Indicated for myelodysplastic syndrome.

Approved for AML in remission.

A cytidine nucleside analog with a mechanism of action that involves incorporation into DNA and RNA.

A DNA methyltransferase inhibitor that restores bone marrow cell growth and differentiation.

DNA hypomethylation through incorporation into DNA is cell cycle dependent, S phase restricted, and DNA remethylation is observed by the end of each treatment cycle.

Most common adverse reactions are nausea, anemia, thrombocytopenia, vomiting, fever, leukopenia, diarrhea, fatigue, constipation, bruising, dizziness, chest pain, myalgias and malaise.

Use in the treatment of myelodysplastic syndrome and AML response rates of up to 23% with limited toxicity.

In higher risk MDS significantly extends median survival over conventional care regimens 24.5 months to 15 months for conventional care.

Vidaza 2 year survival rate 51% vs. 26% for conventional care regimens.

Aim is to treat patients at least 6 cycles.

70% experience nausea, 69% anemia, 65% thrombocytopenia, 54% vomiting, 51.8% fever, 48% leukopenia and 33% constipation.

Patients must be exposed to several cycles of treatment for optimal therapeutic effect.

Short plasma half life.

Azacitidine in 358 patients with advanced myelodysplastic disease compared to conventional care resulted in a median survival of 24.4 months vs. 15 months for conventional care regimens (Juliusson G), and analysis indicated the drug was favored despite age, gender, IPSS score, cytogenetics, subtype of disease or LDH levels.

Azacitidine 75 mg/m2/day for 7 days of a 28 day cycle plus placebo or subcutaneous romiplostim 500 mg or 750mg per week on a randomized basis for patients with myelodysplastic syndrome: incidence of thrombocytopenia events per cycle higher in placebo group (85%) than in the Romiplostim 500 mg (69%) and 750 mg (64%) groups, also 69% of placebo group received platelets, in comparison to 46% and 36% for the romiplostim 500 mg and 750 mg, respectively (Kantarijian ).

Azacitidine increased survival by 74% in patients treated with intermediate 2 to high risk for myelodysplasia compared to three conventional treatments (Fenaux).

Oral Azacitidine Improves Overall Survival in AML Patients in First Remission



Oral azacitidine maintenance therapy is associated with significantly longer overall and relapse-free survival, compared to placebo, in patients with acute myeloid leukemia (AML) who are in remission after chemotherapy.


Is associated with a significantly longer overall and relapse free survival and placebo among all the patients with AML who were in remission.



Phase III trial, median overall survival from the time of randomization was significantly longer with oral azacitidine than with placebo (24.7 months and 14.8 months, respectively), as was median relapse-free survival compared to placebo (10.2 months and 4.8 months, respectively).



The estimated percentage of patients surviving at 1 year was 72.8% in the azacitidine group and 55.8% in the placebo group: The percentages at 2 years were 50.6% and 37.1%, for a difference of 13.5 percentage points.



Median relapse-free survival from the time of randomization was 10.2 months in the azacitidine compared to 4.8 months with placebo. 



The percentage of patients who relapse-free survival at 6 months was 67.4% in the azacitidine group and 45.2% in the placebo group, and 44.9% and 27.45 respectively at 1 year.



The most common adverse events: nausea, vomiting, and diarrhea, neutropenia, thrombocytopenia and anemia.



Patients with acute myeloid leukemia who are in remission after chemotherapy achieve longer overall survival and longer relapse free survival with oral azacitidine maintenance therapy.





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