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Assessment of PD-L1 Status in Urothelial Cancer
Veronika Bahlinger1, Arndt Hartmann2, Markus Eckstein2
1Institute of Pathology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany. Veronika.bahlinger@uk-erlangen.de.
Abstract:
Since 2016, the immunotherapeutic agents targeting PD-1 and PD-L1 are an integral part in first-line and second-line treatment of advanced or metastatic urothelial cancer. By PD-1 and PD-L1 inhibition with these drugs, the immune system is supposed to regain the capacity to actively kill cancer cells. Meanwhile, PD-L1 assessment is prescribed for patients not being eligible for platinum-based chemotherapy in first-line settings in metastatic disease (for monotherapy with atezolizumab or pembrolizumab) and for patients who are intended to receive adjuvant nivolumab treatment following radical cystectomy. Several challenges which are highlighted in this chapter affect PD-L1 testing in daily routine including availability of representative tissue materials, inter-observer variability, and different available PD-L1 immunohistochemistry assays with different analytical properties.
Insights
Immunotherapy targeting PD-1/PD-L1 is crucial for advanced urothelial cancer. However, challenges in PD-L1 testing, including tissue availability and assay variability, impact routine clinical use.
Area of Science:
- Oncology
- Immunology
- Pathology
Background:
- Immunotherapy with PD-1/PD-L1 inhibitors is a standard treatment for advanced or metastatic urothelial cancer since 2016.
- These therapies aim to restore the immune system's ability to combat cancer cells by blocking PD-1 and PD-L1 pathways.
Purpose of the Study:
- To review the role of PD-1/PD-L1 inhibitors in urothelial cancer treatment.
- To highlight the challenges associated with PD-L1 testing in clinical practice.
Main Methods:
- Review of current literature and clinical guidelines regarding PD-1/PD-L1 inhibitors in urothelial cancer.
- Discussion of diagnostic challenges in PD-L1 assessment.
Main Results:
- PD-L1 testing is mandated for specific patient groups, including those ineligible for first-line platinum-based chemotherapy and those receiving adjuvant nivolumab.
- Key challenges identified include the availability of adequate tissue samples, variability among pathologists (inter-observer variability), and differences in analytical performance across various PD-L1 immunohistochemistry assays.
Conclusions:
- Despite the efficacy of PD-1/PD-L1 inhibitors, the clinical utility is significantly influenced by the accuracy and consistency of PD-L1 testing.
- Addressing the identified challenges in PD-L1 assessment is crucial for optimizing patient selection and treatment outcomes in urothelial cancer.
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