The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Who Underwent Radical Cystectomy: A Multicenter Study of the Turkish Urooncology Association
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy.
研究概览
简要总结
The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with squamous cell, micropapillary, nested variant, sarcomatoid, neuroendocrine, or plasmacytoid variant histology
- •Patients who were non-metastatic at diagnosis
- •Patients who completed staging and demographic data,
- •Patients with pathological stage (p)T2 or high grade pT1, clinical stage (c)N0 or cN1, and underwent radical cystectomy
排除标准
- •Although RC histopathology was variant histology, patients in whom variant histology was not detected in previously transurethral resection bladder pathology
- •Patients who received therapies other than radical cystectomy (intravesical bacillus-calmette-guerin or chemotherapy) were excluded from the study.
- •Patients with a concomitant diagnosis of upper urinary tract urothelial carcinoma
- •Patients with histopathologically pure urothelial carcinoma
研究组 & 干预措施
Neoadjuvant chemotherapy prior to radical cystectomy
干预措施: Cisplatin (Drug)
结局指标
主要结局
Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy.
时间窗: 2 years from radical cystectomy surgery
次要结局
- Factors associated with worse survival outcomes in cox-regression analysis at 2-year follow-up of all patients with variant histology who underwent radical cystectomy.(2 years from radical cystectomy surgery)
研究者
Cagri Akpinar
Principal Investigator
Ankara Etlik City Hospital