Updated analyses from a global meta-analysis in metastatic uveal melanoma (mUM) to determine progression free and overall survival benchmarks by line of therapy: An international rare cancers initiative (IRCI) ocular melanoma study.
Bibliographic record
Abstract
9539 Background: PUMMA is an individual trial patient level meta-analysis that established survival and prognostic benchmarks in metastatic uveal melanoma (Khoja et al, 2019) in 912 patients treated 2000-2016. Methods: Herein we describe the dataset further by line of treatment to assist in establishing benchmarks of activity needed to satisfy synthetic control arm surrogates for regulatory purposes for benchmarks of PFS (Progression Free Survival) and OS (Overall Survival) in months (m). Results: Within the PUMMA dataset, 567 (62.2%) received 1st line treatment, 161 (17.7%) received 2 nd /3 rd line treatment. OS was comparable by line of treatment (P=0.2513) with 12m OS rates being 41.3% and 40.5% respectively. Median OS by line of treatment was 9.95 m (95% CI 9.23-10.74) for 1 st line and 10.15 m (7.69-11.60) for 2 nd /3 rd line. PFS was also comparable by line of treatment (p=0.51) with 12m PFS rates being 11.7% and 7.2% respectively. Median PFS by line of treatment was 2.76 m (95% CI 2.66-3.38) for 1 st line and 2.86 m (95% CI 2.73-3.52) for 2 nd /3 rd line. Multivariable analysis of the 1 st and 2 nd /3 rd line treatments separately suggested statistically significant (p<0.05) variables associated with inferior PFS in the first line setting included male sex, LDH>2X ULN, ALP>2X ULN whilst inferior PFS in the 2 nd /3 rd line was predicted by LDH>2X ULN only. Inferior OS in the 1 st line setting was statistically significantly associated with ECOG>2, Age > 65, male sex, LDH>2X ULN, ALP>2X ULN whilst inferior OS in the 2 nd /3 rd line was associated with ECOG>2, LDH>2X ULN, and ALP>2XULN. Conclusions: PUMMA continues to show value in providing benchmarks of activity for future clinical trials or regulatory purposes in mUM. The prognostic ability of LDH>2XULN retains important value across multiple lines of treatment scenarios in the PUMMA dataset.
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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 | 0.019 | 0.031 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.032 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.001 | 0.003 |
| 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".