A new analysis presented at ASH 2016 shows older patients with acute myeloid leukaemia (AML) survived longer after receiving an allogeneic stem cell transplant if they were first treated with the experimental chemotherapy delivery method known as CPX-351 instead of the standard “7 3” administration of chemotherapy drugs cytarabine and daunorubicin.
Researchers say the findings are encouraging for improving survival among high-risk AML patients who currently have limited treatment options and poor survival rates.
The new study is a subgroup analysis of a large Phase III randomised controlled trial completed earlier this year that found CPX-351 nearly doubled overall survival compared to the 7 3 regimen.
The researchers examined survival and other health outcomes among trial participants who received chemotherapy and then haematopoietic stem cell transplantation, a treatment that provides healthy replacement stem cells to the bone marrow to better equip patients to fight the disease on their own.
Of 309 total trial participants, 91 received an allogeneic stem cell transplant, including 52 in patients who received CPX-351 compared with 39 in patients receiving 7 3.
CPX-351-treated patients were also more likely to undergo transplantation while in a remission state (75% of CPX-351 vs. 62% of 7 3).
In the first 100 days after transplantation there were 53 percent fewer deaths among patients receiving CPX-351 compared with those receiving 7 3 therapy.
The active ingredients of CPX-351 are the same as those in the 7 3 regimen, but in contrast to 7 3 in which cytarabine and daunorubicin are delivered separately, CPX-351 encapsulates the drugs into a single delivery vehicle in a fixed synergistic molar ratio.
“The two drugs together are delivered to the cell in the proper synergistic ratio that optimises the cell-killing ability of these two drugs,” said lead study author Jeffrey E. Lancet, MD, of the Moffitt Cancer Center in Tampa, Fla. “We think that by doing this, we can improve delivery to the cancer cells at the proper ratio.”
The trial focused on the group of AML patients considered at high risk; all participants were older than 60 and had therapy-related to prior chemotherapy, AML arising from MDS, or AML MDS-related cytogenetic abnormalities.
Jeffrey E. Lancet, MD, Department of Malignant Hematology, Moffitt Cancer Center, Tampa, Fla., will present this study during an oral presentation on Monday, December 5 at 4:00 p.m. in San Diego Ballroom AB of the Marriott Marquis San Diego Marina.
Source: ASH 2016