Safety and long term efficacy of porfimer sodium photodynamic therapy in locally advanced biliary tract carcinoma

Photodiagnosis Photodyn Ther. 2012 Dec;9(4):287-92. doi: 10.1016/j.pdpdt.2012.03.005. Epub 2012 Aug 30.


Background: In patients with unresectable cholangiocarcinoma, photodynamic therapy (PDT) with porfimer sodium promotes biliary drainage and may improve survival and quality of life.

Aim: To prospectively evaluate the safety and efficacy of PDT in patients with locally advanced biliary tract carcinoma.

Methods: Eligible patients had unresectable, histologically confirmed disease, a Karnofsky performance status of ≥30% and life expectancy >12 weeks. Patients received 2mg/kg i.v. of porfimer sodium, followed by endobiliary laser activation and stent replacement 48 h later. Patients were assessed clinically and radiologically before treatment and on day 28, and followed up thereafter at three-monthly intervals until death.

Results: 36 patients were entered over an 18 months period: 14 males, 22 females, with a median age of 65 (30-79)yr and performance status of 80 (50-100). PDT was technically successful in all cases and was generally well tolerated; there was no grade 4 toxicity and no treatment-associated mortality. The median survival was 12 (1-84) months.

Conclusions: Porfimer sodium PDT can be delivered safely to patients with biliary tract cancer and is suitable for testing in phase III studies (UKCRN ID 1218).

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Biliary Tract Neoplasms / drug therapy*
  • Biliary Tract Neoplasms / mortality*
  • Bilirubin / blood
  • Biomarkers, Tumor / blood
  • Dihematoporphyrin Ether / adverse effects
  • Dihematoporphyrin Ether / therapeutic use*
  • Female
  • Humans
  • Karnofsky Performance Status
  • Male
  • Middle Aged
  • Photochemotherapy / adverse effects
  • Photochemotherapy / methods*
  • Photosensitizing Agents / adverse effects
  • Photosensitizing Agents / therapeutic use*
  • Prospective Studies
  • Quality of Life


  • Biomarkers, Tumor
  • Photosensitizing Agents
  • Dihematoporphyrin Ether
  • Bilirubin