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One-Week Inflammatory Kinetics After First-Line Nivolumab Plus Ipilimumab in Metastatic Renal Cell Carcinoma: A
Toru Inoue1, Kazuyuki Numakura2, Takahiro Osawa3,4
1Department of Urology, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hasama-machi, Yufu, Oita, 879-5593, Japan. i-toru@oita-u.ac.jp.
Background:
First-line nivolumab plus ipilimumab can produce durable survival in metastatic renal cell carcinoma, yet some patients experience early progression or rapid clinical deterioration before first scheduled imaging. Because radiologic response assessment is typically unavailable until approximately 12 weeks, clinically accessible signals during this pre-imaging interval are needed.
Objective:
We aimed to evaluate whether early changes in blood-based inflammatory biomarkers at predefined post-treatment landmarks were associated with overall survival and to determine which biomarker showed the most consistent early prognostic signal.
Methods:
In this multicenter retrospective cohort study across eight Japanese institutions, 219 patients with metastatic renal cell carcinoma treated with first-line nivolumab plus ipilimumab were analyzed. Predefined landmark analyses at 1 week, 1 month, and 3 months compared six blood-based inflammatory biomarkers using restricted cubic splines with multiple imputation. Overall survival was the primary endpoint.
Results:
The 1-week landmark showed the most consistent association with overall survival. Among six biomarkers, change in pan-immune-inflammation value showed the most reproducible pattern. Among 183 patients with paired baseline and 1-week pan-immune-inflammation value data, PIV-BOOST, defined as any pan-immune-inflammation value increase (> 0%) from baseline, was observed in 110 patients (60.1%) and was independently associated with improved overall survival (adjusted hazard ratio 0.60, 95% confidence interval 0.39-0.92; p = 0.018).
Conclusions:
One-week inflammatory kinetics provided early prognostic information before first scheduled imaging in first-line nivolumab plus ipilimumab-treated metastatic renal cell carcinoma. A simple direction-of-change rule for pan-immune-inflammation value may complement baseline risk assessment; however, prospective external validation is required before clinical implementation.
