Is it time to change the primary endpoint in clinical trials in recurrent ovarian cancer (ROC)?: Symptom burden and outcomes in patients with platinum resistant/refractory (PRR) and potentially platinum sensitive ROC receiving ≥ 3 lines of chemotherapy (PPS ≥ 3)—The Gynecologic Cancer Intergroup (GCIG) Symptom Benefit Study (SBS).
Bibliographic record
Abstract
5536 Background: The primary endpoint for clinical trials in PRR/PPS ≥ 3 ROC is progression free survival (PFS) and symptom benefit is not typically measured or reported. The primary aim of GCIG SBS is to validate a patient-reported outcome measure (PROM), the MOST (Measure of Ovarian Symptoms and Treatment concerns), to assess symptom benefit from palliative chemotherapy (PC). The SBS recruited 949 patients; the secondary aims provide insights into symptom burden, patients’ and clinician’s expectations of treatment and outcomes in a “real world” setting. Methods: Patients with PRR/PPS ≥ 3ROC completed 4 PROMs before each cycle of chemotherapy. They reported expectation of symptom improvement. Clinicians documented the indications for PC, symptoms at baseline, adverse events and estimated the number of cycles patients would receive. Results: Palliation was the major indication for chemotherapy. The mean number of prior regimens was 2.6 (range 1-10). 60% of patients had PRR and 40% had PPS > 3 ROC. At baseline, most patients were symptomatic; 75% rated at least one symptom as moderate (³5 on a 0-10 scale) and 30% rated > 5 symptoms as moderate or worse. The symptoms included pain, fatigue, anorexia, abdominal distension, dyspnea, and constipation. Many had symptoms related to prior chemotherapy (e.g. neuropathy in 28%). Most patients had high expectations of symptom benefit from chemotherapy. 36% of patients received the predicted number of cycles. 25% of patients with PRR-ROC stopped treatment in < 8 weeks mainly due to progression/death. The median number of cycles and median PFS were 4 and 5.6m in PPS≥3ROC, and 3 and 3.7m in PRR ROC respectively. Conclusions: Patients with PRR/PPS ≥ 3ROC reported a number of significant baseline symptoms. They had high expectations of symptom improvement and this should be measured. The results underscore the importance of incorporating PROMs and including symptom benefit as primary endpoints in trials in patients with PRR/PPS ≥ 3 ROC. Clinical trial information: ACTRN12607000603415.
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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 | 0.070 | 0.113 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| 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".