在JAVELIN膀胱100期3试验中，阿维鲁马布+最佳支持治疗（BSC）的一线维持治疗相比于单独的BSC能够延长晚期尿路上皮癌（进展期尿路上皮癌）在一线铂类化疗后未出现进展的患者的总生存期（OS）和无进展生存期（PFS）。报告按一线化疗的持续时间和维持治疗之前的间隔进行的事后分析结果。将在经历过四至六个周期的铂类化疗且化疗后间隔为4-10周的进展期尿路上皮癌患者（n=700）进行随机分组，接受阿维鲁马布+BSC或单独的BSC。根据化疗的持续时间（四分位数[Q]）和预计化疗周期数以及化疗和维持治疗之间的间隔来定义亚组。两组中的中位随访时间均大于19个月。评估了OS（主要终点）、PFS和安全性。与单独的BSC相比，阿维鲁马布+ BSC对于不同化疗持续时间的OS的危险比（95%置信区间）分别如下：化疗持续时间-Q3：0.63（0.39-1.00）；化疗周期数-四周期：0.69（0.48-1.00），五周期：0.98（0.57-1.71）和六周期：0.66（0.47-0.92）；以及间隔-4-<6周：0.75 （0.54-1.04），6-<8周：0.67（0.43-1.06）和8-10周：0.69（0.47-1.02）。 PFS的结果与此类似。安全性在亚组间相似。所有分析均为探索性分析。按一线化疗持续时间和维持治疗之前的间隔对OS和PFS进行的事后分析结果与整体人群的结果基本一致，并且存在相似的安全性结果。有必要进行前瞻性试验以确认这些发现。阿维鲁马布维持治疗有助于进展期尿路上皮癌患者在至少四个疗程前期化疗后未出现疾病进展并在化疗后至少4周开始维持治疗的患者延长生存期。版权所有© 2023年作者。由Elsevier B.V.发布。保留所有权利。

In the JAVELIN Bladder 100 phase 3 trial, avelumab first-line maintenance + best supportive care (BSC) prolonged overall survival (OS) and progression-free survival (PFS) versus BSC alone in patients with advanced urothelial carcinoma (advanced UC) without progression after first-line platinum-based chemotherapy.To report post hoc analyses of subgroups defined by the duration of first-line chemotherapy and interval before maintenance.Patients with advanced UC without progression after four to six cycles of platinum-based chemotherapy and a 4-10-wk interval after chemotherapy (n = 700) were randomized to receive avelumab + BSC or BSC alone. Subgroups were defined by duration (quartile [Q]) and estimated number of cycles of chemotherapy, and interval between chemotherapy and maintenance. The median follow-up was >19 mo in both arms.OS (primary endpoint), PFS, and safety were assessed.Hazard ratios (95% confidence interval) for OS with avelumab + BSC versus BSC alone were as follows: by chemotherapy duration-Q3: 0.63 (0.39-1.00); by number of cycles-four cycles: 0.69 (0.48-1.00), five cycles: 0.98 (0.57-1.71), and six cycles: 0.66 (0.47-0.92); and by interval-4-<6 wk: 0.75 (0.54-1.04), 6-<8 wk: 0.67 (0.43-1.06), and 8-10 wk: 0.69 (0.47-1.02). Results were similar for PFS. Safety was similar across subgroups. All analyses were exploratory.Post hoc analyses of OS and PFS in subgroups defined by first-line chemotherapy duration and interval before maintenance were generally consistent with the results in the overall population, with similar safety findings. Prospective trials are warranted to confirm these findings.Avelumab maintenance treatment helped patients with advanced urothelial cancer without disease progression after at least four cycles of prior chemotherapy, and who started maintenance treatment at least 4 wk after chemotherapy, to live longer.Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.