KEY TAKEAWAYS
- The phase 1b study evaluated the safety and efficacy of partial and radical nephrectomy post-neoadjuvant immune checkpoint inhibitor therapy.
- The results confirmed the safety of surgery in patients after receiving neoadjuvant durvalumab +/- tremelimumab for locally advanced renal cell carcinoma.
The effectiveness of immune checkpoint inhibitors in treating metastatic renal cell carcinoma (RCC) has sparked interest in their use before and after surgery. There’s limited understanding of their effects on renal tissue.
In this phase 1b study, researchers evaluated the safety and efficacy of surgery after neoadjuvant immune checkpoint therapy for complex locally advanced renal tumors.
Patients with RCC stage T2b-4 and/or N1, M0 disease, ECOG 0-1, and suitable organ function were enrolled across four cohorts. Neoadjuvant Cohort 1 received durvalumab alone, while cohorts 2, 2a, and 3 received a combination of durvalumab and tremelimumab.
In the adjuvant setting, Cohorts 1-2 received a single dose of durvalumab, cohort 2a received durvalumab for a year, and Cohort 3 received a combination for one dose followed by durvalumab for a full year. Researchers evaluated patient characteristics before and after surgery and presented descriptive statistics.
Out of 25 patients, 23 received both neoadjuvant and adjuvant therapy (two patients solely underwent neoadjuvant therapy). The tumors showed complexity, with the most frequent RENAL score being 11xh. Renal vein involvement occurred in 6 tumors (Level 1 (two patients), Level 2 (one patient), Level 3 (two patients), and Level 4 (one patient).
Tumors in 25 patients were treated with minimally invasive or open surgery, primarily radical nephrectomy (23 patients). The median estimated blood loss was 375cc (IQR: 188–775). No intraoperative complications were observed. Positive margins were identified in 5 patients, localized at the renal vein wall. The median length of hospital stay was 4 days (IQR:3–5).
Notably, 3 patients necessitated readmission due to diabetic ketoacidosis, thrombocytopenia, and pulmonary embolism, respectively. There were 5 complications at 30 and 90 days post-surgery based on Clavien classification.
Surgery for patients was deemed safe after receiving neoadjuvant durvalumab +/- tremelimumab for locally advanced renal cell carcinoma.
Source: https://suo-abstracts.secure-platform.com/a/gallery/rounds/18/details/3088
Clinical Trial: https://www.clinicaltrials.gov/study/NCT02762006
Zabell J, Rini BI, Krishnamurthi V, et al. Safety of partial and radical nephrectomy for complex locally advanced renal cell carcinoma after neo-adjuvant immune checkpoint inhibition (durvalumab +/- tremelimumab). Presented at: 2023 Society of Urologic Oncology Annual Meeting. November 28 – December 1, 2023; Washington, DC. Abstract 7.
