Postoperative recurrence factors in patients with pT3N0M0 clear cell renal cell carcinoma, called M0 intermediate-high-risk group of the KEYNOTE 564 trial

Abstract

Abstract Background KEYNOTE 564, a phase 3 trial, demonstrated the efficacy of pembrolizumab as an adjuvant therapy for clear cell renal cell carcinoma; however, it remains unclear which patients in the M0 intermediate-high-risk group of the trial who were pT3N0M0 with any nuclear grade (> 80% of the cohort) would benefit from pembrolizumab. Additional factors are required to identify these patients. We aimed to examine postoperative recurrence factors in patients with pT3N0M0 clear cell renal cell carcinoma who were retrospectively included in the M0 intermediate-high-risk group. Methods We reviewed the medical records of 386 patients who underwent radical or partial nephrectomy for renal cell carcinoma, identifying 47 with pT3N0M0 clear cell renal cell carcinoma. Preoperative clinical and pathological data were collected. Patients were stratified by median value and category. Disease-free survival was calculated using Kaplan–Meier survival analysis, and the log-rank test was applied to compare survival curves. Results We showed that ≥ 68 years and necrosis were risk factors of worse disease-free survival (median disease-free survival; ≥68 year versus < 68 year: 24.46 months versus 97.54 months, P = 0.017, with necrosis versus without necrosis; 24.43 months versus 317.5 months, P = 0.023). Patients with a higher number of risk factors had significantly worse disease-free survival (median disease-free survival; no factor versus ≥ 68 years or necrosis versus ≥ 68 years and necrosis; 317.5 months versus 45.18 months versus 12.54 months). Conclusion Age and necrosis were suggested to impact on postoperative recurrence in the M0 intermediate-high-risk patients. It would support the indication for adjuvant therapy.