一项多中心、单臂、前瞻性试验,评估对符合顺铂条件的晚期尿路上皮癌患者进行剂量密集型甲氨蝶呤、长春新碱、多柔比星和卡铂(DD-MVACarbo)化疗的有效性和安全性:CARBUNCLE 试验研究方案》。

IF 2.3 Q3 BIOCHEMICAL RESEARCH METHODS
Makito Miyake, Satoshi Anai, Yusuke Iemura, Kazuki Ichikawa, Tatsuki Miyamoto, Atsushi Tomioka, Masaomi Kuwada, Yoshitaka Itami, Yukinari Hosokawa, Yoshiaki Matsumura, Eijiro Okajima, Kazumasa Torimoto, Nobutaka Nishimura, Mitsuru Tomizawa, Takuto Shimizu, Shunta Hori, Yosuke Morizawa, Daisuke Gotoh, Yasushi Nakai, Kiyohide Fujimoto
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引用次数: 0

摘要

无法切除的转移性晚期尿路上皮癌(aUC)是一种侵袭性疾病,通常采用含铂一线化疗,然后是免疫检查点抑制剂和抗体药物共轭物。对一线化疗的反应是序贯治疗策略的重中之重,因为对一线化疗的反应越好,对后续疗法的反应就越好。吉西他滨加卡铂化疗通常被推荐用于不符合顺铂条件的患者。这项多中心、单臂前瞻性试验将研究剂量密集型甲氨蝶呤、长春新碱、多柔比星和卡铂(DD-MVACarbo)化疗在铂类无效、不符合顺铂条件的 aUC 患者中的疗效是否优于吉西他滨加卡铂化疗。经过筛选和注册后,共有46名患者将接受这种新型化疗方案的治疗。主要终点是客观反应率。次要终点包括疾病控制率、患者报告结果和不良事件。截至 2024 年 7 月,还没有关于这种新型干预方法的证据。研究结果有望改变治疗标准,改善对 aUC 患者的管理。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Multicenter, Single-Arm, Prospective Trial to Evaluate Efficacy and Safety of Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Carboplatin (DD-MVACarbo) Chemotherapy for Cisplatin-Ineligible Patients with Advanced Urothelial Cancer: Study Protocol of the CARBUNCLE Trial.

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.

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来源期刊
Methods and Protocols
Methods and Protocols Biochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (miscellaneous)
CiteScore
3.60
自引率
0.00%
发文量
85
审稿时长
8 weeks
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