Neoadjuvant chemoradiation and liver transplantation protocol for hilar cholangiocarcinoma, Mayo Clinic Rochester, 1993 to 2004 (Rea 2005)
Phase observationalN = 71
- Population
- Patients with hilar cholangiocarcinoma that was unresectable or arose with primary sclerosing cholangitis, without extrahepatic disease (including regional lymph node involvement) and without previous chemotherapy or radiotherapy; 71 entered the protocol and 38 were transplanted.
- Design
- Single-centre, non-randomised series (Mayo Clinic Rochester), January 1993 to August 2004, follow-up through October 2004; retrospective review of a protocol database and records. Patients with unresectable hilar cholangiocarcinoma or cholangiocarcinoma arising with primary sclerosing cholangitis were enrolled in a protocol of external-beam radiotherapy with fluorouracil sensitisation, a transcatheter iridium-192 brachytherapy boost, a fluoropyrimidine (fluorouracil, later capecitabine) until transplantation, operative staging and, only if stage I or II disease was confirmed, liver transplantation. 71 patients entered the protocol and 38 had been transplanted by August 2004. A separate group of patients explored for resection (54 explored, 26 resected) was reviewed in the same paper and is not part of this record. The paper states no primary endpoint.
- Arms
- Neoadjuvant chemoradiation then liver transplantation (experimental, n = 71): External-beam radiotherapy with fluorouracil, transcatheter iridium-192 brachytherapy boost, fluoropyrimidine until transplantation, operative staging, then liver transplantation if stage I or II disease was confirmed
- People
- Rea DJ
Show the numbers
| Endpoint | Analysis | Neoadjuvant chemoradiation then liver transplantation | Control | Effect |
|---|---|---|---|---|
| OS38 patients who underwent liver transplantation (survival counted from transplantation)Patient survival after liver transplantation, among the patients who were transplanted. | finalRea 2005 | 92% at 12 mo; 82% at 3 y; 82% at 5 y | — | Survival at 1, 3 and 5 years after transplantation. Patients who dropped out or were excluded at operative staging before transplantation are not in this denominator. The paper compared these figures with a separate non-randomised resection group; that comparison is not recorded here. |
| OSAll 71 patients enrolled in the transplant protocol (survival counted from enrolment)Patient survival counted from enrolment in the transplant protocol (Figure 1 caption: from the start of neoadjuvant therapy), among all patients who entered the protocol. | finalRea 2005 | 79% at 12 mo; 61% at 3 y; 58% at 5 y | — | Survival at 1, 3 and 5 years after enrolment. Of 61 patients who had operative staging, 14 had findings that precluded transplantation; as of August 2004, 9 patients were awaiting transplantation and 1 was awaiting staging. These figures appear in the full text, not in the abstract. |
| Endpoint | Analysis | Neoadjuvant chemoradiation then liver transplantation | Control | Effect |
|---|---|---|---|---|
| OS38 patients who underwent liver transplantation (survival counted from transplantation)Patient survival after liver transplantation, among the patients who were transplanted. | finalRea 2005 | 92% at 12 mo; 82% at 3 y; 82% at 5 y | — | Survival at 1, 3 and 5 years after transplantation. Patients who dropped out or were excluded at operative staging before transplantation are not in this denominator. The paper compared these figures with a separate non-randomised resection group; that comparison is not recorded here. |
| OSAll 71 patients enrolled in the transplant protocol (survival counted from enrolment)Patient survival counted from enrolment in the transplant protocol (Figure 1 caption: from the start of neoadjuvant therapy), among all patients who entered the protocol. | finalRea 2005 | 79% at 12 mo; 61% at 3 y; 58% at 5 y | — | Survival at 1, 3 and 5 years after enrolment. Of 61 patients who had operative staging, 14 had findings that precluded transplantation; as of August 2004, 9 patients were awaiting transplantation and 1 was awaiting staging. These figures appear in the full text, not in the abstract. |
- Neoadjuvant chemoradiation then liver transplantation (experimental)
Data table (modelled values)
| Months | Neoadjuvant chemoradiation then liver transplantation |
|---|---|
| 0 | 100.0% |
| 16 | 89.8% |
| 32 | 82.4% |
| 49 | 82.0% |
| 65 | 82.0% |
- Neoadjuvant chemoradiation then liver transplantation (experimental)
Data table (modelled values)
| Months | Neoadjuvant chemoradiation then liver transplantation |
|---|---|
| 0 | 100.0% |
| 16 | 74.4% |
| 32 | 62.6% |
| 49 | 58.7% |
| 65 | 58.0% |