Abstract
BackgroundThe identification of biomarkers to select patients with metastatic renal cell carcinoma (mRCC) most likely to respond to combination immunotherapy (IO) is needed. We sought to investigate an association of the baseline neutrophil-to-eosinophil ratio (NER) with outcomes to nivolumab plus ipilimumab for patients with mRCC.MethodsWe performed a retrospective review of patients with clear cell mRCC treated with nivolumab plus ipilimumab from Vanderbilt-Ingram Cancer Center and Duke Cancer Institute. Patients with prior receipt of immunotherapy and those without available baseline complete blood count with differential were excluded. Patients were divided into groups by the median baseline NER and analyzed for overall survival (OS), progression free survival (PFS), and objective response rate (ORR). Patients were also divided by median baseline neutrophil-to-lymphocyte ratio (NLR) and analyzed for clinical outcome. Further analyses of patients above/below the median NER and NLR were performed in subgroups of IMDC intermediate/poor risk, IMDC favorable risk, and treatment naïve patients.ResultsA total of 110 patients were included: median age was 61 years and 75% were treatment naïve. The median NER (mNER) at baseline was 26.4. The ORR was 40% for patients with <mNER compared to 21.8% among patients with >mNER (OR 2.39, p = 0.04). The median PFS for patients with <mNER was significantly longer at 8.6 months (mo) compared to 3.2 mo for patients with >mNER (HR 0.50, p < 0.01). Median OS was not reached (NR) for patients with <mNER compared with 27.3 mo for patients with >mNER (HR 0.31, p < 0.01). The median NLR (mNLR) was 3.42. While patients with <mNLR showed improvement in OS (HR 0.42, p = 0.02), PFS and ORR did not differ compared with patients in the >mNLR group.ConclusionsA lower baseline NER was associated with improved clinical outcomes (PFS, OS, and ORR) in patients with mRCC treated with nivolumab plus ipilimumab, and prospective validation of the baseline NER as a predictive biomarker for response to immunotherapy-based combinations in mRCC is warranted.
Highlights
The identification of biomarkers to select patients with metastatic renal cell carcinoma most likely to respond to combination immunotherapy (IO) is needed
A lower baseline neutrophil-to-eosinophil ratio (NER) was associated with improved clinical outcomes (PFS, overall survival (OS), and objective response rate (ORR)) in patients with metastatic renal cell carcinoma (mRCC) treated with nivolumab plus ipilimumab, and prospective validation of the baseline NER as a predictive biomarker for response to immunotherapy-based combinations in mRCC is warranted
Baseline patient characteristics A total of 162 patients with mRCC treated with nivolumab plus ipilimumab were identified (42 from VanderbiltIngram Cancer Center (VICC) and 120 from Duke Cancer Institute (DCI))
Summary
Patients were further divided by quartiles of baseline NER and NLR for subsequent analyses. The optimal NER cutpoint was calculated separately using the Contal and O’Quigley’s method, which uses the log- rank test statistic to estimate the cutpoint [27]. This additional method was performed to assess the accuracy of the use median compared to the optimal cutpoint for NER. A two-sided pvalue < 0.05 was considered statistically significant
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