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Enhancing Decision-Making And Reducing Distress In AML

Photo Credit: Nemes Laszlo

The following is a summary of "Protocol of a decisional intervention for older adults with newly diagnosed acute myeloid leukemia and their caregivers: UR-GOAL 3," published in the January 2025 issue of Oncology by Loh et al.

Therapeutic advancements have enabled a growing number of adults aged ≥60 years with acute myeloid leukemia (AML) to receive life-prolonging treatments, resulting in improved overall survival. Unlike many cancers, AML often presents abruptly, necessitating urgent, high-stakes treatment decisions. The prognosis for older adults with AML is frequently compromised by aging-related factors, such as functional impairments, which complicate treatment outcomes. Studies reveal that up to 78% of older adult patients with AML and their caregivers experience substantial psychological distress, which adversely impacts quality of life, increases healthcare utilization, and raises mortality risk. SDM is a critical tool to alleviate distress, enhance patient and caregiver engagement, and achieve goal-concordant care. Despite its potential, interventions to optimize SDM and reduce distress in this vulnerable population remain underexplored.

To address this gap, researchers propose a multicenter randomized controlled trial to assess the efficacy of the University of Rochester-Geriatric Oncology Assessment for Acute Myeloid Leukemia (UR-GOAL) in reducing distress and enhancing SDM among older adult patients with AML, their caregivers, and oncologists. The trial will recruit 300 patients aged ≥60 years with newly diagnosed AML, their caregivers (if available), and up to 40 oncologists from four institutions. The intervention involves three components: Patients will watch an educational video about AML diagnosis, treatment, and prognosis; complete a values clarification process using Best Worst Scaling; and review a personalized summary report containing tailored questions and resources. Caregivers will engage in the same educational and reporting process as the patients. Oncologists will review a report summarizing the patient's aging-related conditions, prognosis perceptions, and values. During clinical visits, patients, caregivers, and oncologists will discuss these factors to reach an informed treatment decision.

The primary outcome measure is distress, assessed using the Distress Thermometer. Secondary outcomes include observed SDM, patient-perceived SDM, and decisional conflict.

This trial seeks to bridge critical knowledge gaps by demonstrating how patient-centered, evidence-based interventions can reduce psychological distress and decisional conflict while promoting effective SDM in older adult patients with AML. Successful implementation of the UR-GOAL framework may serve as a model for developing decision-support tools in broader oncology populations.

Source: sciencedirect.Com/science/article/abs/pii/S1879406825000037

Galinpepimut-S Immunotherapy Has Preliminary Efficacy In Acute Myeloid Leukemia

Galinpepimut-S therapy showed specific T-Cell immune responses for patients with acute myeloid leukemia in remission following second-line salvage therapy.

The GPS immunotherapeutic agent demonstrated preliminary signals of efficacy in AML.

Among patients with acute myeloid leukemia (AML) in remission following second-line salvage therapy, the immunotherapeutic agent galinpepimut-S (GPS) demonstrated preliminary signals of efficacy and specific T-Cell immune responses in the pivotal phase 3 REGAL trial, according to a press release from SELLAS Life Sciences Group, Inc.

After a median follow-up of 13.5 months, fewer than half of patients enrolled in the REGAL trial were confirmed deceased. These results indicated a median survival of over 13.5 months compared with the historical median survival from a similar phase 2 study of only six months for conventional therapy.

Based on these findings, the Independent Data Monitoring Committee (IDMC) has recommended the continuation of the clinical trial without any modifications. Notably, the IDMC went on to share that the agent exceeded predetermined futility criteria.

"Based on all available data, we believe that GPS could become a transformative treatment option for AML, offering hope to patients with limited choices, especially those with relapsed or refractory disease. We are optimistic about the IDMC's recommendation to continue the study without modifications and diligently preparing for the Biologics License Application (BLA)," said Dr. Angelos Stergiou, President and Chief Executive Officer of SELLAS, in the news release. "Importantly, the REGAL trial provides a clear and straightforward path toward seeking regulatory approval for patients with AML in their second complete remission."

Furthermore, 80% of randomly selected patients enrolled on the REGAL who received GPS exhibited T-cell immune response, outperforming the findings from the previous phase 2 study.

No new safety concerns were noted throughout the duration of the trial.

These efficacy results are consistent with the findings of previous GPS trials. As such, in the phase 2 study of patients with AML in second complete remission, the median overall survival (OS) for GPS-treated patients was 21 months, compared with 5.4 months for patients receiving standard-of-care therapy, with a 64% GPS-specific immune response.

Allogeneic stem cell transplantation (allo-SCT) holds promise for curing some patients with relapsed or refractory AML who can achieve a second or more remissions with salvage therapy. However, several obstacles hinder transplantation, and not all patients with relapsed or refractory AML are eligible to proceed to allo-SCT.

