2SPD-009 Analysis of olaparib and talazoparib as possible therapeutic alternatives in advanced breast cancer and a germline BRCA mutation
Bibliographic record
Abstract
Background To date, the main treatment in advanced breast cancer (ABC) with BRCA mutation is a non-specific chemotherapy of the physician’s choice. Purpose To establish whether olaparib and talazoparib can be declared equivalent therapeutic alternatives (ETA) in patients with ABC and a BRCA mutation, through an indirect treatment comparison (ITC) using a common comparator. Material and methods A bibliographic search was conducted to identify a phase III clinical trial with olaparib or talazoparib in a similar ABC population (with BRCA mutation), duration and endpoints. An ITC was done according to Bucher’s method, using the ITC calculator from the Canadian Agency for Health Technology Assessment. Physician’s choice (capecitabine, eribulin or vinorelbine) was used as a comparator. Delta value (Δ), maximum acceptable difference as a clinical criterion of no-inferiority, was set at 0.650 (and its inverse, 1.538). If the 95% CI deviated from the delta margin, this probability was calculated using the Shakespeare method. Results Clinical trials included were: open-label, randomised, HER 2-negative, capecitabine, eribulin or vinorelbine as comparator, ECOG 0–1, pretreated with taxane, anthracycline or both, and if platinum was used without progression to this one. The primary end point was radiologic progression-free survival (PFS). Two trials were included, one of each drug. Both of them were open-label trials, randomised, in patients with HER2-negative ABC, ECOG 0–1 and pretreated with taxane, anthracycline or both. Differences were found in the percentage of patients with ECOG 0–1 (olaparib 72.2% vs. talazoparib 53.3%), excepting this characteristic the population of both studies was similar. The results of each trial, as well as the ITC conducted, are summarised in the following table 1: The 95% CI was broad (high level of uncertainty) and exceeds the equivalence margin, and the probability of a result falling out the delta margin was <4.5%. Conclusion ITC showed no statistically differences in PFS between olaparib and talazoparib. There is a probable clinical equivalence between both drugs. Although a fraction crosses the confidence interval, this is not statistically significant. Olaparib and talazoparib could be considered as ETA in most patients with advanced breast cancer. References and/or acknowledgements No conflict of interest.
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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 | 0.009 | 0.016 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.011 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.027 | 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".