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Temoporfin improves efficacy of photodynamic therapy in advanced biliary tract carcinoma: A multicenter prospective phase II study.

AbstractUNLABELLED:
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.
AuthorsAndrej Wagner, Ulrike W Denzer, Daniel Neureiter, Tobias Kiesslich, Andreas Puespoeck, Erik A J Rauws, Klaus Emmanuel, Nora Degenhardt, Ulrich Frick, Ulrich Beuers, Ansgar W Lohse, Frieder Berr, Gernot W Wolkersdörfer
JournalHepatology (Baltimore, Md.) (Hepatology) Vol. 62 Issue 5 Pg. 1456-65 (Nov 2015) ISSN: 1527-3350 [Electronic] United States
PMID25990106 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Copyright© 2015 by the American Association for the Study of Liver Diseases.
Chemical References
  • Mesoporphyrins
  • temoporfin
  • Bilirubin
Topics
  • Aged
  • Aged, 80 and over
  • Biliary Tract Neoplasms (blood, drug therapy, mortality)
  • Bilirubin (blood)
  • Cause of Death
  • Female
  • Humans
  • Male
  • Mesoporphyrins (therapeutic use)
  • Middle Aged
  • Photochemotherapy (adverse effects)

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