Phase I study of stereotactic radiotherapy for unresectable hepatobiliary cancer and liver metastases
Bibliographic record
Abstract
4590 Background: Safety of stereotactic radiotherapy (SRT) for unresectable hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (CC) and liver metastases (LM) has not been well established. Results from a phase I study of 6 fraction SRT are reported. Methods: Eligible patients had unresectable or medically inoperable HCC, CC or LM, liver enzymes < 6 fold higher than normal, platelets > 80,000 bil/L, Child score A, > 800 cc uninvolved liver, KPS = 60 and unsuitability for standard therapies. Patients were treated with breath hold and image guided 6 fraction SRT. Dose was individualized to maintain the same risk of liver toxicity at three risk levels (I-5%, II-10%, III-20%). Escalation to level II and III occurred once at least 3 patients had been followed for >3 months without dose limiting toxicity (grade 4/5 < 1 month or grade 4/5 liver < 3 months) for each stratum. Stratification was based on diagnosis and liver volume irradiated (low <20%, mid 20–50%, high 50–80%). Results: From Aug. 2003 to Dec. 2006, 82 patients initiated SRT. Two patients discontinued SRT after 1 fraction for progressive disease (LM) and a variceal bleed (HCC). 80 patients completed SRT (38 LM, 32 HCC, 10 CC). Median age was 64 years (38–92 years). Median tumor volume was 293 cc (3–3088 cc). 24 patients (30%) had extra-hepatic disease. 17 HCC patients had portal vein thrombosis (53%), 14 HBV, 12 HCV and 4 alcoholic cirrhosis. The median prescribed dose was 40 Gy (24 Gy - 60 Gy) in 6 fractions. Within 3 months post SRT, no dose-limiting grade 4/5 toxicity or classic radiation liver toxicity was observed. Grade 3 liver enzymes (2 new, 9 pre-existing), thrombocytopenia (3), nausea (3) and fatigue (1) was observed. Child score declined in 8 patients (5 HCC, 2 CC, 1 LM), 6 with progressive disease. Late toxicity included 1 tumor-duodenal fistula, 1 bowel obstruction and 2 GI bleeds. The in-field response rate was 60% (LM 57%, CC 50%, HCC 67%): CR 14%, PR 46%, SD 23%, PD 17%. Actuarial 12 month local control was 78% (95% CI: 58- 90%). The median survival for LM, CC and HCC was 16.6 months (7.9–25.6), 13.1 months (6.0–28.4) and 11.0 months (8.6–20.8) respectively. Conclusions: Individualized SRT is a safe, promising treatment for unresectable liver cancer. No significant financial relationships to disclose.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".