J Hematol Oncol: Adverse events in the treatment of oral azacitidine in patients with AML in remission

Acute myeloid leukemia (AML) mainly occurs in the elderly, with a median age of 68 years at the time of diagnosis
.

Most elderly AML patients who have achieved morphological remission through intensive chemotherapy (IC) will eventually relapse, and the prognosis after relapse is often poor

In the QUAZAR AML-001 trial, compared with placebo, oral azacitidine maintenance treatment can prolong the overall survival of AML patients who achieved first remission after IC treatment but without indications for transplantation by 9.
9 months (p<0.
001 ), extending the recurrence-free survival period by 5.
3 months (p<0.
001)
.

Compared with placebo, oral azacitidine maintenance treatment can prolong the overall survival of AML patients who have achieved first remission after IC treatment but without transplantation indications by 9.
9 months (p<0.
001), and prolong the recurrence-free survival 5.
3 months (p<0.
001)
.

Compared with placebo, oral azacitidine maintenance treatment can prolong the overall survival of AML patients who have achieved first remission after IC treatment but without transplantation indications by 9.

In the QUAZAR AML-001 trial, the overall survival (A) and recurrence-free survival (B) of the azacitidine group and the placebo group

In the QUAZAR AML-001 trial, the overall survival (A) and recurrence-free survival (B) of the azacitidine group and the placebo group

In addition, the QUAZAR AML-001 trial also provides the most comprehensive safety information related to oral azacitidine maintenance therapy.
This article reports the main analysis results of the QUAZAR AML-001 trial
.

This article reports the main analysis results of the QUAZAR AML-001 trial This article reports the main analysis results of the QUAZAR AML-001 trial

The QUAZAR AML-001 trial is an international, placebo-controlled, randomized phase 3 study that recruits AML patients with low- and medium-risk cytogenetic risk diagnosed at the age of 55 years or older, and requires no more than 4 months before the start of the study Obtained the first complete remission (CR) or CR+ incomplete blood count recovery (CRi)
.

The test patients were randomly divided into two groups 1:1, and received oral azacitidine (300 mg) or placebo (1/day) for 14 consecutive days, 28 days as a course of treatment

Common adverse events in the two groups

Common adverse events in the two groups

A total of 469 patients were recruited, of which 238 received azacitidine and 233 received a placebo
.

The median age of the tested patients was 68 years

Gastrointestinal adverse events (AE) are the most common, mostly low-grade gastrointestinal adverse events (AE) are the most common, mostly low-grade AE events rarely require the discontinuation of oral azacitidine (13%), suggesting to pass The use of concomitant drugs and adjustment of the dose of azacitidine are sufficient to effectively control related adverse events

Occurrence of blood adverse events

Occurrence of blood adverse events

In summary, oral azacitidine maintenance therapy has generally good safety
.

It is recommended to use antiemetics for prevention at least during the first two courses of azacitidine , and to monitor blood cell counts every other week , and then as needed after that

Oral azacitidine maintenance therapy has generally good safety

Original source:

Ravandi, F.

Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial in this message