Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study
Mené aux Etats-Unis sur 718 patients atteints d'un cancer de stade avancé et âgés de plus de 70 ans (âge moyen : 77,2 ans), cet essai randomisé analyse l'intérêt d'une évaluation gériatrique pour réduire la toxicité des traitements anticancéreux
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 olderpatients 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 assessmentdomain who were starting a new treatment regimen. 40 community oncology practice clustersacross the USA were randomly assigned (1:1) to the intervention (oncologists receiveda 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 theproportion of patients who had any grade 3–5 toxic effect (based on National CancerInstitute Common Terminology Criteria for Adverse Events version 4) over 3 months.Practice staff prospectively captured toxic effects. Masked oncology clinicians reviewedmedical 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 hada mean age of 77·2 years (SD 5·4) and 311 (43%) of 718 participants were female. Themean number of geriatric assessment domain impairments was 4·5 (SD 1·6) and was notsignificantly different between the study groups. More patients in intervention groupcompared with the usual care group were Black versus other races (40 [11%] of 349patients vs 12 [3%] of 369 patients; p<0·0001) and had previous chemotherapy (104 [30%] of 349patients vs 81 [22%] of 369 patients; p=0·016). A lower proportion of patients in the interventiongroup had grade 3–5 toxic effects (177 [51%] of 349 patients) compared with the usualcare 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 moremedications 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 reducedserious toxic effects from cancer treatment. Geriatric assessment with managementshould be integrated into the clinical care of older patients with advanced cancerand ageing-related conditions.
The Lancet , résumé, 2020