Stopping study in chronic myeloid leukemia: Defining a new paradigm for Ontario CML1.
Bibliographic record
Abstract
e19069 Background: The National Comprehensive Cancer Network (NCCN) guidelines state that in order to safely stop tyrosine kinase inhibitor (TKI) therapy in chronic myeloid leukemia (CML) patients, we need access to reliable polymerase chain reaction (PCR) tests on a monthly basis (4 weeks). However, Ontario, Canada can only provide a 6-week turnaround reliably. Therefore, we aimed to test a new paradigm for safely stopping TKI treatment by monitoring molecular response every 6 weeks for 6 months instead of the recommended 4-week intervals. Methods: A prospective pilot cohort study was conducted to assess the outcome of cessation of TKI treatment in chronic-phase CML patients. Eligibility criteria includes obtaining MMR4 (4-log reduction) for 2 years and had to have been on TKI therapy for 5 years. Patients' PCR for BCR-ABL, a driver of CML, was tested every 6 weeks for 30 weeks to ensure ongoing major molecular response (MMR). The primary endpoint was successful maintenance of MMR3 (3-log reduction) or greater at 36 weeks. Secondary endpoints include incidence of withdrawal syndrome, psychological effects, and quality of life (QoL) as per the EORTC Global Quality of Life scoring system were assessed during each visit every 6 weeks for 30 weeks. The secondary endpoint was assessing whether MMR was regained once lost. Results: 18 consenting patients were enrolled, 2 were censored from data analysis as additional time is required to assess whether they regained deep molecular response after stopping, 1 patient was deemed too early to analyze. 12 of the 17 enrolled participants were able to successfully stop TKI therapy and remain in remission at 30 weeks, yielding a 71% success rate. 5 patients had relapsed and 3 successfully regained MR 3.0 with resumption of TKI therapy. Conclusions: The findings demonstrated in a small pilot study that testing at 6-week intervals is safe and effective. Most Ontario CML patients treated in large community centers and have not stopped TKI therapy based on the NCNN guidelines that recommend a 4-week testing turnaround. We plan to expand this study to other sites in Ontario and if successful, this new paradigm may enable more CML patients to stop TKI therapy in a safe manner leading to significant financial and clinical impact. Data will be updated at the time of the conference. By determining that Q6 weekly is a safe paradigm, there is potential for increased comfort in patients unable to maintain Q4 weekly testing for various reasons such as compliance or patients in rural settings. Clinical trial information: OCT1250 , CML1 .
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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 | 0.014 | 0.011 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".