Boccardo F, Palmeri L
National Cancer Research Institute and University of Genoa, Genoa, Italy.
Ann Oncol. 2006 May;17 Suppl 5:v129-32. doi: 10.1093/annonc/mdj967.
Bladder cancer is one of the most common genitourinary cancer. 1/3 of patients presents with invasive disease. Radical cystectomy is the standard treatment for patients with muscle invasive disease: although local treatment can be curative, about 50% of patients will develop distant metastases. Optimal treatment for high risk patients includes local and perioperative systemic therapy (adjuvant or neoadjuvant chemotherapy).
We performed a review of clinical trials and metanalysis of adjuvant treatment for muscle-invasive bladder cancer.
Data from single published trials of adjuvant chemotherapy (CT) are not univocal, and several methodological problems were found. A recent meta-analysis of individual patient data (IPD) from all eligible published and unpublished trials, found that adjuvant chemotherapy administration provides a significant survival and disease free survival advantage. Two large, multi-center, randomized trials are on-going to clarify the role of post-operative CT.
A trend in favour of adjuvant chemotherapy comes out from some of the trials reviewed by us and by the metanalysis performed by the ABC collaborative group. However it is not clear yet which patients might derive the maximum benefit from such an approach and which ones might be safety candidate to deferred treatment, on relapse. The incoming results of the EORTC trial and of the Italian trial which are currently comparing the value of early vs. deferred treatment of patients at higher risk of relapse will probably provide an adequate answer to this question. Outside clinical trials, the potential benefit of adjuvant chemotherapy should be appropriately weighted versus the putative hazards and decision making appropriately tailored in the individual patients according to the aggressiveness of his/her disease and the presence of comorbidities.
膀胱癌是最常见的泌尿生殖系统癌症之一。三分之一的患者表现为浸润性疾病。根治性膀胱切除术是肌肉浸润性疾病患者的标准治疗方法：尽管局部治疗可能治愈，但约50%的患者会发生远处转移。高危患者的最佳治疗包括局部和围手术期全身治疗（辅助或新辅助化疗）。
我们对肌肉浸润性膀胱癌辅助治疗的临床试验和荟萃分析进行了综述。
已发表的辅助化疗（CT）单项试验的数据并不明确，且发现了几个方法学问题。最近一项对所有符合条件的已发表和未发表试验的个体患者数据（IPD）进行的荟萃分析发现，辅助化疗可提供显著的生存和无病生存优势。两项大型多中心随机试验正在进行，以阐明术后CT的作用。
我们所综述的一些试验以及ABC协作组进行的荟萃分析显示出支持辅助化疗的趋势。然而，目前尚不清楚哪些患者可能从这种方法中获得最大益处，哪些患者可能是延迟治疗的安全候选者（复发时）。欧洲癌症研究与治疗组织（EORTC）试验和意大利试验即将得出的结果，目前正在比较复发风险较高患者早期治疗与延迟治疗的价值，可能会为这个问题提供一个恰当的答案。在临床试验之外，辅助化疗的潜在益处应与假定的风险进行适当权衡，并根据个体患者疾病的侵袭性和合并症情况，为其做出适当的决策。
