Assessing predictive characteristics vital in older patients with AML
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More than 30% of older patients who achieved complete remission on venetoclax combination therapy needed more than 2 cycles of treatment, according to results from a pooled analysis presented at ASCO20 Virtual Scientific Program.
“AML is a complex and challenging disease, with especially low survival rates among patients who are older or unfit to withstand intensive chemotherapy,” Brian Andrew Jonas, MD, PhD, of the University of California Davis Comprehensive Cancer Center, told Healio. “Until recently, there have been limited treatment advances for AML patients, in particular those who are older or unfit to tolerate intensive chemotherapies.”
Jonas and colleagues examined data from two open-label trials of venetoclax in combination with azacitidine, decitabine or low-dose cytarabine to examine the rapidity and likelihood of response to treatments, and its associated characteristics, in older patients with newly diagnosed AML.
Researchers grouped patients based on CR/CRi timing (within two cycles of therapy, after two cycles, or never achieving remission), then assessed baseline and post-baseline characteristics within each group to determine impact on response timing. They also examined the percentage of patients in each category and duration of response in each category, according to the poster.
“The findings ... determined a clinically relevant percentage of patients with AML that do not receive complete remission or complete remission with incomplete count recovery, but remain on venetoclax combination therapy beyond two cycles can still achieve complete remission,” Jonas said.
Of 197 patients, 42% had CR/CRi in two or less cycles, 22% had CR/CRi in more than two cycles and 36% did not achieve CR/CRi, according to the results. Jonas and colleagues reported that a median duration of response was about 21 months (95% CI, 14.1-NR) patients who responded in two or less cycles and about 8 months (95% CI, 5.3-14.9) for those who responded in more than two cycles.
As for characteristics, the investigators found that patients with baseline IDH1/2 mutation were more likely to achieve CR/CRi in two or less cycles (29 of 83 patients), and patients with secondary AML and no response by the end of cycle 2 were more likely to never achieve CR/CRi (37 of 70 patients), according to the abstract.
Additionally, only 43% of patients who had CR/CRi after two cycles of therapy achieved morphological leukemia-free state (MLFS) within the first two cycles. Of nonresponders, 17% of patients achieved MLFS within 2 cycles, the findings revealed.
“These results further underscore the complexity of treating AML and the importance of assessing key predictive patient characteristics — particularly in the elderly AML patient population — as evidenced by the subset of patients who remained on the combination therapy of venetoclax plus azacitidine or decitabine, or LDAC beyond two cycles and achieved a later complete remission,” Jonas told Healio.