Bibliographic record
Abstract
Purpose: To compare complete response rates (CR) for pain between SABR and CRT to painful site(s) of spinal metastases.Methods and Materials: A randomized Phase II/III trial (NCT02512965) in which participants across Canada and Australia with de novo site(s) of painful spinal metastases were randomized (1:1) to 24 Gy in 2 fractions of SABR or 20 Gy in 5 fractions of CRT.Inclusion criteria £3 consecutive target spinal metastases causing a pain score of ³2 using the Brief Pain Inventory (BPI), an ECOG of 0-2 and stable disease using the Spinal Instability Neoplasia Score (SINS) classification.The primary endpoint was pain CR rate at 3 months post-radiation using International Consensus Pain Response Endpoints.Secondary endpoints included the 6month pain CR rate, radiation site progression-free survival (RSS PFS), and quality of life (QoL).The study had an 80% power to show a 17% improvement in the 3-month CR rate in favour of the SABR arm.Efficacy analyses were intent-to-treat and safety analyses were as treated.Adverse events (AE) were evaluated per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).Results: Of the 229 enrolled patients between Jan 2016 to Sept 2019, 115 were randomized to CRT and 114 to SABR of which 4 patients in the SABR arm were either ineligible or withdrew prior to radiation.38 patients (22 in the CRT and 16 in the SABR arm) were not evaluable for the primary endpoint.The median baseline worst pain score was 5 (range, 2-10) and SINS was 7 (range,3-12) in both arms, and median follow-up was 6.7 months.At 3 months, 16/115 (14%) in the CRT arm vs. 40/114(36%) in the SABR arm (p < 0.001) achieved a CR to pain.At 6 months, 18/115(16%) in the CRT arm vs. 37/114 patients(33%) in the SABR arm achieved a CR (p = 0.004).The 3-month RSS PFS for CRT vs. SABR was 86% vs. 92%(p = 0.4), and at 6 months was 69% vs. 75%(p = 0.42), respectively.For QoL outcomes, only financial perception at 1 month significantly differed (p = 0.03) favouring SABR.There were 20(17%) vs. 12(11%) post-radiation vertebral compression fractures, and 2(2%) vs no(0%) patient progressed to malignant epidural spinal cord compression, in the CRT vs. SABR arm, respectively.Grade 2+ AE were observed in 12% and 11% in the CRT and SABR arms, respectively, with no Grade 5 events.Conclusion: SABR is superior to CRT in improving the CR rate for pain at 3 and 6 months post-radiation.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.455 | 0.238 |
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".