A retrospective study from a UK tertiary renal cancer network provides real-world data on the use of adjuvant pembrolizumab after surgery for clear cell renal cell carcinoma (ccRCC). The study focused not only on oncological outcomes, but also on treatment uptake, patient decision-making, adverse events, treatment discontinuation, and management after recurrence.
The findings were published online in European Urology Oncology on September 24, 2026, in the article, “Adjuvant Pembrolizumab for Surgically Treated Clear Cell Renal Cell Carcinoma: Results from a UK Tertiary Renal Cancer Network.”
Authors: Federica Sordelli, Giuseppe Basile, Eduard Roussel, Veda Kudva, Daniel Hughes, Elizabeth Nally, Ravi Barod, Abhishek Reekhaye, Mark Yao, Alzahrani Hani, Prasad Patki, Faiz Mumtaz, Soha El Sheikh, Omid Sedigh, Nicolò Maria Buffi, Ekaterini Boleti, Thomas Powles, Axel Bex, and Antonio Rullan.
Why This Study Was Conducted
Adjuvant pembrolizumab has become a standard treatment option for patients with ccRCC who are at increased risk of recurrence after surgery. However, the authors noted that evidence regarding its uptake, safety, and oncological outcomes in routine clinical practice remains limited.
The study aimed to assess how adjuvant pembrolizumab was used among patients who met KEYNOTE-564 eligibility criteria within a UK tertiary renal cancer network. The investigators evaluated multidisciplinary team assessment, patient and clinician decision-making, treatment-related adverse events, discontinuation rates, and disease-free survival and overall survival among patients treated with adjuvant pembrolizumab.
Study Design
This was a retrospective observational study of patients treated at two hospitals within the North Central and North East London Renal Cancer Network: Royal Free London NHS Foundation Trust and Barts Health NHS Trust. Patients were included between November 2022 and April 2024.
All patients had histologically confirmed ccRCC after partial or radical nephrectomy performed at the Royal Free Hospital. Cases were reviewed by a centralized kidney cancer multidisciplinary team, which assessed eligibility for adjuvant pembrolizumab according to pathological tumor-node-metastasis criteria from KEYNOTE-564.
After multidisciplinary review, eligible patients were scheduled for a dedicated outpatient clinic and counselled jointly by a treating urologist and medical oncologist. The study also recorded reasons why eligible patients did not receive adjuvant pembrolizumab, including MDT decision or patient refusal.
Pembrolizumab was administered intravenously either every 3 weeks at 200 mg or every 6 weeks at 400 mg for 1 year, or until disease recurrence or unacceptable toxicity. Follow-up was conducted through routine outpatient visits, with cross-sectional imaging performed according to risk stratification.
Patient Population and Treatment Uptake
During the study period, 2353 patients with radiological indeterminate renal masses were discussed at the centralized MDT. Of these, 554 underwent surgery at the network surgical center, and 348 had a final histological diagnosis of ccRCC.
Among these patients, 229 met KEYNOTE-564 inclusion criteria for adjuvant pembrolizumab. Twenty-nine were considered ineligible because of comorbidities or contraindications to immunotherapy during MDT review. Patients managed outside the participating network after MDT discussion were excluded because data were not consistently available.
The final analysis included 154 patients who were considered eligible for adjuvant pembrolizumab after MDT discussion and had complete follow-up data. Among them, 129 were medically fit and offered adjuvant pembrolizumab, but 50% declined treatment after counselling. Among patients who declined, the majority had Leibovich intermediate-risk disease.
In the final treatment groups, 64 patients received adjuvant pembrolizumab and 90 underwent surveillance. Patients who received pembrolizumab were younger than those managed with surveillance, with a median age of 61 years versus 67 years. They also had numerically more tumor necrosis and a higher proportion of high-risk disease according to the Leibovich score. These baseline differences are important when interpreting the outcomes. The study was not randomized, and treatment allocation reflected both clinical recommendation and patient preference.
Oncological Outcomes
Among patients treated with adjuvant pembrolizumab who did not experience a disease-free survival event, the median follow-up was 18 months. The Kaplan-Meier estimated 24-month disease-free survival was 69% with a 95% confidence interval of 55–87. A total of 13 disease-free survival events occurred in the pembrolizumab group, including recurrences and deaths, and 11 of these events were disease recurrences.
Among patients who remained alive, the median follow-up was 19 months. The estimated 24-month overall survival among patients receiving adjuvant pembrolizumab was 95% with a 95% confidence interval of 89–100. Four patients died during follow-up, including two cancer-related deaths.
The authors stated that the observed safety and oncological outcomes in routine clinical practice were consistent with those reported in KEYNOTE-564. However, they also emphasized that direct comparison with trial data should be avoided because this was an observational study and the treated patients differed from those who underwent surveillance.
Safety and Treatment Discontinuation
Among the 64 patients treated with adjuvant pembrolizumab, 92% experienced treatment-related adverse events of any grade. Grade 3 or higher treatment-related adverse events occurred in 19% of patients.
Treatment discontinuation due to toxicity occurred in 23% of patients, and high-dose corticosteroids, defined as at least 40 mg prednisone equivalent, were required in 33%. The most common treatment-related adverse events were fatigue, rash or pruritus, diarrhea or colitis, and thyroid dysfunction. No treatment-related deaths were recorded.
The authors noted that the safety profile was consistent with randomized trial experience and that no new safety concerns emerged. They also highlighted that counselling should address not only potential recurrence reduction, but also chronic toxicity, the possibility of discontinuation, and quality-of-life considerations.
Management After Recurrence
The study also reported early patterns of care after recurrence. Among patients previously treated with adjuvant pembrolizumab, systemic therapy was initiated in three cases, one patient received stereotactic ablative radiotherapy, and one patient was managed with active surveillance.
Among patients who did not receive adjuvant pembrolizumab, systemic therapy was given to three patients, stereotactic ablative radiotherapy to three patients, and active surveillance to three patients.
The authors stated that these early management patterns suggest that recurrence after adjuvant immunotherapy does not preclude subsequent systemic treatment strategies. However, they also acknowledged that the effect of prior pembrolizumab exposure on response to later systemic therapy could not be formally assessed because of the limited number of post-recurrence treatments.
Limitations
Limitations included the retrospective and nonrandomized design, relatively short follow-up, and limited data on the clinical rationale behind treatment selection. Risk-adapted follow-up schedules may also have introduced detection bias, although all recurrence events were confirmed by imaging and centralized MDT review.
The authors also noted that patient-reported outcomes were not collected, limiting evaluation of quality-of-life considerations that may have influenced treatment decisions. In addition, adverse event grading and management occurred in routine clinical workflows rather than under trial protocol conditions.
Conclusion
This UK tertiary renal cancer network study provides real-world evidence on adjuvant pembrolizumab use after surgery for clear cell renal cell carcinoma. Among patients who were medically fit and offered treatment, half declined after counselling, underscoring the importance of patient preference and shared decision-making in the adjuvant setting.
At 24 months, estimated disease-free survival and overall survival among patients treated with adjuvant pembrolizumab were 69% and 95%, respectively. Most treated patients experienced treatment-related adverse events, 19% had grade 3 or higher toxicity, and 23% discontinued therapy due to toxicity.
The findings support the need to move beyond trial-based eligibility alone when considering adjuvant pembrolizumab. In routine practice, treatment decisions should incorporate recurrence risk tools, comorbidities, potential toxicity, patient preferences, and individualized counselling after surgery for kidney cancer.
