M. Tucker, Yu-Wei Chen, Martin H Voss, Bradley A McGregor, M. Bilen, Marc-Oliver Grimm, Paul Nathan, C. Kollmannsberger, Yoshihiko Tomita, Bo Huang, Robert Amezquita, M. Mariani, A. di Pietro, Brian Rini
{"title":"晚期肾细胞癌患者中性粒细胞与嗜酸性粒细胞比率与阿维列单抗加阿西替尼或舒尼替尼疗效之间的关系：JAVELIN肾101试验的事后分析","authors":"M. Tucker, Yu-Wei Chen, Martin H Voss, Bradley A McGregor, M. Bilen, Marc-Oliver Grimm, Paul Nathan, C. Kollmannsberger, Yoshihiko Tomita, Bo Huang, Robert Amezquita, M. Mariani, A. di Pietro, Brian Rini","doi":"10.1136/bmjonc-2023-000181","DOIUrl":null,"url":null,"abstract":"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.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.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.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.NCT02684006.","PeriodicalId":505335,"journal":{"name":"BMJ Oncology","volume":"70 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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\",\"authors\":\"M. Tucker, Yu-Wei Chen, Martin H Voss, Bradley A McGregor, M. Bilen, Marc-Oliver Grimm, Paul Nathan, C. Kollmannsberger, Yoshihiko Tomita, Bo Huang, Robert Amezquita, M. Mariani, A. di Pietro, Brian Rini\",\"doi\":\"10.1136/bmjonc-2023-000181\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.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.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.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.NCT02684006.\",\"PeriodicalId\":505335,\"journal\":{\"name\":\"BMJ Oncology\",\"volume\":\"70 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMJ Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1136/bmjonc-2023-000181\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Oncology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/bmjonc-2023-000181","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
我们报告了根据基线中性粒细胞与嗜酸性粒细胞比率（NER）对JAVELIN肾101 3期试验中晚期肾细胞癌（aRCC）患者一线阿维单抗联合阿西替尼或舒尼替尼疗效进行的事后分析。我们分析了总体人群和程序性死亡配体1（PD-L1+）肿瘤患者的无进展生存期（PFS）、总生存期（OS）和基线NER客观反应。在NER<中位数与≥中位数的阿维单抗加阿西替尼治疗组亚组中，PFS和OS的HR分别为0.81（95% CI 0.630~1.035）和0.67（95% CI 0.481~0.940），客观反应率（ORR）分别为63.9% vs 55.2%。PD-L1+亚组的PFS HR为0.72（95% CI 0.520至0.986）。比较舒尼替尼治疗组中的NER定义亚组，PFS和OS的HR分别为0.93（95% CI 0.728至1.181）和0.57（95% CI 0.424至0.779），ORR分别为32.8%和30.8%。在NER亚组中，PFS、OS和ORR分析结果显示，阿维单抗联合阿西替尼治疗优于舒尼替尼治疗。当NER被评估为二分变量（中位数截点）或连续变量时，评估治疗与NER之间关系的交互检验产生了相互矛盾的结果。假设生成分析表明，无论治疗与否，基线NER可能是延长OS的预后因素。NCT02684006.NCT02684006.NCT02684006.NCT02684006.NCT02684006.NCT02684006.NCT02684006.NCT02684006.NCT02684006.
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
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.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.In NER
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