Treatment algorithm

Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups: see disclaimer

ACUTE

nonmuscle-invasive tumors

1st line – transurethral resection of bladder tumor

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ACUTE
|
nonmuscle-invasive tumors
|
low risk
1st line – 

transurethral resection of bladder tumor

American Urological Association bladder cancer guidelines define low-risk bladder cancer as: solitary, small-volume (≤3 cm), low-grade Ta disease (Ta = noninvasive papillary carcinoma); any papillary urothelial neoplasm of low malignant potential.[40]

Transurethral resection of a bladder tumor (TURBT) is first-line therapy. Guidelines recommend repeat transurethral resection within 6 weeks to lower recurrence if the initial resection was incomplete.[40][47]​​ 

​Patients with nonmuscle-invasive bladder tumors and coexisting obstructive benign prostatic hyperplasia may have transurethral resection of the prostate at the same time as TURBT. Meta-analysis demonstrates that performing the procedures simultaneously improves patient quality of life, without any risk of increasing tumor recurrence or metastasis rates.[100]

Plus – immediate postoperative intravesical chemotherapy

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ACUTE
|
nonmuscle-invasive tumors
|
low risk
Plus – 

immediate postoperative intravesical chemotherapy

Treatment recommended for ALL patients in selected patient group

An immediate, single instillation of intravesical chemotherapy (administered within 24 hours of transurethral resection) is recommended to reduce the risk of recurrence.[40]​ 

Gemcitabine and mitomycin are commonly used.[43] Gemcitabine is preferred; it has favorable tolerability and may reduce the risk of recurrence and progression over time compared with mitomycin.[43][81]​ Epirubicin is an alternative option.[40][43][82]

Instillation should not be done if bladder perforation is suspected or resection is extensive.

See local specialist protocol for dosing guidelines.

Primary options

gemcitabine

OR

mitomycin

Secondary options

epirubicin

1st line – transurethral resection of bladder tumor

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ACUTE
|
nonmuscle-invasive tumors
|
intermediate risk
1st line – 

transurethral resection of bladder tumor

American Urological Association intermediate-risk patients are those with large-volume (>3 cm) or multifocal low-grade Ta disease; high-grade Ta disease ≤3 cm; low-grade T1 disease; or recurrence of Ta tumor within 1 year (Ta = noninvasive papillary carcinoma; T1 = tumor invades subepithelial connective tissue, i.e., the lamina propria).[40] These patients have a high risk of recurrence but a low risk of disease progression.

Transurethral resection of a bladder tumor (TURBT) is first-line therapy. Guidelines recommend repeat transurethral resection within 6 weeks to lower recurrence if the initial resection was incomplete, there is no detrusor muscle in the initial resection specimen, or if T1 tumors are found.[40][47]​​​

Patients with nonmuscle-invasive bladder tumors and coexisting obstructive benign prostatic hyperplasia may have transurethral resection of the prostate at the same time as TURBT. Meta-analysis demonstrates that performing the procedures simultaneously improves patient quality of life, without any risk of increasing tumor recurrence or metastasis rates.[100]

Plus – immediate postoperative intravesical chemotherapy

Back
ACUTE
|
nonmuscle-invasive tumors
|
intermediate risk
Plus – 

immediate postoperative intravesical chemotherapy

Treatment recommended for ALL patients in selected patient group

An immediate, single postoperative instillation of intravesical chemotherapy (administered within 24 hours of transurethral resection) is recommended to reduce the risk of recurrence.[40][82][83]​​​​ 

Gemcitabine and mitomycin are commonly used.[43] Gemcitabine is preferred; it has favorable tolerability and may reduce the risk of recurrence and progression over time compared with mitomycin.[43][81][83] Epirubicin is an alternative option.[40][43]​​[82]

Instillation should not be done if bladder perforation is suspected or resection is extensive.

Bacille Calmette-Guérin is never appropriate for immediate postoperative instillation owing to the risk of sepsis.[84]

See local specialist protocol for dosing guidelines.

