Evaluation of rucaparib in platinum-sensitive recurrent ovarian carcinoma (rOC) in patients (pts) with or without residual bulky disease at baseline in the ARIEL3 study.
Bibliographic record
Abstract
5537 Background: In ARIEL3, pts were randomized 2:1 (oral rucaparib 600 mg or placebo). Rucaparib significantly improved progression-free survival (PFS) vs placebo in all primary analysis groups (Coleman et al. Lancet. 2017;390:1949-61). An exploratory subgroup analysis of ARIEL3 pts with or without bulky residual disease ( > 2 cm per blinded independent central review [BICR]) at baseline is reported. Methods: Pts were assigned to 2 analysis subgroups: with or without bulky residual disease at baseline. PFS was assessed in 3 predefined cohorts: BRCA mutant; homologous recombination deficient (HRD) (BRCA mutant or BRCA wild type/high loss of heterozygosity); and intent-to-treat (ITT) population. Results: PFS data for each subgroup (visit cutoff date 15 Apr 2017) by status of bulky disease at baseline are summarized in the Table. Safety data were consistent with data reported previously. In the rucaparib arm, the most common grade ≥3 treatment-emergent adverse event in pts with and pts without bulky disease was anemia (20.0% and 18.5%, respectively). Clinical trial information: NCT01968213. Conclusions: Rucaparib improved PFS vs placebo in all 3 predefined cohorts for both pts with and without bulky residual disease. PFS benefit with rucaparib was largest in pts with BRCA-mutant rOC. Cohort Rucaparib, n Placebo, n PFS (investigator review) PFS (BICR) HR (95% CI) Median PFS, mo; P value* HR (95% CI) Median PFS, mo; Pvalue* Rucaparib vs placebo Rucaparib vs placebo Bulky disease at baseline (per BICR) Yes BRCA mutant 21 10 0.09 (0.02–0.37) 11.1 vs 2.8; P= 0.0002 0.13 (0.03–0.55) 17.1 vs 2.9; P= 0.0028 HRD 39 18 0.30 (0.13–0.69) 8.3 vs 2.8; P= 0.0030 0.58 (0.25–1.34) 8.3 vs 2.9; P= 0.1994 ITT 71 29 0.40 (0.24–0.69) 8.2 vs 2.9; P= 0.0007 0.46 (0.26–0.81) 8.3 vs 3.0; P= 0.0057 No BRCA mutant 109 56 0.26 (0.17–0.40) 16.6 vs 5.6; P< 0.0001 0.22 (0.13–0.37) 26.8 vs 5.5; P< 0.0001 HRD 197 100 0.31 (0.23–0.43) 13.8 vs 5.5; P< 0.0001 0.32 (0.22–0.47) 24.7 vs 5.6; P< 0.0001 ITT 304 160 0.36 (0.29–0.46) 11.0 vs 5.4; P< 0.0001 0.34 (0.26–0.45) 16.2 vs 5.4; P< 0.0001 *Stratified log-rank P value.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".