Early Progressive Disease During Nivolumab Plus Ipilimumab Therapy Predicts Poor Survival in Japanese Patients with Advanced Renal Cell Carcinoma: A Single-Center 12-Week Landmark Study.
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Abstract
Background: It is clinically important to identify early progressive disease (PD) during nivolumab plus ipilimumab therapy for advanced renal cell carcinoma (RCC). However, the predictors of early PD are unclarified. We evaluated the prognostic impact and baseline predictors of early PD.
Materials and methods: We retrospectively reviewed consecutive patients with advanced RCC who received nivolumab plus ipilimumab at Kyushu Cancer Center between September 2018 and January 2026. Tumor response was assessed using the RECIST version 1.1 guidelines. Early PD was defined as PD within 12 weeks from treatment initiation or PD at the first radiologic assessment. Overall survival (OS) was evaluated at the 12-week landmark. Cox regression was used to identify prognostic factors for landmark OS, and logistic regression was used to explore predictors of early PD.
Results: The 12-week landmark cohort comprised 38 patients (early PD, n=14; non-early PD, n=24). Landmark OS was significantly shorter in the early PD group than in the non-early PD group (median, 12.9 vs. 66.1 months; log-rank P<0.001). In multivariable Cox regression, early PD (hazard ratio 3.67; 95% confidence interval 1.28-10.59; P=0.016) and International Metastatic RCC Database Consortium (IMDC) poor risk (hazard ratio 3.16; 95% confidence interval 1.24-8.07; P=0.016) were independently associated with worse OS. In exploratory multivariable logistic regression, non-clear cell histology was significantly associated with early PD (odds ratio 9.01; 95% confidence interval 1.45-56.20; P=0.019).
Conclusion: Early PD during nivolumab plus ipilimumab identifies a high-risk population with markedly inferior survival. Non-clear cell histology was significantly associated with early PD in exploratory multivariable analysis and may help guide individualized first-line treatment selection and patient counseling in advanced RCC.
期刊介绍：
Research and Reports in Urology is an international, peer-reviewed, open access, online journal. Publishing original research, reports, editorials, reviews and commentaries on all aspects of adult and pediatric urology in the clinic and laboratory including the following topics: Pathology, pathophysiology of urological disease Investigation and treatment of urological disease Pharmacology of drugs used for the treatment of urological disease Although the main focus of the journal is to publish research and clinical results in humans; preclinical, animal and in vitro studies will be published where they will shed light on disease processes and potential new therapies. Issues of patient safety and quality of care will also be considered.
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