Primary options

gemcitabine

OR

mitomycin

Secondary options

epirubicin

Plus – delayed intravesical bacille Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy

Back
ACUTE
|
nonmuscle-invasive tumors
|
intermediate risk
Plus – 

delayed intravesical bacille Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy

Treatment recommended for ALL patients in selected patient group

Delayed intravesical BCG immunotherapy or intravesical chemotherapy may be considered for patients with intermediate-risk disease, starting 3-4 weeks after transurethral resection and administered every week for 6 weeks.[40][43]

Decisions about additional intravesical therapy are based on assessment of risk of recurrence, patient history and symptoms, risks of adverse outcomes from repeat resection, and toxicity of therapy​​.[40]

Maintenance therapy is an option if there is a complete response to delayed treatment.[40][43] The optimal duration of maintenance therapy is not known. Guidelines specify using BCG maintenance for 1 year in intermediate-risk disease.[40][43][85] A 3-week BCG regimen given at 3, 6, and 12 months is commonly used.[43][86]

Patients with persistent or recurrent disease after a single course of induction intravesical BCG may be offered a second course of BCG.[40]

Mitomycin and gemcitabine are alternatives for delayed intravesical chemotherapy. Other options include sequential gemcitabine plus docetaxel, epirubicin, valrubicin, docetaxel, or sequential gemcitabine plus mitomycin.[43] Docetaxel is well tolerated intravesically and is an effective option for BCG-refractory nonmuscle-invasive bladder cancer alone and in combination with gemcitabine.[87][88]​ Chemotherapy maintenance is commonly given at monthly intervals for 6-12 months.[40]

See local specialist protocol for dosing guidelines.

Primary options

BCG live intravesical

Secondary options

mitomycin

OR

gemcitabine

Tertiary options

gemcitabine

and

docetaxel

OR

epirubicin

OR

valrubicin intravesical

OR

docetaxel

OR

gemcitabine

and

mitomycin

1st line – transurethral resection of bladder tumor

Back
ACUTE
|
nonmuscle-invasive tumors
|
high risk
1st line – 

transurethral resection of bladder tumor

Defined as: carcinoma in situ: high-grade Ta >3 cm or multifocal; high-grade T1; any recurrent high-grade Ta tumor; any BCG failure in a high-grade patient; any variant histology or lymphovascular or prostatic urethral invasion.[40]

Transurethral resection is first-line therapy.[40]

Completeness of tumor resection, recurrence at 3 months, and the presence of residual disease at repeat resection all have important prognostic significance.[91][92]

Guidelines recommend repeat transurethral resection within 6 weeks to lower recurrence if the initial resection was incomplete, there is no detrusor muscle in the initial resection specimen, T1 tumors are found, or tumors have variant histology (and the patient is not having cystectomy).[40][47]​ Repeat resection should also be considered for high-risk, high-grade Ta tumors.[40][93][94]​​

Patients with nonmuscle-invasive bladder tumors and coexisting obstructive benign prostatic hyperplasia may have transurethral resection of the prostate at the same time as transurethral resection of a bladder tumor. Meta-analysis demonstrates that performing the procedures simultaneously improves patient quality of life, without any risk of increasing tumor recurrence or metastasis rates.[100]

Consider – immediate postoperative intravesical chemotherapy

Back
ACUTE
|
nonmuscle-invasive tumors
|
high risk
Consider – 

immediate postoperative intravesical chemotherapy

Treatment recommended for SOME patients in selected patient group

While not confirmed to be beneficial in high-risk disease, immediate, single postoperative (within 24 hours) instillation of intravesical chemotherapy is sometimes used in addition to delayed intravesical immunotherapy.[40][89][90]​ 

Gemcitabine and mitomycin are commonly used.[43] Gemcitabine is preferred; it has favorable tolerability and may reduce the risk of recurrence and progression over time compared with mitomycin.[43][81][83] Epirubicin is an alternative option.[40][43][82]​​

Instillation should not be done if bladder perforation is suspected or resection is extensive.

Bacille Calmette-Guérin (BCG) is never appropriate for immediate postoperative instillation owing to the risk of sepsis.[84]

See local specialist protocol for dosing guidelines.

