Impact of Geriatric Assessment and Management on Quality of Life, Unplanned Hospitalizations, Toxicity, and Survival for Older Adults With Cancer: The Randomized 5C Trial

Abstract

PURPOSE American Society of Clinical Oncology recommends that older adults with cancer being considered for chemotherapy receive geriatric assessment (GA) and management (GAM), but few randomized controlled trials have examined its impact on quality of life (QOL). PATIENTS AND METHODS The 5C study was a two-group parallel 1:1 single-blind multicenter randomized controlled trial of GAM for 6 months versus usual oncologic care. Eligible patients were age 70+ years, diagnosed with a solid tumor, lymphoma, or myeloma, referred for first-/second-line chemotherapy or immunotherapy or targeted therapy, and had an Eastern Cooperative Oncology Group performance status of 0-2. The primary outcome QOL was measured with the global health scale of the European Organisation for the Research and Treatment of Cancer QOL questionnaire and analyzed with a pattern mixture model using an intent-to-treat approach (at 6 and 12 months). Secondary outcomes included functional status, grade 3-5 treatment toxicity; health care use; satisfaction; cancer treatment plan modification; and overall survival. RESULTS From March 2018 to March 2020, 350 participants were enrolled. Mean age was 76 years and 40.3% were female. Fifty-four percent started treatment with palliative intent. Eighty-one (23.1%) patients died. GAM did not improve QOL (global QOL of 4.4 points [95% CI, 0.9 to 8.0] favoring the control arm). There was also no difference in survival, change in treatment plan, unplanned hospitalization/emergency department visits, and treatment toxicity between groups. CONCLUSION GAM did not improve QOL. Most intervention group participants received GA on or after treatment initiation per patient request. Considering recent completed trials, GA may have benefit if completed before treatment selection. The COVID-19 pandemic may have affected our QOL outcome and intervention delivery for some participants.

Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update

“…A total of 15 publications met eligibility criteria and form the evidentiary basis for the guideline recommendation pertaining to Clinical Question 1. 3,4,[14][15][16][17][18][19][20][21][22][23][24] The identified publications include the respective primary reports of nine RCTs evaluating GAM 3,4,[14][15][16][17][18][19][20] ; four reports of secondary analyses of data from the primary RCTs [23][24][25][26] ; one systematic review of GA studies 22 ; and one systematic review of GA studies with meta-analysis. 21 The identified RCTs were published between 2020 and 2022.…”

“…The RCTs evaluated comparable GA with management interventions. For the clinical question concerning the role of GA in older adults with cancer to suggest specific interventions to improve clinical outcomes, the primary outcomes of the nine RCTs included completion of planned chemotherapy (n 5 2) 14,19 ; the proportion of patients with grade 3-5 toxicity (n 5 2) 3,4 ; quality of life (n 5 2) 16,17 ; overall survival (n 5 1) 20 ; a composite criterion of 6-month mortality, functional impairment (fall in the Activities of Daily Living [ADL] score ≥2), and weight loss (≥10%; n 5 1) 18 ; and patient satisfaction with communication about agingrelated concerns (n 5 1). 15 A total of 11 publications were identified by the systematic review and form the evidentiary basis for the Clinical Question 2 guideline recommendations concerning which GA tools should be used to predict outcomes, 5,6,12,[27][28][29][30][31][32][33][34] and help inform the development of the PGA.…”

“…There were also no differences between the groups observed in daily life activities, 90 days physical performance, or hospital admissions (55% of controls v 47% of intervention group patients; risk rate, 0.86 [95% CI, 0.69 to 1.07]; P 5 .19). In 96% (68/71) of cases, patients in the intervention group received the GA after treatment initiation (median time to CGA was 14.5 days [IQR,[6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] after the start of treatment). Participants in the usual care group did not receive the study-specific GA but could be referred to a geriatrician by their clinician.…”

“…Patients in the intervention group received the GA at or around the immunotherapy). The integrated oncogeriatric care intervention consisted of GA (review of medications, comorbidities; physical, cognitive, psychological, and social functioning, falls, frailty, nutrition, sensory impairment, advanced care planning, chemotherapy toxicity risk, and immunization status) followed by geriatrician consultation and implementation of GA-guided interventions.In the two-group parallel (1:1) single-blind, multicenter (eight involved hospitals), 5C phase III RCT, Puts et al17 investigated the effectiveness of GA and management (GAM; n 5 173) at 6 and 12 months versus usual oncologic care (n 5 177) on quality of life (QOL) in older (≥70 years) patients diagnosed with solid tumor, lymphoma, or myeloma, and referred for firstor second-line palliative or adjuvant, curative (>54% of patients) chemotherapy, targeted therapy, or immunotherapy. The GAM intervention consisted of completion of a GA (functional status, cognition, mood, medications, mobility and falls, nutritional status, social support, and comorbidity) at baseline on or after treatment initiation for most patients; followed by GA-guided, evidence-based management interventions; and at least monthly follow-up calls from the intervention team registered nurse.…”

Cell cycle arrest: A breakthrough in the supportive care of older cancer patients

“…8 Frail individuals are at high risk for chemotherapy complications, whose incidence increases with the prevalence and severity of functional dependence, evaluated with a geriatric assessment. [9][10][11][12][13][14][15]32,33 With the current reactive approach to chemotherapy toxicity, frail patients may experience severe disabling complications and sometimes death, even when antidotes are utilized. Let us look at the example of neutropenia: if the concentration of myeloid precursors in the bone marrow is critically reduced the growth factor will not have the material necessary to build new neutrophils and protect from neutropenia.…”