An updated retrospective review of the safety and efficacy of sorafenib for recurrent hepatocellular carcinoma post-liver transplantation.
Bibliographic record
Abstract
313 Background: Orthotopic liver transplantation (OLT) is a potentially curative treatment for hepatocellular carcinoma (HCC). Despite an estimated recurrence rate between 15%-20%, there is currently no proven systemic therapy for the treatment of HCC relapse post OLT. Sorafenib has been a standard therapy for advanced HCC however data is lacking for the safety and efficacy of sorafenib in the setting of concurrent immunosuppressive agents. Methods: A retrospective review was performed of patients who received sorafenib for HCC relapse after OLT. Data on patient characteristics, treatment toxicity and efficacy was collected. The primary objectives were to evaluate toxicity and safety of sorafenib when used in combination with immunosuppressive therapies such as calcineurin and mTOR inhibitors. Secondary objectives were objective response rate, progression free survival (PFS), and time on therapy. Results: 35 patients over the last 11 years received sorafenib for HCC recurrence following OLT. 54.3% of patients received concurrent immunosuppression with tacrolimus. Toxicity from sorafenib was as expected, with no cases of acute or chronic organ rejection whilst on treatment. The median maximum tolerated dose was 400 mg a day with 40% of patients requiring dose reductions. The incidence of any adverse events (AEs) was 88.6%, with 17.1% having Grade 3-4 toxicity. Incidence of Grade 3-4 liver dysfunction was higher than historical studies at 6%. The overall response rate was 2.8% with a median PFS of 2.8 months. Median time on sorafenib was 3.1 months. Conclusions: There is a paucity of evidence guiding treatment of HCC recurrence following OLT. This retrospective review is one of the largest in the literature and shows that sorafenib used concurrently with immunosuppressive therapy for organ transplant is safe, with no precipitation of acute or chronic rejection, although liver function should be monitored closely. The median PFS in our cohort was shorter than expected. The efficacy of other agents should be explored in this population.[Table: see text]
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.009 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.006 | 0.010 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".