Primary options

gemcitabine

OR

mitomycin

Secondary options

epirubicin

Plus – delayed intravesical bacille Calmette-Guérin (BCG) immunotherapy

Back
ACUTE
|
nonmuscle-invasive tumors
|
high risk
Plus – 

delayed intravesical bacille Calmette-Guérin (BCG) immunotherapy

Treatment recommended for ALL patients in selected patient group

BCG immunotherapy is most commonly given intravesically 3-4 weeks after transurethral resection and retained for 2 hours. Induction is weekly BCG for 6 weeks.[40][43]

Maintenance BCG is recommended if there is a complete response to induction. The optimal duration of maintenance therapy is not known. Guidelines specify using BCG maintenance for 3 years, if tolerated, for high-risk disease.[40] Maintenance therapy is usually given in weekly instillations for 3 weeks at 3, 6, 12, 18, 24, 30, and 36 months. Dose reductions may be used if there are local symptoms or to prevent escalation of BCG adverse effects.[86]

In high-risk patients, full-dose 3-year BCG reduces recurrences compared with full dose BCG for 1 year.[85]

Patients with persistent or recurrent disease after a single course of induction intravesical BCG should be offered a second course of BCG.[40]

See local specialist protocol for dosing guidelines.

Primary options

BCG live intravesical

2nd line – radical cystectomy or rescue intravesical therapy

Back
ACUTE
|
nonmuscle-invasive tumors
|
high risk
2nd line – 

radical cystectomy or rescue intravesical therapy

BCG is the preferred treatment option for high-risk patients (i.e., without very-high-risk features).[43] Care must be taken when selecting patients for cystectomy, especially in the absence of muscle invasion; overall 90-day mortality for cystectomy is as high as 9%, and increased age, American Society of Anesthesiology score, and presence of lymph-node, or distant metastasis, increase mortality.[96]

Cystectomy constitutes over-treatment in most high-risk patients who do not have muscle invasion. National Comprehensive Cancer Network guidelines suggest that cystectomy is preferred for patients with very-high-risk features, defined as BCG unresponsiveness, variant histologies (e.g., micropapillary, plasmacytoid, sarcomatoid), lymphovascular invasion, and prostatic urethral invasion.[43] 

Other options may include intravesical chemotherapy.[43] 

Optimal management for patients who decline or are unfit for cystectomy has not been established.

Patients should be offered enrollment in a clinical trial or an alternative intravesical therapy, such as mitomycin, gemcitabine, or gemcitabine plus docetaxel.[40][47]

Primary options

mitomycin

OR

gemcitabine

Secondary options

gemcitabine

and

docetaxel

2nd line – pembrolizumab or intravesical nadofaragene firadenovec or intravesical nogapendekin alfa inbakicept plus bacille Calmette-Guérin (BCG)

Back
ACUTE
|
nonmuscle-invasive tumors
|
high risk
2nd line – 

pembrolizumab or intravesical nadofaragene firadenovec or intravesical nogapendekin alfa inbakicept plus bacille Calmette-Guérin (BCG)

Pembrolizumab (a programmed cell death protein-1 inhibitor), nadofaragene firadenovec (a nonreplicating adenovirus vector-based gene therapy), and nogapendekin alfa inbakicept (an immune cell-activating interleukin-15 superagonist) plus BCG are approved by the Food and Drug Administration for the treatment of patients with bacille Calmette-Guérin (BCG)-unresponsive, high-risk, nonmuscle-invasive carcinoma in situ (CIS).[43][97][98][99]

The pembrolizumab approval stipulates that patients are ineligible for or elect not to undergo cystectomy. Systemic immunotherapy with pembrolizumab is given to a patient with CIS within 12 months of completion of adequate BCG therapy.[40] ​

See local specialist protocol for dosing guidelines.

Primary options

pembrolizumab

OR

nadofaragene firadenovec intravesical

OR

nogapendekin alfa inbakicept intravesical

and

BCG live intravesical

locally invasive tumors

1st line – cystectomy with pelvic lymph node dissection

Back
ACUTE
|
locally invasive tumors
|
localized muscle-invasive disease: T2-T4a N0M0 or N1
1st line – 

cystectomy with pelvic lymph node dissection

Radical cystoprostatectomy (in men) or radical cystectomy often accompanied by hysterectomy (in women) is generally required, and it is thought to provide the best chance of cure. Bilateral pelvic lymph node dissection is an essential part of the procedure. Extended node dissection is controversial; evidence of improved survival is equivocal while risk of adverse effects is increased.[43][53][109][110]​ Severe scarring secondary to previous surgery or treatments, advanced age, or severe comorbidities may preclude pelvic lymph node dissection.

Cystectomy is followed by the formation of a urinary diversion by means of an ileal conduit to the skin or by creating an internal reservoir that can be drained by catheter or through the urethra. Relative contraindications to urethral drainage include Tis (carcinoma in situ) in the prostatic ducts or a positive urethral margin.[43] An orthotopic neobladder provides some function similar to a native bladder but has an increased risk of night-time incontinence and retention requiring intermittent self-catheterization. 

