Health-related quality of life (HRQOL) and patient-centered outcomes with maintenance olaparib compared with placebo following chemotherapy in patients with germline (g) BRCA-mutated (m) platinum-sensitive relapsed serous ovarian cancer (PSR SOC): SOLO2 phase III trial.
Bibliographic record
Abstract
5507 Background: The median PFS after chemotherapy in PSR SOC is less than 6 months in many patients. In SOLO2 (ENGOT Ov-21; NCT01874353), maintenance olaparib (O) given after response to chemotherapy resulted in a significant improvement in PFS vs placebo (P) in patients with g BRCAm PSR SOC (hazard ratio [HR] 0.30, 95% CI 0.22, 0.41; P<0.0001; median 19.1 vs 5.5 months; 63% data maturity; Pujade-Lauraine et al. SGO 2017). Our a priori hypothesis was that maintenance therapy with O would not negatively impact HRQOL compared with P and would be associated with additional patient-centered benefits to support the prolongation of PFS, the primary endpoint of SOLO2. Methods: HRQOL was evaluated by the Functional Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O TOI) in all 295 patients. This measures functional and physical well-being and symptoms, including adverse events. Change from baseline in FACT-O TOI score during the first 12 months was the primary HRQOL analysis (mixed model repeated measures). Secondary planned analyses included duration of ‘good quality of life’ by time without symptoms of disease or toxicity (TWiST) and quality-adjusted PFS (QAPFS; a single measure of PFS and HRQOL outcomes). Results: There was no significant detrimental effect of O vs P on HRQOL analyzed by change from baseline in TOI score (–3.1 vs –2.9, respectively, difference (O minus P) –0.2; 95% CI –2.4, 2.1; P=0.88). There was a significant improvement for patients on maintenance O in TWiST (13.5 vs 7.2 months, difference 6.3; 95% CI 2.9, 8.6; P<0.001) and QAPFS (mean 14.0 vs 7.3 months for O and P, respectively, difference 6.7; 95% CI 5.0, 8.5; P<0.0001). Conclusions: Maintenance O did not detrimentally impact HRQOL relative to P. The significant improvement in PFS with O was associated with additional patient-centered benefits, including a longer duration without symptoms of disease or treatment toxicity and longer QAPFS. Clinical trial information: NCT01874353.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 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".