Temoporfin improves efficacy of photodynamic therapy in advanced biliary tract carcinoma: A multicenter prospective phase II study
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Temoporfin improves efficacy of photodynamic therapy in advanced biliary tract carcinoma: A multicenter prospective phase II study. / 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.
in: HEPATOLOGY, Jahrgang 62, Nr. 5, 11.2015, S. 1456-65.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Temoporfin improves efficacy of photodynamic therapy in advanced biliary tract carcinoma: A multicenter prospective phase II study
AU - Wagner, Andrej
AU - Denzer, Ulrike W
AU - Neureiter, Daniel
AU - Kiesslich, Tobias
AU - Puespoeck, Andreas
AU - Rauws, Erik A J
AU - Emmanuel, Klaus
AU - Degenhardt, Nora
AU - Frick, Ulrich
AU - Beuers, Ulrich
AU - Lohse, Ansgar W
AU - Berr, Frieder
AU - Wolkersdörfer, Gernot W
N1 - © 2015 by the American Association for the Study of Liver Diseases.
PY - 2015/11
Y1 - 2015/11
N2 - UNLABELLED: 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).
AB - UNLABELLED: 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).
U2 - 10.1002/hep.27905
DO - 10.1002/hep.27905
M3 - SCORING: Journal article
C2 - 25990106
VL - 62
SP - 1456
EP - 1465
JO - HEPATOLOGY
JF - HEPATOLOGY
SN - 0270-9139
IS - 5
ER -