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

Abstract

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 hrs 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).

Photodynamic therapy with polyhematoporphyrin for malignant biliary obstruction: A nationwide retrospective study of 150 consecutive applications

“…13 In our study, the most frequent adverse event was cholangitis, experienced by almost a quarter of our study population (21/88). This is relatively high compared to previous data on PDT 14,15 and, of course, might not be associated with PDT alone but also with the underlying malignant biliary obstruction or the biliary manipulation during ERC. However, occurring without any obvious association with other clinical parameters and observed with the same frequency among all participating centers, cholangitis might be mainly attributed to local inflammation after PDT.…”

Long-term results of ERCP- or PTCS-directed photodynamic therapy for unresectable hilar cholangiocarcinoma

“…Common adverse events after PDT include acute cholangitis, pancreatitis, hematobilia, liver abscess, and skin photosensitivity reactions. Most of these are ERCP-or PTCS-related complications, including a PDT-specific skin phototoxicity [8][9][10]20]. A meta-analysis of 10 studies found a pooled odds ratio for post-intervention cholangitis in the PDT group vs. stent group of only 0.57 (95% CI 0.35-0.94) and a pooled incidence of photosensitivity secondary to PDT of only 10.51% (95% CI 6.94-14.72%), reactions that were self-limiting [23].…”

Bile Duct Patency Maintained after Intraductal Radiofrequency Ablation in a Case of Hepatocellular Cholangiocarcinoma with Bile Duct Invasion

“…However, PDT is expensive and time-consuming. In addition to complications, including hemobilia of the stenting site and photosensitivity, one multicenter study demonstrated that patients who received PDT with stenting had a 60% increased mortality risk with poorer overall survival compared to that of stenting alone [ 14 ]. A safer and more effective method to resolve HCC-BDI is therefore needed.…”