ABSTRACT

The Javelin Bladder 100 trial was the first trial to establish the role of switch maintenance therapy in patients with metastatic urothelial cancer using avelumab, a PD-L1 inhibitor, for patients who achieve complete response, partial response, or stable disease to standard chemotherapy of 4–6 cycles with gemcitabine and cisplatin or carboplatin. Improvement in parameters of overall survival in both the overall population and the PD-L1 positive population was seen and has led to the US FDA approval of avelumab as maintenance therapy for metastatic urothelial cancer. This manuscript further discusses the highlights of the study, patient population, and considerations regarding choice of therapy for maintenance avelumab.

摘要

Javelin Bladder 100 试验是第一个使用 avelumab（一种 PD-L1 抑制剂）确立转换维持治疗在转移性尿路上皮癌患者中的作用的试验，用于对标准化疗达到完全缓解、部分缓解或疾病稳定的患者–6 个周期，使用吉西他滨和顺铂或卡铂。观察到总体人群和 PD-L1 阳性人群的总体生存参数的改善，并导致美国 FDA 批准 avelumab 作为转移性尿路上皮癌的维持治疗。这份手稿进一步讨论了研究的重点、患者群体以及有关维持 avelumab 治疗选择的注意事项。