@article{c1f6946fdb6d40bd8e26a9285870228b,
title = "Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study",
abstract = "Background: Older adults with advanced cancer are at a high risk for treatment toxic effects. Geriatric assessment evaluates ageing-related domains and guides management. We examined whether a geriatric assessment intervention can reduce serious toxic effects in older patients with advanced cancer who are receiving high risk treatment (eg, chemotherapy). Methods: In this cluster-randomised trial, we enrolled patients aged 70 years and older with incurable solid tumours or lymphoma and at least one impaired geriatric assessment domain who were starting a new treatment regimen. 40 community oncology practice clusters across the USA were randomly assigned (1:1) to the intervention (oncologists received a tailored geriatric assessment summary and management recommendations) or usual care (no geriatric assessment summary or management recommendations were provided to oncologists) by means of a computer-generated randomisation table. The primary outcome was the proportion of patients who had any grade 3–5 toxic effect (based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4) over 3 months. Practice staff prospectively captured toxic effects. Masked oncology clinicians reviewed medical records to verify. The study was registered with ClinicalTrials.gov, NCT02054741. Findings: Between July 29, 2014, and March 13, 2019, we enrolled 718 patients. Patients had a mean age of 77·2 years (SD 5·4) and 311 (43%) of 718 participants were female. The mean number of geriatric assessment domain impairments was 4·5 (SD 1·6) and was not significantly different between the study groups. More patients in intervention group compared with the usual care group were Black versus other races (40 [11%] of 349 patients vs 12 [3%] of 369 patients; p<0·0001) and had previous chemotherapy (104 [30%] of 349 patients vs 81 [22%] of 369 patients; p=0·016). A lower proportion of patients in the intervention group had grade 3–5 toxic effects (177 [51%] of 349 patients) compared with the usual care group (263 [71%] of 369 patients; relative risk [RR] 0·74 (95% CI 0·64–0·86; p=0·0001). Patients in the intervention group had fewer falls over 3 months (35 [12%] of 298 patients vs 68 [21%] of 329 patients; adjusted RR 0·58, 95% CI 0·40–0·84; p=0·0035) and had more medications discontinued (mean adjusted difference 0·14, 95% CI 0·03–0·25; p=0·015). Interpretation: A geriatric assessment intervention for older patients with advanced cancer reduced serious toxic effects from cancer treatment. Geriatric assessment with management should be integrated into the clinical care of older patients with advanced cancer and ageing-related conditions.",
author = "Mohile, {Supriya G.} and Mohamed, {Mostafa R.} and Huiwen Xu and Eva Culakova and Loh, {Kah Poh} and Allison Magnuson and Flannery, {Marie A.} and Spencer Obrecht and Nikesha Gilmore and Erika Ramsdale and Dunne, {Richard F.} and Tanya Wildes and Sandy Plumb and Amita Patil and Megan Wells and Lisa Lowenstein and Michelle Janelsins and Karen Mustian and Hopkins, {Judith O.} and Jeffrey Berenberg and Navin Anthony and William Dale",
note = "Funding Information: This study received funding from the National Cancer Institute (R01CA177592, U01CA233167 SGM, and UG1CA189961 to KM), the National Institute on Aging (K24AG056589 to SGM, K76AG064394 to AM, and R33AG059206 to WD and SGM), and KL2TR001999 from the National Center for Advancing Translational Sciences (to RFD). KPL is supported by the National Cancer Institute (K99CA237744) and Wilmot Cancer Institute Research Fellowship Award. We would like to thank Susan Rosenthal for editing and Charles Heckler, Joseph J Guido, and Javier Bautista for their help with data analysis and management. We would like to thank the geriatric oncology research staff, the University of Rochester NCI Community Oncology Research Base staff, and the Cancer and Aging Research Group. We would also like to thank the patients, community oncologists, and staff who participated in the study. We would like to dedicate this manuscript to the memory of Arti Hurria, who guided substantial progress in the field of geriatric oncology before she unexpectedly passed away in November, 2018. Funding Information: This study received funding from the National Cancer Institute (R01CA177592, U01CA233167 SGM, and UG1CA189961 to KM), the National Institute on Aging (K24AG056589 to SGM, K76AG064394 to AM, and R33AG059206 to WD and SGM), and KL2TR001999 from the National Center for Advancing Translational Sciences (to RFD). KPL is supported by the National Cancer Institute (K99CA237744) and Wilmot Cancer Institute Research Fellowship Award. We would like to thank Susan Rosenthal for editing and Charles Heckler, Joseph J Guido, and Javier Bautista for their help with data analysis and management. We would like to thank the geriatric oncology research staff, the University of Rochester NCI Community Oncology Research Base staff, and the Cancer and Aging Research Group. We would also like to thank the patients, community oncologists, and staff who participated in the study. We would like to dedicate this manuscript to the memory of Arti Hurria, who guided substantial progress in the field of geriatric oncology before she unexpectedly passed away in November, 2018. Funding Information: KPL reports consultant fees from Pfizer and Seattle Genetics and honoraria from Pfizer. RFD received honoraria for consulting from Exelixis. TW reports research funding from Janssen and consultant fees from Seattle Genetics and Carevive. All other authors declare no competing interests. Publisher Copyright: {\textcopyright} 2021 Elsevier Ltd",
year = "2021",
month = nov,
day = "20",
doi = "10.1016/S0140-6736(21)01789-X",
language = "English (US)",
volume = "398",
pages = "1894--1904",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "10314",
}