PHOTOSTENT-02
Porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer (PHOTOSTENT-02)
Phase 3N = 92NCT00513539
- Population
- Adults with confirmed locally advanced or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma or gallbladder carcinoma), ECOG performance status 0 to 3 and adequate biliary drainage before randomisation.
- Design
- Multicentre (eight centres), open-label randomised controlled phase 3 trial in the UK. 92 patients with confirmed locally advanced or metastatic biliary tract cancer, ECOG performance status 0 to 3 and adequate biliary drainage were randomised (46 per group) to porfimer sodium photodynamic therapy plus stenting or stenting alone. Primary endpoint overall survival; progression-free survival and toxicity secondary. Designed to detect an increase in median survival from 8 to 12 months, which required 240 patients; recruitment was stopped on 18 December 2009 on the advice of the Independent Data Monitoring Committee after 92 patients, because overall survival was persistently worse with photodynamic therapy. All analyses intention to treat (full text). Registered ISRCTN 87712758, EudraCT 2005-001173-96 and NCT00513539 (registry enrolment 92, matching the paper).
- Primary endpoint
- OS
- Arms
- Stenting alone (control, n = 46): Biliary stenting without photodynamic therapy
- Photodynamic therapy plus stenting (experimental, n = 46): Porfimer sodium photodynamic therapy plus biliary stenting
- People
- Pereira SP
OSHR 1.56 (95% CI 1.00–2.43)Δ median OS−3.6 monthsPFSHR 1.43 (95% CI 0.93–2.18)Δ median PFS−0.9 months
Show the numbers
| Endpoint | Analysis | Photodynamic therapy plus stenting | Stenting alone | Effect |
|---|---|---|---|---|
| OS | primarymedian follow-up 8.4 monthsPereira 2018 | median 6.2 months | median 9.8 months | HR 1.56 (95% CI 1.00–2.43)P=0.048HR above 1 means a higher hazard of death with photodynamic therapy than with stenting alone. No grade 3-4 adverse events were attributed to photodynamic therapy and grade 3-4 toxicities did not differ significantly. Subsequent palliative chemotherapy was given to 13 (28%) of the photodynamic therapy patients and 24 (52%) of the stent-alone patients; the abstract states the difference in chemotherapy explained the worse outcome only in part. |
| PFS | primarymedian follow-up 8.4 monthsPereira 2018 | median 3.4 months | median 4.3 months | HR 1.43 (95% CI 0.93–2.18)P=0.10Secondary endpoint; the difference was not statistically significant. |
| Endpoint | Analysis | Photodynamic therapy plus stenting | Stenting alone | Effect |
|---|---|---|---|---|
| OS | primarymedian follow-up 8.4 monthsPereira 2018 | median 6.2 months | median 9.8 months | HR 1.56 (95% CI 1.00–2.43)P=0.048HR above 1 means a higher hazard of death with photodynamic therapy than with stenting alone. No grade 3-4 adverse events were attributed to photodynamic therapy and grade 3-4 toxicities did not differ significantly. Subsequent palliative chemotherapy was given to 13 (28%) of the photodynamic therapy patients and 24 (52%) of the stent-alone patients; the abstract states the difference in chemotherapy explained the worse outcome only in part. |
| PFS | primarymedian follow-up 8.4 monthsPereira 2018 | median 3.4 months | median 4.3 months | HR 1.43 (95% CI 0.93–2.18)P=0.10Secondary endpoint; the difference was not statistically significant. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 1.56 | 1–2.43 |
| PFS | 1.43 | 0.93–2.18 |
- Photodynamic therapy plus stenting (experimental)
- Stenting alone (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 stenting | Stenting alone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 6 | 51.1% | 65.4% |
| 12 | 26.1% | 42.8% |
| 18 | 13.4% | 28.0% |
| 25 | 6.1% | 17.1% |
- Photodynamic therapy plus stenting (experimental)
- Stenting alone (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 stenting | Stenting alone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 3 | 54.2% | 61.7% |
| 5 | 36.1% | 44.7% |
| 8 | 19.6% | 27.5% |
| 11 | 10.6% | 17.0% |
Appears in
Sources
Pereira SP, Jitlal M, Duggan M, Lawrie E, Beare S, O'Donoghue P, et al. PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer. ESMO Open. 2018;3(5):e000379.