Primary analysis of study MO19391, an open-label safety study of bevacizumab (B) plus taxane-based therapy as 1st-line treatment of patients (pts) with locally recurrent (LR) or metastatic breast cancer (mBC).
Bibliographic record
Abstract
Abstract Abstract #4118 Background: The addition of B (15mg/kg q3w) to 1st-line taxane therapy significantly improved PFS in pts with LR or mBC in 2 phase III studies, E2100 and AVADO. MO19391 investigated B plus 1st-line taxane-based chemotherapy (CTx) in LR or mBC to obtain safety and efficacy data in a community-based population. Methods: This open-label, multicentre study has completed enrolment of 2,000 pts with LR or mBC and an ECOG PS of 0–2. Exclusion criteria included prior CTx for LR or mBC and evidence of CNS metastases. The primary endpoint was safety; secondary endpoints included TTP and OS. B was administered at 10mg/kg q2w or 15mg/kg q3w plus the physician's choice of taxane regimen (or investigator's SOC, excluding anthracyclines). Treatment with B continued until disease progression or unacceptable toxicity. As well as AEs, attention was paid to AEs of special interest (hypertension, proteinuria, wound-healing complications, thromboembolic events, CNS bleeding, other haemorrhages, GI perforation, fistulae, RPLS and CHF). The safety population included all pts who received at least one dose of B. Results: As of March 2008, the safety population consisted of 1,553 pts from 35 countries. The median number of cycles received was 6 for both B (range 1–28) and CTx (range 1–28). Pts received: single-agent taxane 66.2%, taxane combination 13.5%, other single agent 8.5%, other combination 3.3%. Frequently reported AEs are shown below. Grade 3/4 AEs of special interest were reported in 6.3% of pts, most commonly hypertension 2.2%, proteinuria 0.7%, pulmonary embolism 0.5%, epistaxis 0.4%. AEs leading to death during the study phase were reported in 27 pts (1.7%)*. Conclusions: MO19391 is the largest study population of pts with LR or mBC receiving B plus CTx. Toxicity was low and preliminary results are consistent with previous B safety studies. Final analysis of the primary endpoint and secondary efficacy analyses will be presented. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4118.
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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 | 0.007 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.002 |
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".