Low-intensity combination therapy yields strong outcomes in hard-to-treat AML

  • Researchers combined an alternating regimen of lower-intensity therapy with a targeted agent in older or medically fragile patients with newly diagnosed AML
  • Study found 84% of patients achieved remission 
  • Sixty percent of all cases of AML are in people aged 65 and older

A novel lower-intensity treatment yielded high rates of remission in older or medically fragile patients with acute myeloid leukemia (AML), according to researchers at The University of Texas MD Anderson Cancer Center. The findings were published in American Journal of Hematology.

The Phase 2 trial investigated a combination of cladribine, low-dose cytarabine, plus venetoclax alternating with azacitidine plus venetoclax. The trial found 84% of patients achieved remission, with 75% of them having no detectable leukemia cells.

“Standard intensive chemotherapy can occasionally be too harsh for many older patients, and existing lower-intensity approaches may be ineffective in several subsets,” said Tapan Kadia, M.D., professor of Leukemia. “The results from this trial provide us with a safer and highly effective treatment option with high rates of deep response.” 

What are the trial’s other key findings? 

The study also revealed the two- and five-year overall survival rates were 60% and 45%, respectively. The median overall survival was 52.2 months, and 43% of patients were able to move forward with a stem cell transplant in first remission. 

What should older or medically fragile patients with AML know about this trial? 

“For this patient population, we observed some of the best survival outcomes to date,” Kadia said.

This lower-intensity regimen offers a promising treatment option for patients who cannot tolerate intensive chemotherapy. The median age of trial participants was 68 years, with 13% of participants being 75 years or older. 

The study was limited as it represented a single, large institution. 

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The trial was supported by AbbVie. A full list of collaborating authors and their disclosures can be found with the paper in American Journal of Hematology.

The results from this trial provide us with a safer and highly effective treatment option with high rates of deep response.

Tapan Kadia, M.D.

Leukemia