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.