Association of C-reactive protein with efficacy of avelumab plus axitinib in advanced renal cell carcinoma: long-term follow-up results from JAVELIN Renal 101.
Association of C-reactive protein with efficacy of avelumab plus axitinib in advanced renal cell carcinoma: long-term follow-up results from JAVELIN Renal 101.
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DOI：
10.1016/j.esmoop.2022.100564
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发表时间：
2022-10
期刊：
影响因子：
7.3
通讯作者：
Choueiri, T. K.
中科院分区：
文献类型：
--
作者：
Tomita, Y.;Larkin, J.;Venugopal, B.;Haanen, J.;Kanayama, H.;Eto, M.;Grimm, M-O;Fujii, Y.;Umeyama, Y.;Huang, B.;Mariani, M.;di Pietro, A.;Choueiri, T. K.
关键词：
C反应蛋白（CRP）是晚期肾癌（aRCC）的重要预后预测因子。我们报告了基线和治疗后早期CRP水平与III期JAVELIN Renal 101试验中avelumab+阿西替尼或舒尼替尼疗效的相关性。将患者分为正常（基线CRP <10 mg/l）、正常化（基线CRP ≥10 mg/l且6周治疗期间≥1个CRP值降至<10 mg/l）和非正常化（基线和6周治疗期间CRP ≥10 mg/l）CRP组。评估了第二次中期分析的无进展生存期和最佳总缓解以及第三次中期分析的总生存期（OS）。在avelumab+阿西替尼和舒尼替尼组中，分别有234、51和108例患者和232、36和128例患者被分为正常、标准化和非标准化CRP组。各CRP组的客观缓解率[95%置信区间（CI）]为56.0%（49.4%至62.4%）、66.7%（52.1%至79.2%）和45.4% avelumab+阿西替尼组（35.8%-55.2%）和30.6%（24.7%至37.0%）、41.7%舒尼替尼组分别为25.5%~ 59.2%和19.5%~ 27.5%;完全缓解率分别为3.8%、11.8%和0.9%和3.0%、0%和1.6%。中位无进展生存期（95% CI）为15.2个月（12.5-21.0个月）、未达到（NR）[11.1个月-无法估计（NE）]和7.0个月avelumab+阿西替尼组（5.6-9.9个月）和11.2个月（8.4-13.9个月）、11.2个月（6.7-13.8个月）和4.2个月舒尼替尼组2.8-5.6个月;中位OS（95% CI）为NR（42.2个月-东北），未报告NR组（39.0个月-NE）、39.8个月（21.7-NE）和19.1个月（16.3-25.3个月）。多变量分析表明，标准化或非标准化CRP水平分别是预测avelumab+阿西替尼客观缓解率或OS的独立因素。在aRCC患者中，基线和治疗后早期的CRP水平可预测avelumab+阿西替尼的疗效。C反应蛋白是晚期肾癌的重要预后预测因子。评价了C反应蛋白水平与avelumab+阿西替尼或舒尼替尼疗效之间的相关性。基线和治疗后早期的C反应蛋白水平可能预测avelumab+阿西替尼的疗效。
C-reactive protein (CRP) is an important prognostic and predictive factor in advanced renal cell carcinoma (aRCC). We report the association of CRP levels at baseline and early after treatment with efficacy of avelumab plus axitinib or sunitinib from the phase III JAVELIN Renal 101 trial. Patients were categorized into normal (baseline CRP <10 mg/l), normalized (baseline CRP ≥10 mg/l and ≥1 CRP value decreased to <10 mg/l during 6-week treatment), and non-normalized (CRP ≥10 mg/l at baseline and during 6-week treatment) CRP groups. Progression-free survival and best overall response from the second interim analysis and overall survival (OS) from the third interim analysis were assessed. In the avelumab plus axitinib and sunitinib arms, respectively, 234, 51, and 108 patients and 232, 36, and 128 patients were categorized into normal, normalized, and non-normalized CRP groups. In respective CRP groups, objective response rates [95% confidence interval (CI)] were 56.0% (49.4% to 62.4%), 66.7% (52.1% to 79.2%), and 45.4% (35.8% to 55.2%) with avelumab plus axitinib and 30.6% (24.7% to 37.0%), 41.7% (25.5% to 59.2%), and 19.5% (13.1% to 27.5%) with sunitinib; complete response rates were 3.8%, 11.8%, and 0.9% and 3.0%, 0%, and 1.6%, respectively. Median progression-free survival (95% CI) was 15.2 months (12.5-21.0 months), not reached (NR) [11.1 months-not estimable (NE)], and 7.0 months (5.6-9.9 months) with avelumab plus axitinib and 11.2 months (8.4-13.9 months), 11.2 months (6.7-13.8 months), and 4.2 months (2.8-5.6 months) with sunitinib; median OS (95% CI) was NR (42.2 months-NE), NR (30.4 months-NE), and 23.0 months (18.4-33.1 months) and NR (39.0 months-NE), 39.8 months (21.7-NE), and 19.1 months (16.3-25.3 months), respectively. Multivariate analyses demonstrated that normalized or non-normalized CRP levels were independent factors for the prediction of objective response rate or OS, respectively, with avelumab plus axitinib. In patients with aRCC, CRP levels at baseline and early after treatment may predict efficacy with avelumab plus axitinib. C-reactive protein is an important prognostic and predictive factor in advanced renal cell carcinoma. The association between C-reactive protein levels and the efficacy of avelumab plus axitinib or sunitinib was evaluated. C-reactive protein levels at baseline and early after treatment might predict efficacy with avelumab plus axitinib.
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影响因子：
5.7
作者：
Eto M;Uemura H;Tomita Y;Kanayama H;Shinohara N;Kamei Y;Fujii Y;Umeyama Y;Ozono S;Naito S;Akaza H;Japan Axitinib Phase II Study Group
通讯作者：
Japan Axitinib Phase II Study Group
DOI：
10.1038/s41571-020-00455-z
发表时间：
2021-04
期刊：
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影响因子：
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作者：
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影响因子：
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作者：
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