ESMO Guidelines for Bladder Cancer
Management Exam with Complete
Solutions
What is the recommendation for patients with progressive disease after first-line
immunotherapy? - Answer-Recommendations are similar to those for front-line ChT.
What is the payload drug within Monomethyl auristatin E? - Answer-It is a microtubule-
disrupting agent.
What were the response rates (RRs) and progression-free survival (PFS) reported in
the single-arm phase II trial for EV? - Answer-RRs of 52%, PFS of 5.8 months (95% CI
5.0-8.3).
What is the overall survival (OS) reported for EV in the same trial? - Answer-14.7
months (95% CI 10.5-18.2).
What is the survival advantage of Pembrolizumab compared to chemotherapy (ChT) in
patients with tumors relapsed after platinum-based therapy? - Answer-mOS of 10.3
months for Pembrolizumab compared to 7.4 months for ChT (HR 0.73, 95% CI 0.59-
0.91).
What were the response rates for Pembrolizumab compared to ChT? - Answer-21% for
Pembrolizumab versus 11% for ChT.
What was the 3-year response duration for Pembrolizumab compared to ChT? -
Answer-44% for Pembrolizumab compared to 28.3% for ChT.
What did the IMVigor211 trial explore and what was its outcome? - Answer-It explored
atezolizumab in PD-L1 biomarker-positive tumors and failed to show a significant OS
advantage.
What was the response rate (RR) associated with atezolizumab? - Answer-RR of 13%.
What was the 30-month OS for atezolizumab compared to ChT? - Answer-18% for
atezolizumab compared to 10% for ChT.
What is the recommendation level for using atezolizumab compared to Pembrolizumab?
- Answer-Atezolizumab has a weaker recommendation than Pembrolizumab.
,What are three other drugs mentioned that have data from single-arm trials? - Answer-
Nivolumab, durvalumab, and avelumab.
What were the confirmed response rates (RRs) for EV in the phase II study? - Answer-
44% (95% CI 35% to 53%).
What were the results of the phase III trial comparing EV to ChT? - Answer-Superior
RRs (41% versus 17%), PFS (HR 0.62, 95% CI 0.51-0.75), and OS (HR 0.70, 95% CI
0.56-0.89; 12.8 versus 9.0 months) for EV versus ChT.
What grade 3 or more adverse events were associated with EV? - Answer-Rash (15%),
peripheral neuropathy (5%), and hyperglycemia (4%).
What is the standard of care in patients with progression of disease after first-line ChT
and maintenance avelumab? - Answer-EV should be considered the standard of care.
What is the response rate for further ChT in platinum-refractory disease? - Answer-RR
of 21%.
What agents can be considered for treatment in patients where anti-PD-1/PD-L1
therapy is not possible? - Answer-Vinflunine, docetaxel, and paclitaxel.
What is the only EMA-approved agent for treating this condition? - Answer-Vinflunine.
What was the response rate to erdafitinib in the phase II trial? - Answer-59% in the
population whose tumors progressed after immunotherapy and ChT.
What were the median progression-free survival (mPFS) and median overall survival
(mOS) for erdafitinib? - Answer-mPFS of 5.7 months (95% CI 4.9-8.3) and mOS of 10.9
months (95% CI 8.0-21.1).
What is the recommendation level for erdafitinib in the FGFR-selected population? -
Answer-Recommended with less robust evidence [III, B].
What is the role of adjuvant carboplatin-based treatment according to the POUT trial? -
Answer-Not fully elucidated due to power limitations on the analyses.
What is the current recommendation for adjuvant carboplatin-based chemotherapy in
UTUC? - Answer-It should not be recommended at the present time.
What is the controversy surrounding adjuvant immune checkpoint inhibitors (ICIs) in
UTUC? - Answer-Patients with UTUC in the CheckMate 274 study seemed to benefit
less from adjuvant nivolumab compared to bladder tumors, and overall survival data are
unavailable.
,What percentage of urothelial carcinomas (UCs) do UTUCs account for? - Answer-5%-
10%.
