Effect of anticoagulation therapy on bleeding and thromboembolic events (TEs) in the AVADO phase III study of docetaxel (D) ± bevacizumab (BV) in inoperable locally recurrent (LR) or metastatic breast cancer (mBC).
Bibliographic record
Abstract
Abstract Abstract #1035 Background: In first-line mBC, the anti-VEGF monoclonal antibody BV (Avastin®) has demonstrated PFS improvement when combined with taxanes in two large phase III trials (E2100 and AVADO). Thromboses and bleeding are among the possible side effects of BV. Pts receiving full-dose anticoagulation therapy have historically been excluded from clinical trials of BV due to the hypothetical risk of bleeding and TEs. AVADO enrolled pts receiving full-dose anticoagulation provided that their level of anticoagulation was stable for ≥2 weeks prior to study entry. We investigated the incidence of bleeding and arterial and venous TEs (ATEs; VTEs) in pts receiving concomitant anticoagulation therapy in AVADO. Methods: Pts with inoperable LR or mBC, with no CTx 6 months prior to randomisation (12 months if taxane-based), ECOG PS 0–1 and adequate LVEF were eligible for enrolment. 736 pts were randomised to D 100mg/m2 + placebo (PL) or D + BV 7.5 or 15mg/kg. D was administered q3w for ≥9 cycles, BV/PL q3w until disease progression or unacceptable toxicity. Anticoagulation therapy was defined as coumarin, heparin or low molecular weight heparins. Results: Safety data are available from 730 pts. Grade ≥3 TEs and grade ≥3 bleeding were each reported by six pts (1.2%) who received BV, compared with nine pts (3.9%) and two pts (0.9%), respectively in the control arm. Eleven pts received anticoagulants at study entry (PL: 4, BV 7.5mg/kg: 6, BV 15mg/kg: 1) and 73 pts began anticoagulants during the study (PL: 21, BV 7.5mg/kg: 26, BV 15mg/kg: 26). No grade ≥3 ATEs were reported in pts receiving anticoagulation therapy either before or during the study. Conclusions: The rate of grade ≥3 ATEs, VTEs and bleeding events was relatively low in the entire study and did not appear to increase with BV use. The incidence of TEs and bleeding events was not increased relative to the control arm in the subpopulation of pts receiving anticoagulants concurrently with BV, although patient numbers are small, particularly for bleeding events. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 1035.
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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 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".