Trajectories of Change in Physical Wellbeing Reported for AML Subgroups

Group-based trajectory models (GBTM) found 4 trajectories of change in the Functional Assessment of Cancer Therapy Physical Well-Being (FACT-PWB) over 5 time points over 0 to 200 days of follow-up of patients with acute myeloid leukemia (AML), with most patients experiencing either little to no changes or slight declines in physical wellbeing, according to findings from a secondary analysis published in Blood Advances.¹

Of all patients (n = 343), the 2 most prominent trajectories include group m3 (n = 153; 45%), categorized as experiencing relatively little change in PWB compared with baseline, and group m2 (n = 141; 40.8%), defined as experiencing a slight decline after starting treatment for AML. Additional groups noted were group m4 (n = 41; 11.8%), categorized as experiencing improvement in PWB compared with baseline, and group m1 (n = 8; 2.4%), defined as experiencing a sharp decline in PWB.

The data show that patients in improving trajectories had lower FACT-PWB baselines (group m4: mean, 9.9; SD, 3.8), the only demographic or clinical characteristic affiliated with group membership. Furthermore, higher PWB scores (group m2: mean, 24.0; SD, 3.2) were associated with those who declined. Of note, no baseline characteristics were found to be linked to PWB trajectory after baseline PWB adjustment.

“This secondary analysis is, to the best of our knowledge, the first study to explore risk factors associated with PWB trajectories among adults with AML. Factors associated with change in PWB have important potential clinical applications in identifying patients with high need who may be at risk for future decline,” lead study author Marielle Jensen-Battaglia of the James P. Wilmot Cancer Institute and University of Rochester Medical Center in Rochester, New York, and coinvestigators wrote in the publication.

Patients with AML may experience physical decline, which can further lead to negative outcomes in health-related quality of life that can impact prognosis. There are limited data of both patients undergoing intensive and lower-intensive chemotherapy and how those relate to PWB and any PWB changes over time.

The secondary analysis was conducted through combined samples from 1 nonintervention study1 and 3 United States supportive care clinical trials: NCT02975869² (study 2), NCT03310918³ (study 3), and NCT03372291⁴ (study 4) conducted between 2015 and 2019. New diagnoses of AML and capability of informed consent were inclusion criteria of all studies.

All enrolled patients were in their first treatment year with planned intensive chemotherapy treatments at baseline; the nonintervention study and the NCT03310918trial included patients undergoing lower-intensity treatment.

An original sample size of 405 patients was pooled, however, 343 remained for the analytic sample after eliminating those with fewer than 2 PWB measures during follow up (n = 49) and with missing predictor variables of interest values (n = 13).

The notable differences between the samples were exclusion from study 3 (excluded, 50.0%; analytic, 16.6%; P < .001), age difference (excluded, 64.4 years; SD, 12.7; analytic, 69.5; SD, 12.1; P < .001), proportion of lower-intensity chemotherapy (excluded, 62.9%; analytic, 28.8%; P < .001), and follow-up period mortality (excluded, 67.8%; analytic, 58.0%; P = .04).

The analytic sample had a mean age of 69.5 years (SD, 12.1) and most patients were male (61.8%), White (90.3%), and college educated (52.7%). More than half of patients had intermediate-risk AML (51.8%); 58% of patients died on study (n = 199). The baseline PWB score for the sample was 19.9 (SD, 5.8), and 113.7 follow-up days (SD, 63.6) was the average patient contribution (range, 11-200).

A total 183 patients (53.4%) of the initial 343-sized sample with baseline FACT-PWB scores had measures tabulated for the final time point. The 160 (46.6%) with missing data comprised of 61 (38.1%) missing data at random as it was not part of data collection within a participating trial and 99 (61.9%) were due to loss to follow-up related to mortality.

Despite a higher proportion of m1 and m4 groups comprising females or those receiving intensive chemotherapy than those in stabler groups, treatment intensity was not found to be significantly affiliated with group membership in a multinominal logistic regression.

Additionally, the m3 group had the lowest proportion of females (n = 43, 28.1%), lowest on-study mortality (54.3%), and second lowest PWB baseline (mean, 18.9; SD, 4.3). The smallest group, m1, composed of primarily females (62.5%), had most deaths during follow-up (75%), but begun with a higher PWB baseline (mean, 24.0; SD, 3.3).

Studies with similar patient populations were combined to address prior limitations of previous research, such as insufficient power for longitudinal analyses due to mortality and poor generalizability.

References

1. Jensen-Battaglia M, Sohn M B, Consagra W, et al. Trajectories of physical well-being among adults with acute myeloid leukemia. Blood Advances. 2024; 8(11):2612-2621. doi:10.1182/ bloodadvances.2023011804
2. A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome. Clinicaltrials.gov. Last updated June 11, 2024. https://clinicaltrials.gov/study/NCT02975869
3. A Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy. Clinicaltrials.gov. Last updated May 22, 2024. https://clinicaltrials.gov/study/NCT03310918?term=NCT03310918&rank=1
4. Psychological Intervention Mobile App for Patients With AML. Clinicaltrials.gov. Last updated February 13, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT03372291