Phase II study of exemestane (E) in refractory ovarian cancer (ROC)
Bibliographic record
Abstract
5026 Background: Despite biologic rationale, endocrine therapeutic strategies have been under investigated in ovarian cancer. This is the first study to report the efficacy of an aromatase inhibitor, E, in patients (pts) with ROC. Methods: This was a pilot, phase II, single-centre, non-comparative, open-label study. Pts with ROC stage II - IV who had received no more than 2 lines of prior chemotherapy, had ECOG PS ≤ 2, and measurable disease or non-measurable disease with a CA 125 ≥ 30 U/mL and/or ascites were eligible. All pts must have received prior platinum and taxane chemotherapy. Treatment consisted of E 25mg p.o. daily until disease progression. The primary endpoint was objective response rate (ORR) and secondary endpoints were time to progression (TTP), duration of response (DR) and toxicity. Results: 24 pts have been enrolled to date. Only 2 pts who withdrew consent or never started E were excluded from this analysis. Subjects had stage III (77%) or IV (18%) ovarian cancer, the majority were grade 3,serous histology. 15 pts (68%) had 2 prior lines of therapy and 7 pts (32%) had only 1 prior line of therapy. Treatment was commenced in the majority immediately after progression on chemotherapy. There were no objective clinical responses; however 8/22 (36%) pts had stable disease (SD) >14 weeks (med. duration 23 wks). One pt remains with SD > 95 wks duration. The median TTP was 8.8 wks. Receptor status was available in 16/22 pts: ER+ (41%), PgR+ (32%), BCL-2+ (23%) and HER2+ (0%). Correlation of ORR/SD with receptors and CA 125 will be presented. Toxicity was evaluated in all pts who received at least one dose of E. Hyponatremia (gr 4), attributed to disease, was observed in 1 pt. All other toxicities were NCI CTC grade ≤ 2: fatigue (14%), hot flashes (9%), skin reaction (5%), and fluid retention (5%). Conclusions: In this highly refractory ROC pt population, E was associated with an impressive, clinically meaningful SD rate of 36%. As this potentially represents a less toxic, well-tolerated therapeutic option for women with ROC, further investigation is warranted. Supported by a grant from Pfizer Canada No significant financial relationships to disclose.
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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 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".