TY - JOUR
T1 - Integrated Geriatric Assessment and Treatment Effectiveness (INTEGERATE) in older people with cancer starting systemic anticancer treatment in Australia
T2 - a multicentre, open-label, randomised controlled trial
AU - Soo, Wee Kheng
AU - King, Madeleine T.
AU - Pope, Alun
AU - Parente, Phillip
AU - Dārziņš, Pēteris
AU - Davis, Ian D.
N1 - Funding Information:
This work was supported by grants APP10774676 and APP1102604 from the Australian National Health and Medical Research Council and grants from Monash University and Eastern Health. The authors thank the funders of this study, participants and their carers who participated in the study, all staff involved at the three participating hospitals, and Eastern Health Clinical School, Monash University. The authors acknowledge Rosemary Petrie and Belinda Rutledge for providing administrative support to this study.
Funding Information:
WKS reports grants from the National Health and Medical Research Council, Monash University, and Eastern Health, during the conduct of the study. WKS has received honoraria for advisory board membership and speakers’ fees from Janssen, outside of the submitted work. IDD reports grants from the National Health and Medical Research Council, during the conduct of the study. All other authors declare no competing interests.
Funding Information:
This work was supported by grants APP10774676 and APP1102604 from the Australian National Health and Medical Research Council and grants from Monash University and Eastern Health. The authors thank the funders of this study, participants and their carers who participated in the study, all staff involved at the three participating hospitals, and Eastern Health Clinical School, Monash University. The authors acknowledge Rosemary Petrie and Belinda Rutledge for providing administrative support to this study.
Publisher Copyright:
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license
PY - 2022/9
Y1 - 2022/9
N2 - Background: The effectiveness of comprehensive geriatric assessment (CGA) in improving health outcomes in cancer settings is unclear. We evaluated whether CGA can improve health-related quality of life (HRQOL) in older people with cancer who are starting systemic anticancer treatment. Methods: INTEGERATE is a multicentre, open-label, pragmatic, parallel-group, randomised controlled trial that was done at three hospitals in Australia. Participants aged 70 years and older with solid cancer or diffuse large B-cell lymphoma planned for chemotherapy, targeted therapy, or immunotherapy, were randomly assigned (1:1; using a central computer-generated minimisation algorithm with a random element, balancing treatment intent, cancer type, age, sex, and performance status) to receive CGA integrated into oncology care (integrated oncogeriatric care) or usual care only. Group assignment was not concealed from the participants and clinicians. The primary outcome was HRQOL over 24 weeks, assessed at baseline, week 12, week 18, and week 24, using the Elderly Functional Index (ELFI; score range 0–100). Analyses were by intention to treat. The trial is registered with ANZCTR.org.au, ACTRN12614000399695, and is completed. Findings: Between Aug 18, 2014, and Sept 5, 2018, 154 participants were randomly assigned to integrated oncogeriatric care (n=76) or usual care (n=78). 13 participants died by week 12 and 130 (92%) of the remaining 141 participants completed two or more ELFI assessments. Participants assigned to integrated oncogeriatric care reported better adjusted ELFI change scores over 24 weeks compared with those in the usual care group (overall main effect of group: t=2·1, df=213, p=0·039; effect size=0·38), with maximal between-group differences at week 18 (mean difference in change 9·8 [95% CI 2·4–17·2]; p=0·010, corrected p=0·030, effect size=0·48). The integrated oncogeriatric care group also had significantly fewer unplanned hospital admissions at 24 weeks (multivariable-adjusted incidence rate ratio 0·60 [95% CI 0·42–0·87]; p=0·0066). No statistically significant between-group difference was observed in overall survival. Interpretation: CGA led to better quality of life and health-care delivery in older people receiving systemic anticancer treatment. Routine CGA-based interventions should be considered in at-risk older people starting systemic anticancer treatment. Funding: National Health and Medical Research Council (Australia), Monash University, and Eastern Health.
AB - Background: The effectiveness of comprehensive geriatric assessment (CGA) in improving health outcomes in cancer settings is unclear. We evaluated whether CGA can improve health-related quality of life (HRQOL) in older people with cancer who are starting systemic anticancer treatment. Methods: INTEGERATE is a multicentre, open-label, pragmatic, parallel-group, randomised controlled trial that was done at three hospitals in Australia. Participants aged 70 years and older with solid cancer or diffuse large B-cell lymphoma planned for chemotherapy, targeted therapy, or immunotherapy, were randomly assigned (1:1; using a central computer-generated minimisation algorithm with a random element, balancing treatment intent, cancer type, age, sex, and performance status) to receive CGA integrated into oncology care (integrated oncogeriatric care) or usual care only. Group assignment was not concealed from the participants and clinicians. The primary outcome was HRQOL over 24 weeks, assessed at baseline, week 12, week 18, and week 24, using the Elderly Functional Index (ELFI; score range 0–100). Analyses were by intention to treat. The trial is registered with ANZCTR.org.au, ACTRN12614000399695, and is completed. Findings: Between Aug 18, 2014, and Sept 5, 2018, 154 participants were randomly assigned to integrated oncogeriatric care (n=76) or usual care (n=78). 13 participants died by week 12 and 130 (92%) of the remaining 141 participants completed two or more ELFI assessments. Participants assigned to integrated oncogeriatric care reported better adjusted ELFI change scores over 24 weeks compared with those in the usual care group (overall main effect of group: t=2·1, df=213, p=0·039; effect size=0·38), with maximal between-group differences at week 18 (mean difference in change 9·8 [95% CI 2·4–17·2]; p=0·010, corrected p=0·030, effect size=0·48). The integrated oncogeriatric care group also had significantly fewer unplanned hospital admissions at 24 weeks (multivariable-adjusted incidence rate ratio 0·60 [95% CI 0·42–0·87]; p=0·0066). No statistically significant between-group difference was observed in overall survival. Interpretation: CGA led to better quality of life and health-care delivery in older people receiving systemic anticancer treatment. Routine CGA-based interventions should be considered in at-risk older people starting systemic anticancer treatment. Funding: National Health and Medical Research Council (Australia), Monash University, and Eastern Health.
UR - http://www.scopus.com/inward/record.url?scp=85137295800&partnerID=8YFLogxK
U2 - 10.1016/S2666-7568(22)00169-6
DO - 10.1016/S2666-7568(22)00169-6
M3 - Article
C2 - 36102776
AN - SCOPUS:85137295800
SN - 2666-7568
VL - 3
SP - e617-e627
JO - The Lancet Healthy Longevity
JF - The Lancet Healthy Longevity
IS - 9
ER -
