Phase II study of sagopilone (ZK-Epo) in patients with recurrent metastatic breast cancer (MBC)
Bibliographic record
Abstract
1083 Background: Sagopilone is a novel, fully synthetic epothilone, which represents a new class of microtubule stabilizing agents. It has shown significant pre-clinical activity in taxane resistant breast cancer cell lines and in tumor models, as well as clinical activity in both taxane naïve and pretreated MBC. Methods: MBC patients who received ≤ 3 prior anthracycline and taxane containing chemotherapies were eligible. Sagopilone was given either at 16 mg/m2 (arm A) or at 22 mg/m2 (arm B, amended additional cohort) IV over 3 hours every 21 days for up to 6 cycles. The primary end point was tumor response by RECIST. The Simon 2-Stage design required 3 responders in the first 24 evaluable patients in stage 1 and 10 responders in 65 evaluable patients to declare success. Results: Between June 2006 and June 2008, 65 patients were enrolled and treated (39 in arm A, 26 in arm B). Majority of metastases were in lymph nodes (62%), liver (55%), bone (49%), lung (37%), and cutaneous sites (19%). Median number of cycles delivered was 2 (1–17). Neither arm met Stage 1 criteria for responders. Nevertheless, 2 patients in arm A and 1 in arm B had confirmed partial response, and lasted 4, 7, and 2 months, respectively. 26% patients in arm A, and 42% in arm B had stable disease. 42 patients discontinued study prior to cycle 6 due to progressive disease/death, 14 due to adverse events, and 1 due to other reasons. All 65 patients are evaluable for safety. Adverse events documented or reported in ≥ 20% patients are: sensory neuropathy 80% (23% grade 3), nausea 57% (no grade 3), fatigue 45% (12% grade 3), vomiting 29% (no grade 3), myalgia 28% (5% grade 3), diarrhea 25% (2% grade 3), insomnia 25% (no grade 3), pain in extremity 25% (2% grade 3), headache 23% (5% grade 3), arthralgia 22% (5% grade 3), constipation 22% (2% grade 3). Conclusions: Sagopilone had limited activity in these heavily pretreated MBC patients. It appeared tolerable at both dose levels. [Table: see text]
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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 | 0.000 |
| 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 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".