A randomized, double-blind trial evaluating the palliative benefit of either continuing pamidronate or switching to zoledronate in patients with high-risk bone metastases from breast cancer (The Odyssey Study).
Bibliographic record
Abstract
155 Background: Questions remain around the optimal use of bone-targeted agents (BTA) in patients with bone metastases (BM) from breast cancer (BC). In Canada pamidronate (PAM) is the most commonly used BTA in BC.We explored whether a switch to a more potent BTA, like zoledronic acid (ZA), in patients who remain at high risk of skeletal related events (SREs) despite PAM use is associated with significant palliative benefit. Methods: BC patients with high risk BM (prior SRE, bone progression, bone pain or levels of bone turnover marker serum C-telopeptide (sCTX) >400ng/L) despite >3 months of PAM use were eligible. Patients were randomized in a double–blind manner to either switch to ZA or continue on PAM every 4 weeks for 12 weeks. Primary outcome was the proportion of patients achieving a fall in sCTX at 12 weeks. Secondary outcomes were pain control (BPI and FACT-BP) and toxicity. Results 73 patients completed the study. Median age 61 years (range 37 – 87), prior duration of PAM use 10 months (range 3 – 118). sCTX levels for all patients at baseline, 372+/- 471, week 12, 209 +/-290. Proportion of patients achieving a fall in sCTX from week 0 to week 12, 26/31 (84%) in ZA arm, 17/30 (57%) in PA arm, p=0.0262. Two patients were unable to complete the study due to deterioration in renal function (both receiving PAM), four due to progressive disease (two receiving ZA, two PAM), two patients chose to discontinue the study before completion (both receiving ZA). Four patients (5%) had SRE’s during the study, two receiving ZA, two receiving PAM. Quality of life and pain analysis shows no difference between week 0 and week 12 scores in either arm. Toxicity was predominantly grade 1 and 2, numerically there were more adverse effects in the ZA arm than PAM. Conclusion Switching patients with high risk BM from PAM to ZA leads to a reduction in sCTX levels but may be associated with more toxicity. Quality of life and pain scores were similar between the two treatments. While the literature suggests that a reduction in sCTX may correlate with reduced rate of SREs, given the lack of symptom improvement a switching strategy cannot be recommended. NCT01907880 Clinical trial information: NCT01907880.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 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".