Full analysis from AVENANCE: A real-world study of avelumab first-line (1L) maintenance treatment in patients (pts) with advanced urothelial carcinoma (aUC).
Full analysis from AVENANCE: A real-world study of avelumab first-line (1L) maintenance treatment in patients (pts) with advanced urothelial carcinoma (aUC).
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AVENANCE 的全面分析：对晚期尿路上皮癌 (aUC) 患者 (pts) 进行 avelumab 一线 (1L) 维持治疗的真实世界研究。
DOI：
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发表时间：
2023
影响因子：
45.3
通讯作者：
C. Thibault
中科院分区：
文献类型：
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作者：
P. Barthélémy;Y. Loriot;E. Voog;J. Eymard;A. Ravaud;A. Fléchon;C. Abraham Jaillon;M. Chasseray;V. Lorgis;W. Hilgers;A. Gobert;S. Le Moulec;Camille Simon;E. Nicolas;A. Escande;D. Pouessel;C. Josse;M. Solbes;Prisca Lambert;C. Thibault
471 背景：在 3 期 JAVELIN Bladder 100 试验中，avelumab 1L 维持 + 最佳支持护理 (BSC) 与单独 BSC 相比，在使用 1L 铂类化疗 (CTx) 未进展的 aUC 患者中显着延长总生存期 (OS)。 JAVELIN 膀胱疗法现已成为国际治疗指南中 1 级证据的护理标准。 AVENANCE 研究 (NCT04822350) 正在法国真实世界的 aUC 患者群体中调查 avelumab 1L 维持治疗的有效性和安全性。首次报告完整分析集的数据。方法：在这项正在进行的、非干预性、双向性研究中，符合条件的患者患有局部晚期或转移性 UC，但在接受 1L 铂类 CTx 和既往、正在进行或计划的 avelumab 1L 维持治疗后未出现进展。主要终点是从 avelumab 开始使用后的 OS；次要终点包括无进展生存期 (PFS)、治疗持续时间 (DOT) 和安全性。结果：591 名患者接受了 avelumab。截至数据截止（2022 年 7 月 31 日），中位随访时间为 12.0 个月（95% CI，10.9-12.9）。中位年龄为 73.1 岁（IQR，67.0-78.1）。在 1L CTx 开始时（不包括缺失数据的患者），524 例患者（90.5%）的疾病阶段为转移；426 例（81.5%）为内脏转移，54 例（9.3%）为局部晚期。 ECOG PS 为 0-1 分（407 分）（85.3%），2-3 分（69 分）（14.5%）。 528 例 (91.8%) 肿瘤组织学为纯 UC，47 例 (8.2%) 为变异或纯变异 UC。 1L CTx 为吉西他滨 + 卡铂 (GemCarbo)、吉西他滨 + 顺铂 (GemCis)、剂量密集甲氨蝶呤 + 长春花碱 + 阿霉素 + 顺铂 (DD-MVAC)，其他 353 例 (61.0%)、170 例 (29.4%)、28 例 (4.8%) 和 28 例 (4.8%)分，分别。中位周期数为 5（范围：1-10）。 avelumab 的中位 DOT 为 5.8 个月（95% CI，5.2-7.0）；截至数据截止时，241 名患者 (40.8%) 仍在接受治疗。停止治疗的最常见原因是疾病进展 (74.1% [n=258])、死亡 (11.5% [n=40]) 和不良事件 ([AE] 10.3% [n=36])。开始使用 avelumab 后的中位 OS 为 18.4 个月（95% CI，15.4-不可估计 [NE]），12 个月 OS 率为 64.8%（95% CI，60.0%-69.1%），中位 PFS 为 5.7 个月（95% CI，5.3-7.0）。在接受 GemCarbo、GemCis 或 DD-MVAC 的患者中，中位 OS (95% CI) 分别为 16.2 个月 (13.4-NE)、未达到 (NR；18.1-NE) 和 NR (15.2-NE)。将提出亚组分析。 218 例患者接受了后续 2L，包括 CTx、抗体药物偶联物、免疫治疗和其他治疗，分别为 186 例（85.3%）、22 例（10.1%）、6 例（2.8%）和 4 例（1.8%）。 217 名患者 (36.7%) 发生任何级别的治疗相关 AE (TRAE)，其中 29 名患者 (4.9%) 发生严重 TRAE。结论：来自 AVENANCE 的 aUC 患者的 avelumab 1L 维持的真实世界数据支持 JAVELIN Bladder 100 的研究结果，并证实了 avelumab 在异质人群中的临床活性和可接受的安全性。临床试验信息：NCT04822350。
