Survival Benefit of Neoadjuvant Systemic Chemotherapy in Muscle Invasive Bladder Cancer and Factors Affecting Its Response - Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 87
- 主要终点
- Evaluating the factors affecting the response of neoadjuvant chemotherapy in muscle invasive bladder cancer
研究概览
简要总结
Muscle-invasive bladder cancer (MIBC) is an aggressive disease with a high-risk of early metastasis and cancer specific mortality. The gold standard treatment of MIBC is radical cystectomy (RC) in conjunction with concomitant bilateral pelvic lymphadenectomy . While radical cystectomy remains a primary management strategy for MIBC, high rates of recurrence with surgery alone highlight the likelihood of occult micrometastatic disease at the time of diagnosis. Due to the development and implementation of neoadjuvant chemotherapy prior to radical cystectomy, the prognosis for MIBC patients undergoing radical cystectomy has improved .
详细描述
The goals of neoadjuvant chemotherapy administration are to; eradicate the micro-metastases, avoid the release and implantation of malignant cells during cystectomy, and extend the survival of these patients.
Clinical trial data supports the use of neoadjuvant platinum-based chemotherapy for patients with non-metastatic MIBC. Based on Level I evidence, use of preoperative platinum based chemotherapy is now included in the guideline recommendations from the American Urologic Association (AUA), American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and European Association of Urology (EAU) . In the Southwest Oncology Group (SWOG) Intergroup study, RC alone was compared with three cycles of neoadjuvant MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin), followed by radical cystectomy. This randomized trial showed that the median survival duration was 77 months in patients with combination treatment, and 46 months in patients with upfront RC alone.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological proven MIBC patient treated with neoadjuvant systemic chemotherapy( platinum based )
排除标准
- •Non muscle invasive bladder cancer (NMIBC)
- •Metastatic patients
- •Patients treated with surgery firstly
研究组 & 干预措施
MIBC patients who received NAT
muscle invasive bladder cancer patients who received neoadjuvant chemotherapy
干预措施: Chemotherapy with platine (Drug)
结局指标
主要结局
Evaluating the factors affecting the response of neoadjuvant chemotherapy in muscle invasive bladder cancer
时间窗: 3 to 6 months (from previous medical reports )
evaluating the neoadjuvant respose by clinical examination and radiological tools ( CT , MRI ) according to Recist criteria
次要结局
- Disease free survival (DFS)(thorough study completion (an average 1 year ))
- overall survival (OS)(from the randomization until the date of 1st decument progression or death from any cause , whichever come first assesed up to 100 weeks)
- Progression Free Survival ( PFS )(an average 2 years)
研究者
Sara Mahmoud Ahmed Mahmoud
doctor
Assiut University