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From Clinical Trials to Real-life Clinical Practice: The Role of Immunotherapy with PD-1/PD-L1 Inhibitors in Advanced
Syed A Hussain1, Alison Birtle2, Simon Crabb3
1Institute of Translational & Stratified Medicine, Plymouth University, Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
Context:
A number of PD-1/PD-L1 inhibitors have recently been approved for use in patients with locally advanced or metastatic urothelial carcinoma (UC) on the basis of results from several clinical trials.
Objective:
To review the evidence from these trials and consider what it means for the use of these drugs in first-line and post-platinum settings in real-life clinical practice.
Evidence Acquisition:
PubMed was searched for full reports of clinical trials of single-agent PD-1/PD-L1 inhibitors in advanced UC. Twelve publications were included.
Evidence Synthesis:
Responses to PD-1/PD-L1 inhibitors appear to be durable but are only achieved in 17-26% of patients. These drugs offer different toxicity and efficacy profiles to standard chemotherapy regimens. This should be considered when choosing a treatment strategy for each patient.
Conclusions:
PD-1/PD-L1 inhibitors represent a major step forward in the management of advanced UC, although several questions remain regarding their optimal use in routine clinical practice. A validated predictive biomarker of response is yet to be defined, and this is perhaps the most significant unmet need for currently available drugs.
Patient Summary:
We reviewed the results from clinical trials that investigated how well certain types of anticancer drugs called PD-1/PD-L1 inhibitors worked in patients with bladder cancer. We found that more research is required to identify (1) the factors that might predict which patients with bladder cancer will respond to PD-1/PD-L1 inhibitors and (2) the optimum duration of treatment with these drugs.
Insights
Programmed cell death protein 1 (PD-1)/PD-1 ligand 1 (PD-L1) inhibitors show durable responses in advanced urothelial carcinoma (UC), but efficacy is limited to 17-26% of patients. Further research is needed to define predictive biomarkers and optimal treatment durations.
Area of Science:
- Oncology
- Immunotherapy
- Urothelial Carcinoma Research
Background:
- Recent approvals of PD-1/PD-L1 inhibitors for advanced urothelial carcinoma (UC).
- Need to evaluate clinical trial evidence for real-world application.
Purpose of the Study:
- Review evidence of PD-1/PD-L1 inhibitors in advanced UC.
- Assess implications for first-line and post-platinum settings.
- Consider real-life clinical practice.
Main Methods:
- PubMed search for clinical trials of single-agent PD-1/PD-L1 inhibitors in advanced UC.
- Inclusion of twelve relevant publications.
Main Results:
- Responses to PD-1/PD-L1 inhibitors can be durable.
- Achieved response rates range from 17-26%.
- Distinct toxicity and efficacy profiles compared to chemotherapy.
Conclusions:
- PD-1/PD-L1 inhibitors are a significant advancement in advanced UC management.
- Optimal use in routine practice requires further investigation.
- A validated predictive biomarker for response remains a critical unmet need.
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