Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus: international, partially blinded, randomized phase III trial
Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus: international, partially blinded, randomized phase III trial
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DOI：
10.1016/j.gie.2005.06.047
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发表时间：
2005-10-01
影响因子：
7.7
通讯作者：
Depot, M
中科院分区：
文献类型：
--
作者：
Overholt, BF;Lightdale, CJ;Depot, M
背景：巴雷特食管（BE）可能导致高度不典型增生（HGD）和腺癌。目的是检查使用卟啉钠 (POR) 和光动力疗法 (PDT) 治疗 BE 和 HGD 患者对消除 HGD 和降低食管腺癌发病率的影响。 方法：该设计是一项在患有 HGD 的 BE 患者中进行的多中心、部分盲法（病理学）随机临床试验。有 30 个贡献中心。共有 485 名患者接受了筛查，其中 208 名患者属于意向治疗人群，202 名患者属于安全人群。患者以 2:1 的比例随机分配，以比较 PDT 联合 POR 加奥美拉唑 (PORPDT) 与仅奥美拉唑 (OM)。主要结果测量是研究期间任何时间发生的完全 HGD 消融。 结果：在研究期间任何时间的 HGD 完全消融方面，PORPDT (106/138 [77%]) 与 OM (27/70 [39%]) 相比，存在显着差异 (p < 0.0001)。 PORPDT 组的腺癌发生率 (13%) (n = 18) 显着低于 OM 组 (20%) (n = 20) (p < 0.006)。安全性显示，PORPDT 组中 94% 的患者和 OM 组中 13% 的患者出现与治疗相关的不良反应。该研究的局限性在于，PDT 疗法可能必须多次应用，并且患者需要花费更多的时间进行治疗。患者和医生对治疗均未知情。结论：PORPDT 联合奥美拉唑是消除 BE 患者 HGD 并降低食管腺癌发病率的有效疗法。
Background: Barrett's esophagus (BE) may lead to high-grade dysplasia (HGD) and adenocarcinoma. The objective was to examine the impact of treating patients with BE and with HGD by using porfimer sodium (POR) and photodynamic therapy (PDT) for ablating HGD and reducing the incidence of esophageal adenocarcinoma.Methods: The design was a multicenter, partially blinded (pathology), randomized clinical trial conducted in patients with BE who have HGD. There were 30 contributing centers. A total of 485 patients were screened, with 208 in the intent-to-treat population and 202 in the safety population. Patients were randomized on a 2:1 basis to compare PDT with POR plus omeprazole (PORPDT) with omeprazole only (OM). The main outcome measurement was complete HGD ablation occurring at any time during the study period.Results: There was a significant difference (p < 0.0001) in favor of PORPDT (106/138 [77%]) compared with OM (27/70 [39%]) in complete ablation of HGD at any time during the study period. The occurrence of adenocarcinoma in the PORPDT group (13%) (n = 18) was significantly lower (p < 0.006) compared with the OM group (20%) (n = 20). The safety profile showed 94% of patients in the PORPDT group and 13% of patients in the OM group had treatment-related adverse effects. The limitations of the study were that PDT therapy may have had to be applied more than once and that patients spent more time in treatment. The patients and the physicians were not blinded to the treatment.Conclusions: PORPDT in conjunction with omeprazole is an effective therapy for ablating HGD in patients with BE and in reducing the incidence of esophageal adenocarcinoma.