Adib Elio, El Zarif Talal, Jain Rohit K, Skelton William P, Freeman Dory, Curran Catherine, Akl Elie, Nassar Amin H, Ravi Praful, Mantia Charlene, Kwiatkowski David J, Choueiri Toni K, Sonpavde Guru
Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
BJUI Compass. 2022 Mar;3(2):169-172. doi: 10.1002/bco2.125. Epub 2021 Nov 10.
Enfortumab Vedotin (EV) is approved for metastatic urothelial carcinoma (mUC) progressing post-platinum and PD1/L1 inhibitor therapy. Erdafitinib is approved for post-platinum mUC with activating somatic genomic alterations (GAs) in . Information on the activity of EV in mUC with alterations will facilitate optimal clinical management. In this multi-center, retrospective analysis, we assessed the overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) to EV in mUC patients with and without GAs including mutations and fusions. Multivariable cox-regression and logistic regression analyses with 2-tailed p-values were used to evaluate the association of GAs with outcomes. A majority of the evaluable 60 patients were male (44/60, 78%), exhibited ECOG performance score 0-1 (53/60, 88.3%) and had a median age of 70.5 (range 48 - 88) years when starting EV. GAs in did not influence the ORR (=0.32), OS (=0.79) or PFS ( 0.32) with EV. In conclusion, GAs did not appear to compromise major outcomes with EV in mUC. Larger studies are required to further evaluate the impact of GAs on the activity of EV and the optimal sequencing of EV and erdafitinib in mUC.
恩杂鲁胺（EV）被批准用于铂类和PD1/L1抑制剂治疗后进展的转移性尿路上皮癌（mUC）。厄达替尼被批准用于铂类治疗后的mUC，其具有激活的体细胞基因组改变（GAs）。关于EV在伴有[具体基因]改变的mUC中的活性信息将有助于优化临床管理。在这项多中心回顾性分析中，我们评估了伴有和不伴有包括突变和融合在内的[具体基因]GAs的mUC患者接受EV治疗后的总生存期（OS）、无进展生存期（PFS）和客观缓解率（ORR）。采用多变量cox回归和双尾p值的逻辑回归分析来评估GAs与预后的关联。60例可评估患者中大多数为男性（44/60，78%），ECOG体能状态评分为0 - 1（53/60，88.3%），开始接受EV治疗时的中位年龄为70.5岁（范围48 - 88岁）。[具体基因]中的GAs不影响EV治疗的ORR（p = 0.32）、OS（p = 0.79）或PFS（p = 0.32）。总之，在mUC中，[具体基因]GAs似乎不会影响EV的主要预后。需要更大规模的研究来进一步评估[具体基因]GAs对EV活性的影响以及EV和厄达替尼在mUC中的最佳序贯治疗。
