Chemoembolization with super absorbent polymer microspheres (SAP-MS) loaded with doxorubicin (D) using escalating doses and adverse events (AE) in resectable hepatocellular carcinoma.
Bibliographic record
Abstract
e15084 Background: SAP-MS have demonstrated utility in the treatment of hepatocellular carcinoma (HCC) as a bland embolic and have demonstrated the ability to load and release D in vivo. Little is known about its toxicity profile. We aimed to determine if the dose and maximum plasma concentration (Cmax) of D were correlated with occurrence of AE. Methods: A phase II dose-escalation study was performed to systematically evaluate AEs relating to outpatient-based D/ SAP-MS embolization in HCC using a D dose of 0-75 mg. D plasma levels were assessed at multiple time points (0.5, 2, 24 and 675h), in addition to standard analyses of liver and hematologic function. All AEs were reported following the Common Toxicity Criteria Version 3.0. A Pearson product-moment correlation was run to determine the relationship between Cmax and AE. Results: Of 25 patients enrolled, 24 were evaluable (6 = 0mg, 6 = 25mg, 6 = 50mg, 6 = 75mg). The side-effect profile was similar to other abdominal embolization procedures, with abdominal pain (62.5%), fatigue-like symptoms (41.7%), and nausea (41.7%) being the most common AE. There were no correlation between the administered doses of D and all grade AE (r = .209, p .328) or between Cmax's of D and all grade AE (r = .321, p .127). All patients were discharged on the same day. There were no grade 4 or 5 AE and no hepatic decompensation. One patient required hospitalization 7 days post-procedure for groin puncture related complication. Conclusions: In our phase II dose-escalation study, patients experienced minimal post-embolization syndrome, which was not correlated with the amount of doxorubicin administered. The toxicities relating to SAP-MS delivery likely result from the embolic effect as opposed to dose response relating to the use of doxorubicin and can be managed on an outpatient basis. Clinical trial information: NCT01116635.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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".