Association of basophil to lymphocyte ratio (BLR) with clinical outcomes in metastatic hormone sensitive prostate cancer.

e17049 Background: There is limited biomarker data available for metastatic hormone sensitive prostate cancer (mHSPC). Inflammatory markers found on routine clinical lab data, including leukocyte to lymphocyte ratios calculated from complete blood counts (CBC), is associated with clinical outcomes (CO) in different malignancies. We investigated the association between basophil-to-lymphocyte ratio (BLR) and CO in a racially diverse patient population with mHSPC. Methods: We performed a retrospective multicenter review from Winship Cancer Institute at Emory University and Georgia Cancer Center for Excellence at Grady Memorial Hospital (2014 – 2020). Demographics, disease characteristics, and laboratory data were collected at the start of upfront therapy with either docetaxel (DOC) or abiraterone (ABI). Overall survival (OS) and progression-free survival (PFS) were used to measure CO. Results: Included were 165 patients with mHSPC with a median follow-up time of 22.6 months. 89 (53.9%) were Black and 76 (46.1%) were Non-Black (White, Asian, or Hispanic). 106 (63%) had Gleason scores of 8-10 and 105 (63.6%) were classified as high-volume disease (per CHAARTED trial criteria). 92 (55.8%) received DOC and 73 (44.2%) received ABI. Worse CO were associated with high BLR at an optimal cut of 0.0265 (range 0 – 0.81 , mean of 0.03, standard deviation 0.09). Elevated BLR is associated with decreased OS (HR 3.51, 1.79 – 6.91, p <0.001) and PFS (HR 1.85, 1.14 – 3.00, p 0.013) in multivariable analyses (MVA). High BLR and low BLR groups were similar except for age as a continuous variable, which was associated with high BLR. Otherwise, there were no significant difference for all reported clinical characteristics, including drug (DOC vs ABI), race (Black vs Non-Black), Gleason, disease volume (per CHARRTED criteria), ECOG, or BMI. Conclusions: In mHSPC, high baseline BLR is associated with worse OS and PFS. Our results are the first to identify that BLR is associated with CO in mHSPC. Further study is needed to validate BLR as a potential biomarker.[Table: see text]

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Treatments for metastatic hormone-sensitive prostate cancer: A systematic review.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.6_suppl.346 ◽

2018 ◽

Vol 36 (6_suppl) ◽

pp. 346-346

Author(s):

Belal Firwana ◽

Mohamad Bassam Sonbol ◽

Fade A. Mahmoud ◽

Konstantinos Arnaoutakis

Keyword(s):

Prostate Cancer ◽

Progression Free Survival ◽

Standard Of Care ◽

P Value ◽

Free Survival ◽

Appropriate Treatment ◽

Individual Trial ◽

Efficacy Outcome ◽

Significant Difference ◽

Hormone Sensitive

346 Background: Over the past few years, the treatment of metastatic hormone sensitive prostate cancer (mHSPC) was revolutionized with the addition of docetaxel (DOC) or abiraterone (ABI) to the previous standard of care androgen deprivation treatment (ADT). Here, we sought to compare the effectiveness of docetaxel and abiraterone directly against ADT and indirectly to each other. Methods: We included randomized controlled trials (RCT) evaluating the efficacy of treatments in adults with newly diagnosed mHSPC. First-line treatments with DOC and ABI were considered. Efficacy outcome measures are overall survival (OS) and failure-free survival as (FFS) as defined by individual trial. If FFS was not reported, biochemical progression-free survival was considered FFS due to its specificity. The overall effect was pooled using the DerSimonian random effects model. Testing for subgroup difference was conducted using meta-regression method. Results: A total of five RCTs were included; three RCTs compared DOC+ADT versus ADT involving 2,992 participants, and two RCT compared ABI+ADT versus ADT involving 2,201 participants. The addition of DOC to ADT showed a significant improvement in OS compared to ADT monotherapy (HR 0.77, 95% CI 0.66 to 0.89) as well did the addition of ABI to ADT (HR 0.62, 95% CI 0.53 to 0.71). p-value for subgroup interaction was <0.05, suggesting a significant difference between pooled DOC and ABI effects, favoring the addition of ABI vs. DOC to ADT. Similar effects were found in significantly improving FFS when adding DOC (HR 0.64, 95% CI 0.58 to 0.70) or ABI (HR 0.30, 95% CI 0.27 to 0.34) to ADT compared to ADT monotherapy. p-value for interaction subgroup interaction was again significant <0.05 favoring the addition of ABI vs. DOC to ADT. Conclusions: The addition of either DOC or ABI to ADT showed significant improvement in OS and FFS when compared to ADT monotherapy in patients with mHSPC. Test for interaction suggests better outcome of ABI in comparison against DOC. Discussion with patients is encouraged to choose the appropriate treatment considering the adverse event profile for each. Further head-to-head comparison is needed to determine the effect.

