Decitabine prior to idarubicin and cytarabine in the treatment of R/R AML - a Chinese study

On 27^th April 2017, in an article published ahead of print in Acta Haematologica, Hongyu Zhao and colleagues from the Jinan Central Hospital, Jinan, China, discuss results from their retrospective single-center study.

Zhao et al. retrospectively studied the safety and efficacy of decitabine given prior to full-dose idarubicin and cytarabine (D-IA) in patients with Refractory or Recurrent (R/R) Acute Myeloid Leukemia (AML).

In total, twenty-one R/R AML patients (median age = 43) treated between 2013–2016 at the Jinan Central Hospital were included in this study. Patients received either one cycle of the D-IA regimen (20 mg/m² decitabine on days 1–5, 10 mg/m² idarubicin on days 6–8, and 100 mg/m² cytarabine on days 6–10) or additional cycles depending on if they achieved Complete Response (CR) or if bone marrow blasts decreases by > 50%.

The key results of the study were:

• 47.6% (10/21) patients had CR and 9.5% (2/21) had Partial Response (PR) after one cycle of D-IA
• After two cycles of D-IA, 1-month Overall Response Rate (ORR) in patients was 57.1% (12/21)
• 42.8% (9/21) of patients survived and 33.3% (7/21) of them were in continuous CR after D-IA induction regimen
• Grade III–IV toxicities occurred in patients including nausea/vomiting (42.8%) and liver enzyme abnormalities (14.2%)

The authors concluded their study by stating that the D-IA regimen “was well tolerated” and the ORR was “encouraging”. They further suggested that the D-IA regimen “may offer a novel and potentially effective” therapeutic strategy for R/R AML patients.

Abstract

AIMS:

To investigate the safety and efficacy of the triple therapy of decitabine, idarubicin, and cytarabine in the treatment of refractory or recurrent acute myeloid leukemia (R/R AML).

METHODS:

We conducted a single-center retrospective study in which decitabine treatment was administered prior to full-dose idarubicin and cytarabine (D-IA) for 21 R/R AML patients.

RESULTS:

After 1 cycle of D-IA, 10/21 (47.6%) patients experienced a complete remission (CR) and 2/21 (9.5%) showed a partial response. There was a 1-month response rate (RR) in 12/21 patients (57.14%); these patients achieved CR after 2 cycles of D-IA. Five of these 12 (40%) patients then received sequential allogeneic stem cell transplantation. At the last follow-up date, 9/21 (42.8%) patients had survived, and 7/21 (33.3%) were in continuous CR. Hematological toxicity and infections were the most prominent toxicities of this regimen. Other toxicities included nausea, vomiting, bleeding, and liver enzyme abnormalities. No mortalities were recorded due to treatment-related toxicity during remission.

CONCLUSIONS:

The combination was well tolerated, and the RR was encouraging. Our study suggests that D-IA may offer a novel and potentially effective treatment regimen for R/R AML patients.