Decitabine-Cedazuridine and Pleural Effusions
Decitabine-cedazuridine does not cause pleural effusions based on available clinical trial data. The provided evidence discusses pleural effusions exclusively in the context of tyrosine kinase inhibitors (particularly dasatinib and imatinib) used for chronic myeloid leukemia, not with decitabine-cedazuridine, which is a DNA methyltransferase inhibitor used for myelodysplastic syndromes.
Evidence from Decitabine-Cedazuridine Clinical Trials
The pivotal phase 1 and phase 3 studies of oral decitabine-cedazuridine in patients with myelodysplastic syndromes and chronic myelomonocytic leukemia did not report pleural effusions as an adverse event 1, 2.
Most Common Adverse Events with Decitabine-Cedazuridine
The safety profile is dominated by hematologic toxicities:
- Thrombocytopenia occurred in 41-61% of patients (grade 3 or higher) 1, 2
- Neutropenia occurred in 30-57% of patients (grade 3 or higher) 1, 2
- Anemia occurred in 25-50% of patients (grade 3 or higher) 1, 2
- Febrile neutropenia occurred in 16% of patients 1
- Pneumonia occurred in 16% of patients 1
Important Distinction from Tyrosine Kinase Inhibitors
The evidence provided extensively documents pleural effusions as a well-established complication of dasatinib (occurring in 28-33% of patients), not decitabine-cedazuridine 3. These are entirely different drug classes with distinct mechanisms of action and toxicity profiles:
- Dasatinib is a tyrosine kinase inhibitor for chronic myeloid leukemia that causes pleural effusions through fluid retention mechanisms 3
- Decitabine-cedazuridine is a DNA hypomethylating agent for myelodysplastic syndromes with primarily hematologic toxicities 1, 2
Clinical Implications
If a patient on decitabine-cedazuridine develops a pleural effusion, alternative etiologies should be investigated rather than attributing it to the medication, including:
- Underlying malignancy progression
- Infection (particularly given the high rate of pneumonia with this agent) 1
- Heart failure
- Other concurrent medications
- Unrelated pulmonary or cardiac conditions
The absence of pleural effusion reporting in the comprehensive phase 1 dose-escalation study (44 patients) and the large phase 3 registrational trial (133 patients) strongly suggests this is not a recognized toxicity of decitabine-cedazuridine 1, 2.