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Association of telomere length (TL) with clinical outcomes in patients with colorectal carcinoma (CRC).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.4_suppl.418 ◽

2013 ◽

Vol 31 (4_suppl) ◽

pp. 418-418

Author(s):

Mahadi Ali Baig ◽

Amartej Merla ◽

Titto A Augustine ◽

Gil Atzmon ◽

Temuri Budagov ◽

...

Keyword(s):

Clinical Outcomes ◽

Copy Number ◽

Tandem Repeats ◽

Progression Free Survival ◽

Housekeeping Gene ◽

Tissue Samples ◽

Paired Samples ◽

Potential Biomarker ◽

Significant Difference ◽

Metastatic Sites

418 Background: Telomeres (T) consist of thousands of copies of TTAGGG tandem repeats capping the ends of the chromosome. T along with enzyme telomerase provides protection against any threats to the genome that might arise as a consequence of “end replication problem.” During aberrant cell proliferations the normal check points of cell cycle is compromised leading to unrestricted cell division with extremely short T and subsequent genomic instability. Studies have linked short TL with premalignant and malignant stages of CRC carcinogenesis. However, the relation of TL to the clinical outcomes has not been conclusively determined. In this study we evaluated the association of TL with clinical outcomes in a cohort of 75 CRC patients. Methods: Tumor DNA was isolated from formalin fixed paraffin embedded specimens. TL was measured by using a qRT-PCR method that provided the relative T copy number, compared to reference copy number of the housekeeping gene, β-Globin, which resulted in a T/S ratio. One T/S ratio unit is equivalent to a mean TL of 4,270 base pairs (BP). Results: From 75 patients, 122 tissue samples were identified (66 primary, 52 metastases, 29 matched pairs). Age at diagnosis (>/< median) had a statistically significant difference in TL (mean BP 4700 vs. 4374; p=0.05) with shorter TL in the advanced age. Females had longer TL compared to men (mean BP 4722 vs. 3669 respectively; p=0.04). Shorter TL was associated with shorter progression free survival (PFS) for patients treated with cetuximab/panitumumab (3963 vs. 5295 p=0.04). There was a trend towards increased overall survival (>/< median) with longer TL (4934 vs. 4117; p=0.08). We failed to find a difference in the TL between primary and metastatic sites in the 29 patients with paired samples. Conclusions: TL is a potential biomarker predictive of clinical outcome (PFS) for patients treated with cetuximab/panitumumab. Tumor TL reduces with advancing age and appears to be sex dependent. Further studies to validate TL’s predictive role in patient outcomes are underway.

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Germ-line single nucleotide polymorphism (SNP) predictors of progression-free survival and overall survival in patients with advanced prostate cancer treated with androgen-deprivation therapy (ADT).

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.7_suppl.51 ◽

2011 ◽

Vol 29 (7_suppl) ◽

pp. 51-51 ◽

Cited By ~ 1

Author(s):

M. T. Campbell ◽

J. Jung ◽

S. Philips ◽

Y. Mohammadi ◽

K. A. Carr ◽

...

Keyword(s):

