Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial

Objective We report post hoc analyses of efficacy with first-line avelumab plus axitinib or sunitinib according to baseline neutrophil-to-eosinophil ratio (NER) in patients with advanced renal cell carcinoma (aRCC) from the JAVELIN Renal 101 phase 3 trial.Methods and analysis Progression-free surviv...

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Main Authors: Brian Rini, Mariangela Mariani, Alessandra di Pietro, Paul Nathan, Christian Kollmannsberger, Marc-Oliver Grimm, Martin H Voss, Bradley A McGregor, Mehmet A Bilen, Yoshihiko Tomita, Bo Huang, Robert Amezquita, Matthew Tucker, Yu-Wei Chen
Format: Article
Language:English
Published: BMJ Publishing Group 2024-07-01
Series:BMJ Oncology
Online Access:https://bmjoncology.bmj.com/content/3/1/e000181.full
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author Brian Rini
Mariangela Mariani
Alessandra di Pietro
Paul Nathan
Christian Kollmannsberger
Marc-Oliver Grimm
Martin H Voss
Bradley A McGregor
Mehmet A Bilen
Yoshihiko Tomita
Bo Huang
Robert Amezquita
Matthew Tucker
Yu-Wei Chen
author_facet Brian Rini
Mariangela Mariani
Alessandra di Pietro
Paul Nathan
Christian Kollmannsberger
Marc-Oliver Grimm
Martin H Voss
Bradley A McGregor
Mehmet A Bilen
Yoshihiko Tomita
Bo Huang
Robert Amezquita
Matthew Tucker
Yu-Wei Chen
author_sort Brian Rini
collection DOAJ
description Objective We report post hoc analyses of efficacy with first-line avelumab plus axitinib or sunitinib according to baseline neutrophil-to-eosinophil ratio (NER) in patients with advanced renal cell carcinoma (aRCC) from the JAVELIN Renal 101 phase 3 trial.Methods and analysis Progression-free survival (PFS), overall survival (OS) and objective response per baseline NER were analysed in the overall population and in patients with programmed death ligand 1 (PD-L1+) tumours. Multivariable Cox regression analyses to assess the effect of NER after adjustment for other baseline variables were conducted.Results In NER <median versus ≥median subgroups of the avelumab plus axitinib arm, HRs for PFS and OS were 0.81 (95% CI 0.630 to 1.035) and 0.67 (95% CI 0.481 to 0.940), and objective response rates (ORRs) were 63.9% vs 55.2%, respectively. The HR for PFS in the PD-L1+ subgroup was 0.72 (95% CI 0.520 to 0.986). Comparing NER-defined subgroups in the sunitinib arm, HRs for PFS and OS were 0.93 (95% CI 0.728 to 1.181) and 0.57 (95% CI 0.424 to 0.779), and ORRs were 32.8% versus 30.8%, respectively. Within NER subgroups, analyses of PFS, OS and ORR favoured avelumab plus axitinib versus sunitinib treatment. Interaction tests that assessed the association between treatment and NER yielded conflicting results when NER was assessed as a dichotomised variable (median cut-off) or continuous variable.Conclusion Hypothesis-generating analyses suggest that baseline NER may be prognostic for longer OS irrespective of treatment. Analyses of the association between NER level and treatment outcomes with avelumab plus axitinib versus sunitinib were inconclusive.Trial registration number NCT02684006.
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spelling doaj-art-e21e585079dc450abadbe8a2b44d6e732025-01-30T06:25:10ZengBMJ Publishing GroupBMJ Oncology2752-79482024-07-013110.1136/bmjonc-2023-000181Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trialBrian Rini0Mariangela Mariani1Alessandra di Pietro2Paul Nathan3Christian Kollmannsberger4Marc-Oliver Grimm5Martin H Voss6Bradley A McGregor7Mehmet A Bilen8Yoshihiko Tomita9Bo Huang10Robert Amezquita11Matthew Tucker12Yu-Wei Chen13Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USAPfizer srl, Milan, ItalyPfizer srl, Milan, ItalyMount Vernon Cancer Centre, Northwood, Middlesex, UKBC Cancer—Vancouver Cancer Centre, Vancouver, British Columbia, CanadaDepartment of Urology, Jena University Hospital, Jena, GermanyMemorial Sloan Kettering Cancer Center, New York, New York, USAThe Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA5Winship Cancer Institute of Emory University, Atlanta, GA, USA8 Department of Urology, Department of Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, JapanDepartment of Pathology, Cancer Hospital of China Medical University, Shenyang, Liaoning, ChinaPfizer, La Jolla, California, USAVanderbilt University Medical Center, Nashville, Tennessee, USAVanderbilt University Medical Center, Nashville, Tennessee, USAObjective We report post hoc analyses of efficacy with first-line avelumab plus axitinib or sunitinib according to baseline neutrophil-to-eosinophil ratio (NER) in patients with advanced renal cell carcinoma (aRCC) from the JAVELIN Renal 101 phase 3 trial.Methods and analysis Progression-free survival (PFS), overall survival (OS) and objective response per baseline NER were analysed in the overall population and in patients with programmed death ligand 1 (PD-L1+) tumours. Multivariable Cox regression analyses to assess the effect of NER after adjustment for other baseline variables were conducted.Results In NER <median versus ≥median subgroups of the avelumab plus axitinib arm, HRs for PFS and OS were 0.81 (95% CI 0.630 to 1.035) and 0.67 (95% CI 0.481 to 0.940), and objective response rates (ORRs) were 63.9% vs 55.2%, respectively. The HR for PFS in the PD-L1+ subgroup was 0.72 (95% CI 0.520 to 0.986). Comparing NER-defined subgroups in the sunitinib arm, HRs for PFS and OS were 0.93 (95% CI 0.728 to 1.181) and 0.57 (95% CI 0.424 to 0.779), and ORRs were 32.8% versus 30.8%, respectively. Within NER subgroups, analyses of PFS, OS and ORR favoured avelumab plus axitinib versus sunitinib treatment. Interaction tests that assessed the association between treatment and NER yielded conflicting results when NER was assessed as a dichotomised variable (median cut-off) or continuous variable.Conclusion Hypothesis-generating analyses suggest that baseline NER may be prognostic for longer OS irrespective of treatment. Analyses of the association between NER level and treatment outcomes with avelumab plus axitinib versus sunitinib were inconclusive.Trial registration number NCT02684006.https://bmjoncology.bmj.com/content/3/1/e000181.full
spellingShingle Brian Rini
Mariangela Mariani
Alessandra di Pietro
Paul Nathan
Christian Kollmannsberger
Marc-Oliver Grimm
Martin H Voss
Bradley A McGregor
Mehmet A Bilen
Yoshihiko Tomita
Bo Huang
Robert Amezquita
Matthew Tucker
Yu-Wei Chen
Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial
BMJ Oncology
title Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial
title_full Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial
title_fullStr Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial
title_full_unstemmed Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial
title_short Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial
title_sort association between neutrophil to eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma post hoc analyses from the javelin renal 101 trial
url https://bmjoncology.bmj.com/content/3/1/e000181.full
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