Phase III ASAP trial results: role of remission induction chemotherapy before alloHCT in R/R AML скачать в хорошем качестве

Phase III ASAP trial results: role of remission induction chemotherapy before alloHCT in R/R AML

Patients with acute myeloid leukemia (AML) receiving allogeneic hematopoietic cell transplantation (alloHCT) show more favorable outcomes when they have achieved complete remission ahead of transplant. However, it is unknown whether this is also true for patients with relapsed or refractory (R/R) AML. In his presentation, Johannes Schetelig, MD, MSc, University Hospital TU Dresden, Dresden, Germany, describes the results from the Phase III ASAP trial (NCT02461537), which compared the outcomes of patients receiving intensive remission induction chemotherapy prior to alloHCT to those only receiving sequential conditioning with no attempts to induce complete remission before alloHCT. In this trial, patients were randomized 1:1 into one of two arms: a remission induction strategy (RIST) arm where patients received high-dose cytarabine and mitoxantrone, or a disease control (DISC) arm. Watchful waiting was recommended for patients in the DISC-arm, although low-dose cytarabine and single doses of mitoxantrone were also permitted for disease-control. The primary endpoint used was complete response (CR) at 56 days after alloHCT. Dr Schetelig reports that administering high-dose cytarabine and mitoxantrone did not improve overall alloHCT success rate or survival. The primary endpoint was reached by 81.3% of patients in the RIST-arm and 84.1% of patients in the DISC-arm. One-year leukemia-free survival from CR at day 56 was 71.5% in the DISC-arm versus 69.9% in the RIST-arm. Taken together, these findings suggest that intensive remission induction chemotherapy is not necessary for alloHCT, and that watchful waiting followed by sequential conditioning may be the best approach for patients with R/R AML whenever a stem cell donor is readily available for allo-HCT. This press briefing took place at the 64th ASH Annual Meeting and Exposition congress in New Orleans, LA. These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.