Single agent trabectedin in heavily pretreated patients with recurrent ovarian cancer (ROC).
Bibliographic record
Abstract
5553 Background: Trabectedin is approved in Canada since 2010 in combination with liposomal doxorubicin for platinum-sensitive ROC in patients who are not expected to benefit, are ineligible or not willing to receive retreatment with platinum-based chemotherapy. In 2012, due to a shortage of liposomal doxorubicin, single agent trabectedin was proposed to patients with ROC. The aim of this study was to evaluate the efficacy and tolerability of trabectedin in this context. Methods: This retrospective IRB approved study included all patients who received trabectedin for ROC between January 1st 2012 and June 30th 2014 at the CHUM. This study was not funded.The primary outcome was progression free survival (PFS) based on CA-125 and clinical exam. We also evaluated overall survival (OS), response rate and toxicities (CTCAE v4.0). PFS and OS were estimated by Kaplan-Meier method. Results: A total of 25 evaluable patients with a median age of 59 years received trabectedin 1.3 mg/m2 I.V. in 3 hours every 3 weeks in 3rd or 4th line (36%), 5th or 6th line (36%) and ≥ 7 lines (28%). Among the patients, 60% were platinum-sensitive and 40% platinum-resistant. The median number of cycles received was 5 (range 1-16 cycles) for a total of 130 cycles. Complete response (CR), partial response (PR), stable disease (SD) and progression occurred in 16%, 20%, 24% and 40% of patients respectively. The median PFS was 3.7 months (95% CI 1.9-5.6). In patients with a response (CR, PR, SD), the median PFS was 4.9 vs 0.8 months (p < 0.001). Death occurred in 15 patients (60%). The median OS was 16.2 months. The Cox model reported that response to treatment is the only variable influencing the PFS and the OS (p < 0.001), but not the platinum status or the number of previous lines received. Grade 3 or 4 toxicities include: neutropenia (8%), febrile neutropenia (4%) and muscle weakness (4%). Dose reduction was required in 4 patients for hepatic and hematologic toxicities. No death was attributable to toxicities. Conclusions: Our results demonstrate that trabectedin has an interesting efficacy as a single agent in heavily treated ROC patients. At a dose of 1.3 mg/m2 every 3 weeks, trabectedin is well tolerated with few adverse events.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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 | 0.000 |
| 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".