In a U.S. cluster-randomized trial (GAP70+) reported in The Lancet, Supriya G. Mohile, MD, and colleagues found that geriatric assessment and management recommendations reduced the incidence of grade ≥ 3 toxicity vs usual care among patients aged ≥ 70 years with incurable advanced cancers who were beginning a new systemic treatment regimen.
Study Details
The study enrolled patients with incurable solid tumors or lymphoma—as well as at least one impaired geriatric assessment domain—who were starting a new systemic therapy regimen with a high risk of toxic effects within 4 weeks. A total of 40 community oncology practice clusters across the United States were randomly assigned between July 2014 and March 2019 to the geriatric assessment intervention, in which oncologists received a tailored geriatric assessment summary and management recommendations, or usual care, with no geriatric assessment summary or management recommendations being provided to oncologists.
The study included 718 eligible patients treated by 156 oncologists, with 349 patients in the intervention group and 369 in the usual-care group. The primary outcome measure was proportion of patients with any grade ≥ 3 toxicity over 3 months. Practice staff prospectively recorded toxic effects, with verification provided by masked oncology clinician review of medical records.
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 aging-related conditions.— Supriya G. Mohile, MD, and colleagues
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Key Findings
Patients had a mean age of 77.2 years, 43% were female, and the mean number of geriatric assessment domain impairments was 4.5, with no difference between groups. More patients in intervention group were Black (11% vs 3%, P < .0001) and had received previous treatment with chemotherapy (30% vs 22%, P = .016).
A greater number of medications were discontinued in patients in the intervention group prior to starting the new treatment regimen (mean difference = 0.14 medications, 95% confidence interval [CI] = 0.03–0.25, P = .015).
Grade ≥ 3 toxicity over 3 months occurred in 51% of those in the intervention group vs 71% of the usual-care group (adjusted relative risk [RR] = 0.74, 95% confidence interval [CI] = 0.64–0.86, P = .0001).
The intervention group had a significant reduction in the incidence of nonhematologic grade ≥ 3 adverse events (32% vs 52%, adjusted RR = 0.72, 95% CI = 0.52–0.99, P = .045) and a numeric reduction in hematologic grade ≥ 3 toxicity that did not achieve significance (37% vs 44%, adjusted RR = 0.85, 95% CI = 0.70–1.04, P = .11).
Patients in the intervention group had fewer new falls over 3 months (12% of 298 patients vs 21% of 329 patients, adjusted RR = 0.58, 95% CI = 0.40–0.84, P = .0035).
Overall survival at 6 months was 72% in the intervention group vs 75% in the usual-care group (adjusted hazard ratio [HR] = 1.13, 95% CI = 0.85–1.50, P = .39). No difference in 1-year survival was observed (adjusted HR = 1.05, 95% CI = 0.85–1.29, P = .68).
The investigators concluded, “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 aging-related conditions.”
Dr. Mohile, of the Department of Medicine, University of Rochester Medical Center, is the corresponding author for The Lancet article.
Disclosure: The study was funded by the National Cancer Institute. For full disclosures of the study authors, visit thelancet.com.
