Gemtuzumab Ozogamicin in Favorable and Intermediate Risk Acute Myeloid Leukemia: A Single-Center Experience
Bibliographic record
Abstract
Background Acute Myeloid Leukemia (AML) is a common form of leukemia in adults. Gemtuzumab Ozogamicin (GO), an anti-CD33 antibody linked to a chemotherapy molecule, demonstrated improved event-free survival (EFS) and overall survival (OS) in favorable and intermediate risk AML when given with standard induction chemotherapy. Purpose This retrospective study will examine outcomes of AML patients at the McGill University Health Center (MUHC) who received GO with standard induction chemotherapy compared to induction chemotherapy alone. Methods We selected favorable and intermediate risk AML patients who received GO with induction chemotherapy from January 1, 2015, to November 23, 2023, with matched controls based on cytogenetic and molecular characteristics. The European LeukemiaNet AML classification was used, noting that the ALFA-0701 study identified favorable patients based on cytogenetics and NPM1 or CEBPA mutations. We extracted age, sex, length of hospital stays, complete remission (CR), time to neutrophil (ANC >1.0) and platelet (platelet >50 and >100) recovery, hepatic toxicity (bilirubin >1.5x upper limit of normal (ULN), transaminases >3x ULN, or veno-occlusive disease (VOD)), stem cell transplantation (SCT), relapse rate, and survival. We performed statistical analysis to obtain hazard ratios (HR) and odds ratios (OR). Results Our cohort had 16 GO and 16 control patients, evenly distributed across favorable and intermediate AML risk categories. GO patients received treatment between 2020 and 2023, and controls between 2016 and 2022. Median age was 56.0 years (range 19-71) in GO and 53.5 years (range 23-71) in controls. Both groups had 63% male patients. Mean duration of follow-up was 12.8 months in GO and 39.8 months in controls. There was no increase in hepatic toxicity in GO compared to controls (19% versus 25%; OR 0.69, 95% CI 0.13-3.75), no longer mean platelet recovery time (plt >50 in 26.8 days vs. 27.0 days; HR 0.58, 95% CI 0.28-1.20) nor longer mean neutrophil recovery time (ANC >1.0 in 32.4 days vs. 30.5 days; HR 0.79, 95% CI 0.39-1.59). Other parameters did not demonstrate statistical significance in GO compared to controls, including mean length of stay (37.9 days vs. 37.8 days; HR 0.879, 95% CI 0.43-1.78), CR (88% vs. 94%; HR 1.65, 95% CI 0.32-8.58), one-year relapse (12.5% vs. 6.3%; OR 2.14 95% CI 0.17-26.33), and one-year survival (93.8% vs. 87.0%; OR 2.31 95% CI 0.19-28.47). GO patients showed a trend to being less likely to receive SCT. Conclusion GO was well-tolerated with no increase in delayed cell count recovery or hepatic toxicity, in contrast to the ALFA-0701 study. There were no significant differences in CR or relapse rates. A trend towards decreased SCT was observed with GO, which was likely due to the selection of more non-transplant candidates in the intermediate risk group to receive GO, based on the consideration that they would benefit the most. The absence of significant differences may be due to the small cohort size and short follow-up time. Further evaluation of this cohort will help clarify these outcomes.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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".