Photodynamic therapy plus endoprostheses versus endoprostheses alone for nonresectable bile duct cancer (Zoepf 2005)
N = 32
- Population
- 32 patients with nonresectable bile duct cancer; the groups were comparable for age, gender, performance status, bilirubin level and Bismuth stage.
- Design
- Randomised controlled study of 32 patients with nonresectable bile duct cancer. The photodynamic therapy group received Photosan-3 2 mg/kg intravenously with light activation 48 hours later; the control group was treated with endoprostheses but no photodynamic therapy. The abstract does not state a primary endpoint, phase, masking, number of centres or analysis population.
- Arms
- Endoprostheses alone (control) (control): Endoprostheses without photodynamic therapy
- Photodynamic therapy plus endoprostheses (experimental): Photosan-3 2 mg/kg intravenously, light activation 48 hours later, plus endoprostheses
- People
- Zoepf T
Δ median OS+14 months
Show the numbers
| Endpoint | Analysis | Photodynamic therapy plus endoprostheses | Endoprostheses alone (control) | Effect |
|---|---|---|---|---|
| OS32 randomised patients (analysis population not stated in the abstract)Median survival time after randomisation. | primaryZoepf 2005 | median 21 months | median 7 months | P=0.0109Four patients had infectious complications after photodynamic therapy versus one in the control group; the abstract describes a considerable post-interventional cholangitis rate. No hazard ratio or confidence interval is given in the abstract. |
| Endpoint | Analysis | Photodynamic therapy plus endoprostheses | Endoprostheses alone (control) | Effect |
|---|---|---|---|---|
| OS32 randomised patients (analysis population not stated in the abstract)Median survival time after randomisation. | primaryZoepf 2005 | median 21 months | median 7 months | P=0.0109Four patients had infectious complications after photodynamic therapy versus one in the control group; the abstract describes a considerable post-interventional cholangitis rate. No hazard ratio or confidence interval is given in the abstract. |
- Photodynamic therapy plus endoprostheses (experimental)
- Endoprostheses alone (control) (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Photodynamic therapy plus endoprostheses | Endoprostheses alone (control) |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 13 | 65.1% | 27.6% |
| 26 | 42.4% | 7.6% |
| 39 | 27.6% | 2.1% |
| 53 | 17.4% | 0.5% |