Supriya G Mohile1, Mostafa R Mohamed2, Huiwen Xu3, Eva Culakova3, Kah Poh Loh2, Allison Magnuson2, Marie A Flannery3, Spencer Obrecht2, Nikesha Gilmore3, Erika Ramsdale2, Richard F Dunne2, Tanya Wildes2, Sandy Plumb2, Amita Patil2, Megan Wells2, Lisa Lowenstein4, Michelle Janelsins3, Karen Mustian3, Judith O Hopkins5, Jeffrey Berenberg6, Navin Anthony5, William Dale7. 1. Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA; Department of Surgery, University of Rochester Cancer Center National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base, Rochester, NY, USA. Electronic address: supriya_mohile@urmc.rochester.edu. 2. Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA. 3. Department of Surgery, University of Rochester Cancer Center National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base, Rochester, NY, USA. 4. Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. 5. Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, NC, USA. 6. Hawaii Minority Underserved NCORP, Honolulu, HI, USA. 7. Department of Supportive Care, City of Hope National Medical Center, Duarte, CA, USA.
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. FUNDING: National Cancer Institute.
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. FUNDING: National Cancer Institute.
Authors: Lisa M Lowenstein; Robert J Volk; Richard Street; Marie Flannery; Allison Magnuson; Ronald Epstein; Supriya G Mohile Journal: J Geriatr Oncol Date: 2018-06-06 Impact factor: 3.599
Authors: Supriya G Mohile; William Dale; Mark R Somerfield; Mara A Schonberg; Cynthia M Boyd; Peggy S Burhenn; Beverly Canin; Harvey Jay Cohen; Holly M Holmes; Judith O Hopkins; Michelle C Janelsins; Alok A Khorana; Heidi D Klepin; Stuart M Lichtman; Karen M Mustian; William P Tew; Arti Hurria Journal: J Clin Oncol Date: 2018-05-21 Impact factor: 44.544
Authors: David C Grossman; Susan J Curry; Douglas K Owens; Michael J Barry; Aaron B Caughey; Karina W Davidson; Chyke A Doubeni; John W Epling; Alex R Kemper; Alex H Krist; Martha Kubik; Seth Landefeld; Carol M Mangione; Michael Pignone; Michael Silverstein; Melissa A Simon; Chien-Wen Tseng Journal: JAMA Date: 2018-04-24 Impact factor: 56.272
Authors: T Kalsi; G Babic-Illman; P J Ross; N R Maisey; S Hughes; P Fields; F C Martin; Y Wang; D Harari Journal: Br J Cancer Date: 2015-04-14 Impact factor: 7.640
Authors: Supriya G Mohile; Ronald M Epstein; Arti Hurria; Charles E Heckler; Beverly Canin; Eva Culakova; Paul Duberstein; Nikesha Gilmore; Huiwen Xu; Sandy Plumb; Megan Wells; Lisa M Lowenstein; Marie A Flannery; Michelle Janelsins; Allison Magnuson; Kah Poh Loh; Amber S Kleckner; Karen M Mustian; Judith O Hopkins; Jane Jijun Liu; Jodi Geer; Rita Gorawara-Bhat; Gary R Morrow; William Dale Journal: JAMA Oncol Date: 2020-02-01 Impact factor: 31.777
Authors: Courtney P Williams; Amy Davidoff; Michael T Halpern; Michelle Mollica; Kathleen Castro; Benjamin Allaire; Janet S de Moor Journal: JCO Oncol Pract Date: 2022-08
Authors: Maria T Bourlon; Haydee Verduzco-Aguirre; Elizabeth Molina; Elisabeth Meyer; Elizabeth Kessler; Simon P Kim; Philippe E Spiess; Thomas Flaig Journal: Front Oncol Date: 2022-06-29 Impact factor: 5.738