In selected patients with T2 disease, a partial cystectomy may be feasible.[43]​ This requires a solitary tumor, located in an area of the bladder where a minimum clear margin of 2 cm of noninvolved urothelium can be achieved as well as sufficient soft tissue to enable the tumor to be removed without significantly reducing bladder capacity or causing incontinence. Mostly this is reserved for tumors in the dome of the bladder that have no associated Tis (carcinoma in situ) in other areas of the bladder. Relative contraindications are lesions in the trigone or bladder neck.

Consider – preoperative chemotherapy

Back
ACUTE
|
locally invasive tumors
|
localized muscle-invasive disease: T2-T4a N0M0 or N1
Consider – 

preoperative chemotherapy

Treatment recommended for SOME patients in selected patient group

Guidelines recommend neoadjuvant chemotherapy (followed by cystectomy) for eligible patients with T2-T4a disease without lymph node involvement (N0) or with involvement in a single pelvic lymph node (N1).[43][53][101] 

Neoadjuvant platinum-based combination chemotherapy reduces mortality risk without increased perioperative complications or mortality.[102][103] 

Dose-dense methotrexate plus vinblastine plus doxorubicin plus cisplatin (ddMVAC) is the preferred regimen; toxicity and efficacy are improved compared with traditional MVAC. Gemcitabine plus cisplatin may be an alternative option.[43][104][105][106][107][108] 

See local specialist protocol for dosing guidelines.

Primary options

ddMVAC

methotrexate

and

vinblastine

and

doxorubicin

and

cisplatin

OR

gemcitabine

and

cisplatin

Consider – postcystectomy chemotherapy or chemoradiation therapy

Back
ACUTE
|
locally invasive tumors
|
localized muscle-invasive disease: T2-T4a N0M0 or N1
Consider – 

postcystectomy chemotherapy or chemoradiation therapy

Treatment recommended for SOME patients in selected patient group

Postcystectomy chemotherapy or chemoradiation therapy may be considered in select high-risk patients (e.g., pathologic T3-4, positive nodes, positive margins).[43][114][115]​ 

A cisplatin-based combination such as dose-dense methotrexate plus vinblastine plus doxorubicin plus cisplatin (ddMVAC), or gemcitabine plus cisplatin may be used.[43] Data regarding the use of postcystectomy radiation therapy and chemoradiation therapy are limited.[43][53][111] One systematic review reported no clear benefit attributable to adjuvant radiation therapy following cystectomy.[116] In a randomized phase 2 trial of postcystectomy patients with locally advanced bladder cancer (urothelial carcinoma or squamous cell carcinoma), adjuvant sequential chemotherapy and radiation therapy significantly improved local control compared with adjuvant chemotherapy alone (96% vs. 69%, respectively, at 2 years).[117] Disease-free and overall survival did not differ significantly between treatment groups.

See local specialist protocol for dosing guidelines.

Primary options

ddMVAC

methotrexate

and

vinblastine

and

doxorubicin

and

cisplatin

Secondary options

gemcitabine

and

cisplatin

Consider – postcystectomy nivolumab

Back
ACUTE
|
locally invasive tumors
|
localized muscle-invasive disease: T2-T4a N0M0 or N1
Consider – 

postcystectomy nivolumab

Treatment recommended for SOME patients in selected patient group

Postcystectomy nivolumab may be considered for select high-risk patients with residual disease who are not eligible for, or who decline, cisplatin-based adjuvant therapy.[43][53]​

In one randomized controlled trial, postoperative nivolumab significantly improved disease-free survival at 6 months compared with placebo (HR 0.70); the increase in survival was greater among patients with a PD-L1 expression ≥1% (HR 0.55). Patients in the trial had pathological evidence of urothelial carcinoma with a high risk of recurrence.[118] 

See local specialist protocol for dosing guidelines.

