Study Shows Older Patients With AML Respond to Treatment With VEN-HMA
Researchers observed that patients aged 80 years and older with acute myeloid leukemia who were treated with venetoclax and a hypomethylating agent had prolonged overall survival.
Recent study results demonstrate that standard of care treatment for acute myeloid leukemia (AML) is both safe and effective for patients who are 80 years of age and older. The standard of care, venetoclax in combination with a hypomethylating agent (VEN-HMA), has prolonged survival for approximately a quarter of patients with AML.1
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Because AML treatment can be intensive and suppress the immune system, putting the patient at risk of other health conditions, older adult patients with AML are often considered ineligible for treatment and are recommended to begin palliative care. It was unknown whether the treatment was considered feasible or tolerable in older patient populations. For this reason, investigators assessed the overall survival (OS) and remission rates among patients who are 80 years of age and older with AML after receiving treatment with VEN-HMA.1,2
A total of 154 patients aged 80 to 92 years of age (median: 82) with AML who were treated with VEN-MHA were enrolled in the study. The majority of patients were male (69%) and newly diagnosed (77%), with the remaining patients having relapsed or refractory disease (10%) or an unknown disease status (14%).1
For treatment, patients received VEN ramp-up on either an inpatient or outpatient basis as well as starting dose depending on the physician’s choice. Additionally, the final dose and duration of VEN was defined as the dose and duration that the patient was receiving at the time of last follow-up. HMA dose reductions were defined as any dose and schedule less than the standard azacytidine (75 mg/m2 per day for 7 days every 28 days) or decitabine (20 mg/m2 per day for 5 days every 28 days). No patients received oral decitabine/cedazuridine. Approximately 77% of patients received the standard dose and schedule of VEN (400 mg for 28 days) and HMA (azacytidine: 95%; decitabine: 100%) for the first cycle, and 72% of patients underwent a VEN dose reduction, duration reduction, and/or a cycle extension, and 42% of these patients had a reduction in VEN duration following the first cycle.2
The median final VEN dose and schedule in all patients was 400 mg (range: 20-400 mg) for 21 days (range: 4-28 days) with a median cycle length of 35 days (28-84 days), and in patients achieving a complete response rate it was 200 mg (range 50-400 mg) for 21 days (4-28 days) with a median cycle length of 35 days (28-84 days). Additionally, 54% of patients had an HMA dose reduction, of which the majority changed from 7 to 5 days of azacytidine.2
According to the findings, approximately 20% to 25% of all treated patients experienced prolonged survival. The median OS was 8.1 months, and for those who responded to treatment, it was 13.2 months. Further, at a median follow-up of 7.7 months, approximately 23% of patients (n = 36) remained in remission, with 20% (n = 31) remaining on VEN-HMA.2
“A second major theme here is that treating this patient population requires adjusting the dosage and duration of VEN-HMA," study corresponding author Justin Watts, MD, hematologist at the University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, in a press release. "Unlike typical adult AML cases, these patients exhibit lower tolerance to VEN, suggesting that they may benefit from a reduced dosage.”1
Additionally, for patients with newly diagnosed AML—and without prior myelodysplastic syndrome—the proportion of patients who achieved complete remission or complete remission with incomplete recovery (CRc) was about 73%. The death rates within 30 and 60 days of treatment were approximately 8.5% and 17%, respectively.1,2
“Our study reveals that a significant portion of these patients at the extremes of older age still derive benefit from the VEN-HMA regimen—which is the standard of care for older AML patients and those who are ineligible to receive intensive chemotherapy,” said Watts in the press release. “While acknowledging it certainly isn’t for everyone, we hope our findings encourage health care providers to thoughtfully explore all treatment avenues for elderly patients with AML, rather than prematurely resorting to HMA alone, best supportive care, or hospice care.”1
