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Temoporfin-PDT may extend OS in patients with bile duct cancer

In a new study published in Hepatology, researchers found temoporfin-photodynamic therapy prolonged bile ducts and could lead to increased overall survival in patients with nonresectable hilar bile duct cancer.

In a phase 2 study, researchers treated 29 patients (14 female, 15 male) with nonresectable hilar bile duct cancer with temoporfin-photodynamic therapy (temoporfin-PDT). Each patient underwent therapy with a dose of 0.15 mg/kg Foscan (Biolitec Pharma Ltd.) T-PDT, which was administered via a single dose by slow injection into the cubital vein, according to the research. The follow-up period was until mortality. This data was compared to data of previous treatment with PDT using porfimer (P-PDT).

Overall, PDT was well-tolerated in this cohort of patients. T-PDT therapy showed a longer time to local tumor progression compared with previous P-PDT (median 6.5 vs. 4.3 months, P < .01). In addition, T-PDT therapy did not need as many PDT treatments as previous P-PDT therapy (median 1 vs. 3, P < .01), showed a greater 6-month survival rate (83% vs. 70%, P < .01) and longer overall median survival (15.4 vs. 9.3 months, P = .72).

“Cholestasis and performance significantly improved [after therapy],” according to the researchers.

The time to local tumor progression was a median of 6.5 months and overall survival time was a median of 15.4 months.

The 6- and 12-month survival rates were 83% and 62% in the T-PDT group compared with 70% and 39% in the P-PDT group, respectively.

Among the patients, 55% died from tumor progression, 18% from cholangitis, 7% from pneumonia, 7% from hemobilia, 3% from esophagus variceal hemorrhage and 10% from vascular diseases.

T-PDT showed good palliative effects on functional status and quality of life, according to the research. Common adverse events observed by the researchers were cholangitis (n = 4), liver abscess (n = 2), cholecystitis (n = 2), phototoxic skin (n = 5) and injection site reactions (n = 7).

“The risk of adverse events is not increased except for [preventable] subcutaneous phototoxicity at the injection site,” the researchers wrote.

The researchers concluded: “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.” – by Melinda Stevens

Disclosures: Wagner reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.