Prostate Cancer ◽

Overall Survival ◽

Clinical Outcomes ◽

Germ Line ◽

Specific Antigen ◽

Progression Free Survival ◽

Cancer Center ◽

Clinical Parameters ◽

Free Survival ◽

Hormone Synthesis

51 Background: Significant variation in response duration and overall survival exists among prostate cancer (PCa) patients treated with ADT. Germ-line SNPs affecting function of genes critical to hormone synthesis, transport, metabolism, binding sites, and degradation may contribute to variability in clinical outcomes observed in PCa patients treated with ADT. Methods: Between 1/07 and 10/08, all PCa patients seen in the Indiana University Simon Cancer Center oncology clinics were approached for recruitment to the Prostate Cancer Genetic Risk Evaluation of SNPs Study (PROGRESS). Participants completed a demographic and clinical questionnaire and provided a peripheral blood sample. Only patients with confirmed ADT initiation dates were included in this analysis. Germ-line DNA was analyzed for SNP genotyping on a 128-SNP chip using a TaqMan OpenArray GT Kit (Applied Biosystems). The chip included genes critical to hormone signaling, transport, and elimination pathways with minor allele frequencies > 5%. Patients were followed for progression-free survival (PFS) and overall survival (OS) endpoints. Univariable analyses were performed to identify significant associations between SNP genotype, clinical parameters, and PFS and OS outcomes. Results: 107 patients with PCa initiated on ADT enrolled. Demographics included: age (median)–69 yrs, prostate specific antigen (PSA) (median)–28.0 ng/ml, PSA doubling time (median)–4.9 months, biochemical/metastatic–25%/75%, concurrent anti-androgen therapy–44%. No clinical parameters were associated with PFS and OS. Significant SNP associations with PFS and OS are summarized in the Table. Conclusions: Interpatient differences in hormone pathway germ-line SNPs may contribute to variability in clinical outcomes in patients treated with ADT. [Table: see text] [Table: see text]

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Association of telomere length with clinical outcomes in patients with colorectal carcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e14540 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e14540-e14540

Author(s):

Mahadi Ali Baig ◽

Titto A Augustine ◽

Amartej Merla ◽

Gil Atzmon ◽

Temuri Budagov ◽

...

Keyword(s):

Clinical Outcomes ◽

Copy Number ◽

Tandem Repeats ◽

Progression Free Survival ◽

Housekeeping Gene ◽

Tissue Samples ◽

Paired Samples ◽

Potential Biomarker ◽

Significant Difference ◽

Metastatic Sites

e14540 Background: Telomeres (T) consist of thousands of copies of TTAGGG tandem repeats capping the ends of the chromosome. T along with enzyme telomerase provides protection against any threats to the genome that might arise as a consequence of “end replication problem”. Studies have linked short TL with premalignant and malignant stages of CRC carcinogenesis. However, the relation of TL to the clinical outcomes has not been conclusively determined. In this study we evaluated the association of TL with clinical outcomes in a cohort of 75 CRC patients. Methods: Tumor DNA was isolated from formalin fixed paraffin embedded specimens. TL was measured by using a qRT-PCR method that provided the relative T copy number, compared to reference copy number of the housekeeping gene, β-Globin, which resulted in a T/S ratio. One T/S ratio unit is equivalent to a mean TL of 4,270 base pairs (BP). Results: From 75 patients, 118 tissue samples were identified (66 primary, 52 metastases, 29 matched pairs). Age at diagnosis (>/< median) had a statistically significant difference in TL (mean BP 4700 vs. 4374; p=0.05) with shorter TL in the advanced age. Females had longer TL compared to men (mean BP 4722 vs. 3669 respectively; p=0.04). Stage at diagnosis (localized Vs Metastatic) had a statistically significant difference in TL (mean BP 4047 vs. 5704; p=0.03). Shorter TL was associated with shorter progression free survival (PFS) for patients treated with cetuximab/panitumumab (3963 vs 5295 p=0.022). Patients treated with cetuximab/panitumumab who had Shorter TL were also found to have significantly decreased Overall Survival (OS) (101.1 Months vs 153.02 Months p<0.0001). We failed to find a difference in the TL between primary and metastatic sites in the 29 patients with paired samples. There was no difference of TL seen with size of the tumor. Furthermore there was no difference in TL between various metastatic sites. Conclusions: TL is a potential biomarker predictive of clinical outcome (OS & PFS) for patients treated with cetuximab/panitumumab. Tumor TL reduces with advancing age and appears to be sex dependent. Further studies to validate TL’s predictive role in patient outcomes are underway.

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Prognostic Significance of Preoperative Neutrophil-to-Lymphocyte Ratio in Patients With Meningiomas

Frontiers in Oncology ◽

10.3389/fonc.2020.592470 ◽

2020 ◽

Vol 10 ◽

Author(s):

Yuki Kuranari ◽

Ryota Tamura ◽

Noboru Tsuda ◽

Kenzo Kosugi ◽

Yukina Morimoto ◽

...

