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.
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。