Department of Medicine I, Paracelsus Medical University/Salzburger Landeskliniken (SALK), Salzburg, Austria.
Department of Medicine I, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Hepatology. 2015 Nov;62(5):1456-65. doi: 10.1002/hep.27905. Epub 2015 Jul 22.
Photodynamic therapy using porfimer (P-PDT) improves palliation and survival in nonresectable hilar bile duct cancer. Tumoricidal penetration depth of temoporfin-PDT (T-PDT) is twice that of P-PDT. In a single-arm phase II study we investigated the safety, efficacy, survival time, and adverse events of T-PDT compared with previous data on P-PDT. Twenty-nine patients (median 71 [range 47-88] years) with nonresectable hilar bile duct cancer were treated with T-PDT (median 1 [range 1-4] sessions) plus stenting and followed up every 3 months. The PDT was well tolerated. In patients with occluded segments at baseline (n=28) a reopening of a median of 3 (range 1-7) segments could be achieved: n=16 local response and n=11 stable local disease, one progressive disease. Cholestasis and performance significantly improved when impaired at baseline. Time to local tumor progression was a median of 6.5 (2.7-41.0) months. Overall survival time was a median of 15.4 (range 4.4-62.4) months. Patients died from tumor progression (55%), cholangitis (18%), pneumonia (7%), hemobilia (7%), esophagus variceal hemorrhage (3%), and vascular diseases (10%). Adverse events were cholangitis (n=4), liver abscess (n=2), cholecystitis (n=2), phototoxic skin (n=5), and injection site reactions (n=7). Compared to previous P-PDT, T-PDT shows prolonged time to local tumor progression (median 6.5 versus 4.3 months, P<0.01), fewer PDT treatments needed (median 1 versus 3, P<0.01), a higher 6-month survival rate (83% versus 70%, P<0.01), and a trend for longer overall median survival (15.4 versus 9.3 months, P=0.72) yet not significantly different. The risk of adverse events is not increased except for (avoidable) subcutaneous phototoxicity at the injection site.
Temoporfin-PDT can safely be delivered to hilar bile duct cancer patients and results in prolonged patency of hilar bile ducts, a trend for longer survival time, and similar palliation as with P-PDT.
使用卟啉（P-PDT）的光动力疗法可改善不可切除的肝门胆管癌的缓解和生存。替莫泊芬-PDT（T-PDT）的肿瘤杀伤穿透深度是 P-PDT 的两倍。在一项单臂 II 期研究中，我们研究了 T-PDT 的安全性、疗效、生存时间和不良事件，并与之前 P-PDT 的数据进行了比较。29 例（中位年龄 71[范围 47-88]岁）不可切除的肝门胆管癌患者接受 T-PDT（中位 1[范围 1-4]次）联合支架置入，并每 3 个月随访一次。PDT 耐受性良好。在基线时存在闭塞段的患者（n=28），中位可再通 3（范围 1-7）个节段：n=16 局部反应和 n=11 局部疾病稳定，1 例进展性疾病。当基线时存在胆汁淤积和功能障碍时，其改善显著。局部肿瘤进展的时间为中位 6.5（2.7-41.0）个月。总生存时间的中位值为 15.4（范围 4.4-62.4）个月。患者死于肿瘤进展（55%）、胆管炎（18%）、肺炎（7%）、肝内出血（7%）、食管静脉曲张出血（3%）和血管疾病（10%）。不良事件包括胆管炎（n=4）、肝脓肿（n=2）、胆囊炎（n=2）、光毒性皮肤（n=5）和注射部位反应（n=7）。与之前的 P-PDT 相比，T-PDT 显示出更长的局部肿瘤进展时间（中位 6.5 与 4.3 个月，P<0.01）、需要的 PDT 治疗次数更少（中位 1 与 3，P<0.01）、6 个月生存率更高（83%与 70%，P<0.01）和总生存时间更长的趋势（中位 15.4 与 9.3 个月，P=0.72），但无统计学差异。除了（可避免的）注射部位的皮下光毒性外，不良事件的风险并未增加。
替莫泊芬-PDT 可安全地应用于肝门胆管癌患者，可延长肝门胆管的通畅性，延长生存时间，并与 P-PDT 一样具有相似的缓解效果。
