PDF(Pubmed)
Abstract：
BACKGROUND: The advent of immune-checkpoint inhibitors has challenged previous treatment paradigms for advanced urothelial carcinoma (UC) in the post-platinum setting as well as in the first-line setting for cisplatin-ineligible patients. In this study, we investigated the effectiveness of pembrolizumab as first-line treatment for cisplatin-ineligible UC.
METHODS: Data from patients aged ≥ 18 years with cisplatin-ineligible UC and receiving first-line pembrolizumab from January 1st 2017 to September 1st 2022 were collected. Cisplatin ineligibility was defined according to the Galsky criteria. Thirty-three Institutions from 18 countries were involved in the ARON-2 study.
RESULTS: Our analysis included 162 patients. The median follow-up time was 18.9 months (95%CI 15.3-76.9). In the overall study population, the median OS was 15.8 months (95%CI 11.3-32.4). The median OS was significantly longer in males versus females while no statistically significant differences were observed between patients aged < 65y versus ≥ 65y and between smokers and non-smokers. According to Recist 1.1 criteria, 26 patients (16%) experienced CR, 32 (20%) PR, 39 (24%) SD and 55 (34%) PD.
CONCLUSIONS: Our data confirm the role of pembrolizumab as first-line therapy for cisplatin-unfit patients. Further studies investigating the biological and immunological characteristics of UC patients are warranted in order to optimize the outcome of patients receiving immunotherapy in this setting.
METHODS: Data from patients aged ≥ 18 years with cisplatin-ineligible UC and receiving first-line pembrolizumab from January 1st 2017 to September 1st 2022 were collected. Cisplatin ineligibility was defined according to the Galsky criteria. Thirty-three Institutions from 18 countries were involved in the ARON-2 study.
RESULTS: Our analysis included 162 patients. The median follow-up time was 18.9 months (95%CI 15.3-76.9). In the overall study population, the median OS was 15.8 months (95%CI 11.3-32.4). The median OS was significantly longer in males versus females while no statistically significant differences were observed between patients aged < 65y versus ≥ 65y and between smokers and non-smokers. According to Recist 1.1 criteria, 26 patients (16%) experienced CR, 32 (20%) PR, 39 (24%) SD and 55 (34%) PD.
CONCLUSIONS: Our data confirm the role of pembrolizumab as first-line therapy for cisplatin-unfit patients. Further studies investigating the biological and immunological characteristics of UC patients are warranted in order to optimize the outcome of patients receiving immunotherapy in this setting.
摘要：
背景：免疫检查点抑制剂的出现挑战了铂类药物后以及顺铂不合格患者的一线治疗晚期尿路上皮癌（UC）的先前治疗模式。在这项研究中,我们调查了pembrolizumab作为顺铂不合格UC一线治疗的有效性.
方法：从2017年1月1日至2022年9月1日收集年龄≥18岁顺铂不合格UC并接受一线派姆单抗治疗的患者的数据。根据Galsky标准定义顺铂不合格。来自18个国家的33个机构参与了ARON-2研究。
结果：我们的分析包括162例患者。中位随访时间为18.9个月(95CI15.3-76.9)。在整个研究人群中，中位OS为15.8个月(95CI11.3-32.4).男性与女性的中位OS明显更长，而年龄<65岁与≥65岁的患者之间以及吸烟者和非吸烟者之间没有统计学上的显着差异。根据Recist1.1标准，26例（16%）患者出现CR，32（20%）PR，39(24%)SD和55(34%)PD。
结论：我们的数据证实了派姆单抗作为顺铂不适合患者的一线治疗的作用。需要进一步研究UC患者的生物学和免疫学特征，以优化在这种情况下接受免疫治疗的患者的结果。
方法：从2017年1月1日至2022年9月1日收集年龄≥18岁顺铂不合格UC并接受一线派姆单抗治疗的患者的数据。根据Galsky标准定义顺铂不合格。来自18个国家的33个机构参与了ARON-2研究。
结果：我们的分析包括162例患者。中位随访时间为18.9个月(95CI15.3-76.9)。在整个研究人群中，中位OS为15.8个月(95CI11.3-32.4).男性与女性的中位OS明显更长，而年龄<65岁与≥65岁的患者之间以及吸烟者和非吸烟者之间没有统计学上的显着差异。根据Recist1.1标准，26例（16%）患者出现CR，32（20%）PR，39(24%)SD和55(34%)PD。
结论：我们的数据证实了派姆单抗作为顺铂不适合患者的一线治疗的作用。需要进一步研究UC患者的生物学和免疫学特征，以优化在这种情况下接受免疫治疗的患者的结果。