What is the prevalence of multifocal tumors in UTUC cases? - Answer-10%-20%.
What is the range of concomitant carcinoma in situ (CIS) presence in the upper tract for
UTUC? - Answer-11% to 36%.
What is the standard treatment for advanced or metastatic UC in patients fit for
cisplatin-based combination chemotherapy? - Answer-Cisplatin-based chemotherapy
followed by maintenance avelumab.
At first diagnosis, what percentage of UTUCs are invasive compared to bladder tumors?
- Answer-60% of UTUCs are invasive, while 15%-25% of bladder tumors are invasive.
What is the most common symptom of UTUC? - Answer-Hematuria (70%-80%) or flank
pain (10%-20%).
What are the key investigations for UTUC? - Answer-CT urography and diagnostic
ureteroscopy.
What should be collected during ureteroscopy for UTUC? - Answer-An in situ cytology
sample of the upper tract.
What is the prognosis for UTUCs invading the muscle wall? - Answer-They usually have
a poor prognosis, with 5-year cancer-specific survival rates of <50% for pT2-pT3 tumors
and <10% for pT4 tumors.
What is the standard of care for patients not eligible for cisplatin-based therapy? -
Answer-Gemcitabine/carboplatin followed by maintenance avelumab.
What are alternative treatments for patients with PD-L1 biomarker-positive tumors not
eligible for cisplatin-based chemotherapy? - Answer-Atezolizumab or pembrolizumab,
though with weaker evidence than for chemotherapy followed by maintenance
avelumab.
How are UTUCs stratified in terms of risk? - Answer-Into low-risk and high-risk tumors.
What defines low-risk UTUC tumors? - Answer-Unifocal tumors <1 cm, low-grade
disease at cytology/biopsy, and no invasive features on CT urography.
What defines high-risk UTUC tumors? - Answer-Tumors >2 cm, possible
hydronephrosis, high-grade disease at cytology/biopsy, multifocal disease, variant
histology, or previous radical cystectomy for bladder cancer.
, What is the recommended primary treatment option for low-risk UTUC? - Answer-
Kidney-sparing management, such as endoscopic laser ablation.
What is the recommended treatment for high-risk UTUC patients? - Answer-Open or
laparoscopic radical nephroureterectomy with bladder cuff excision.
What immunotherapy has the most robust data for treatment after progression of
disease following platinum-based chemotherapy? - Answer-Pembrolizumab.
What is an alternative to ICIs in tumors with FGFR alterations? - Answer-Erdafitinib,
though it has weaker levels of evidence than pembrolizumab.
What should be considered for treatment in immunotherapy-refractory disease? -
Answer-Enfortumab vedotin or platinum-based chemotherapy.
What is the current state of studies evaluating systemic therapy for locally advanced or
metastatic UTUC? - Answer-There are limited studies, and most clinical decision-
making is extrapolated from bladder cancer literature.
What is included in the recommendations for systemic therapy for advanced disease? -
Answer-It should follow the recommendations for urothelial bladder cancer, including
adjuvant cisplatin-based chemotherapy.
What is the primary treatment recommended for patients with locally advanced upper
tract urothelial cancer (UTUC)? - Answer-EV (Erdafitinib) is recommended as standard
treatment.
What was the outcome of the POUT trial regarding disease-free survival (DFS) for
patients with locally advanced UTUC? - Answer-The POUT trial showed improved DFS
with a hazard ratio (HR) of 0.45 (95% CI 0.30-0.68).
What is the alternative treatment for patients with FGFR alterations in UTUC? - Answer-
Erdafitinib is an alternative treatment with a weaker level of evidence.
What is the recommended follow-up imaging schedule after systemic therapy for
UTUC? - Answer-Regular cross-sectional imaging should occur every 3-4 months for 2
years.
What imaging may be required if CT scans do not adequately address concerns in
UTUC follow-up? - Answer-Bone scans or MRI may be required.
What treatment can be considered for patients with UTUC instead of best supportive
care? - Answer-Chemotherapy (ChT) can be considered if clinically appropriate.
