Photodynamic therapy in patients with non-resectable hilar cholangiocarcinoma: 5-year follow-up of a prospective phase II study.

Abstract

BACKGROUND:

Median survival of patients with non-resectable hilar cholangiocarcinoma is 3 to 6 months, even after biliary drainage. Therefore, a single-arm phase II study was conducted (July 1996 to October 1998) to investigate the effect of local photodynamic therapy; a significant improvement in survival (74%) was noted at 6 months. The present study is an analysis of the long-term follow-up for patients enrolled in that phase II study.

METHODS:

Five-year follow-up data for the 23 patients enrolled in the original prospective study were analyzed by using Kaplan-Meier log-rank analysis.

RESULTS:

Median survival after treatment was 11.2 months for patients without distant metastases (M0) and 9.3 months for all patients (M0+M1). The 1-year, 2-year, 3-year, and 4-year survival rates were estimated to be 47%, 21%, 11% and 5%, respectively, for patients with stage M0 cholangiocarcinoma, and 39%, 17%, 9%, and 4%, respectively, for patients with stages M0 and M1. Of the patients who died, 73.9% (n=17) were because of tumor progression; 26.1% (n=6) died as a result of cholangitis (n=4), septic shock (n=1), or appendicitis/peritonitis (n=1). For all patients, except one with diffuse liver metastases, there was improvement in cholestasis, performance, and quality of life, which was maintained for an extended period.

CONCLUSIONS:

This 5-year follow-up study confirms that photodynamic therapy is safe and effective for non-resectable hilar cholangiocarcinoma, although it does not prevent progression of the disease.

• Authors: Marcus Wiedmann, Frieder Berr, Ingolf Schiefke, Helmut Witzigmann, Kay Kohlhaw, Joachim Mössner, Karel Caca
• Journal: Gastrointestinal endoscopy (Gastrointest Endosc) Vol. 60 Issue 1 Pg. 68-75 (Jul 2004) ISSN: 0016-5107 [Print] United States
• PMID: 15229428 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Bilirubin

Topics

• Adult
• Aged
• Bile Duct Neoplasms (blood, drug therapy, mortality, pathology)
• Bilirubin (blood)
• Cholangiocarcinoma (blood, drug therapy, mortality, pathology)
• Disease Progression
• Female
• Follow-Up Studies
• Humans
• Length of Stay
• Male
• Middle Aged
• Neoplasm Staging
• Treatment Outcome
• Weight Loss