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

SummaryBackgroundIn patients with unresectable cholangiocarcinoma, photodynamic therapy (PDT) with porfimer sodium promotes biliary drainage and may improve survival and quality of life.AimTo prospectively evaluate the safety and efficacy of PDT in patients with locally advanced biliary tract carcinoma.MethodsEligible patients had unresectable, histologically confirmed disease, a Karnofsky performance status of ≥30% and life expectancy >12 weeks. Patients received 2 mg/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.Results36 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.ConclusionsPorfimer sodium PDT can be delivered safely to patients with biliary tract cancer and is suitable for testing in phase III studies (UKCRN ID 1218).