Management Exam with Complete
Solutions
What is the recommendation for patients with progressive disease after first-line
immunotherapy? - Answer-Recommendations are similar to those for front-line ChT.
What is the payload drug within Monomethyl auristatin E? - Answer-It is a microtubule-
disrupting agent.
What were the response rates (RRs) and progression-free survival (PFS) reported in
the single-arm phase II trial for EV? - Answer-RRs of 52%, PFS of 5.8 months (95% CI
5.0-8.3).
What is the overall survival (OS) reported for EV in the same trial? - Answer-14.7
months (95% CI 10.5-18.2).
What is the survival advantage of Pembrolizumab compared to chemotherapy (ChT) in
patients with tumors relapsed after platinum-based therapy? - Answer-mOS of 10.3
months for Pembrolizumab compared to 7.4 months for ChT (HR 0.73, 95% CI 0.59-
0.91).
What were the response rates for Pembrolizumab compared to ChT? - Answer-21% for
Pembrolizumab versus 11% for ChT.
What was the 3-year response duration for Pembrolizumab compared to ChT? -
Answer-44% for Pembrolizumab compared to 28.3% for ChT.
What did the IMVigor211 trial explore and what was its outcome? - Answer-It explored
atezolizumab in PD-L1 biomarker-positive tumors and failed to show a significant OS
advantage.
What was the response rate (RR) associated with atezolizumab? - Answer-RR of 13%.
What was the 30-month OS for atezolizumab compared to ChT? - Answer-18% for
atezolizumab compared to 10% for ChT.
What is the recommendation level for using atezolizumab compared to Pembrolizumab?
- Answer-Atezolizumab has a weaker recommendation than Pembrolizumab.
,What are three other drugs mentioned that have data from single-arm trials? - Answer-
Nivolumab, durvalumab, and avelumab.
What were the confirmed response rates (RRs) for EV in the phase II study? - Answer-
44% (95% CI 35% to 53%).
What were the results of the phase III trial comparing EV to ChT? - Answer-Superior
RRs (41% versus 17%), PFS (HR 0.62, 95% CI 0.51-0.75), and OS (HR 0.70, 95% CI
0.56-0.89; 12.8 versus 9.0 months) for EV versus ChT.
What grade 3 or more adverse events were associated with EV? - Answer-Rash (15%),
peripheral neuropathy (5%), and hyperglycemia (4%).
What is the standard of care in patients with progression of disease after first-line ChT
and maintenance avelumab? - Answer-EV should be considered the standard of care.
What is the response rate for further ChT in platinum-refractory disease? - Answer-RR
of 21%.
What agents can be considered for treatment in patients where anti-PD-1/PD-L1
therapy is not possible? - Answer-Vinflunine, docetaxel, and paclitaxel.
What is the only EMA-approved agent for treating this condition? - Answer-Vinflunine.
What was the response rate to erdafitinib in the phase II trial? - Answer-59% in the
population whose tumors progressed after immunotherapy and ChT.
What were the median progression-free survival (mPFS) and median overall survival
(mOS) for erdafitinib? - Answer-mPFS of 5.7 months (95% CI 4.9-8.3) and mOS of 10.9
months (95% CI 8.0-21.1).
What is the recommendation level for erdafitinib in the FGFR-selected population? -
Answer-Recommended with less robust evidence [III, B].
What is the role of adjuvant carboplatin-based treatment according to the POUT trial? -
Answer-Not fully elucidated due to power limitations on the analyses.
What is the current recommendation for adjuvant carboplatin-based chemotherapy in
UTUC? - Answer-It should not be recommended at the present time.
What is the controversy surrounding adjuvant immune checkpoint inhibitors (ICIs) in
UTUC? - Answer-Patients with UTUC in the CheckMate 274 study seemed to benefit
less from adjuvant nivolumab compared to bladder tumors, and overall survival data are
unavailable.
,What percentage of urothelial carcinomas (UCs) do UTUCs account for? - Answer-5%-
10%.
