern external beam)
- Institut Jules BordetBrussels, BEvia Pembrolizumab
- Institut National d'Oncologie, RabatRabat, MAvia IMRT / IGRT (modern external beam)
- Institut Salah AzaïezTunis, TNvia IMRT / IGRT (modern external beam)
- Institute of Oncology LjubljanaLjubljana, SIvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- International Extranodal Lymphoma Study GroupBellinzona, CHvia IMRT / IGRT (modern external beam)
- Istanbul University Institute of OncologyIstanbul, TRvia IMRT / IGRT (modern external beam)
- via Nivolumab
- via IMRT / IGRT (modern external beam)
- Juravinski Cancer Centre / Escarpment Cancer Research InstituteHamilton, ON, CAvia IMRT / IGRT (modern external beam)
- Kenyatta National HospitalNairobi, KEvia IMRT / IGRT (modern external beam)
- Korle Bu Teaching HospitalAccra, GHvia IMRT / IGRT (modern external beam)
- Kyoto University HospitalKyoto, JPvia Nivolumab
- Lagos University Teaching HospitalLagos, NGvia IMRT / IGRT (modern external beam)
- via Nivolumab
- via Pembrolizumab
- via IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- via Gemcitabine
- National Cancer Center Hospital EastKashiwa, Chiba, JPvia Nivolumab
- via IMRT / IGRT (modern external beam)
- National Institute of Oncology, HungaryBudapest, HUvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- Ocean Road Cancer InstituteDar es Salaam, TZvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- Rajiv Gandhi Cancer Institute and Research CentreNew Delhi, INvia IMRT / IGRT (modern external beam)
- Rambam Health Care CampusHaifa, ILvia IMRT / IGRT (modern external beam)
- Rigshospitalet, Copenhagen University HospitalCopenhagen, DKvia IMRT / IGRT (modern external beam)
- Royal Adelaide HospitalAdelaide, AUvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- Siriraj Hospital, Mahidol UniversityBangkok, THvia IMRT / IGRT (modern external beam)
- SWOG Cancer Research NetworkPortland, OR, USvia Nivolumab
- Tata Medical Center, KolkataKolkata, INvia IMRT / IGRT (modern external beam)
- Tawam HospitalAl Ain, AEvia IMRT / IGRT (modern external beam)
- Tel Aviv Sourasky Medical CenterTel Aviv, ILvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- TROG Cancer ResearchNewcastle, NSW, AUvia IMRT / IGRT (modern external beam)
- UMC Utrecht Cancer CenterUtrecht, NLvia IMRT / IGRT (modern external beam)
- University of Malaya Medical CentreKuala Lumpur, MYvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- Velindre Cancer CentreCardiff, GBvia IMRT / IGRT (modern external beam)
- via IMRT / IGRT (modern external beam)
- via Nivolumab
- Zhejiang Cancer HospitalHangzhou, CNvia IMRT / IGRT (modern external beam)
Questions to ask
topQuestions to ask your oncologist about Muscle-invasive and advanced bladder cancer
Newly diagnosed
- What is my exact diagnosis, stage, and grade, and which tests established them?Why: Everything else follows from an accurate stage and subtype.
- Which biomarkers have been tested on my tumour (for example Cisplatin eligibility, PD-L1 expression, FGFR3 mutations and fusions, Nectin-4 expression, Circulating tumour DNA after cystectomy), and what were the results?Why: These results decide eligibility for targeted therapy, immunotherapy, and trials.
- Which subtype is my cancer, and does that change the recommended treatment?Why: Recognised subtypes for this cancer include Muscle-invasive, organ-confined, Locally advanced, Metastatic urothelial carcinoma.
- Is germline (inherited) genetic testing recommended for me or my family?Why: Inherited variants can change treatment and matter for relatives.
Muscle-invasive, cisplatin-eligible
- For my situation (muscle-invasive, cisplatin-eligible), which of the standard options do you recommend and why?Why: Guideline options include: Neoadjuvant cisplatin-based chemotherapy (dose-dense MVAC or gemcitabine-cisplatin) with durvalumab (NIAGARA), then radical cystectomy with lymph node dissection and adjuvant durvalumab; adjuvant nivolumab for high-risk residual disease (CheckMate 274).
- Am I a candidate for Cisplatin, Gemcitabine, Durvalumab or related drugs, and what side effects should I expect?Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
- How do the results of NIAGARA and CheckMate 274 apply to someone like me?Why: Trial populations differ from individual patients; ask how closely you match.
Bladder preservation
- For my situation (bladder preservation), which of the standard options do you recommend and why?Why: Guideline options include: Maximal transurethral resection followed by chemoradiation, with salvage cystectomy for recurrence, in patients with unifocal tumours and no carcinoma in situ or in those unfit for surgery.
- Am I a candidate for Cisplatin, and what side effects should I expect?Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
Metastatic, first line
- For my situation (metastatic, first line), which of the standard options do you recommend and why?Why: Guideline options include: Enfortumab vedotin plus pembrolizumab (EV-302); gemcitabine-platinum followed by avelumab maintenance where the combination is unavailable.
- Am I a candidate for Enfortumab vedotin, Pembrolizumab, and what side effects should I expect?Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
- How do the results of EV-302 / KEYNOTE-A39 apply to someone like me?Why: Trial populations differ from individual patients; ask how closely you match.
Later lines
- For my situation (later lines), which of the standard options do you recommend and why?Why: Guideline options include: Erdafitinib for FGFR3 alterations; platinum chemotherapy or enfortumab vedotin if not given first line; clinical trials.
- Am I a candidate for Erdafitinib, Enfortumab vedotin, and what side effects should I expect?Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
Any stage
- Would a second opinion at a high-volume centre change anything, and can you help arrange it?Why: Rare or high-stakes decisions benefit from a centre that treats many similar patients.
- What supportive care (symptom control, nutrition, exercise, mental health, financial help) is available from the start?Why: Supportive care improves quality of life and helps patients complete treatment.
- I read that “Cisplatin-ineligible patients still have fewer options”. How does that affect my plan?Why: Open problems are where trials and second opinions matter most.
- I read that “Choosing between cystectomy and bladder preservation lacks randomised evidence”. How does that affect my plan?Why: Open problems are where trials and second opinions matter most.
Print this page for your appointment (your browser's print command). These prompts are for discussion; your clinical team knows your case.
Direct links plus the targets, companies, and technologies of this cancer's products.
technologies
8targets
5drugs
7companies
7terms
1trials
3Latest papers
topQuery for this cancer: (TITLE:"Muscle-invasive and advanced bladder cancer" OR ABSTRACT:"Muscle-invasive and advanced bladder cancer" OR TITLE:"MIBC" OR ABSTRACT:"MIBC" OR TITLE:"Invasive urothelial carcinoma" OR ABSTRACT:"Invasive urothelial carcinoma" OR TITLE:"Metastatic urothelial carcinoma" OR ABSTRACT:"Metastatic urothelial carcinoma") AND (treatment OR therapy OR trial OR survival OR diagnosis). Results are unfiltered search hits about Muscle-invasive and advanced bladder cancer, not a curated reading list.
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