Nikki Burdett1, Andrew D Vincent2, Michael O'Callaghan1,3,4,5, Ganessan Kichenadasse1,5,6. 1. Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Bedford Park, South Australia. 2. University of Adelaide, Adelaide, South Australia. 3. Flinders Centre for Innovation in Cancer and Urology Unit, Flinders Medical Centre, Bedford Park, South Australia. 4. Freemasons Foundation Centre for Men's Health, University of Adelaide, Adelaide, South Australia. 5. South Australian Prostate Cancer Clinical Outcomes Collaborative, Adelaide, South Australia. 6. Flinders University, Bedford Park, South Australia.
Abstract
Background: It is increasingly recognized that older adults with cancer represent a diverse cohort of patients and that other comorbidities may have an equal impact on survival and quality of life as any diagnosis of malignancy. Competing risk has consequently emerged as an important concept in the design and reporting of geriatric oncology trials. Methods: We performed a systematic review of phase II and III oncology trials for systemic therapy in older patients with solid organ malignancy from the year 2000 until April 30, 2017. Forty-one trials including 7864 patients were identified for evaluation. Results: Only 15 trials (36.6%) employed disease-related end points to account for death from other causes, and only one study used statistical analysis that addressed competing risk. Seventeen studies (41.5%) of trials included some assessment of comorbidity or frailty. Twenty-one trials (51.2%) included any assessment of quality of life. Conclusions: This review demonstrates clear areas for improvement for future studies and highlights the need for careful consideration of trial design, data collection, and appropriate statistical methodology for reporting of competing risks in geriatric oncology trials.
Background: It is increasingly recognized that older adults with cancer represent a diverse cohort of patients and that other comorbidities may have an equal impact on survival and quality of life as any diagnosis of malignancy. Competing risk has consequently emerged as an important concept in the design and reporting of geriatric oncology trials. Methods: We performed a systematic review of phase II and III oncology trials for systemic therapy in older patients with solid organ malignancy from the year 2000 until April 30, 2017. Forty-one trials including 7864 patients were identified for evaluation. Results: Only 15 trials (36.6%) employed disease-related end points to account for death from other causes, and only one study used statistical analysis that addressed competing risk. Seventeen studies (41.5%) of trials included some assessment of comorbidity or frailty. Twenty-one trials (51.2%) included any assessment of quality of life. Conclusions: This review demonstrates clear areas for improvement for future studies and highlights the need for careful consideration of trial design, data collection, and appropriate statistical methodology for reporting of competing risks in geriatric oncology trials.
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