Primary options

nivolumab

2nd line – maximal transurethral resection + chemoradiation therapy

Back
ACUTE
|
locally invasive tumors
|
localized muscle-invasive disease: T2-T4a N0M0 or N1
2nd line – 

maximal transurethral resection + chemoradiation therapy

For patients who decline or are not candidates for cystectomy, trimodal organ-preservation therapy (TMT) with the combination of maximal TURBT, chemotherapy, and radiation therapy may be an alternative option.[53][111][112]​​ Preferred candidates for organ preservation therapy include those with smaller solitary tumors, no nodal involvement, no extensive or multifocal carcinoma in situ, no hydronephrosis, and good pretreatment bladder function.[53] 

Adequate patient counseling of the risks and regular posttreatment surveillance are essential. While one meta-analysis found that TMT was noninferior to radical cystectomy at <10 years, overall TMT was associated with an increased risk of all-cause and bladder-specific cancer mortality.[113] About 30% of patients treated with multimodal organ-preservation therapy will have recurrent invasive disease and require subsequent radical cystectomy.[111]

See local specialist protocol for chemoradiation therapy regimens.

1st line – systemic chemotherapy or chemoradiation therapy

Back
ACUTE
|
locally invasive tumors
|
unresectable locally advanced: T4b or N2-3
1st line – 

systemic chemotherapy or chemoradiation therapy

T4b and N2-3 disease is typically considered unresectable (defined as a fixed bladder mass or positive nodes evident before laparotomy) and is generally treated by chemotherapy alone or chemoradiation therapy.[43]

For patients who show no nodal disease on computed tomography (CT) scans, 2 or 3 courses of chemotherapy with or without radiation therapy is recommended, followed by cystoscopy and repeat CT scan.[43]

If the tumor responds to treatment, subsequent options include cystectomy or consolidation chemotherapy with or without radiation therapy.

If there is no response, chemotherapy with radiation therapy or a new chemotherapy regimen can be used.

See local specialist protocol for dosing guidelines.

Primary options

ddMVAC

methotrexate

and

vinblastine

and

doxorubicin

and

cisplatin

Secondary options

gemcitabine

and

cisplatin

Consider – radical cystectomy

Back
ACUTE
|
locally invasive tumors
|
unresectable locally advanced: T4b or N2-3
Consider – 

radical cystectomy

Treatment recommended for SOME patients in selected patient group

If the tumor responds to treatment (systemic chemotherapy or chemoradiation therapy), subsequent options include cystectomy or consolidation chemotherapy with or without radiation therapy.

Radical cystectomy is appropriate for T4b disease if there is tumor response and a fixed mass is no longer palpable.

It is also appropriate for patients with previous pelvic radiation and others who cannot receive irradiation.

Consider – maintenance avelumab

Back
ACUTE
|
locally invasive tumors
|
unresectable locally advanced: T4b or N2-3
Consider – 

maintenance avelumab

Treatment recommended for SOME patients in selected patient group

Maintenance avelumab is recommended following completion of chemotherapy for patients with good response and no disease progression.[43]​ In a phase 3 trial, maintenance avelumab increased overall survival by 7.1 months compared with supportive therapy.[119]

See local specialist protocol for dosing guidelines.

Primary options

avelumab

metastatic disease

1st line – systemic immunotherapy and/or chemotherapy

Back
ACUTE
|
metastatic disease
1st line – 

systemic immunotherapy and/or chemotherapy

Patients who present with metastatic disease, or subsequently develop metastatic disease, are generally treated with systemic therapy.[43][53]

The therapy regimen used may vary according to factors such as the presence and severity of comorbidities (e.g., cardiac disease, neuropathy, hearing loss, renal dysfunction), together with an assessment of risk based on extent of disease.

Guidelines recommend pembrolizumab plus the antibody-drug conjugate enfortumab vedotin as the preferred first-line treatment for patients with metastatic disease who are fit enough for combination therapy.[43][53][120] Improved survival outcomes have been reported with pembrolizumab plus enfortumab vedotin compared with cisplatin-based chemotherapy.[121][122]

For patients with metastatic disease who are not able to receive pembrolizumab plus enfortumab vedotin (e.g., due to contraindications or availability), recommended regimens for cisplatin-eligible patients include dose-dense methotrexate plus vinblastine plus doxorubicin plus cisplatin (ddMVAC), or gemcitabine plus cisplatin, or gemcitabine plus cisplatin plus nivolumab.[43][53][120][123]​ 

Gemcitabine plus carboplatin is the preferred chemotherapy regimen for cisplatin-ineligible patients ​(i.e., those with any of: creatinine clearance <60 mL/min; Eastern Cooperative Oncology Group performance score 2; grade ≥2 neuropathy or hearing loss; New York Heart Association class III heart failure).[43][53][120]​​[124][125]​​ After 2 or 3 cycles of chemotherapy, patients are reevaluated and treatment is continued for up to 6 cycles in total if the disease has responded or remained stable.[43]

See local specialist protocol for dosing guidelines.