What is the prevalence of multifocal tumors in UTUC cases? - Answer-10%-20%.
What is the range of concomitant carcinoma in situ (CIS) presence in the upper tract for
UTUC? - Answer-11% to 36%.
What is the standard treatment for advanced or metastatic UC in patients fit for
cisplatin-based combination chemotherapy? - Answer-Cisplatin-based chemotherapy
followed by maintenance avelumab.
At first diagnosis, what percentage of UTUCs are invasive compared to bladder tumors?
- Answer-60% of UTUCs are invasive, while 15%-25% of bladder tumors are invasive.
What is the most common symptom of UTUC? - Answer-Hematuria (70%-80%) or flank
pain (10%-20%).
What are the key investigations for UTUC? - Answer-CT urography and diagnostic
ureteroscopy.
What should be collected during ureteroscopy for UTUC? - Answer-An in situ cytology
sample of the upper tract.
What is the prognosis for UTUCs invading the muscle wall? - Answer-They usually have
a poor prognosis, with 5-year cancer-specific survival rates of <50% for pT2-pT3 tumors
and <10% for pT4 tumors.
What is the standard of care for patients not eligible for cisplatin-based therapy? -
Answer-Gemcitabine/carboplatin followed by maintenance avelumab.
What are alternative treatments for patients with PD-L1 biomarker-positive tumors not
eligible for cisplatin-based chemotherapy? - Answer-Atezolizumab or pembrolizumab,
though with weaker evidence than for chemotherapy followed by maintenance
avelumab.
How are UTUCs stratified in terms of risk? - Answer-Into low-risk and high-risk tumors.
What defines low-risk UTUC tumors? - Answer-Unifocal tumors <1 cm, low-grade
disease at cytology/biopsy, and no invasive features on CT urography.
What defines high-risk UTUC tumors? - Answer-Tumors >2 cm, possible
hydronephrosis, high-grade disease at cytology/biopsy, multifocal disease, variant
histology, or previous radical cystectomy for bladder cancer.
, What is the recommended primary treatment option for low-risk UTUC? - Answer-
Kidney-sparing management, such as endoscopic laser ablation.
What is the recommended treatment for high-risk UTUC patients? - Answer-Open or
laparoscopic radical nephroureterectomy with bladder cuff excision.
What immunotherapy has the most robust data for treatment after progression of
disease following platinum-based chemotherapy? - Answer-Pembrolizumab.
What is an alternative to ICIs in tumors with FGFR alterations? - Answer-Erdafitinib,
though it has weaker levels of evidence than pembrolizumab.
What should be considered for treatment in immunotherapy-refractory disease? -
Answer-Enfortumab vedotin or platinum-based chemotherapy.
What is the current state of studies evaluating systemic therapy for locally advanced or
metastatic UTUC? - Answer-There are limited studies, and most clinical decision-
making is extrapolated from bladder cancer literature.
What is included in the recommendations for systemic therapy for advanced disease? -
Answer-It should follow the recommendations for urothelial bladder cancer, including
adjuvant cisplatin-based chemotherapy.
What is the primary treatment recommended for patients with locally advanced upper
tract urothelial cancer (UTUC)? - Answer-EV (Erdafitinib) is recommended as standard
treatment.
What was the outcome of the POUT trial regarding disease-free survival (DFS) for
patients with locally advanced UTUC? - Answer-The POUT trial showed improved DFS
with a hazard ratio (HR) of 0.45 (95% CI 0.30-0.68).
What is the alternative treatment for patients with FGFR alterations in UTUC? - Answer-
Erdafitinib is an alternative treatment with a weaker level of evidence.
What is the recommended follow-up imaging schedule after systemic therapy for
UTUC? - Answer-Regular cross-sectional imaging should occur every 3-4 months for 2
years.
What imaging may be required if CT scans do not adequately address concerns in
UTUC follow-up? - Answer-Bone scans or MRI may be required.
What treatment can be considered for patients with UTUC instead of best supportive
care? - Answer-Chemotherapy (ChT) can be considered if clinically appropriate.
