For people with high-risk muscle-invasive urothelial carcinoma, including bladder cancer, treatment doesn’t always end after surgery.
Even after the bladder and surrounding tissue are removed, there’s still a risk that cancer can come back. That’s why some patients receive adjuvant therapy, treatment given after surgery to lower the risk of recurrence.
The AMBASSADOR trial found that the immunotherapy drug pembrolizumab (Keytruda) helped patients stay cancer-free for significantly longer after surgery. A new analysis from the same study examined the well-being of patients while receiving treatment.
The findings revealed that while some side effects were more common with pembrolizumab, overall quality of life remained similar to patients who did not receive additional treatment.
What did the AMBASSADOR trial show?
The study included 702 patients with high-risk muscle-invasive urothelial carcinoma whose cancer had been removed with surgery.
Participants were randomly assigned to either:
- Receive pembrolizumab every three weeks for up to one year, or
- Be closely monitored without additional treatment (observation).
The primary results, published in 2025, showed a clear benefit.
Patients who received pembrolizumab remained free from cancer recurrence or progression for a median of nearly 30 months, compared with just over 14 months for patients who were observed without treatment.
That translated to a 27% lower risk of the cancer returning or worsening during the study period.
Importantly, the benefit was seen regardless of:
- PD-L1 status
- Cancer stage
- Whether patients had received chemotherapy before surgery
Quality of life analysis
Living longer without cancer returning is important, but so is feeling well enough to enjoy everyday life.
To answer that question, researchers asked more than 560 patients to regularly complete questionnaires about their:
- Overall health and well-being
- Physical functioning
- Daily activities
- Fatigue
- Shortness of breath
- Urinary symptoms
- Sexual function
After one year, patients receiving pembrolizumab reported similar overall quality of life compared with those who were simply monitored after surgery.
Researchers found no meaningful differences in:
- Overall health
- Physical functioning
- Ability to carry out daily activities
- Urinary symptoms
- Sexual function
Adding immunotherapy didn’t appear to reduce patients’ overall sense of well-being during treatment.
Some side effects did become more noticeable over time
While overall quality of life remained stable, researchers did identify some differences after two years.
Patients treated with pembrolizumab reported:
- More fatigue
- More shortness of breath (dyspnea)
- Slightly greater difficulty with some physical activities and daily roles
These symptoms were generally modest but could affect everyday functioning for some people.
Researchers also noted that serious (grade 3 or higher) side effects occurred more often in the pembrolizumab group than in the observation group, which is consistent with what is already known about the medication’s safety profile.
Why these findings matter
This new analysis shows that pembrolizumab can significantly delay cancer recurrence after surgery, while maintaining overall quality of life for most patients. At the same time, it highlights the importance of recognizing and managing symptoms like fatigue and shortness of breath if they develop.
What this means for patients
These findings suggest that for many people with high-risk muscle-invasive bladder cancer, the benefits of pembrolizumab after surgery may outweigh the added side effects.
However, treatment decisions are always personal.
Factors such as your overall health, recovery from surgery, risk of recurrence, and your preferences should all be part of the discussion with your oncology team. Below are some questions to help guide your conversation:
- Am I a candidate for pembrolizumab after surgery?
- How much could this treatment reduce my risk of recurrence?
- What side effects should I watch for?
- How can fatigue or shortness of breath be managed if they occur?
- Are there supportive care services, such as physical therapy or rehabilitation, that could help me stay active during treatment?
You don’t have to navigate this alone. The Outcomes4Me app helps patients like you translate complex clinical information into clear, actionable guidance, so every conversation with your care team counts.
