Efficacy of neoadjuvant chemoradiation, followed by liver transplantation, for perihilar cholangiocarcinoma at 12 US centers (Darwish Murad 2012)
Phase observationalN = 287
- Population
- 287 eligible patients with perihilar cholangiocarcinoma that was unresectable or arose with primary sclerosing cholangitis, treated with neoadjuvant therapy in anticipation of liver transplantation.
- Design
- Multicentre retrospective study of 12 large-volume US liver transplant programmes that had treated three or more patients with perihilar cholangiocarcinoma with neoadjuvant therapy followed by liver transplantation, 1993 to 2010; centre protocols and charts reviewed on site. 287 eligible patients; 71 dropped out before liver transplantation; most patients (193) came from one centre. The abstract does not state a primary endpoint.
- Arms
- Neoadjuvant chemoradiation then liver transplantation (experimental, n = 287): Centre-specific protocols; patients completed external radiation (99%), brachytherapy (75%), radiosensitising therapy (98%) and/or maintenance chemotherapy (65%), then liver transplantation
- People
- Darwish Murad S
Show the numbers
| Endpoint | Analysis | Neoadjuvant chemoradiation then liver transplantation | Control | Effect |
|---|---|---|---|---|
| OSITT: all 287 eligible patients (the abstract reports intent-to-treat survival)Survival after the start of therapy in all eligible patients, including those who dropped out before transplantation (the abstract calls this intent-to-treat survival). | finalDarwish 2012 | 68% at 2 y; 53% at 5 y | — | Survival at 2 and 5 years after therapy. 71 patients dropped out before liver transplantation (11.5% per 3 months, as printed in the abstract). Patients outside the United Network for Organ Sharing criteria (tumour mass above 3 cm, transperitoneal tumour biopsy, or metastatic disease) or with a prior malignancy had significantly shorter survival (P < .001). |
| RFSPatients who underwent liver transplantation (number not given in the abstract)Recurrence-free survival counted after liver transplantation, among transplanted patients. | finalDarwish 2012 | 78% at 2 y; 65% at 5 y | — | Post-transplantation recurrence-free survival at 2 and 5 years. |
| Endpoint | Analysis | Neoadjuvant chemoradiation then liver transplantation | Control | Effect |
|---|---|---|---|---|
| OSITT: all 287 eligible patients (the abstract reports intent-to-treat survival)Survival after the start of therapy in all eligible patients, including those who dropped out before transplantation (the abstract calls this intent-to-treat survival). | finalDarwish 2012 | 68% at 2 y; 53% at 5 y | — | Survival at 2 and 5 years after therapy. 71 patients dropped out before liver transplantation (11.5% per 3 months, as printed in the abstract). Patients outside the United Network for Organ Sharing criteria (tumour mass above 3 cm, transperitoneal tumour biopsy, or metastatic disease) or with a prior malignancy had significantly shorter survival (P < .001). |
| RFSPatients who underwent liver transplantation (number not given in the abstract)Recurrence-free survival counted after liver transplantation, among transplanted patients. | finalDarwish 2012 | 78% at 2 y; 65% at 5 y | — | Post-transplantation recurrence-free survival at 2 and 5 years. |
- Neoadjuvant chemoradiation then liver transplantation (experimental)
Data table (modelled values)
| Months | Neoadjuvant chemoradiation then liver transplantation |
|---|---|
| 0 | 100.0% |
| 16 | 77.0% |
| 32 | 62.4% |
| 49 | 56.5% |
| 65 | 53.0% |
- Neoadjuvant chemoradiation then liver transplantation (experimental)
Data table (modelled values)
| Months | Neoadjuvant chemoradiation then liver transplantation |
|---|---|
| 0 | 100.0% |
| 16 | 84.3% |
| 32 | 73.8% |
| 49 | 68.3% |
| 65 | 65.0% |