First Results of NURE-Combo: A Phase II Study of Neoadjuvant Nivolumab and Nab-Paclitaxel, Followed by Postsurgical Adjuvant Nivolumab, for Muscle-Invasive Bladder Cancer

医学 无容量 膀胱切除术 紫杉醇 紫杉醇 临床终点 佐剂 膀胱癌 肿瘤科 不利影响 阶段(地层学) 新辅助治疗 泌尿科 癌症 内科学 化疗 外科 临床试验 免疫疗法 乳腺癌 古生物学 生物
作者
Chiara Mercinelli,Marco Moschini,Antonio Cigliola,Benedetta Mattorre,Valentina Tateo,Giuseppe Basile,Laura Lucia Cogrossi,Brigida Anna Maiorano,D. Patanè,Daniele Raggi,Giovanni Luigi Pastorino,Chiara Re,Maurizio Colecchia,Roberta Lucianò,Renzo Colombo,Giorgio Brembilla,Francesco De Cobelli,Alberto Briganti,Dean C. Pavlick,Jeffrey S. Ross
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:42 (35): 4196-4205 被引量:5
标识
DOI:10.1200/jco.24.00576
摘要

PURPOSE To evaluate the activity and safety of nivolumab with nab-paclitaxel as neoadjuvant therapy, followed by radical cystectomy (RC) and postsurgical adjuvant nivolumab in patients with muscle-invasive bladder cancer (MIBC). PATIENTS AND METHODS Eligible patients had an Eastern Cooperative Oncology Group performance status of ≤1 and a T2-4aN0-1M0 stage with >50% urothelial carcinoma histology and were ineligible for or refused cisplatin-based chemotherapy. Patients received four cycles of nivolumab 360 mg once every 3 weeks + nab-paclitaxel 125 mg/m 2 once on days 1 and 8, every 3 weeks, followed by RC, and then adjuvant nivolumab 360 mg once every 3 weeks × 13 cycles. The primary end point was the pathologic complete response (CR) rate (ypT0N0). Secondary end points were major pathologic response (ypT≤1N0), safety, event-free survival (EFS), and overall survival. RESULTS Thirty-one patients were enrolled from December 2021 to June 2023; 19 (61.3%) had a cT2 stage, two (6.5%) had N1 stage, and 16 (51.6%) had a variant histology. Five patients (16.1%) received less than four full courses of neoadjuvant treatment because of treatment-related adverse events (TRAEs). Grade 3/4 TRAEs occurred in eight patients (25.8%). Twenty-eight patients underwent RC, and three refused RC after evidence of clinical CR and received a redo transurethral resection of the bladder tumor (reTURBT). The trial met its primary end point: 10 patients (32.3%; 95% CI, 16.7 to 51.4) achieved an ypT0N0 response. By including those who underwent reTURBT, 22 (70.9%; 95% CI, 55 to 87) achieved an ypT≤1N0-x response. After a median follow-up of 12 months (range, 5-22), two patients had a disease relapse after surgery. The 12-month EFS was 89.8% (95% CI, 79.5 to 100). CONCLUSION To our knowledge, the first results from NURE-Combo trial suggest that this combination could expand the therapeutic opportunities of immune-chemotherapy in patients with MIBC.
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