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替莫泊芬光动力疗法联合化疗治疗不可切除胆管癌的随机对照试验——北欧PCS研究

Randomised controlled trial of temoporfin photodynamic therapy plus chemotherapy in nonresectable biliary carcinoma--PCS Nordic study.

作者信息

Hauge T, Hauge P W, Warloe T, Drolsum A, Johansen C, Viktil E, Aabakken L, Buanes T, Konopski Z

机构信息

Dept. of Gastroenterology, Oslo University Hospital, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway.

Dept. of Oncology, Oslo University Hospital, Norway.

出版信息

Photodiagnosis Photodyn Ther. 2016 Mar;13:330-333. doi: 10.1016/j.pdpdt.2015.09.004. Epub 2015 Sep 28.

DOI:10.1016/j.pdpdt.2015.09.004
PMID:26415549
Abstract

BACKGROUND

Photodynamic therapy (PDT) in combination with stent have shown promising results in the treatment of biliary tract cancer (BTC) in patients not suitable for surgery. Chemotherapy has been shown to improve survival in patients with local advanced and metastatic BTC.

MATERIAL AND METHODS

In the current randomized trial the combination of chemotherapy and stent with and without temoporfin (Foscan) photodynamic therapy (PDT), with a primary endpoint on feasibility and safety, has been performed. Ten patients in each group.

RESULTS

No serious, acute procedure-related complication related to PDT or the treatment combination was seen. The number of patients with cholangitis was equal in both groups. In the PDT group--arm A--two patients had cutaneous erythema after sun exposition, one of them with a localized blister. No neutropenic infection was seen. Quality of Life (QoL) was similar in both treatment groups. Progression free survival was numerically longer in the PDT group.

CONCLUSION

The treatment combination was feasible. There was no serious complication related to PDT or the treatment combination. Number of cholangitis was equal in both groups, two abscesses were observed in the PDT group. Progression free survival was numerically longer in the PDT group.

摘要

背景

光动力疗法(PDT)联合支架置入术在治疗不适合手术的胆管癌(BTC)患者方面已显示出有前景的结果。化疗已被证明可提高局部晚期和转移性BTC患者的生存率。

材料与方法

在当前的随机试验中,已开展了化疗联合支架置入术并对比有无替莫泊芬(福斯卡林)光动力疗法(PDT)的研究,主要终点为可行性和安全性。每组10名患者。

结果

未观察到与PDT或治疗组合相关的严重急性手术相关并发症。两组胆管炎患者数量相等。在PDT组(A组)中,两名患者在日晒后出现皮肤红斑,其中一人有局部水疱。未观察到中性粒细胞减少性感染。两个治疗组的生活质量(QoL)相似。PDT组的无进展生存期在数值上更长。

结论

该治疗组合是可行的。未观察到与PDT或治疗组合相关的严重并发症。两组胆管炎患者数量相等,PDT组观察到两例脓肿。PDT组的无进展生存期在数值上更长。

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