Keyword(s):

Prognostic Significance ◽

Laboratory Data ◽

Progression Free Survival ◽

Cost Effective ◽

Tumor Location ◽

Neutrophil To Lymphocyte Ratio ◽

Ki 67 ◽

Who Grade ◽

Lymphocyte Ratio ◽

Subtotal Removal

BackgroundMeningiomas are the most common benign intracranial tumors. However, even WHO grade I meningiomas occasionally show local tumor recurrence. Prognostic factors for meningiomas have not been fully established. Neutrophil-to-lymphocyte ratio (NLR) has been reported as a prognostic factor for several solid tumors. The prognostic value of NLR in meningiomas has been analyzed in few studies.Materials and MethodsThis retrospective study included 160 patients who underwent surgery for meningiomas between October 2010 and September 2017. We analyzed the associations between patients’ clinical data (sex, age, primary/recurrent, WHO grade, extent of removal, tumor location, peritumoral brain edema, and preoperative laboratory data) and clinical outcomes, including recurrence and progression-free survival (PFS).ResultsForty-four meningiomas recurred within the follow-up period of 3.8 years. WHO grade II, III, subtotal removal, history of recurrence, Ki-67 labeling index ≥3.0, and preoperative NLR value ≥2.6 were significantly associated with shorter PFS (P < 0.001, < 0.001, 0.002, < 0.001, and 0.015, respectively). Furthermore, NLR ≥ 2.6 was also significantly associated with shorter PFS in a subgroup analysis of WHO grade I meningiomas (P = 0.003). In univariate and multivariate analyses, NLR ≥2.6 remained as a significant predictive factor for shorter PFS in patients with meningioma (P = 0.014).ConclusionsNLR may be a cost-effective and novel preoperatively usable biomarker in patients with meningiomas.

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Impact of pretreatment anemia on upfront abiraterone acetate therapy for metastatic hormone-sensitive prostate cancer: a multicenter retrospective study

BMC Cancer ◽

10.1186/s12885-021-08206-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Teppei Okamoto ◽

Daisuke Noro ◽

Shingo Hatakeyama ◽

Shintaro Narita ◽

Koji Mitsuzuka ◽

...

Keyword(s):

Prostate Cancer ◽

Prognostic Factor ◽

Abiraterone Acetate ◽

Tumor Burden ◽

Hazard Ratio ◽

Historical Cohort ◽

High Tumor Burden ◽

Significant Difference ◽

Hormone Sensitive ◽

The Impact

Abstract Background Anemia has been a known prognostic factor in metastatic hormone-sensitive prostate cancer (mHSPC). We therefore examined the effect of anemia on the efficacy of upfront abiraterone acetate (ABI) in patients with mHSPC. Methods We retrospectively evaluated 66 mHSPC patients with high tumor burden who received upfront ABI between 2018 and 2020 (upfront ABI group). We divided these patients into two groups: the anemia-ABI group (hemoglobin < 13.0 g/dL, n = 20) and the non-anemia-ABI group (n = 46). The primary objective was to examine the impact of anemia on the progression-free survival (PFS; clinical progression or PC death before development of castration resistant PC) of patients in the upfront ABI group. Secondary objectives included an evaluation of the prognostic significance of upfront ABI and a comparison with a historical cohort (131 mHSPC patients with high tumor burden who received androgen deprivation therapy (ADT/complete androgen blockade [CAB] group) between 2014 and 2019). Results We found that the anemia-ABI group had a significantly shorter PFS than the non-anemia-ABI group. A multivariate Cox regression analysis showed that anemia was an independent prognostic factor of PFS in the upfront ABI group (hazard ratio, 4.66; P = 0.014). Patients in the non-anemia-ABI group were determined to have a significantly longer PFS than those in the non-anemia-ADT/CAB group (n = 68) (P < 0.001). However, no significant difference was observed in the PFS between patients in the anemia-ABI and the anemia-ADT/CAB groups (n = 63). Multivariate analyses showed that upfront ABI could significantly prolong the PFS of patients without anemia (hazard ratio, 0.17; P < 0.001), whereas ABI did not prolong the PFS of patients with anemia. Conclusion Pretreatment anemia was a prognostic factor among mHSPC patients who received upfront ABI. Although the upfront ABI significantly improved the PFS of mHSPC patients without anemia, its efficacy in patients with anemia might be limited.

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Genomic profiles and clinical outcomes in primary versus secondary metastatic hormone‐sensitive prostate cancer

The Prostate ◽

10.1002/pros.24135 ◽

2021 ◽

Author(s):

Emily Nizialek ◽

Su Jin Lim ◽

Hao Wang ◽

Pedro Isaacsson Velho ◽

Srinivasan Yegnasubramanian ◽

...

