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  • Temoporfin improves efficac...
    Wagner, Andrej; Denzer, Ulrike W.; Neureiter, Daniel; Kiesslich, Tobias; Puespoeck, Andreas; Rauws, Erik A.J.; Emmanuel, Klaus; Degenhardt, Nora; Frick, Ulrich; Beuers, Ulrich; Lohse, Ansgar W.; Berr, Frieder; Wolkersdörfer, Gernot W.

    Hepatology, November 2015, Letnik: 62, Številka: 5
    Journal Article

    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. Conclusion: 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. (Hepatology 2015;62:1456–1465)