作者
Andrea Necchi, Daniele Raggi, Andrea Gallina, Russell Madison, Maurizio Colecchia, Roberta Luciano, Rodolfo Montironi, Patrizia Giannatempo, Elena Fare, Filippo Pederzoli, Marco Bandini, Marco Bianchi, Renzo Colombo, Giorgio Gandaglia, Nicola Fossati, Laura Marandino, Umberto Capitanio, Federico Deho, Siraj M Ali, Jon H Chung, Jeffrey S Ross, Andrea Salonia, Alberto Briganti, Francesco Montorsi
发表日期
2020/4/1
期刊
European urology
卷号
77
期号
4
页码范围
439-446
出版商
Elsevier
简介
Background
Patients with predominant variant histology (VH) of bladder tumors, defined as involving >50 % of the tumor specimens, are typically excluded from clinical trials, and for these patients, the efficacy of standard chemotherapy is limited.
Objective
To evaluate the activity of preoperative pembrolizumab in patients with muscle-invasive bladder carcinoma (MIBC) and VH, enrolled in PURE-01 study (NCT02736266).
Design, setting, and participants
In the open-label, single-arm, phase 2 PURE-01 study, three courses of 200 mg pembrolizumab preceding radical cystectomy (RC) were administered in T2-4aN0M0 MIBC patients. The amended study design included patients with predominant VH.
Intervention
Neoadjuvant pembrolizumab and RC.
Outcome measurements and statistical analysis
Pathological complete response (pT0) in intention-to-treat population was the primary endpoint. Biomarker analyses …
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A Necchi, D Raggi, A Gallina, R Madison, M Colecchia… - European urology, 2020