Keyword(s):

Prostate Cancer ◽

Clinical Outcomes ◽

Hormone Sensitive

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Retrospective cohort analysis of real-world clinical outcomes in nonmetastatic (M0) castration-resistant prostate cancer (CRPC) treated with novel androgen receptor pathway inhibitors (ARPI).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.6_suppl.51 ◽

2021 ◽

Vol 39 (6_suppl) ◽

pp. 51-51

Author(s):

Richard Gagnon ◽

Nimira S. Alimohamed ◽

Alexander Watson ◽

Eugene Batuyong ◽

Alyssa Chow ◽

...

Keyword(s):

Prostate Cancer ◽

Clinical Outcomes ◽

Real World ◽

Retrospective Cohort ◽

Cohort Analysis ◽

Progression Free Survival ◽

Rank Test ◽

Castration Resistant Prostate Cancer ◽

Survival Times ◽

Free Survival

51 Background: The landscape of M0 CRPC has changed with the recent demonstration of metastasis-free survival (MFS) and overall survival (OS) improvements with the use of ARPIs in clinical trial settings. However, the extrapolation of this data to clinical practice is limited by strict exclusion criteria in these trials, including prior or concurrent malignancy, cardiovascular disease, or hypertension. The purpose of this study was to assess real-world outcomes in patients with M0 CRPC treated with ARPIs compared to historical controls. Methods: We designed a retrospective cohort study with the inclusion of patients in Alberta, Canada diagnosed with M0 CRPC between 2001-2020. Via chart review, we identified baseline characteristics, potential confounders, treatment details, and clinical outcomes. The primary outcome of interest was MFS. Secondary outcomes included: second progression-free survival (PFS2) and OS. Median survival times were measured using the Kaplan-Meier method and the log-rank test was used for comparison of outcomes based on ARPI exposure. Cox proportional hazard regression models were used to calculate hazard ratios (HR) accounting for impact of PSA doubling time (PSADT), use of osteoclast inhibiting agents, and presence of pelvic lymphadenopathy. Results: We identified 211 patients across multiple centres in Alberta with M0 CRPC, with 54 having received apalutamide (40/54), enzalutamide (7/54), or darolutamide (7/54). Median age at M0 CRPC diagnosis was 74 years; median PSADT was 4.4 months; and 19% of patients (40/211) had pelvic lymphadenopathy at diagnosis. Median MFS in patients treated with ARPIs was 47.5 months compared to 20.6 months in those not treated with ARPIs (HR, 0.23; 95% confidence interval [CI], 0.11-0.49; p < 0.001). Median PFS2 in ARPI treated patients was 66.3 months compared with 35.6 months (HR, 0.40; 95% CI, 0.18-0.87; p = 0.022). Median OS for patients treated with ARPI was not reached. Conclusions: Given the older age of men with advanced prostate cancer, real-world outcomes that include patients with comorbidities are important adjuncts to the interpretation of clinical trials exploring the benefit of novel therapeutics. Here, we demonstrate that in a real-world, unselected population of men with M0 CRPC, apalutamide, enzalutamide, and darolutamide seem to confer similar MFS and PFS2 benefits to those demonstrated in the SPARTAN, PROSPER, and ARAMIS studies. Real-world OS data remain immature and will be an important addition to these findings.

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Population-Based Study of Docetaxel or Abiraterone Effectiveness and Predictive Markers of Progression Free Survival in Metastatic Castration-Sensitive Prostate Cancer

Frontiers in Oncology ◽

10.3389/fonc.2021.658331 ◽

2021 ◽

Vol 11 ◽

Author(s):

Juan Briones ◽

Maira Khan ◽

Amanjot K. Sidhu ◽

Liying Zhang ◽

Martin Smoragiewicz ◽

...

Keyword(s):

