ASH Releases Evidence-Based Guidelines for Treating Older Patients With AML

Mikkael Sekeres, MD

The American Society of Hematology (ASH) has published new evidence-based guidelines to support older patients with acute myeloid leukemia (AML) and their health care providers in guiding treatment decisions.¹

“Clinical practice guidelines help advise those of us who are treating patients and are particularly important for patients with rarer diagnoses like AML,” said Mikkael Sekeres, MD, chair of the AML guideline panel, chief of the Division of Hematology in the Department of Medicine, and physician liaison in Hematology, at Sylvester Comprehensive Cancer Center, in a video regarding the guidelines.²

In partnership with the McMaster Grading of Recommendations Assessment, Development and Evaluation (GRADE) Centre, the panel recommends that older patients with AML should be offered antileukemic therapy over best supportive care.

Suggestions from the panel include:

• Offering intensive antileukemic therapy over less intensive therapy in older patients with newly diagnosed AML
• Giving post-remission therapy versus no additional therapy in older patients with AML who achieve remission following a least 1 cycle of intensive therapy and who are ineligible for allogeneic hematopoietic stem cell transplant (allo-HSCT)
• Using a hypomethylating agent (HMA) or low-dose cytarabine monotherapy in older patients with AML who are ineligible for intensive antileukemic therapy but eligible for a less-intensive regimen
• Using HMAs or low-dose cytarabine as monotherapy versus in combination with other agents in patients eligible for less intensive therapy
• Continuing therapy for patients who achieve a response following less intensive therapy until disease progression or development of unacceptable toxicities
• Having red blood transfusions available for patients who are no longer receiving therapy, including those receiving hospice care

Although the guidelines, which were published in Blood Advances, draw these specific conclusions regarding optimal treatment among older patients with AML, they are based on the notion that discussions between patients and health care providers is a critical component of treatment. 

“These guidelines take providers through the conversations they have with newly diagnosed patients, almost in real-time,” Sekeres stated in a press release.³ “A discussion between patient and physician is instrumental to creating a personalized treatment plan, and these guidelines are unique in that they keep a patient’s goals and wishes front and center in that conversation.”

A critical factor of these guidelines is that they include recommendations and suggestions for patients at every stage of AML treatment: newly diagnosed, post-remission, and hospice care.

The recommendations were formed by a multidisciplinary guidelines panel that included experts in myeloid leukemia, geriatric oncology, patient-reported outcomes, decision-making, frailty, epidemiology, and methodology. The panel also included patients.

Inclusion criteria for the clinical trials that served as the basis for the recommendations included patients with newly diagnosed de novo, treatment-related, or secondary AML who are 55 years of age or older, patients who received intensive or less intensive antileukemic therapy, patients treated as part of randomized controlled clinical trials, and comparative observational studies that included at least 20 patients. 

Exclusion criteria included patients with acute promyelocytic leukemia and myeloid neoplasms associated with Down syndrome, and studies in which more than 75% of patients did not meet an eligibility criterion, based on patient characteristics or intervention.

Critical outcomes for decision-making were considered for each question. Key critical outcomes considered for each question were mortality/survival and functional-status impairment. Other outcomes included in some of the questions, included quality-of-life impairment, severe toxicity, morphologic complete response, burdens on caregivers, hospitalization, major bleeding, recurrence or duration of response, and allo-HSCT.

“We recognize the serious issues that patients face, including the [adverse] effects and risks of chemotherapy and time in the hospital,” Sekeres added in the press release. “Weighing these issues against possible benefits, including remission and extended life, patients can decide what treatment is consistent with their goals.”

According to the press release, these guidelines have been established as part of a larger initiative by ASH to update existing guidance and develop new recommendations in hematologic malignancies.

References:

1. Sekeres MA, Guyatt G, Abel G, et al. American Society of Hematology 2020 guidelines for treating newly diagnosed acute myeloid leukemia in older adults. Blood Advances. 2020;4(15):3528-3549. doi:10.1182/bloodadvances.2020001920
2. ASH clinical practice guidelines on acute myeloid leukemia in older adults. Accessed August 7, 2020. bit.ly/3fBY0ZB
3. ASH releases new clinical practice guidelines on acute myeloid leukemia in older adults. News release. August 6, 2020. Accessed August 7, 2020. bit.ly/3kq7V8n