TY - JOUR
T1 - Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia
AU - Peipert, John Devin
AU - Efficace, Fabio
AU - Pierson, Renee
AU - Loefgren, Christina
AU - Cella, David
AU - He, Jianming
N1 - Funding Information:
This work was not funded. JP and DC were supported by the Claude D. Pepper Older Americans Independence Center (OAIC) at Northwestern University (1P30AG059988-01A1).
Publisher Copyright:
© 2021 Elsevier Ltd
PY - 2022/9
Y1 - 2022/9
N2 - Introduction: Patient-reported outcomes (PROs) predict overall survival (OS) in many cancer types, but there is little evidence of their prognostic value in older patients with acute myeloid leukemia (AML). We examined whether the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) predicted OS beyond established prognostic factors among these patients. Materials and Methods: Data were from AML2002 (n = 309), a randomized phase 2/3 study comparing decitabine plus talacotuzumab versus decitabine alone in older AML patients ineligible for intensive chemotherapy. We used ridge-penalized Cox proportional hazards models to estimate the association between baseline FACT-Leu scales and OS. We then conducted a bootstrap analysis to determine how often FACT-Leu scales appeared in forward- and backward- selected “final models” predicting OS relative to prognosticators from the AML Composite Model (AML-CM; e.g., chronic comorbidities, previous cancer, cytogenetic/molecular risk). Results: In ridge-penalized models, the FACT-Leu Physical Well-Being (PWB), Trial Outcomes Index (TOI), and Total scales predicted OS. Adjusting for AML-CM factors, an important increase (3 points) in PWB score was associated with a 14% reduction in the hazard of death. In the bootstrap analysis, the PWB scale appeared in 93% of backward- and 98% of forward selected models, while the TOI [57% (backward), 79% (forward)] and FACT-Leu Total [51% (backward), 78% (forward)] appeared less often in final models. Discussion and Conclusions: These results indicate PROs' value for predicting outcomes among older AML patients and underscore the need to more systematically collect PRO data in routine care with these patients. ClinicalTrials.gov
AB - Introduction: Patient-reported outcomes (PROs) predict overall survival (OS) in many cancer types, but there is little evidence of their prognostic value in older patients with acute myeloid leukemia (AML). We examined whether the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) predicted OS beyond established prognostic factors among these patients. Materials and Methods: Data were from AML2002 (n = 309), a randomized phase 2/3 study comparing decitabine plus talacotuzumab versus decitabine alone in older AML patients ineligible for intensive chemotherapy. We used ridge-penalized Cox proportional hazards models to estimate the association between baseline FACT-Leu scales and OS. We then conducted a bootstrap analysis to determine how often FACT-Leu scales appeared in forward- and backward- selected “final models” predicting OS relative to prognosticators from the AML Composite Model (AML-CM; e.g., chronic comorbidities, previous cancer, cytogenetic/molecular risk). Results: In ridge-penalized models, the FACT-Leu Physical Well-Being (PWB), Trial Outcomes Index (TOI), and Total scales predicted OS. Adjusting for AML-CM factors, an important increase (3 points) in PWB score was associated with a 14% reduction in the hazard of death. In the bootstrap analysis, the PWB scale appeared in 93% of backward- and 98% of forward selected models, while the TOI [57% (backward), 79% (forward)] and FACT-Leu Total [51% (backward), 78% (forward)] appeared less often in final models. Discussion and Conclusions: These results indicate PROs' value for predicting outcomes among older AML patients and underscore the need to more systematically collect PRO data in routine care with these patients. ClinicalTrials.gov
KW - Acute myeloid leukemia
KW - FACT-Leu
KW - Health related quality of life
KW - Overall survival
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U2 - 10.1016/j.jgo.2021.09.007
DO - 10.1016/j.jgo.2021.09.007
M3 - Article
C2 - 34521609
AN - SCOPUS:85114728542
VL - 13
SP - 935
EP - 939
JO - Journal of Geriatric Oncology
JF - Journal of Geriatric Oncology
SN - 1879-4068
IS - 7
ER -