Prostate Cancer ◽

Predictive Factors ◽

Real World ◽

Univariate Analysis ◽

Multivariable Analysis ◽

Progression Free Survival ◽

Predictive Markers ◽

Age At Diagnosis ◽

Free Survival ◽

Significant Difference

BackgroundBoth Docetaxel (DOC) and Abiraterone (ABI) improve the survival of men with metastatic, castration sensitive prostate cancer (mCSPC). However, the outcome among mCSPC patients is highly variable, while there is a lack of predictive markers of therapeutic benefit. Furthermore, there is limited data on the comparative real-world effectiveness of adding DOC or ABI to androgen deprivation therapy (ADT).MethodsWe conducted a retrospective analysis of 121 mCSPC patients treated at Odette Cancer Centre (Toronto, ON, Canada) between Dec 2014 and Mar 2021 (DOC n = 79, ABI n = 42). The primary endpoint studied was progression free survival (PFS), defined as the interval from start of ADT to either (i) biochemical, radiological, or symptomatic progression, (ii) start of first-line systemic therapy for castration-resistant prostate cancer (CRPC), or (iii) death, whichever occurred first. To identify independent predictive factors for PFS in the entire cohort, a Cox proportional hazard model (stepwise selection) was applied. Overall survival (OS) was among secondary endpoints.ResultsAfter a median follow-up of 39.6 and 25.1 months in the DOC and ABI cohorts, respectively, 79.7% of men in the DOC and 40.5% in the ABI group experienced a progression event. PFS favored the ABI cohort (p = 0.0038, log-rank test), with 78.0% (95%CI 66.4–91.8%) of ABI versus 67.1% (57.5–78.3%) of DOC patients being free of progression at 12 months. In univariate analysis superior PFS was significantly related to older age at diagnosis of mCSPC, metachronous metastatic presentation, low-volume (CHAARTED), and low-risk (LATITUDE) disease, ≥90% PSA decrease at 3 months (PSA90), and PSA nadir ≤0.2 at 6 months. Age (HR = 0.955), PSA90 (HR = 0.462), and LATITUDE risk stratification (HR = 1.965) remained significantly associated with PFS in multivariable analysis. OS at 12 months was 98.7% (96.3–100%) and 92.7% (85.0–100%) in the DOC and ABI groups (p = 0.97), respectively.ConclusionsIn this real-world group of men undergoing treatment intensification with DOC or ABI for mCSPC, we did not find a significant difference in OS, but PFS was favoring ABI. Age at diagnosis of mCSPC, PSA90 at 3 months and LATITUDE risk classification are predictive factors of PFS in men with mCSPC.

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Association of the neutrophil to eosinophil ratio with response to immunotherapy-based combinations in metastatic renal cell carcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.6_suppl.341 ◽

2021 ◽

Vol 39 (6_suppl) ◽

pp. 341-341

Author(s):

Matthew D Tucker ◽

Katy Beckermann ◽

Kristin Kathleen Ancell ◽

Kerry Schaffer ◽

Renee McAlister ◽

...

Keyword(s):

Renal Cell Carcinoma ◽

Cell Carcinoma ◽

Clinical Outcomes ◽

Metastatic Renal Cell Carcinoma ◽

Renal Cell ◽

Objective Response ◽

Progression Free Survival ◽

Rank Test ◽

Cancer Center ◽

Exact Test

341 Background: Neutrophilia is known to be associated with worse prognosis in metastatic renal cell carcinoma (mRCC); however, less is known about the role of eosinophils in the response to immunotherapy (IO). We investigated the association of the baseline neutrophil to eosinophil ratio (NER) with outcomes to IO-based combination treatment in mRCC. Methods: Patients with mRCC treated with ipilimumab plus nivolumab, pembrolizumab plus axitinib, or avelumab plus axitinib at the Vanderbilt-Ingram Cancer Center were retrospectively identified. Patients on >10mg prednisone and patients with prior IO were excluded. Baseline NER (at time of first IO) and association with progression free survival (PFS), overall survival (OS), and objective response rate (ORR) were investigated. Data cutoff was 9/1/2020. Analysis for PFS and OS was performed using the log-rank test and Mantel-Haenszel method, and analysis of the odds ratio for ORR was performed using Fischer’s exact test. Results: Sixty-one patients were identified: 89% clear cell histology, 74% prior nephrectomy, 69% IMDC intermediate risk, and 72% treatment-naïve. Patients with baseline NER < median (N=31) had improved clinical outcomes compared to patients with baseline NER > median (N=30) (Table). Improvement in PFS by NER was maintained when stratified by anti-PD-1/CTLA-4 and anti-PD(L)-1/VEGF (p= 0.0062 and p= 0.049); however, differences in OS and ORR were no longer significant. The median baseline NER among patients with partial response (PR) was significantly lower at 22.7 (95% CI 18.9-31.1) vs. 51.6 (95% CI 39.5-93.1) among those with progressive disease (PD) (p= 0.0054). For comparison, the median neutrophil to lymphocyte ratio was not significantly different between PR (2.60) and PD (3.84, p= 0.056). Conclusions: Patients with a low baseline NER treated with IO-based combinations had improved clinical outcomes compared to patients with a high baseline NER. Additional investigation of this parameter in larger cohorts is warranted. [Table: see text]

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