Efficacy and safety of niraparib in older patients with advanced ovarian cancer (OC): results from the PRIMA/ENGOT-OV26/GOG-3012 trial
Bibliographic record
Abstract
Objective To assess the efficacy and safety of niraparib from older patients enrolled in the PRIMA/ENGOT-OV26/GOG-3012 trial (NCT02655016). Materials and methods This double-blind, placebo-controlled phase 3 trial evaluated niraparib in patients with newly diagnosed, advanced, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response to first-line platinum-based chemotherapy. Patients were randomized 2:1 to receive either a fixed starting dose (FSD) of 300 mg niraparib or placebo QD. A protocol amendment introduced an individualized starting dose (ISD): 200 mg QD in patients with bodyweight < 77 kg or platelet count < 150,000/µL or 300 mg QD for all others. Here, patients were dichotomized by age group < 65 vs ≥65 years old (yo) to analyze efficacy and safety of niraparib vs placebo in older patients. The primary endpoint was PFS assessed by blinded independent central review. Results Of 733 enrolled patients, 444 were < 65 yo (297 niraparib, 147 placebo), and 289 were ≥65 yo (190 niraparib, 99 placebo). Efficacy was comparable in patients < 65 yo (HR 0.61; 95% CI 0.47-0.81) and ≥65 yo (HR 0.53; 95% CI 0.39-0.74) who received niraparib compared with placebo. Safety data by age group, older patients who received FSD/ISD, and patient-reported outcomes will be presented.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".