Primary options

pembrolizumab

and

enfortumab vedotin

Secondary options

ddMVAC

methotrexate

and

vinblastine

and

doxorubicin

and

cisplatin

OR

gemcitabine

and

cisplatin

OR

gemcitabine

and

cisplatin

and

nivolumab

Tertiary options

gemcitabine

and

carboplatin

Consider – surgery or radiation therapy

Back
ACUTE
|
metastatic disease
Consider – 

surgery or radiation therapy

Treatment recommended for SOME patients in selected patient group

Radiation therapy, usually in combination with systemic therapy, can be used to reduce symptoms or improve local control.

Surgery or radiation therapy, often in combination with chemotherapy, may be considered in highly selected patients who show a major partial response in an unresectable primary tumor or have a solitary site of residual disease that is resectable after chemotherapy.[43][53]​​ In selected series this has been shown to afford survival benefit.[126]

If disease is completely resected, two additional cycles of chemotherapy can be given if tolerated by the patient.

Consider – maintenance avelumab or nivolumab

Back
ACUTE
|
metastatic disease
Consider – 

maintenance avelumab or nivolumab

Treatment recommended for SOME patients in selected patient group

​Maintenance avelumab is recommended following completion of chemotherapy (without nivolumab) for patients with good response and no disease progression.[43][53][119]

For patients receiving gemcitabine and cisplatin plus nivolumab, maintenance nivolumab is recommended.[43][53][123] 

See local specialist protocol for dosing guidelines.

Primary options

avelumab

OR

nivolumab

2nd line – clinical trial or platinum-based chemotherapy or immunotherapy

Back
ACUTE
|
metastatic disease
2nd line – 

clinical trial or platinum-based chemotherapy or immunotherapy

Enrollment into a clinical trial, if eligible, is strongly recommended for second-line therapies for advanced and metastatic disease; evidence for optimal treatment selection is lacking. Choice of treatment should be based on prior therapy and cisplatin eligibility.

For patients who progress following first-line treatment with pembrolizumab plus enfortumab vedotin, guidelines recommend platinum-based chemotherapy or enfortumab vedotin monotherapy (if ineligible for cisplatin-based chemotherapy).[43][53][120] 

Pembrolizumab (preferred), nivolumab, avelumab, or enfortumab vedotin may be used as second-line treatments in patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy.[43][127][128]

Consult a specialist for guidance on optimal treatment options for these patients.

2nd line – erdafitinib

Back
ACUTE
|
metastatic disease
2nd line – 

erdafitinib

Molecular/genomic analysis, including testing for FGFR3 genetic alterations and HER2 overexpression, may help guide subsequent treatment options and/or eligibility for clinical trials.[43]

​The fibroblast growth factor receptor (FGFR) inhibitor erdafitinib is an alternative option for certain patients with susceptible FGFR3 genetic alterations who have received at least one line of prior systemic therapy.[53][120]​​​​ Erdafitinib is approved in the US and Europe for locally advanced or metastatic urothelial carcinomas that express FGFR3 gene alterations and have progressed during or after at least one line of prior systemic therapy (which should include immunotherapy for eligible patients).

See local specialist protocol for dosing guidelines.

Primary options

erdafitinib

3rd line – clinical trial or systemic therapy or targeted therapy

Back
ACUTE
|
metastatic disease
3rd line – 

clinical trial or systemic therapy or targeted therapy

Enrollment into a clinical trial, if eligible, is strongly recommended for subsequent-line therapies for advanced and metastatic disease; evidence for optimal treatment selection is lacking.

Molecular/genomic analysis, including testing for FGFR3 genetic alterations and HER2 overexpression, may help guide subsequent treatment options and/or eligibility for clinical trials.[43] 

Subsequent lines of therapy depend on prior therapy, and may include enfortumab vedotin, erdafitinib (if positive for FGFR3 genetic alterations), or chemotherapy.

The FDA has approved fam-trastuzumab deruxtecan (a HER2-directed antibody-conjugate) for the treatment of HER2-positive unresectable or metastatic bladder tumors in patients who have received prior treatment (or who have no further alternative treatment options).

Consult a specialist for guidance on optimal treatment options for these patients.

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Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups. See disclaimer

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