471 Background: In the phase 3 JAVELIN Bladder 100 trial, avelumab 1L maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) vs BSC alone in pts with aUC that had not progressed with 1L platinum-based chemotherapy (CTx). The JAVELIN Bladder regimen is now standard of care with level 1 evidence in international treatment guidelines. The AVENANCE study (NCT04822350), is investigating the efficacy and safety of avelumab 1L maintenance in a real-world population of pts with aUC in France. Data from the full analysis set are reported for the first time. Methods: In this ongoing, noninterventional, ambispective study, eligible pts have locally advanced or metastatic UC that has not progressed with 1L platinum-based CTx and previous, ongoing, or planned avelumab 1L maintenance treatment. The primary endpoint is OS from start of avelumab; secondary endpoints include progression-free survival (PFS), duration of treatment (DOT), and safety. Results: 591 pts received avelumab. At data cutoff (July 31, 2022), median follow-up was 12.0 mo (95% CI, 10.9-12.9). Median age was 73.1 y (IQR, 67.0-78.1). At start of 1L CTx (excluding pts with missing data), disease stage was metastatic in 524 pts (90.5%; visceral metastases in 426 [81.5%]) and locally advanced in 54 (9.3%). ECOG PS was 0-1 in 407 pts (85.3%) and 2-3 in 69 (14.5%). Tumor histology was pure UC in 528 pts (91.8%) and UC with variant or pure variant in 47 (8.2%). 1L CTx was gemcitabine + carboplatin (GemCarbo), gemcitabine + cisplatin (GemCis), dose-dense methotrexate + vinblastine + adriamycin + cisplatin (DD-MVAC), and other in 353 (61.0%), 170 (29.4%), 28 (4.8%), and 28 (4.8%) pts, respectively. Median number of cycles was 5 (range, 1-10). Median DOT with avelumab was 5.8 mo (95% CI, 5.2-7.0); 241 pts (40.8%) remained on treatment at data cutoff. The most common reasons for treatment discontinuation were disease progression (74.1% [n=258]), death (11.5% [n=40]), and adverse events ([AEs] 10.3% [n=36]). Median OS from start of avelumab was 18.4 mo (95% CI, 15.4-not estimable [NE]), the 12-month OS rate was 64.8% (95% CI, 60.0%-69.1%), and median PFS was 5.7 mo (95% CI, 5.3-7.0). In pts who had received GemCarbo, GemCis, or DD-MVAC, median OS (95% CI) was 16.2 mo (13.4-NE), not reached (NR; 18.1-NE), and NR (15.2-NE), respectively. Subgroups analyses will be presented. 218 pts received subsequent 2L, including CTx, antibody-drug conjugates, immunotherapy, and other in 186 (85.3%), 22 (10.1%), 6 (2.8%), and 4 (1.8%) pts, respectively. Any-grade treatment-related AEs (TRAEs) occurred in 217 pts (36.7%), including serious TRAEs in 29 (4.9%). Conclusions: Real-world data for avelumab 1L maintenance in pts with aUC from AVENANCE support the findings of JAVELIN Bladder 100 and confirm the clinical activity and acceptable safety profile of avelumab in a heterogeneous population. Clinical trial information: NCT04822350 .