Concurrent gemcitabine and radiotherapy for the treatment of muscle-invasive bladder cancer: A pooled individual data analysis of eight phase I-II trials
Concurrent gemcitabine and radiotherapy for the treatment of muscle-invasive bladder cancer: A pooled individual data analysis of eight phase I-II trials
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DOI：
10.1016/j.radonc.2016.09.006
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发表时间：
2016-11-01
影响因子：
5.7
通讯作者：
Choudhury, Ananya
中科院分区：
文献类型：
--
作者：
Caffo, Orazio;Thompson, Catherine;Choudhury, Ananya
目的：尽管根治性膀胱切除术仍被认为是大多数局限性肌层浸润性膀胱癌（MIBC）患者的标准治疗方法，但在调整肿瘤分期时，放化疗联合膀胱保留策略已证明具有相当的局部控制率和生存率。我们对已发表的基于吉西他滨的 MIBC 放化疗试验中的个体患者数据进行了汇总分析。方法和材料：个体患者数据是从将患者纳入评估基于吉西他滨的 MIBC 放化疗的试验的机构收集的。结果：我们确定了 8 项已发表的关于基于吉西他滨的放化疗的研究，该分析中纳入了 190 名患者。 166 名患者 (93%) 观察到完全缓解 (CR)。中位随访 44.5 个月后，36 名患者 (18.9%) 出现膀胱复发，14 名患者随后接受了膀胱切除术。 5年总生存率（OS）、疾病特异性生存率（DSS）和无膀胱切除生存率（CFS）分别为59%、80.9%和93.3%。放化疗后 CR 的实现是主要的预后变量，与 OS、DSS 和 CFS 的改善相关。治疗耐受性良好。结论：这项汇总分析强化了同步吉西他滨放化疗方案可行且耐受性良好的证据。前瞻性随机对照试验正在进行中，以明确评估基于吉西他滨的放化疗对 MIBC 的疗效。 (C) 2016 Elsevier Ireland Ltd. 保留所有权利。
Purpose: Although radical cystectomy is still considered the standard of care for most localized muscle-invasive bladder cancer (MIBC) patients, bladder-sparing strategies with chemoradiotherapy have demonstrated comparable local control and survival rates when adjusting for tumor stage. We present a pooled analysis of individual patient data out of published trials with gemcitabine-based chemoradiotherapy for MIBC.Methods and materials: Individual patient data were collected from Institutions that enrolled patients into trials that evaluated gemcitabine-based chemoradiotherapy for MIBC.Results: We identified eight studies published on gemcitabine-based radiochemotherapy and 190 patients were included in this analysis. A complete response (CR) was observed in 166 patients (93%). After a median follow up of 44.5 months, 36 patients (18.9%) presented a bladder recurrence and 14 subsequently underwent cystectomy. The 5-year overall survival (OS), disease-specific survival (DSS), and cystectomy-free survival (CFS) rates were 59%, 80.9%, and 93.3%, respectively. The achievement of CR after chemoradiotherapy was the main prognostic variable which was associated with improved OS, DSS, and CFS. The treatment was well tolerated.Conclusion: This pooled analysis strengthens the evidence that chemoradiotherapy regimens with concurrent gemcitabine are feasible and well tolerated. Prospective randomized controlled trials are on-going to definitively assess the efficacy of gemcitabine-based chemoradiotherapy for MIBC. (C) 2016 Elsevier Ireland Ltd. All rights reserved.