Miyake Makito, Anai Satoshi, Iemura Yusuke, Ichikawa Kazuki, Miyamoto Tatsuki, Tomioka Atsushi, Kuwada Masaomi, Itami Yoshitaka, Hosokawa Yukinari, Matsumura Yoshiaki, Okajima Eijiro, Torimoto Kazumasa, Nishimura Nobutaka, Tomizawa Mitsuru, Shimizu Takuto, Hori Shunta, Morizawa Yosuke, Gotoh Daisuke, Nakai Yasushi, Fujimoto Kiyohide
Department of Urology, Nara Medical University, Kashihara 634-8522, Nara, Japan.
Department of Urology, Nara Prefectural Seiwa Medical Center, Ikoma 636-0802, Nara, Japan.
Methods Protoc. 2024 Jul 29;7(4):58. doi: 10.3390/mps7040058.
Unresectable, metastatic, advanced urothelial carcinoma (aUC) is an aggressive disease and is treated with platinum-containing first-line chemotherapy, followed by immune checkpoint inhibitors and antibody-drug conjugates. Response to first-line chemotherapy is a vital priority in sequential treatment strategies because a better response to first-line chemotherapy is associated with a better response to subsequent therapies. Gemcitabine plus carboplatin chemotherapy is conventionally recommended for cisplatin-ineligible patients. This multicenter, single-arm prospective trial will investigate whether dose-dense methotrexate, vinblastine, doxorubicin, and carboplatin (DD-MVACarbo) chemotherapy is superior to gemcitabine plus carboplatin chemotherapy in terms of efficacy in platinum-naïve, cisplatin-ineligible patients with aUC. After screening and registration, a total of 46 patients will be treated with this novel chemotherapy regimen. The primary endpoint is the objective response rate. The secondary endpoints include disease control rate, patient-reported outcomes, and adverse events. No evidence of this novel intervention is available as of July 2024. The results are expected to change the standard of care and improve the management of patients with aUC.
不可切除的转移性晚期尿路上皮癌（aUC）是一种侵袭性疾病，采用含铂一线化疗，随后使用免疫检查点抑制剂和抗体药物偶联物进行治疗。在序贯治疗策略中，对一线化疗的反应是至关重要的优先事项，因为对一线化疗的更好反应与对后续治疗的更好反应相关。对于不符合顺铂治疗条件的患者，传统上推荐吉西他滨联合卡铂化疗。这项多中心、单臂前瞻性试验将研究在铂类初治、不符合顺铂治疗条件的aUC患者中，剂量密集型甲氨蝶呤、长春碱、阿霉素和卡铂（DD-MVACarbo）化疗在疗效方面是否优于吉西他滨联合卡铂化疗。经过筛选和登记，共有46例患者将接受这种新型化疗方案治疗。主要终点是客观缓解率。次要终点包括疾病控制率、患者报告的结果和不良事件。截至2024年7月，尚无这种新型干预措施的证据。预计结果将改变治疗标准并改善aUC患者的管理。
