目的:在晚期肾细胞癌(aRCC)患者的3期JAVELINRenal101试验中,与舒尼替尼相比,一线阿维鲁单抗联合阿西替尼治疗的患者的客观缓解率(ORR)和无进展生存期(PFS)显著改善.在这里,我们评估了一线阿维鲁单抗联合阿西替尼治疗日本aRCC患者的实际结果。
方法:在这个多中心中,非干预性,回顾性研究,我们回顾了2019年12月至2020年12月在日本接受一线阿维鲁单抗联合阿西替尼治疗的aRCC患者的临床数据.终点包括每个研究者评估的ORR和PFS,和治疗终止时间(TTD)。
结果:来自48名患者的数据(中位年龄,69年)对12个地点进行了分析。中位随访时间为10.4个月(范围,2.6-16.5),中位治疗时间为7.4个月(范围,0.5-16.5)。国际转移性碾压混凝土数据库联盟风险类别有利,中间,或差16.7%,54.2%,29.2%的病人,分别。ORR为48.8%(95%CI,33.3%-64.5%),包括3/43例患者的完全缓解(7.0%)。13例患者(27.1%)出现疾病进展或死亡,中位PFS为15.3个月(95%CI,9.7个月-不可估计).在数据截止时,24例患者(50.0%)仍在接受阿维鲁单抗联合阿西替尼治疗,中位TTD为15.2个月(95%CI,7.4个月-不可估计).3例患者(6.3%)因免疫相关不良事件接受大剂量皮质类固醇治疗,8例(16.7%)接受输液相关反应治疗.
结论:我们报告了一线阿维鲁单抗联合阿西替尼在日本aRCC患者中的有效性和耐受性的第一个真实世界证据。结果与JAVELIN肾101试验相当。
OBJECTIVE: In the phase 3 JAVELIN Renal 101
trial in patients with advanced renal cell carcinoma (aRCC), objective response rate (ORR) and progression-free survival (PFS) were significantly improved in patients treated with first-line avelumab plus axitinib vs sunitinib. Here we evaluate real-world outcomes with first-line avelumab plus
axitinib in Japanese patients with aRCC.
METHODS: In this multicenter, noninterventional, retrospective
study, clinical data from patients with aRCC treated with first-line avelumab plus
axitinib between December 2019 and December 2020 in Japan were reviewed. Endpoints included ORR and PFS per investigator assessment, and time to treatment discontinuation (TTD).
RESULTS: Data from 48 patients (median age, 69 years) from 12 sites were analyzed. Median follow-up was 10.4 months (range, 2.6-16.5), and median duration of treatment was 7.4 months (range, 0.5-16.5). International Metastatic RCC Database Consortium risk category was favorable, intermediate, or poor in 16.7%, 54.2%, and 29.2% of patients, respectively. The ORR was 48.8% (95% CI, 33.3%-64.5%), including complete response in 3/43 patients (7.0%). Thirteen patients (27.1%) had disease progression or died, and median PFS was 15.3 months (95% CI, 9.7 months - not estimable). At data cutoff, 24 patients (50.0%) were still receiving avelumab plus axitinib, and median TTD was 15.2 months (95% CI, 7.4 months - not estimable). Three patients (6.3%) received high-dose corticosteroid treatment for immune-related adverse events, and 8 (16.7%) received treatment for infusion-related reactions.
CONCLUSIONS: We report the first real-world evidence of the effectiveness and tolerability of first-line avelumab plus axitinib in Japanese patients with aRCC. Results were comparable with the JAVELIN Renal 101
trial.