Currently, no drug has been approved for the maintenance of remission in patients with AML following second-line salvage therapy, which further emphasizes the importance of this development, according to the news release.

GPS is a type of cancer vaccine that uses pieces of a protein called WT1, which is often found in cancer cells, according to the SELLAS website. Furthermore, the vaccine is designed to help the body's immune system create a strong innate immune response and fight cancer cells that have this protein, according to the National Cancer Institute's website.

The REGAL phase 3 study is an open-label registrational clinical trial evaluating the efficacy of GPS in patients with AML who have achieved complete remission following second-line salvage therapy.

A final analysis to confirm the efficacy of GPS will be conducted once 80 events, or deaths, have occurred, which is expected to take place this year, the trial anticipates, according to the release.

The primary end goal of the study was OS.

"The interim results represent a major step forward in the treatment of AML, offering hope for patients in remission," Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center, in Dallas, said in the news release. "I am very hopeful that we will see a new standard of care in treating AML patients based on the outcomes we have observed in previous GPS trials."

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Disparities In AML Highlight Need For Tailored Strategies For Elderly Patients

Patients with AML aged 80 years and older face poor survival despite treatment advances, highlighting the need for improved, equitable care strategies and tailored treatment approaches.

An analysis of the National Cancer Database showed that patients aged 80 years and older diagnosed with acute myeloid leukemia (AML) face significant barriers to treatment, as they are often ineligible for curative therapies like stem cell transplantation due to comorbidities, frailty, and the presence of high-risk genomic lesions.

Despite advancements in treatment options, survival outcomes showed there to be a median overall survival (mOS) of just 1.71 months (95% CI, 1.68-1.74), for this patient population according to the study. The research, which utilized data from 31,195 patients diagnosed between 2004 and 2021, found disparities in outcomes based on age, gender, ethnicity, insurance status, and treatment facility.

Survival in the trial was analyzed using Kaplan-Meier methods, with comparisons based on sociodemographic factors, treatment data, and facility type. Temporal trends in chemotherapy use and survival were evaluated using chi-squared tests and log-rank p-values.

Younger elderly patients aged 80 to 84 years had anmOS of 2.17 months (95% CI, 2.07-2.23) compared with 1.31 months for those aged 85 years and older (95% CI, 1.28-1.38; P <.01). Male patients had better survival outcomes compared with female patients, with anmOS of 1.84 months (95% CI, 1.77-1.90) vs 1.61 months(95% CI, 1.54-1.64), respectively (P <.01). Asian patients had the longest mOS at 2.40 months (95% CI, 2.00-3.06), vs 1.84 months (95% CI, 1.64-2.00) for Black patients, and 1.68 months (95% CI, 1.64-1.78) for non-Hispanic White patients (P <.01).

Insurance coverage also played a role, as Medicaid-insured patients experienced mOS (2.14 months; 95% CI, 1.71-2.83) vs uninsured individuals (1.38 months; 95% CI, 0.99-2.04) and those with Medicare (1.71 months; 95% CI, 1.64-1.74).

Overall, 46% of patients received chemotherapy, with 29% receiving multi-agent chemotherapy and 66% receiving single-agent regimens. Multi-agent chemotherapy yielded an mOS of 5.95 months compared with 3.38 months for single-agent therapy.

The study also revealed significant disparities in treatment delivery across facility types. Patients treated at academic or research centers were more likely to receive chemotherapy (59% vs 39% at community facilities) and had better outcomes, with an mOS of 2.33 months vs 1.48 months in community settings. Twelve patients underwent bone marrow transplantation, reaching an mOS of 15.57 months.

Looking at temporal trends, the mOS increased significantly over time, from 1.38 months in 2004-2008 to 2.00 months in 2019-2021. Chemotherapy use also grew from 35% of patients in 2004-2008 to 56% in 2019-2021. The use of multi-agent chemotherapy also reached 53% in the most recent period. Despite these promising results, the prognosis for very elderly patients with AML remains poor.

Based on these findings, experts suggest that future research should focus on refining treatment approaches for very elderly patients with AML, including optimizing patient selection for intensive therapies and exploring the long-term impact of newer regimens. The study also calls attention to the importance of improving access to specialized care to ensure that all patients, regardless of demographic or geographic factors, can benefit from advances in AML treatment.

REFERENCE: Zhang TY, Ge AY, Epstein MM, et al. Treatment patterns and survival outcomes for very elderly patients with acute myeloid leukemia: A national cancer database study. Blood. 2024;144(suppl 1):2418. Doi:10.1182/blood-2024-209125

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