Azacitidine Has Limited Activity in Patients with MDS and AML
Bibliographic record
Abstract
Abstract Abstract 5057 Background: The multicenter, randomized AZA-001 trial demonstrated that azacitidine (AZA) significantly improved overall survival in patients with intermediate-2/high risk MDS (including patients with AML < 30 % marrow blasts), compared with conventional care regimens, including supportive care, low dose cytarabine (LDAC) and intensive chemotherapy (Lancet Oncol 2009;10:223–32). Recent data has suggested that AZA may have limited efficacy in the “real life” situation (Hematol Oncol 2011Mar8; Epub ahead of print). This retrospective analysis evaluates the responses and outcomes of patients with MDS and AML < 30% marrow blasts who received AZA at the Princess Margaret Hospital. Methods: Between July 2009 and July 2011, 87 patients received AZA at the Princess Margaret Hospital. This analysis is restricted to patients with MDS and AML < 30% marrow blasts (n = 60), excluding AML with > 30% blasts (n = 6), MDS/myeloproliferative neoplasm (n = 1), and patients previously treated with intensive chemotherapy and/or alloSCT within the last 5 years (n = 20). Azacitidine was planned to be administered subcutaneously at the dose-schedule of 75 mg/m2/d for 6 days every 28 days. However, 8 patients received subsequent cycles of AZA in local centers at the dose schedule of 75 mg/m2/d for 5 days, 2 days off, followed by 75 mg/m2/d for 2 days (AZA 5-2-2). Results: Median age was 73 (range, 43 to 87), and 63% were male. Twenty-three patients (38%) had secondary or therapy-related MDS or AML. Two patients had received a prior organ transplant (heart and liver). Forty-two patients (70%) had MDS (7 RCMD, 10 RAEB-1, 17 RAEB-2, 3 CMML-1, 5 CMML-2). Cytogenetic risk (by IPSS criteria) was good in 19 (32%), intermediate in 6 (10%), and poor in 33 (55%) patients, respectively. Karyotype analysis failed in 2 patients (3%). IPSS was intermediate-1 in 4 (7%), intermediate-2 in 32 (53%), and high in 24 (40%) of the patients. Median baseline hemoglobin level, absolute neutrophil count and platelet count were 90.5 g/L, 0.9 × 109/L, and 44.5 × 109/L, respectively. Median prior therapies was 0 (range, 0–2) with 5, 3, 1, and 1 patients having previously received erythropoiesis-stimulating agent, hydroxyurea, LDAC, and decitabine, respectively. The median number of AZA cycles administered was 5.5 (range, 0–19). The best response was CR in 4 (7%), marrow CR in 8 (13%), and hematologic improvements in platelets, neutrophils, and erythroid in 15 (25%), 9 (15%), and 5 (8%) patients, respectively. Fifteen patients remain on treatment. Treatment discontinuation was mostly due to disease progression, lack of response, and/or intercurrent illness/infection, with 7 (12%) patients stopping therapy to proceed to an alloSCT. Twenty patients have died. Median overall survival was 36.7 weeks (range, 4.4 weeks-86.6+ weeks). Conclusions: Azacitidine has limited efficacy in this group of patients. Optimal therapy for this patient population still needs to be determined. Disclosures: Yee: Celgene: Honoraria. Schuh:Celgene: Honoraria.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| 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".