Three-Day Decitabine Combined with Venetoclax in Patients with Newly Diagnosed or Relapsed/Refractory AML

INTRODUCTION

Venetolax (VEN) combined with azacytidine (AZA), decitabine (DEC), and low-dose cytarabine has been the first-line therapy for newly diagnosed (ND) AML patients who are elderly or unfit for intensive chemotherapy. Previous reports shown that ten-day DEC with VEN (DEC 10-VEN) was an effective therapy for newly diagnosed elderly patients. Though higher remission rate in ND AML compared five-day DEC with VEN, DEC 10-VEN induced prolonged myelosuppression. Therefore, optimizing the combination of DEC with VEN is still being explored.

In this study, we retrospectively collected and analyzed the clinical data of three-day DEC combined with VEN (DEC 3-VEN) ( Tianjin-Handan regimen) in twelve patients with ND or relapsed/refractory (R/R) AML who were elder or ineligible for intensive chemotherapy to evaluate the efficacy and safety of the regimen.

METHODS

Retrospectively collected and analyzed the clinical data of twelve ND or R/R AML patients treated with three-day DEC combined with VEN as induction therapy between July 2022 and June 2023 at 4 hospitals in china.

The induction regimen consisted of oral Ven (100mg Day 1; 200mg Day 2; 400mg Day 3-9 or 3-14), intravenous DEC (20mg/m²/q8h, days 4-6), sorafenib were administered (600mg days 8-14) in relapsed/refractory patients with FLT3/ITD. The primary objective was composite complete response rate (CR + CRi) and the secondary objectives was safety.

RESULTS

Until June 2023, twelve patients with de novo or relapsed/refractory AML were treated with three-day DEC combined with VEN as induction therapy. The median age of the twelve patinets was 67 years (range, 32-76), with 58.3% (7/12) male. Seven (58.3%) patients were ND AML, and five patients (41.7%) were R/R AML. The clinical data and treatment information of the patients are shown in table 1.

The composite complete response rate (CR + CRi) after one cycle of induction was 100% (CR 10/12, CRi 2/12). For patients who achieved CR or CRi, MRD negative rate was 77.8% (7/9) by flow cytometry. None of patients died during the induction therapy.The median time to recovery of the absolute white blood count (WBC) to ≥1.0 × 10 ⁹/L and the platelet count to ≥20 × 10 ⁹/L after induction was 13 (range: 7-25) and 15 days (range: 0-27), respectively.

CONCLUSION:

DEC 3-VEN is a highly effective and safe induction therapy for ND and R/R AML patients who are elderly or unfit for intensive chemotherapy. Further study with more patients will be updated.

【Keywords】Venetoclax; decitabine; AML; induction treatment.