Phase II trial of stereotactic ablative radiation (SAbR) for oligometastatic kidney cancer.
Bibliographic record
Abstract
311 Background: Stereotactic ablative radiotherapy (SAbR) is a promising treatment option for selected oligometastatic renal cell carcinoma (RCC) patients that can provide longitudinal disease control while preserving quality of life. Retrospective data have shown a local control (LC) rate greater than 90% and longitudinal disease control of over a year without systemic therapy. However, prospective validation of SAbR for oligometastatic RCC is lacking. In this prospective phase II single arm trial, we evaluated the impact of SAbR on freedom from systemic therapy (FFST). Methods: Treatment naïve patients with RCC confirmed by pathology and radiographic evidence of three or fewer extracranial metastases received SAbR with curative intent to all measurable sites of disease. Follow-up included radiographic imaging at three-month intervals to assess disease control. The primary endpoint was FFST defined as time from SAbR to the initiation of systemic therapy. Secondary endpoints included LC, modified progression-free survival (mPFS) (time from first SAbR to progression not amenable to further SAbR), PFS on subsequent systemic therapy, cancer-specific survival (CSS), overall survival (OS), toxicity and health-related quality of life (QOL) indices as measured with EQ-5D-5L and FACT-G. A Wilcoxon signed-rank test was used to evaluate the QOL indices. Results: The trial completed accrual with the enrollment of 23 patients who received SAbR to a total of 38 sites. At a median follow-up of 12 months (interquartile range 1.8-16), 1-year FFST was 87% (95% CI: 56%-96%). The 1-year mPFS was 79% (95% CI:49%-93%), while the median mPFS has not yet been reached. Three patients had disease progression at individual time points of 3.5, 4.0, and 12 months. One of these patients developed brain metastases that were controlled with gamma knife radiosurgery without initiating systemic therapy. The LC, CSS, and OS were 100% (38/38), 100% (23/23), and 95% (22/23), respectively. When compared to baseline, no significant decline in QOL was detected. Three patients experienced treatment-related grade 1 toxicity; no ≥grade 2 toxicities were reported. One patient died of an unrelated cause. Conclusions: SAbR is a safe and effective treatment for oligometastatic RCC that can provide longitudinal disease control and preserve quality of life. These data support further evaluation of SAbR for oligometastatic RCC in a randomized study. Clinical trial information: NCT02956798 .
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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 | 0.002 | 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 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.002 |
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".