Geriatric assessment among older adults receiving intensive therapy for acute myeloid leukemia: Report of CALGB 361006 (Alliance)

Abstract

a b s t r a c tObjective: To demonstrate feasibility of performing geriatric assessment (GA) in the National Clinical Trials Network (NCTN) and to explore the utility of GA to characterize treatment tolerance. Materials and methods: We conducted a multisite companion study (CALGB 361006) to CALGB 11001, a phase 2 trial of adults ≥60 years old with newly diagnosed FLT3-mutated AML, testing the efficacy of adding sorafenib to intensive chemotherapy. On 361006, a GA was administered prior to induction and prior to post-remission therapy. The GA is divided into items requiring administration by a health care professional (HCP) and patient selfadministered questionnaires. Feasibility outcomes were recruitment rate, time to GA completion, difficulty with GA administration, percent of patients requiring assistance, and satisfaction. Change in GA measures preand post-induction were compared using Wilcoxon signed rank test and McNemar's tests. Results: The recruitment rate was 80% (N = 43, median age 68 years). Median completion time of the GA was 30 min; (10 and 21 min for HCP and patients, respectively). HCP reported no difficulty completing assessments (100%). Most patients completed questionnaires without assistance (77%), and were satisfied with the length (89%). Self-reported physical function, mental health, social activity and nutritional parameters worsened after induction. Conclusion: GA is feasible to administer in the setting of intensive induction for older adults with AML in the NCTN and provides evidence of the impact of induction therapy on physical and emotional health.

Conventional chemotherapy for acute myeloid leukemia in older adults: Impact on nutritional, cognitive, and functional status

“…In both studies, there was neither improvement nor deterioration in ADL over time. A recent study assessing GA feasibility in patients treated with intensive chemotherapy for AML showed that induction chemotherapy had a negative impact on functional status with a decrease in IADL after induction chemotherapy 17 . Our results are different, possibly because we omitted to assess the impact of AML intensive treatment on functional status immediately after induction.…”

“…Other parameters to predict treatment toxicities, morbidity, and mortality in cancer patients can be provided by geriatric assessment tools (GA). [11][12][13][14] These GA tools are validated; multidimensional and multidisciplinary assessments and their feasibility and performance in older patients have been evaluated in AML patients prior to intensive chemotherapy [15][16][17] and before Allo-HSCT. 18,19 Here, such tools were applied to the LAMSA 2007 trial (clinicaltrials.gov NCT00590837), and a multicentric prospective randomized trial evaluating the impact of lomustine added to standard induction and consolidation therapy with cytarabine and idarubicin, in a population of fit older adult patients with de novo AML without adverse cytogenetic characteristics.…”

Geriatric assessment in older patients with a hematologic malignancy: a systematic review

“…The median sample size of the studies was 100 (range, 25-869), and the me(di)an age of included patients ranged from 58 to 86 years. Eight studies focused on acute myeloid leukemia and/or myelodysplastic syndromes, [19][20][21][22][23][24][25]27 two on chronic lymphocytic leukemia, 28,29 13 on lymphoma, [30][31][32][33][34][35][36][37][38][39][40][41][42] seven on multiple myeloma, [42][43][44][45][46][47][48] and 15 studies included various hematologic malignancies. [49][50][51][52][53][54][55][56][57][58][59][60][61][62][63] The median number of domains addressed in the geriatric assessment was four (range, 2-9).…”

“…median age less than 68 years old, or more than one third of the patients younger than 65 years old); 22,27,41,43,46,48,50,58,59 these studies were assessed as not being fully representative of the target cohort of the average older patients with a hematologic malignancy. Similarly, eight studies focused on a very specific treatment 20,23,24,31,51,55,56,60 which we considered as not fully representative of our target population. Overall, the duration of follow-up was sufficient but in nine studies the followup rate was less than 90% 24,30,46 or the adequacy of followup was not reported.…”

“…Similarly, eight studies focused on a very specific treatment 20,23,24,31,51,55,56,60 which we considered as not fully representative of our target population. Overall, the duration of follow-up was sufficient but in nine studies the followup rate was less than 90% 24,30,46 or the adequacy of followup was not reported. 27,32,33,56,57,62 There were no other quality concerns.…”