Department of Urology, Nara Medical University, Nara, Japan.
Department of Urology, Yamatotakada Municipal Hospital, Nara, Japan.
Jpn J Clin Oncol. 2023 Mar 7;53(3):253-262. doi: 10.1093/jjco/hyac186.
To develop the first Japanese real-world evidence of switch-maintenance avelumab in advanced, unresectable or metastatic urothelial carcinoma (aUC).
A multicenter-derived database registered 505 patients diagnosed with aUC between 2008 and 2021. Of these, 204 patients (40%) were selected and stratified according to the type of therapy used: maintenance avelumab group (27 [5.3%]), second-line (2 L) pembrolizumab group (103 [20%]) and 2 L cytotoxic chemotherapy group (74 [15%]). The progression-free survival and overall survival from the initiation of following therapy were compared. Tumor response was evaluated based on the Response Evaluation Criteria in Solid Tumors guideline v1.1 during the treatment period. A detailed analysis was performed in the maintenance avelumab group to investigate possible factors associated with response to avelumab therapy.
The maintenance avelumab group had a longer overall survival, not progression-free survival, compared with the other two treatment groups. The median treatment-free interval between the last dose of first-line (1 L) chemotherapy and the initiation of avelumab therapy was 6 weeks (range, 3-22). Disease control rate of maintenance avelumab therapy in patients with a treatment-free interval of ≤6 weeks was higher than that in patients with a treatment-free interval of >6 weeks (77 vs 40%, P = 0.029). The patients showing objective response to 1 L chemotherapy were less likely to experience tumor relapse (4 of 19) after the initiation of avelumab therapy compared with those showing stable disease (7 of 8).
Objective response to 1 L chemotherapy and early induction of maintenance avelumab therapy may be associated with increased benefit from maintenance avelumab therapy.
开发首个日本真实世界证据，证明阿维鲁单抗在晚期、不可切除或转移性尿路上皮癌（aUC）中的维持治疗效果。
从多中心数据库中登记了 2008 年至 2021 年期间诊断为 aUC 的 505 例患者。其中，根据治疗类型选择了 204 例患者（40%）进行分层：维持阿维鲁单抗组（27 例[5.3%]）、二线（2L）帕博利珠单抗组（103 例[20%]）和 2L 细胞毒性化疗组（74 例[15%]）。比较了起始后续治疗后的无进展生存期和总生存期。在治疗期间，根据实体瘤反应评价标准 v1.1 评估肿瘤反应。在维持阿维鲁单抗组中进行了详细分析，以探讨与阿维鲁单抗治疗反应相关的可能因素。
与其他两组相比，维持阿维鲁单抗组的总生存期更长，无进展生存期无差异。从一线（1L）化疗的最后一次剂量到阿维鲁单抗治疗开始之间的中位无治疗间隔为 6 周（范围，3-22）。无治疗间隔≤6 周的患者维持阿维鲁单抗治疗的疾病控制率高于无治疗间隔>6 周的患者（77%比 40%，P=0.029）。对 1L 化疗有客观反应的患者在开始阿维鲁单抗治疗后肿瘤复发的可能性较小（19 例中有 4 例，而稳定疾病的 8 例中有 7 例）。
对 1L 化疗有客观反应和早期启动维持阿维鲁单抗治疗可能与维持阿维鲁单抗治疗的获益增加相关。
